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Archive for the ‘Stem Cell kidney Failure’ Category

Mini kidneys bioprinted in the lab – Lab + Life Scientist

Friday, December 4th, 2020

Researchers from the Murdoch Childrens Research Institute (MCRI) and biotech company Organovo have used cutting-edge technology to bioprint miniature human kidneys in the lab, paving the way for new treatments for kidney failure and possibly lab-grown transplants. Their study has been published in the journal Nature Materials.

Like squeezing toothpaste out of a tube, extrusion-based 3D bioprinting uses a bioink made from a stem cell paste, squeezed out through a computer-guided pipette to create artificial living tissue in a dish. According to MCRI Professor Melissa Little, a world leader in modelling the human kidney, this new bioprinting method is faster and more reliable than previous methods, allowing the whole process to be scaled up. 3D bioprinting could now create about 200 mini kidneys in 10 minutes without compromising quality.

From larger than a grain of rice to the size of a fingernail, bioprinted mini kidneys fully resemble a regular-sized kidney, including the tiny tubes and blood vessels that form the organs filtering structures called nephrons. Prof Little said the mini organs will be used to screen drugs to find new treatments for kidney disease or to test if a new drug was likely to injure the kidney.

Drug-induced injury to the kidney is a major side effect and difficult to predict using animal studies; bioprinting human kidneys are a practical approach to testing for toxicity before use, she said.

In the study, researchers tested the toxicity of aminoglycosides a class of antibiotics that commonly damage the kidney. Prof Little said, We found increased death of particular types of cells in the kidneys treated with aminoglycosides.

By generating stem cells from a patient with a genetic kidney disease, and then growing mini kidneys from them, also paves the way for tailoring treatment plans specific to each patient, which could be extended to a range of kidney diseases.

Prof Little said the study also showed that 3D bioprinting of stem cells can produce large enough sheets of kidney tissue needed for transplants. She noted, 3D bioprinting can generate larger amounts of kidney tissue but with precise manipulation of biophysical properties, including cell number and conformation, improving the outcome.

Prof Little said prior to this study the possibility of using mini kidneys to generate transplantable tissue was too far away to contemplate, but that may no longer be the case.

The pathway to renal replacement therapy using stem cell-derived kidney tissue will need a massive increase in the number of nephron structures present in the tissue to be transplanted, she said.

By using extrusion bioprinting, we improved the final nephron count, which will ultimately determine whether we can transplant these tissues into people.

Image credit: stock.adobe.com/au/bluebay2014

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Telix Pharmaceuticals Limited Acquires TheraPharm GmbH, Broadening Reach to Hematologic Cancers and Transplant Medicine – BioSpace

Friday, December 4th, 2020

MELBOURNE, Australia and BAAR, Switzerland, Nov. 29, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces it has entered into an agreement with Scintec Diagnostics GmbH (Scintec) to acquire TheraPharm GmbH (TheraPharm), a Swiss-German biotechnology company developing innovative diagnostic and therapeutic solutions in the field of hematology.

The acquisition of TheraPharm provides Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in relation to the use of Molecularly Targeted Radiation (MTR) in hematology and immunology. TheraPharm is developing antibody MTR technology against CD66, a cell surface target highly expressed by neutrophils (a type of white blood cell) and tumor-infiltrating lymphocytes. As such, the technology has potentially very broad applications in the diagnosis and treatment of hematologic diseases (e.g. blood cancers), lymphoproliferative disorders and immune-mediated diseases (e.g. lupus, and multiple sclerosis). Of particular interest is the demonstrated use of the technology to safely and effectively perform bone marrow conditioning (BMC) prior to bone marrow stem cell transplant.

Telix CEO, Dr. Christian Behrenbruch stated, Telix is committed to extending and improving the lives of patients with serious diseases. As such, the acquisition of TheraPharm and its MTR assets are uniquely aligned to Telixs mission and technical strengths in antibody engineering and radiochemistry. TheraPharms technology has a significant role to play in BMC and stem cell transplantation across a broad range of blood cancers and rare diseases. The current approach to BMC employs highly toxic drugs that have a poor morbidity and mortality profile, and for which many patients are ineligible. MTR offers an excellent safety profile that may greatly expand the number of patients able to undergo life prolonging stem cell transplantation while greatly reducing the hospitalisation burden and cost associated with such procedures.

TheraPharm co-founder and Managing Director, Dr. Klaus Bosslet added, Over the past 5 years, TheraPharm, in collaboration with Dr. Kim Orchard from the University of Southampton (UK), has made excellent progress developing 90Y-besilesomab for the treatment of hematologic cancers and several related conditions including multiple myeloma, leukemia and amyloidosis. This unique asset is a logical addition to Telixs portfolio, offering a potentially rapid development path to a first commercial indication for the treatment of patients with SALA, while at the same time having potentially broad applications for stem cell transplantation in patients with more common cancers of the blood, including multiple myeloma and leukemia. We look forward to joining the Telix team in order to expedite the development of products for this under-served field.

Full transaction details, including financial terms, can be found via the Telix website and ASX portal here.

About Hematopoietic Stem Cell Transplant (HSCT)

Bone marrow conditioning (BMC) followed by hematopoietic stem cell transplantation (HSCT) is presently performed to treat patients with hematologic malignancies (blood cancers), with the objective of extending patient survival or achieving cure. HSCT is also performed for a broad range of non-cancer conditions. HSCT is preferentially performed in countries of high income (Europe >30,000, Americas >20,000, worldwide >65,000 p.a., respectively) and is growing at around 5% annually.

About Systemic Amyloid Light-Chain Amyloidosis (SALA)

SALA is a rare, but serious protein deposition disease, caused by a protein known as amyloid that is produced by abnormal plasma cells residing in the bone marrow. As amyloid accumulates in the organs of the body, organ function will eventually deteriorate, ultimately causing organ failure. SALA has an estimated prevalence of 30,000 and 45,000 in United States and Europe, respectively and while a rare disease, SALA portends a very poor prognosis, with a median survival from diagnosis of ~11 months if untreated.

The current standard of care comprises of induction therapy (typically cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC, followed by HSCT. This approach is typically only accessible to a small proportion of patients (<20%) who are able to tolerate induction therapy and melphalan BMC.

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit http://www.telixpharma.com.

AboutTheraPharm GmbH

TheraPharm is a biotechnology company specialised in the research, development and manufacturing of monoclonal antibodies for targeted radiation of hematopoietic malignant and non-malignant diseases, lymphoproliferative diseases, conditioning for allogeneic stem cells as well as in diagnostics of inflammatory diseases and bone marrow metastases.

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News briefing: Four biotechs announce IPO terms, setting the pace to round out a busy year; FDA sets PDUFA date for Kadmon’s graft-versus-host drug -…

Friday, December 4th, 2020

Four more biotechs set the terms for their IPOs, lining up yet another busy week on Wall Street.

Silverback Therapeutics, which initially filed for a $100 million raise, is now shooting for $125 million from 7 million shares at a range of $17 to $19. About $70 million is tagged for the companys lead Phase I/Ib antibody-drug conjugate, SBT6050, for advanced or metastatic HER2-expressing solid tumors. Interim data from the Phase I dose-escalation cohorts are expected in the second half of 2021. Another $55 million is set aside for Silverbacks two other candidates, which have yet to reach the clinic.

Kinnate Biopharma is looking for a $170 million raise, and set a $16 to $18 range for its 10 million share offering. About $105 is earmarked for its RAF inhibitors, including its lead preclinical candidate KIN002787 for patients with lung cancer, melanoma and other solid tumors. An IND is coming in the first half of 2021, the company says. Back in August, it hooked a $98 million Series C.

Seer also set its shares at a $16 to $18 range. The company, which is working on next-gen proteome analysis tests, is offering 8.8 million shares, going for a $150 raise. About $65.0 million would go to its Proteograph Product Suite, which already has one collaborator and could have a second by the end of the year.

Sigilon Therapeutics is seeking $101 million from 5.6 million shares at a $17 to $19 range. Between $30 to $35 million will be set aside for its lead candidate, SIG-001, which is in a Phase I/II trial to prevent bleeding episodes in patients with hemophilia A. Another $30 to $35 million would fund a scale-up of the companys GMP manufacturing processes SIG-001 and SIG-005, its preclinical candidate for patients with mucopolysaccharidosis type 1, or MPS-1.

More than 72 biotech and biopharma companies and counting have hit Nasdaq so far this year, and head of healthcare listings Jordan Saxe predicted rounding out the year with just under $14 billion in proceeds.

Kadmons chronic graft-versus-host drug belumosudil is in the FDAs hands.

The agency accepted the biotechs NDA under its real-time oncology review (RTOR) pilot program, and set the PDUFA date for May 30, 2021. The submission was based on positive results from a pivotal, open-label trial dubbed ROCKstar, which enrolled 132 patients who had received at least two prior lines of therapy.

Belumosudil is designed to tamp down the inflammatory response seen after hematopoietic stem cell transplant by blocking Rho-associated coiled-coil kinase 2 (ROCK2). Instead of a comparator arm, Kadmon set the bar at a 30% overall response rate, based on conversations with the FDA. Patients were given 200 mg of the drug either once or twice daily. At six months after the completion of enrollment, Kadmon saw an ORR of 73% and 75% in the respective arms.

Thats it for data, until the full report is read out at ASH in December. The companys stock $KDMN was up 6.68% on Monday, at $4.39 per share.Kadmon was founded by Sam Waksal, the biotech exec who was sentenced to prison for his insider trading conviction involving Martha Stewart.

Hookipa Pharma said no one from a small group of Phase II participants treated with its prophylactic cytomegalovirus vaccine came down with the disease, according to interim results.

The analysis was based on 41 participants 8 of whom received 3 doses, 19 of whom received 2 doses, and 14 of whom received a placebo. Compared to the placebo, researchers saw a 48% reduction in CMV viremia, and a 42% reduction in the use of antiviral therapy. There were no cases of CMV disease in the treatment arm, compared to 2 in the placebo group.

While these interim data are from a small group of patients, they offer early insight into the potential of a three-dose schedule of HB-101 to help protect kidney transplant recipients against CMV disease, CEO Joern Aldag said in a statement.

The candidate is going head-to-head with Modernas mRNA-1647, which produced positive results from a proof-of-concept study back in January. Researchers said they saw an increasing level of neutralizing antibody titers in those who had received a third vaccination.

This could really be a company builder, CEO Stphane Bancel said at the time, adding that the candidate could turn into a $2 billion to $5 billion annual franchise.

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Government of Canada and JDRF Canada announce new research funding to accelerate stem cell-based therapies for type 1 diabetes – Philippine Canadian…

Friday, December 4th, 2020

There are more than 300,000 Canadians living with type 1 diabetes (T1D), an autoimmune disease with no known cause or cure, resulting in the dysfunction, damage or loss of pancreatic beta cells that produce insulin in our bodies. People with T1D must treat themselves with insulin several times per day to keep their blood glucose levels normal, and despite their best efforts, they often experience serious, and even life-threatening, complications.

To mark the end of Diabetes Awareness Month, Sonia Sidhu, Member of Parliament for Brampton South, on behalf of the Honourable Patty Hajdu, Minister of Health, announced an investment of $6 million through the CIHR-JDRF Partnership to Defeat Diabetes for two Canadian research teams to accelerate the development of stem cell-based therapies for the treatment of T1D.

Stem cells show great promise as a source of insulin-producing cells that could be transplanted to provide a new source of insulin, to replace dysfunctional, damagedor lost pancreatic beta cells. Canada has a remarkable legacy in leading discoveries in this area. Stem cells were discovered in Toronto in 1961, and in 2000, a team in Edmonton were the first to pioneer transplantation of pancreatic islets (the part of the pancreas that contains insulin-producing cells). These achievements represent important steps toward a treatment that will allow people with T1D to live healthy lives without daily insulin injections.

The research teams are led by Dr. Maria Cristina Nostro at the University Health Network and the University of Toronto and Dr. Francis Lynn at the BC Childrens Hospital Research Institute and the University of British Columbia. The teams will build on Canadas demonstrated research excellence and leadership in clinical islet transplantation, stem cell biology, diabetes, immunology and genetic engineering to accelerate stem cell-based therapies for T1D. They will work in collaboration with other Canadian researchers to tackle some of the biggest scientific challenges that impede our progress in this area and move us closer to a future where people with T1D will no longer rely on insulin therapy.

This funding was provided by the Canadian Institutes of Health Research Institute of Nutrition, Metabolism and Diabetes (CIHR-INMD), and JDRF Canada, through the CIHR-JDRF Partnership to Defeat Diabetes established in 2017. Each partner will invest $3 million over five years. This investment is part of a large research initiative,100 Years of Insulin: Accelerating Canadian Discoveries to Defeat Diabetes, funded by CIHR and partners. This initiative commemorates the 100th anniversary of the discovery of insulin to be marked in 2021a discovery that changed the lives of millions of Canadians and people around the world and won researchers Sir Frederick Banting and John Macleod the Nobel Prize in Physiology or Medicine.

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Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic…

Wednesday, November 11th, 2020

Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA (pembrolizumab) in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic Non-Small Cell Lung Cancer To Stop for Futility and Patients to Discontinue Ipilimumab

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that it will be stopping KEYNOTE-598, a Phase 3 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with ipilimumab (Yervoy ), compared with KEYTRUDA monotherapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] 50%) with no EGFR or ALK genomic tumor aberrations. Merck is discontinuing the study following the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of the combination did not support continuing the trial. At an interim analysis, the combination of KEYTRUDA and ipilimumab showed no incremental benefit in overall survival (OS) or progression-free survival (PFS), the studys dual primary endpoints, compared with KEYTRUDA alone and crossed futility boundaries. No new safety signals for KEYTRUDA monotherapy were observed, however the combination of KEYTRUDA and ipilimumab was associated with a higher incidence of grade 3-5 adverse events (AEs), serious AEs, and AEs leading to discontinuation or death, compared with KEYTRUDA monotherapy. Merck will inform study investigators of the recommendation from the DMC and the DMC is advising that patients in the study discontinue treatment with ipilimumab/placebo. Data from this study will be submitted for presentation at an upcoming scientific congress and communicated to regulatory agencies.

We conducted KEYNOTE-598 in order to explicitly explore whether combining our anti-PD-1 therapy, KEYTRUDA, with ipilimumab provided additional benefits beyond treatment with KEYTRUDA alone in the metastatic non-small cell lung cancer setting, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. KEYTRUDA monotherapy remains a standard of care for the treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1.

While the combination of an anti-PD-1 therapy plus ipilimumab has been approved in certain indications, studies supporting these approvals have, for the most part, not compared the combination directly with anti-PD-1 monotherapy. Bristol Myers Squibb has reported topline results of CheckMate-915, a Phase 3 study in adjuvant melanoma that directly compared treatment with ipilimumab in combination with an anti-PD-1 therapy versus the anti-PD-1 therapy alone. In two separate news releases issued over the last year, the company announced the study did not meet its co-primary endpoints in the all-comer population or in patients whose tumors expressed PD-L1

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies with KEYTRUDA in combination with other treatments and as monotherapy. The lung program is evaluating KEYTRUDA across all stages of disease and lines of therapy in over 200 trials with more than 10,000 patients.

About KEYNOTE-598

KEYNOTE-598 (ClinicalTrials.gov, NCT03302234 ) is a randomized, double-blind, Phase 3 trial investigating KEYTRUDA in combination with ipilimumab compared to KEYTRUDA monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumors express PDL1 (TPS 50%) with no EGFR or ALK genomic tumor aberrations. The dual primary endpoints are OS and PFS. Secondary endpoints include objective response rate, duration of response and safety. The study enrolled 568 patients who were randomized (1:1) to receive:

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10% to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients. Pneumonitis occurred in 8% (31/389) of patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and post-marketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risk of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients; those 1% included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression. The most common adverse reactions (20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, and cough (20% each).

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Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic...

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KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall…

Wednesday, November 11th, 2020

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK):

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

LENVIMA Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib

Results of Investigational Phase 3 KEYNOTE-581/CLEAR Trial (Study 307) to be Presented at Upcoming Medical Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 KEYNOTE-581/CLEAR trial (Study 307). In the trial, the combinations of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYTRUDA plus LENVIMA met the trials primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population. LENVIMA plus everolimus also met the trials primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. The ITT population included patients across all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor). The safety profiles of both KEYTRUDA plus LENVIMA and LENVIMA plus everolimus were consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.

The results for KEYTRUDA plus LENVIMA versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival and objective response rate, build on the growing scientific evidence that supports the investigation of KEYTRUDA-based combinations for the first-line treatment of advanced renal cell carcinoma, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.

The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy, said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. These findings energize our efforts as we continue to advance our understanding and address the unmet needs of patients with difficult-to-treat cancers.

Merck and Eisai are continuing to study the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).

About KEYNOTE-581/CLEAR (Study 307)

KEYNOTE-581/CLEAR (Study 307) is a multi-center, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT02811861) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC. The primary endpoint is PFS by independent review per RECIST v1.1 criteria. Key secondary endpoints include OS, ORR and safety. The study enrolled approximately 1,050 patients who were randomized to one of three treatment arms to receive:

About Renal Cell Carcinoma (RCC)

Worldwide, it is estimated there were more than 403,000 new cases of kidney cancer diagnosed and more than 175,000 deaths from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCCs. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

Read the original here:
KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall...

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Gilead and Kite to Share Latest Scientific Advances in Hematologic Malignancies at ASH 2020 – Investing News Network

Wednesday, November 11th, 2020

16 Abstracts, Including Three Oral Presentations, Highlight Breadth of Companys Innovation in Immuno-Oncology for Patients with Blood Cancers

Kite Data Highlight Yescarta Long-Term Efficacy in Relapsed/Refractory Large B-Cell Lymphoma, its Potential as An Earlier Line of Therapy in DLBCL, as well as Results in Other Cancers, and One-Year Follow-up Results for Tecartus in Relapsed Mantle Cell Lymphoma

Magrolimab Demonstrates Continued Response Rates in Updated Results of Phase 1b Study of Acute Myeloid Leukemia Patients, Including Those with TP53 Mutation

Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced that 16 abstracts, including three oral presentations from the companies combined immuno-oncology research and development programs, have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting, which is being held virtually on December 5-8, 2020, will feature presentations on Yescarta (axicabtagene ciloleucel), Tecartus (brexucabtagene autoleucel, KTE-X19) and other ongoing research from Kites chimeric antigen receptor (CAR) T cell therapy development program, as well as magrolimab, Gileads first-in-class, investigational anti-CD47 monoclonal antibody.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201105005130/en/

The evidence supporting our innovation in hematologic malignancies continues to grow, providing assurance of the lasting and positive impact our diverse oncology pipeline could achieve over time, said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. We continue to see broad potential across our oncology portfolio anchored by Kite in cell therapy and Gileads anti-CD47 monoclonal antibody to transform care for patients with hard-to-treat blood cancers.

New Long-Term Efficacy Data and the Potential of CAR T Therapy for More Patients

Building on three-year data presented at ASH 2019, overall survival results at four years from the pivotal ZUMA-1 trial of Yescarta in patients with refractory large B-cell lymphoma will be presented (Abstract #1187). Additionally, new data include one-year follow-up results from the ZUMA-2 study evaluating KTE-X19 in relapsed or refractory mantle cell lymphoma (Abstract #1120), as well as several studies evaluating the potential of Yescarta in new indications include an interim analysis of ZUMA-12 in first-line large B-cell lymphoma among patients with high-risk features (Abstract #405) and the ZUMA-5 primary analysis in relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL; Abstract #700).

Data from the ZUMA-5 primary analysis form the basis for the supplemental Biologics License Application (sBLA) for Yescarta currently under review by the U.S. Food & Drug Administration (FDA). Yescarta has previously been granted a Breakthrough Therapy Designation by the FDA for relapsed or refractory FL or MZL after at least two prior therapies and has been granted a Priority Review with a target action date, under the Prescription Drug User Fee Act (PDUFA), of March 5, 2021.

Our data at ASH build on the established strengths of our CAR T franchise, including practice-changing potential in new cancers, said Ken Takeshita, MD, Kites Global Head of Clinical Development. As we become the first company to present four-year CAR T data from a pivotal study in large B-cell lymphoma and continue to expand our leadership in cell therapy across different hematologic malignancies and into earlier lines of therapy, we remain committed to bringing the benefits of cell therapies to as many patients as possible.

Harnessing Potential First-in-Class Anti-CD47 Antibody in Difficult-to-Treat Malignancies

Researchers will give an oral presentation of updated results from the Phase 1b study of magrolimab in patients with previously-untreated acute myeloid leukemia (AML) who cannot undergo treatment with intensive chemotherapy, including patients with TP53 -mutant AML (Abstract #330). The FDA recently assigned Breakthrough Designation to magrolimab, in combination with azacitidine for the treatment of adult patients with newly-diagnosed MDS including intermediate-, high-, or very high-risk tumor types to expedite the development and regulatory review of this investigational treatment. Magrolimab also received PRIME Designation for treatment of MDS from the European Medicines Agency (EMA).

Dates and times for all accepted abstracts are as follows:

Area of Focus, Presentation Number and Date/Time

Abstract Title

Oral Presentations

Acute Myeloid Leukemia

Abstract #330

Sunday, Dec 6

(12:30pm ET / 9:30am PT)

The First-in-Class Anti-CD47 Antibody Magrolimab Combined with Azacitidine Is Well-Tolerated and Effective in AML Patients: Phase 1b Results

Large B-cell Lymphoma

Abstract #405

Sunday, Dec 6

(4:15pm ET / 1:15pm PT)

Interim Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) as First-Line Therapy in Patients (Pts) with High-Risk Large B Cell Lymphoma (LBCL)

Non-Hodgkin Lymphoma Abstract #700

Monday, Dec 7

(4:30pm ET / 1:30pm PT)

Primary Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL)

Poster Presentations

Follicular Lymphoma

Abstract #1145

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Safety Profile of Idelalisib in Patients with Refractory Follicular Lymphoma: Interim Analysis of a Noninterventional Study

Large B-cell Lymphoma Abstract #1187

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Long-Term Survival and Gradual Recovery of B Cells in Patients With Refractory Large B Cell Lymphoma Treated With Axicabtagene Ciloleucel (Axi-Cel)

Large B-cell Lymphoma Abstract #2100

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Outcomes of Patients (Pts) in ZUMA-9, A Multicenter, Open-Label Study of Axicabtagene Ciloleucel (Axi-Cel) in Relapsed/Refractory Large B Cell Lymphoma (R/R LBCL) for Expanded Access and Commercial Out-of-Specification (OOS) Product

Large B-cell Lymphoma

Abstract #1224

Saturday, Dec 5

(10:00am ET / 7:00am PT)

The First Retrospective Commercial Claims-Based Analysis of CAR T Treated Patients With Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL)

Large B-cell Lymphoma

Abstract #2500

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Cost and Healthcare Utilization in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Real-World Analysis of Medicare Beneficiaries Receiving Chimeric Antigen Receptor T-Cell Vs. Autologous and Allogeneic Hematopoietic Stem Cell Transplants

Large B-cell Lymphoma

Abstract #2548

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Burden of Illness and Outcomes in the 2nd Line Treatment of Large B-Cell Lymphoma: A Real-World Comparison of Medicare Beneficiaries with and without Stem Cell Transplants

Large B-cell Lymphoma

Abstract #1646

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Lines of Therapy in Patients with Relapsed or Refractory Large B-Cell Lymphoma and Stem Cell Transplant-Intended Treatment

Mantle Cell Lymphoma

Abstract #1120

Saturday, Dec 5

(10:00am ET / 7:00am PT)

One-Year Follow-Up of ZUMA-2, the Multicenter, Registrational Study of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Mantle Cell Lymphoma

Abstract #1126

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Pharmacological Profile and Clinical Outcomes of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitors (BTKi) Exposure or Mantle Cell Lymphoma (MCL) Morphology in Patients With Relapsed/Refractory (R/R) MCL in the ZUMA-2 Trial

Non-Hodgkin Lymphoma

Abstract #2036

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Retreatment With Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma in ZUMA-5

Trials-In-Progress

Acute Lymphoblastic Leukemia & Non-Hodgkin Lymphoma

Abstract #1896

Sunday, Dec 6

(10:00am ET / 7:00am PT)

ZUMA-4: A Phase 1/2 Multicenter Study of KTE-X19 in Pediatric and Adolescent Patients With Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Large B-cell Lymphoma

Abstract #2103

Sunday, Dec 6

(10:00am ET / 7:00am PT)

ZUMA-19: A Phase 1/2 Multicenter Study of Lenzilumab Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients (Pts) With Relapsed or Refractory Large B Cell Lymphoma (R/R LBCL)

Online Publication

Follicular Lymphoma

Efficacy Outcomes of Treatments for Double Relapsed/Refractory Follicular Lymphoma (R/R FL): A Systematic Literature Review

For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2020/webprogram/start.html .

Yescarta was the first CAR T cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from FL. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. In July, Tecartus became the first CAR T cell therapy to receive accelerated approval from the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on overall response rate and durability of response. Continued approval for this indication may be contingent upon additional data from a confirmatory trial. The U.S. Prescribing Information for Yescarta and Tecartus each have BOXED WARNINGS for the risks of CRS and neurologic toxicities, and Yescarta and Tecartus are each approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

The uses of Yescarta in relapsed or refractory FL or MZL or as a first-line treatment for patients with large B-cell lymphoma and high-risk genetics are investigational and not approved anywhere globally. Its efficacy and safety have not been established for these indications.

Magrolimab is investigational and not approved anywhere globally. Its efficacy and safety have not been established. More information about clinical trials with magrolimab is available at http://www.clinicaltrials.gov .

ABOUT MAGROLIMAB

Magrolimab is a first-in-class, investigational monoclonal antibody against CD47 and macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRP receptor on macrophages, thus blocking the dont eat me signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic and solid tumor malignancies, including MDS. Magrolimab has been granted Fast Track Designation for the treatment of MDS, AML, DLBCL and FL. Magrolimab has also been granted Orphan Drug Designation by the FDA and EMA for treatment of MDS and AML.

About Yescarta

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Gilead and Kite to Share Latest Scientific Advances in Hematologic Malignancies at ASH 2020 - Investing News Network

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The great reset: new danger on the horizon – Amandala

Wednesday, November 11th, 2020

Belize City, Nov. 2, 2020 Most people in Belize are either taken up these days with finding a job/income, with fears of COVID-19, or with anticipation of the General Elections of Nov. 11, 2020. But lurking in the shadows is a much more dangerous foe.

In the past it was called The New World Order, but that has been so discredited, that the wizard behind the curtain had to change the name to The Great Reset. What is this Great Reset?

The Great Reset is a new social contract that ties you to it through an electronic ID linked to your bank account and health records, and a social credit ID that will dictate every facet of your life. While the COVID-19 pandemic is being used as a justification for the Great Reset movement, the agenda has nothing to do with health and everything to do with a long-term plan to monitor and control the world through digital surveillance and artificial intelligence.

The Great Reset and the Fourth Industrial Revolution are rebranded terms for the old New World Order, melded with the trans-humanist movement. Technocracy (which is the new name for Fascism) is an economic system of resource allocation that revolves around computer technology in particular artificial intelligence, digital surveillance, and Big Data (5G) collection and the digitization of industry and government, which in turn allows for the automation of social engineering and social rule, thereby doing away with the need for democratically elected leadership.

While the real plan is to usher in a tech-driven dystopia free of democratic controls, the elites speak of this plan as a way to bring us back into harmony with nature the Green New Deal. Importantly, the pandemic is being used to destroy local economies around the world, which will then allow the World Economic Forum to come in through the IMF and rescue debt-ridden countries through facilitated financial bailouts.

However, the price for this salvation is your personal freedom and liberty. And, again, one of the aspects of the Fascist plan is to eliminate national borders and nationalism in general.

Who are the main actors behind the Great Reset?

Bill Gates and the World Economic Forum, along with the United Nations (which keeps a relatively low profile), appear to be at the heart of the big boys agenda. Gates is also the largest money-bag for the World Health Organization the medical branch of the U.N. Other key partners that play important roles in the implementation of the elites/globalists agenda include foundations such as the Rockefeller Foundation, the Rockefeller Brothers Fund, the Ford Foundation, Bloomberg Philanthropies, the UN Foundation, and George Soros Open Society Foundation; companies such as: Avanti Communications, a British provider of satellite technology with global connectivity, and 2030 Vision, a partnership of technology giants that is aimed at providing the infrastructure and technology solutions needed to realize the U.N.s 2030 Sustainable Development Goals. 2030 Vision is also partnered with Frontier 2030, which is a partnership of organizations under the helm of the World Economic Forum.

These organizations include the major Wall Street bankers/financiers; Google, the No. 1 Big Data collector in the world and a leader in AI services; MasterCard, which is leading the globalist charge to develop digital IDs and banking services, and Salesforce, a global leader in cloud computing, the internet of things and artificial intelligence.

Incidentally, Salesforce is led by Marc Benioff, who is also on the World Economic Forums board of directors, and Professor Klaus Schwab, chairman of the World Economic Forum.

Most Belizeans know little or nothing about the trans-humanist movement, or Human 2.0, which is geared at transcending biology through computer technology. Or, as Dr. Carrie Madej of USA explains in a blog, their goal is to meld human biology with computer technology and artificial intelligence. Two visible proponents of trans-humanism are Ray Kurzweil (director of engineering at Google since 2012) and Elon Musk (founder of SpaceX, Tesla and Neuralink). According to Dr. Madej, today we may be standing at the literal crossroads of trans-humanism, thanks to the fast approaching release of one or more mRNA COVID-19 vaccines.

Many of the COVID 19 vaccines https://articles.mercola.com/sites/articles/archive/2020/05/22/coronavirus-vaccine-timetable.aspx are not conventional vaccines. Their design is aimed at manipulating your very biology, and therefore have the potential to alter the biology of the entire human race. Conventional vaccines train your body to recognize and respond to the proteins of a particular virus by injecting a small amount of the actual viral protein into your body, thereby triggering an immune response from your body and the development of antibodies.This is not what happens with an mRNA vaccine. The theory behind these vaccines is that when you inject the mRNA into your cells, it will stimulate your cells to manufacture their own viral protein. The mRNA COVID-19 vaccine will be the first of its kind. No mRNA vaccine has ever been licensed before. And, to add insult to injury, theyre forgoing all animal safety testing.

Madej has reviewed the background of certain individuals participating in the race for a COVID-19 vaccine, which include Moderna co-founder Derrick Rossi, a Harvard researcher who successfully reprogrammed stem cells using modified RNA, thus changing the function of the stem cells. Moderna was founded on this concept of being able to modify human biological function through genetic engineering.

The mRNA vaccines are designed to instruct your cells to make the SARS-CoV-2 spike protein, the glycoprotein that attaches to the ACE2 receptor of the cell. The idea is that by creating the SARS-CoV-2 spike protein, your immune system will mount a response to it and begin producing antibodies to the virus.

However, as we now know, Moderna is having problems, because both the CEO and CFO have, according to the Wall Street Journal, dumped their shares and sold everything, making some $350 million + dollars.

But the biggest insult by the globalists to our intelligence is the censorship of the news about the research done by genetic analysis using the Oak Ridge National Lab supercomputer called the Summit which has revealed an interesting new hypothesis that helps explain the disease progression of COVID-19. A September 1, 2020 Medium article1 by Thomas Smith reviewed the findings of what is now referred to as the Bradykinin hypothesis.

As reported by Smith, the computer crunched data on more than 40,000 genes obtained from 17,000 genetic samples.

Summit is the second-fastest computer in the world, but the process which involved analysing 2.5 billion genetic combinations still took more than a week. When Summit was done, researchers analysed the results. It was, in the words of Dr. Daniel Jacobson, lead researcher and chief scientist for computational systems biology at Oak Ridge, a eureka moment.

Bradykinin is a chemical that helps regulate your blood pressure and is controlled by your renin-angiotensin system (RAS). As explained in the Academic Press book on vitamin D (which has a significant impact on the RAS):

The renin-angiotensin system (RAS) is a central regulator of renal and cardiovascular functions. Over-activation of the RAS leads to renal and cardiovascular disorders, such as hypertension and chronic kidney disease, the major risk factors for stroke, myocardial infarction, congestive heart failure, progressive atherosclerosis, and renal failure.

The Bradykinin hypothesis provides a model that helps explain some of the more unusual symptoms of COVID-19, including its bizarre effects on the cardiovascular system. It also strengthens the hypothesis that vitamin D plays a really important role in the disease.

Your ACE2 receptors are the primary gateways of the virus, as the virus spike protein binds to the ACE2 receptor. As explained2 by Smith:

COVID-19 infection generally begins when the virus enters the body through ACE2 receptors in the nose The virus then proceeds through the body, entering cells in other places where ACE2 is also present But once Covid-19 has established itself in the body, things start to get really interesting The data Summit analysed shows that COVID-19 isnt content to simply infect cells that already express lots of ACE2 receptors. Instead, it actively hijacks the bodys own systems, tricking it into up-regulating ACE2 receptors in places where theyre usually expressed at low or medium levels, including the lungs.

In this sense, COVID-19 is like a burglar who slips in your unlocked second-floor window and starts to ransack your house. Once inside, though, they dont just take your stuff they also throw open all your doors and windows so their accomplices can rush in and help pillage more efficiently.

The end result is a Bradykinin storm, and according to the researchers, this appears to be an important factor in many of COVID-19s lethal effects, even more so than the Cytokine storms associated with the disease. As Bradykinin accumulates, the more serious COVID-19 symptoms appear. Mounting clinical data suggest COVID-19 is actually primarily a vascular disease rather than a respiratory one, and runaway Bradykinin build-up help explain this.

The good news is that since Bradykinin storms are to blame, there are a number of already existing drugs (Icatibant, Danazol, Stanozolol) that can help prevent Bradykinin storms, and there are many other safe, inexpensive strategies like nebulized peroxide, ozone, molecular hydrogen, steroids, exogenous ketones, and Quercetin with zinc, vitamin D, and high-dose vitamin C.

And there are two reports by the American CDC. One says that 70.6% of COVID-19 patients always wore a mask3. The other says only 6% of all COVID-19 deaths were due ONLY to coronavirus4. And yet another said that the common seasonal flu caused more deaths than COVID-19.

So, if COVID-19 deaths are not what is being reported by the mass media, if the SAR CoV-2 virus is not as deadly to humans, then why the lockdowns, the face masks, the social distancing, the destruction of the way we live, of our economies? Why? Why?

But not all men are blind. On Oct 25, 2020, the Archbishop of Ulpiana, former Apostolic Nuncio to the United States of America, Carlo Maria Vigano, wrote an open letter (which over 100 million Americans have read) to President Donald Trump. The letter is long and is all over the internet. This is some of it:

at this hour in which the fate of the whole world is being threatened by a global conspiracy against God and humanityin the midst of the silence of both civil and religious authoritiesthis historical moment sees the forces of Evil aligned in a battle against the children of Lightwe see heads of nations and religious leaders pandering to this suicide of Western culture and its Christian soul, while the fundamental rights of citizens and believers are denied in the name of a health emergency that is revealing itself more and more fully as instrumental to the establishment of an inhuman faceless tyranny.

A global plan called the Great Reset is underway. Its architect is a global lite that wants to subdue all of humanity, imposing coercive measures with which to drastically limit individual freedoms and those of entire populations Behind the world leaders who are the accomplices and executors of this infernal project, there are unscrupulous characters who finance the World Economic Forum and Event 201, promoting their agenda.

The purpose of the Great Reset is the imposition of a health dictatorship aiming at the imposition of liberticidal measures, hidden behind tempting promises of ensuring a universal income and cancelling individual debt. The price of these concessions from the International Monetary Fund will be the renunciation of private property and adherence to a program of vaccination against Covid-19 and Covid-21 promoted by Bill Gates with the collaboration of the main pharmaceutical groups. Beyond the enormous economic interests that motivate the promoters of the Great Reset, the imposition of the vaccination will be accompanied by the requirement of a health passport and a digital ID, with the consequent contact tracing of the population of the entire world. Those who do not accept these measures will be confined in detention camps or placed under house arrest, and all their assets will be confiscated.

Mr President, I imagine that you are already aware that in some countries the Great Reset will be activated between the end of this year and the first trimester of 2021. For this purpose, further lockdowns are planned, which will be officially justified by a supposed second and third wave of the pandemic. But this world, Mr. President, includes people, affections, institutions, faith, culture, traditions, and ideals: people and values that do not act like automatons, who do not obey like machines, because they are endowed with a soul and a heart, because they are tied together by a spiritual bond that draws its strength from above, from that God that our adversaries want to challenge, just as Lucifer did at the beginning of time with his non serviam.

Until a few months ago, it was easy to smear as conspiracy theorists those who denounced these terrible plans, which we now see being carried out down to the smallest detail. No one, up until last February, would ever have thought that, in all of our cities, citizens would be arrested simply for wanting to walk down the street, to breathe, to want to keep their business open, to want to go to church on Sunday. Yet, now it is happening all over the world.

Mr. President, you have clearly stated that you want to defend the nation One Nation under God, fundamental liberties, and non-negotiable values that are denied and fought against today. It is you, dear President, who are the one who opposes the deep state, the final assault of the children of darkness.

For this reason, it is necessary that all people of goodwill be persuaded of the epochal importance of the imminent election Your adversary is also our adversary: it is the Enemy of the human race, He who is a murderer from the beginning (Jn 8:44).

And yet, in the midst of this bleak picture, this apparently unstoppable advance of the Invisible Enemy, an element of hope emerges. The adversary does not know how to love, and it does not understand that it is not enough to assure a universal income or to cancel mortgages in order to subjugate the masses and convince them to be branded like cattle. This people, which for too long has endured the abuses of a hateful and tyrannical power, is rediscovering that it has a soul; it is understanding that it is not willing to exchange its freedom for the homogenization and cancellation of its identity; it is beginning to understand the value of familial and social ties, of the bonds of faith and culture that unite honest people.

This Great Reset is destined to fail because those who planned it do not understand that there are still people ready to take to the streets to defend their rights, to protect their loved ones, to give a future to their children and grandchildren. The levelling inhumanity of the globalist project will shatter miserably in the face of the firm and courageous. To be an instrument of Divine Providence is a great responsibility, for which you will certainly receive all the graces of state that you need, since they are being fervently implored for you by the many people who support you with their prayers.

Meanwhile, here in Belize, we kill our so-called COVID-19 patients. Ventilators will kill you. Doctors of Belize, read the report of the US Oak Ridge National Lab on COVID-19. NO one needs to die anymore from COVID-19. US President Trump, who is 74 years old, was cured after 3 days of COVID-19.

And by the time you read this article, the world will know who won the elections in the United States.

Curfew on Nov. 11, election night in Belize, is part of the Globalist agenda. Let the people celebrate their victory. Open the churches, the schools, the bars; open the society. Send the globalist/elites back to Hell with Lucifer.

(Footnotes)1https://elemental.medium.com/a-supercomputer-analyzed-covid-19-and-an-interesting-new-theory-has-emerged-31cb8eba9d63

2ibid3https://www.cdc.gov/mmwr/volumes/69/wr/mm6936a5.htmRead the table at the end.4https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.html

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The great reset: new danger on the horizon - Amandala

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Teladoc Is A Strong Buy: A Radical Healthcare Change Will Come – Seeking Alpha

Wednesday, November 11th, 2020

Introduction

Last week, the Teladoc (TDOC) and Livongo (LVGO) merger was completed. That means that Livongo doesn't trade anymore. If you still had your Livongo shares, you got (or will get if your broker is a bit slower) 0.5920 per share of Livongo in Teladoc shares plus cash of $11.33, paid with a special dividend of $7.09 on October 29th, and the rest when your shares were changed to Teladoc shares.

(Source)

As a former shareholder of Livongo, you may not be completely familiar with how Teladoc is positioned now. If there is a buy-out or a merger, that always generates mixed feelings, or at least it should. If it doesn't, it means that you had a bad stock in your portfolio.

With Potential Multibaggers, my marketplace service here on Seeking Alpha, I try to find multibaggers early on. I picked Livongo as a Potential Multibagger on December 26, 2019. The stock then traded at $24.86 and had a market cap of just $2.5B. The stock returned 462.2%, so it's more than a fivebagger in less than a year. But still, quite a few shareholders, from both companies, didn't feel great about the merger.

I think Teladoc could still be a multibagger at this point for patient investors. I think most investors underestimate that this combined company could represent the future of our healthcare system. In this article, written from a bird's eye perspective, I will try to explain why.

I think a lot of people know that the American healthcare system (and that of most Western countries) is unsustainable. It's too expensive but nobody seems to find a way out to cut costs.

The problem is that our healthcare is one of the last sectors that has not been disrupted by tech yet. The system originates from a time when bigger was better because it was more affordable to have standard procedures. Long ago, there was a family doctor and he knew you and you knew him and you had a personal relationship with that man (female doctors almost didn't exist back then).

After the Second World War, two evolutions emerged that made this system unsustainable: people reached a higher and higher age and the Baby Boomers were born. That put pressure on both ends of the healthcare system and the solutions were more scale and introducing standard procedures, so the productivity of healthcare workers became higher. Specialized care also contributed to more efficiency. And it worked.

But there was a side effect. People don't feel connected to the people that should care for them. They often feel treated like numbers, like patients at best, but mostly not like individual people. I'm not throwing a stone here at doctors, nurses and other healthcare workers. They often share that feeling. They don't have the time to deeply care about people. Their time is limited, they have to reach the quota. A doctor is not paid for listening to you. He's paid per patient that he handles. In other words, the less he or she listens, the more the doctor is incentivized. And that wears out a lot of healthcare workers.

Normally, such a market would correct itself. If you are not properly served in Lowe's (LOW), you go to Home Depot (HD) or the other way around. If one is really not giving enough attention to its clients, the company will go bankrupt eventually. That's where the efficiency of the market plays its role.

But in healthcare, the patients are not the customers. They are the goods, as it were. Customers are the paying party. And who pays for healthcare costs? Exactly, the insurance companies. Their only objective is as little costs as possible and that's why they pay per visit, for example.

But this creates the strange effect that a doctor that treats you very well is only paid once, while a bad doctor, who follows the wrong procedure and has to repair the damage or gives the wrong diagnosis, is rewarded each time he or she treats you and so earns more money than the good doctor.

To fix the healthcare system, a little reparation here and there won't help. We saw in the last decades that tech has entered almost every industry and has disrupted industries completely. Think of how Amazon (AMZN) made Sears obsolete. The same thing should (and probably will) happen in healthcare.

Disruption comes from the Latin verb 'disrumpere', which means to break apart and that is what healthcare needs: breaking things apart to build them up again. The bottom line of every healthcare reform should be to use tech and turn the system upside down. Health should be rewarded and paid for, not sickness.

All insurance is meant for emergency cases, except for healthcare insurance. Doctors are incentivized to do as many consults and tests as possible because someone makes money on that: the doctor himself or the hospital, mostly both. A hospital, for example, makes 10 or 20 times more money if you go to the emergency room than if you use an online platform to talk to a telehealth doctor.

As a patient, if you see a doctor, most of that little time you spend with him or her is dedicated to tests, collecting data. But suppose the doctor already would have all the data when you come in and he or she has already been able to look into your case, your history, and tens of up-to-date data points before you came in, that doctor could have time for that which we all crave when we visit a doctor: talking about what you exactly have and what it means, what we can do to get better, a discussion about what the underlying cause could be, talking about the psychological effects that your condition brings with it, what the best plan of action would be for you, etc. In other words, the doctor could become some kind of health coach, a professional that, with the help of precise data, could prescribe a trajectory to better health, hold you accountable, help you when sticking to the plan is tough etc. A doctor could partly become a real healthcare worker, not just a sickcare worker.

That would mean that you wouldn't have to visit a doctor as often. If you have a chronic condition, you could be monitored 24/7 by sensors, assisted by AI, as Livongo does for diabetes. You are not only monitored but you also get health nudges. That means that you would know exactly what is the right path for you. And that path is much more individualized than most people can imagine.

Hemant Taneja, a venture capitalist of General Catalyst who founded Livongo with Glen Tullman, calls this new space in healthcare 'health assurance'.

(Hemant Taneja, right, together with Livongo founder Glen Tullman, source)

Taneja is convinced that health assurance industry will see several $100B+ companies. I suspect that he was the great driving force behind the Livongo/Teladoc merger, together with Glen Tullman. They realized that Livongo can become so much more combined with Teladoc than on its own.

This is how health assurance is defined:

Health assurance is an emerging category of consumer-centric, data-driven healthcare services that are designed to bend the cost curve of care and help us stay well. Built on the principles of open technology standards, these services employ empathetic user design and responsible AI. This is the future of your health experience.

If you want to know more about this, you could read Taneja's interesting book Unhealthcare.

(Source)

Now that you know the basics of the concept of health assurance, I think you can see the potential for Teladoc and Livongo in this market. There is no company that is as well-positioned as the combination of Teladoc and Livongo. Livongo brings measuring, data collection and especially AI to the table, Teladoc has a worldwide network of telehealth.

Investors who just see what there is now could get scared away from Teladoc. They look at the number of telehealth visits that could slow down after the peak of the coronavirus and they are afraid that Teladoc will just have been a COVID-19-induced fad. But if you look at the future, you see that this company could be in the sweet spot when healthcare will be disrupted over the next decade.

Insurance companies will help them with this. As we have already seen, they just want to pay as little as possible. Livongo saved insurance companies $88 per patient per month. The reason: the monitoring of diabetes patients, the fact that they have a diabetes coach that is always available and the health nudges reduce the medical costs dramatically. $88 per patient per month means more than $1,000 per year per patient. I think you see the potential.

Besides that, the patients also feel freer than before. Their diabetes doesn't control their lives as much. They need less medication and if they need it, the data will indicate it before the attack.

This is just for diabetes. That's already a big market. But Livongo doesn't just focus on diabetes but also on hypertension and obesity. Those are two huge markets as well. The hypertension market is estimated to be $23B in 2026 and the obesity treatment market is estimated to be around $20B in 2026. But suppose you add the weight loss market to this, which is worth about $70B in the US alone, and you can see the potential.

The obesity-related healthcare costs are estimated at around $147B annually, so this might mean big savings for healthcare spending.

There will certainly be other companies in this space than just Livongo and Teladoc, companies that will also focus on other domains, but so far, I don't see any competitor that is as advanced as Livongo/Teladoc is.

When I pick a Potential Multibagger, I turn a company inside out and that means that I know Livongo, its founders Glen Tullman and Hemant Taneja and what the company exactly does really well.

I didn't know Teladoc as well before the merger was announced. I had it on my watchlist, but I had not done a really deep dive. When I did, I found a lot that I liked. This statement by Teladoc's CEO Jason Gorevic on the closing of the merger is worth reading word for word if you want to understand the combination of the companies:

Both Teladoc Health and Livongo were founded with the same mission: to create a new kind of healthcare experience, one that empowers people everywhere to live their healthiest life. Today's news (the merger, FGTV) dramatically accelerates our ability to make this a reality for the tens of millions of consumers and healthcare professionals we serve around the world. Together, our team will achieve the full promise of whole-person virtual care, leveraging our combined applied analytics, expert guidance and connected technology to deliver, enable and empower better health outcomes."

There are a few critical phrases here. Let's look at them one by one.

"a new kind of healthcare experience" This is the disruption that I mentioned. Not just fine-tuning the current system, but a completely fresh start.

"one that empowers people everywhere to live their healthiest life".

This is the health assurance that I was talking about. Helping people to live their healthiest life is the reverse of what the current healthcare system thrives on. Empowerment means that people will be able to decide for themselves and take their health into their own hands. The 'everywhere' in this phrase refers to the global footprint Teladoc has.

"whole-person virtual care"

This refers to everything from health assurance to data, treatment plans, health nudges, and specialized diagnosis and surgery. Teladoc/Livongo will be the only one-stop-shop for taking your healthcare into your own hands. Healthcare is one of the few paternalistic sectors left. Paternalistic here means: "We know everything, you don't. Your only function is to give us the money and shut up."

Again, that's not throwing a stone to healthcare workers. I have a really, really deep respect for the people working in healthcare and this pandemic has highlighted even more how crucial they are. Several of my friends work in the sector.

They actually often feel the same frustration as patients. They don't have enough time to really listen, which would help them to diagnose more accurately, they have to do too much administration, they lose precious time gathering simple data and there are no efficient follow-up programs. Most healthcare workers would love to have the time to establish a human connection with each of their patients and listen to every detail that could count. But there is just no time. That's why a lot of people seek help from all kinds of coaches.

This is Teladoc's representation of whole-person care:

(Source)

Let's look into this in a bit more detail.

As you see from the graph, and I think this is really important, the category Wellness and Prevention is included in that care too. It is explained as 'Complete regular screenings and improve nutrition, exercise and well-being'. That means planning your health.

No company flies blindly and every company has a clearly-defined goal for the future often with step-by-step roadmaps. But for health, the advice is often: "Eat well and exercise." That's like saying to a company: "Execute well and make money." In other words, although it's true, it's too general.

A personal note here to illustrate what I mean. For years, I was very tired and I had trouble staying awake after meals or after drinking coffee. The advice I got from my doctors? Eat healthily, do regular exercise.

I found out 5 years ago that I have a milk allergy but I had to find out all about what it meant for my life (dairy-free cooking, avoiding almost all cookies, but also potato chips etc.) on my own. It would have been great to have a specialist that could have coached me there.

The example of my own life is just to illustrate the truth about healthcare that we all intuitively know but that is not acknowledged enough under this system: we are all individuals, with our differences, our unique needs. In stock terms, we are as different as a steel producer stock and a SaaS stock. I'm a man of 6 feet and 5 inches and almost always, I get the same dose of medicine as a woman of barely 5 feet high.

We are on the brink of other breakthroughs in healthcare: stem cell therapy, gene therapy, cheap genome sequencing, CRISPR, and many more. All these trends point in one direction: individualized healthcare. Medicine will not be a mass-produced, mass-prescribed drug anymore. We will evolve to personalized medicine.

Initially, people will be split into different groups based on certain data points (age, weight, condition...) and later it will be really about you, the individual. Your genome, your microbiome, your allergies, your reactions to certain drugs, everything will be known and taken into account for your prescription. Lots of medicines contain milk, for example, as a filling agent. Each time again, I have to say this to a doctor and sometimes there are even no medicines on the market without milk. These will be produced in the individualized healthcare that will come, if only for me. Medicines will be prepared on who you are, not on who the masses are.

But it will be much more than just medicines. Which supplements should you take? What is the perfect exercise regimen for your type of body? How could you build up your condition for that marathon or triathlon you always dreamed of without the risk of an injury because of your specific body composition? What are the best shoes for your feet so they can be 3D-printed? What is the best diet for the specific microbes that you have in your gut? What are the diseases you are genetically susceptible to and what can you change in your lifestyle to prevent them?

Don't get me wrong, I'm not a pie-in-the sky thinker. This will not be for the first years, of course not. And at first, it could be unevenly distributed, as a lot has been throughout healthcare's history. The first individualized programs could come with a hefty price ticket. But probably that will democratize, as a lot of procedures have in healthcare. Or maybe it will democratize from the start but with different degrees of quality, a bit like smartwatches.

The medical know-how of Teladoc, its wide network of doctors and health specialists, combined with Livongo's AI, data gathering and processing capabilities, make that this company is, like no other that I know, prepared for the future of healthcare.

I haven't seen any other AI healthcare platform that even comes close to that of Livongo at this point. With its AI+AI approach (aggregate, interpret + apply, iterate) it has already learned a lot, both from the whole pool of patients as from individual patients. With more patients because of the merger, there will be more data and more data means more insights and new products over time.

And Livongo will double down on its AI and data analysis. Revealera.com is a website that looks at jobs, job openings and it tries to find relevant information from these data.

It showed that of all publicly-traded companies, Livongo had the highest percentage of job openings that require data science and machine learning. 16% of Livongo's jobs openings ask for experience in those fields.

This clearly shows to me that Teladoc/Livongo is skating where the puck will be, not just where it is.

If you look at the combination of the two companies that merged, you can see that they are very complementary. These are Teladoc's key growth strategies and in blue, Livongo could help to accelerate Teladoc's strategy:

(Source)

The companies estimate that there will be $500M in synergies.

(Source)

Now, I know that it's all too common in an acquisition or a merger to overestimate these synergies by a wide margin. But in this case, I think the synergy opportunities are actually very conservative. The companies even acknowledge that in their merger presentation:

There will be a lot of cross-selling, as there is only a 25% overlap in the customers of the companies. Even before the merger officially was closed, Livongo was cross-sold in two deals already by Teladoc.

The first deal was Fresenius Medical Care, a company specialized in working with patients that suffer from CKD (chronic kidney disease). Partnerships and distribution are quintessential in healthcare and in its field, Fresenius is a big player. It provides dialysis for 347,000 kidney patients. The press release of Fresenius explains:

This marks the first time Livongo will use its robust virtual care solutions to specifically support those with CKD and is a significant step forward in Fresenius Medical Care's efforts to provide a more coordinated care experience. With earlier intervention, Fresenius Health Partners also seeks to increase optimal dialysis starts, as well as offer earlier evaluation of transplantation and home dialysis options.

This shows that the possibilities for Livongo to branch out are numerous.

The second deal was with Florida Blue, part of GuideWell Mutual Holding. Together with its merging partner Teladoc, Livongo will offer Florida Blue members with diabetes virtual care, including connected devices, advanced data science, and telehealth.

Being the only one-stop-shop for digital healthcare will provide Teladoc/Livongo with a competitive advantage that others simply don't have at the moment. The companies shared an example about Claire, an imaginary future client. You can see the different stages and situations in which she can be helped by Teladoc after the merger with Livongo:

As you can see, there is not a single moment in the whole process that Claire has to leave the platform. In this way, Teladoc and Livongo show that they are very complimentary. And the data component of Livongo, combined with preventive healthcare, gives Teladoc a lot of flexibility to introduce even more products, each one more and more targeted and eventually personalized.

There are risks to every investment, of course, although I generally believe that too many investors overemphasize risk. What is risk? Risk is not the same as volatility, no matter what some want you to believe. Volatility is risky if you are a short-term investor. If you need the money in 2 years, volatility is a risk. But if you need the money in, let's say, 20 years, why would it matter if a certain stock is up or down 50% this year or the next?

If you read the great book 100 baggers by Chris Mayer, you'll see that ALL (!) of the 100 baggers (stocks that turn your $10K into $1M) saw drops of 50% and more at least once. Most several times, and often they dropped substantially more than 50%.

Risk is the chance that you will lose your money permanently, not volatility. That also means that you should look at risks in their context. All companies make mistakes and if you sell because of a mistake, you'll never find multibaggers. Do I need to remind you of the Amazon Fire phone, the Netflix Quikster failure, the Windows phone, Google Plus and so many more mistakes? Don't let one failed product mislead you. The company as a whole is much more important.

Having said that, what will I keep my eyes on for Teladoc?

First, I want to see that Livongo really has an impact on Teladoc because health assurance is more a part of what Livongo does right now. There is a risk that Teladoc doesn't leverage Livongo's capacities enough.

The second element that I will watch is how the two companies work together when it comes to company culture. Teladoc has a good tracking record when it comes to acquisitions and giving them a place where they feel good inside of the company but this merger with Livongo is on a whole different level. I see some good signs because Teladoc CEO Jason Gorevic and Livongo's founder and executive chairman have already come out together several times and the two seem to share the same vision.

The third and final element of risk that I want to touch on is competition. At this moment, I don't see any competitor that is even close to Teladoc after the merger with Livongo but that can always change fast, of course. On the other hand, this market is so big that there will be several winners. And the size of the market, that's the next topic of this article.

The market cap of the combined company is around $30B at this moment. For Potential Multibagger stocks, I want to see the possibility that the stock could be a tenbagger in the next 10 years. For Teladoc, I think this is still possible, despite its already substantial market cap. The company has everything it needs to start a new era in healthcare as I showed, and it's in a gigantic market. This is the title of recent research:

Global Digital Health Market was Valued at USD 111.4 billion in 2019 and is Expected to Reach USD 510.4 billion by 2025, Observing a CAGR of 29.0% during 2020-2025

Teladoc operates in a TAM (total addressable market) of $510B in 2025 and at this moment it is the only 360 digital health company. That's a great position to be in. For those who wouldn't know: TAM is the yearly total addressable market. The fact that Teladoc projects a CAGR (compound annual growth rate) of 30% to 40% seems conservative to me. If you would add the synergies, it will be at least to the higher end of that margin, in my opinion.

If Teladoc could just bring in 3% of that TAM of 2025, that would already mean $15.3B. If you slap a P/S ratio of 20 on that, you already have a company with a market cap of more than $300B. A P/S of 20 might seem aggressive but for a company growing at more than 30% per year and gross margins which will probably be in the mid-70s, I think it's very reasonable. You can tinker with the numbers but the conclusion to me is always that if Teladoc executes well, it has the potential to become a giant.

I'm not saying that the company will already have 3% of the global digital health market by 2025, mind you. I think revenue of 1% of the TAM, about $5.1B, is possible at that moment, though, and much more growth will be in the pipeline.

There are always a lot of ifs but when I look at Teladoc, I can see the potential to become really big, ten times or more bigger than today.

With a lot of healthcare disruption knocking at the door, such as cheap genome sequencing, CRISPR, personalized medicines and much more, data will become more and more important for healthcare. Livongo's AI will add that to Teladoc.

The combination of Teladoc and Livongo definitely has the first-mover advantage in a very important and big emerging market because it can provide a 360 degrees one-stop-shop for personalized digital healthcare.

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In the meantime, keep growing!

Potential Multibaggers focuses on finding multibaggers early on.

Potential Multibaggers is not for those who trade in and out of stocks but for long-term investors who want life-changing returns.

More here:
Teladoc Is A Strong Buy: A Radical Healthcare Change Will Come - Seeking Alpha

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COVID Drug Given to Trump Developed From Aborted Fetus Cells – Quint Fit

Saturday, October 10th, 2020

Embryonic stem cell research has been always disputed by the 2020 Republican party. In 2019, Trumps administration paused funding for government scientists to work on studies involving embryonic stem cells, affecting about $31m in research, according to Science Magazine.

Regeneron, on the other hand, doesnt consider these cells fetal tissue because the HEK-293T line of cells has been immortalized and they divide and regenerate themselves in the laboratory.

The investigational drug has been in clinical trials since June. Even though early results from a trial with around 300 non-hospitalised COVID patients showed the drug was safe and could reduce viral levels and improve symptoms, the data is yet to be peer-reviewed.

According to CNN, the treatment is not yet approved for any use from the US FDA. The company, however, is in talks for an emergency approval. Regeneron has also confirmed that it had provided the drug under a compassionate use request for President Trump from the doctors.

(Make sure you don't miss fresh news updates from us. Click here to stay updated)

See the article here:
COVID Drug Given to Trump Developed From Aborted Fetus Cells - Quint Fit

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Lars Jaeger: The Future is Veggie, With 3D Printing – finews.asia

Saturday, October 10th, 2020

The energy market as well as political have changed strongly in recent years. In many countries around the world, the cards on the energy mix are being reshuffled. Lars Jaeger writes in an essay for finews.first.

This article is published on finews.first, a forum for authors specialized in economic and financial topics.

The latest example is China, where President Xi Jinping announced a few days ago that his country aims to be CO2-neutral by 2060. Political decision-makers seem to have finally started on their mission to stop climate change. But is enough when politicians pay lip service?

What about our individual responsibilities for greenhouse gas emissions? What have we personally done to curb those? Many residents of industrialized countries still drive around in large cars as a matter of course, eat large quantities of meat, eat avocados from Thailand and wear T-shirts from Bangladesh. Even the corona crisis has done little to change us from wanting to take airplanes not only for our summer vacations but increasingly also for our spring and fall vacation.

Animal husbandry accounts for a particularly large proportion of the emissions

A significant amount of greenhouse gases emission is also caused by our food consumption. What we eat is cultivated, harvested, transported, stored, processed, before it finally ends up on the market and is then consumed by us, again after storage, cooling, and preparation.

Animal husbandry accounts for a particularly large proportion of the emissions. According to the Food and Agriculture Organization of the United Nations (FAO) the keeping and processing of animals account for almost 15 percent of greenhouse gas emissions worldwide. Estimates for total food production go up to 30 percent.

To produce one kilogram of beef (approx. 2,500 kcal nutritional value) the greenhouse effective equivalent of approx. 13 kilograms of CO2 is emitted, one kilo of butter (approx. 7,000 kcal nutritional value) even comes to 24 kilograms of CO2, one kilo of lamb (approx. 3,000 kcal nutritional value) to no less than 39 kg CO2, cheese (approx. 3,000 kcal nutritional value) to an average of 8.5 kilograms of CO2 per kilo. For potatoes (approx. 860 kcal nutritional value) this value stands at just 0.4 kilograms of CO2, and the production of one kilo of fresh vegetables (approx. 400 kcal nutritional value) produces on average only 0.15 kilo CO2. Vegetables, therefore, have the best CO2 balance among the basic foodstuffs.

Transportation and packaging of the finished food products play a rather minor role in the environment

Here, methods of genetic engineering, even if they are controversial in Europe, could bring further improvements. For example, there is genetically modified rice, the production of which emits fewer greenhouse gases and which at the same time yields more. The prerequisite for this is that behind these methods stands not only the greed of companies for profit, but that they are also proven by nutritional scientists to be perfectly beneficial to our health and by environmental experts to be not harmful to the biosphere.

Transportation and packaging of the finished food products play a rather minor role in the environment (as long as they are not transported by air). Relying on regional products alone only improves the food footprint by about 4 percent (some products can even be produced overseas at lower CO2 emissions). It is more important to pay attention to seasonal foods: Apples that are stored for months in cold stores are far from being as good as fresh apples in terms of their climate balance. After six months, the energy required for cooling amounts to about 22 percent of the total energy input.

According to the WWF, the CO2 footprint of a Central Europeans diet is reduced by around 25 percent if he or she switches to a vegetarian diet. With a vegan diet, it is even 40 percent. No wonder that the Intergovernmental Panel on Climate Change (IPCC) in its Special Report on Climate Change and Land Systems of August 2019 calls for a radical change in human meat consumption. In order to feed the growing world population, we need further improved methods of food production. We simply can no longer afford to keep animals for 10 billion people.

Will we there have to do without our steak or chops in the future?

In addition, it has been well-known for a long time that meat consumption, in particular that of processed meat, is not necessarily health-promoting. It significantly increases the risk of developing colon cancer (because of the proliferation of potentially aggressive bacteria in the microbiome, the bacterial intestinal flora, which causes inflammation and cells to mutate), as well as pancreatic and prostate cancer. Further consequences of heavy meat-eating are diabetes, cardiovascular diseases, kidney failure, chronic inflammation, arthrosis and rheumatism, doctors, therefore, advise reduced meat consumption.

Will we there have to do without our steak or chops in the future? No, because also in food production we will experience dramatic technological changes. They will enable us to eat healthier and more ecological food which will at the same time be tastier than what we eat today.

The production of artificial meat in the laboratory reduces greenhouse gas emissions by up to 95 percent

Food is really just a combination of protein, fat and carbohydrates plus vitamins and trace elements. These can also be put together technically with suitable processes, and this even more efficient and nutritionally more valuable than nature does. In addition, its creation in sterile cell cultures is much more suitable for industrial meat production, because it is easier to control pathogens and toxins. In addition, the time-consuming and appetizing removal of offal, hair and bones is no longer necessary. The fat content of the meat can also be controlled. And last but not least: The production of artificial meat in the laboratory reduces greenhouse gas emissions by up to 95 percent.

As early as 2013 scientists at Maastricht University produced an artificial meatball. They took muscle stem cells from cattle, mixed those with nutrients, salts, pH buffers and growth factors and left them to reproduce. The cells became cell strands, about 20,000 of which were needed for a 140-gram meatball. Almost like meat, not quite as juicy, but the consistency is perfect, test eaters commented. The effort for this prototype was immense, however, the meatball cost 250,000 euros.

Seven years later, in-vitro meat is almost ready for the market. Appropriate 3D bio-printers serially assemble the cultured cell strands into muscle tissue. In 2020, prices were around 8 to 10 euros per burger (about 140 grams). Today, a number of start-ups are striving to bring their products to market soon at competitive prices.

Farms are also significant virus spinners

Anyone who thinks that artificially produced in-vitro meat is not very appetizing or that a diet of artificially produced meat would take people too far away from nature should spend a few hours in a large slaughterhouse or watch a large agricultural producer.

In the summer of 2020 with the Tnnies crisis in Germany, we became involuntary witnesses of the terrible conditions of todays industrial meat production. The mass production of animals in todays large farms is hardly more appetizing.

Next to wild animals, farms are also significant virus spinners. And the monocultures of todays plant food production, including those for animal feed, are coming with such massive damage to nature (soil compaction, soil erosion, fertilizers and pesticides in the groundwater, bee deaths due to pesticides) that the call for an agricultural turnaround is becoming ever louder. Instead of being a step away from nature, artificial meat production is a powerful step for its protection, i.e. a step towards nature!

Diet becomes healthier without having to sacrifice taste

And as far as palatability is concerned, probably the most important criterion for what we eat, apart from health, the alternative meat producers work together with gourmet chefs and butchers, but also with food technicians, taste experts and manufacturers of flavors and fragrances to optimize juiciness, texture and mouthfeel. Their aim is to simulate the taste of the steak deceptively realistically and by adding appropriate flavors even improve it. First testers unanimously certify that the printed steaks taste like real meat, tasty, firm to the bite and fibrous like the original.

The food market is facing a revolution. Plant food stands up quite favorably in terms of climate balance, in contrast to meat from animal production. Meat and seafood grown from cells and printed by 3D printers will dramatically reduce industrial animal husbandry and even increase our gourmet pleasure. It is estimated that by 2040 35 percent of all meat will be produced in this way.

The popular German philosopher Richard David Precht already paints the picture of a society without livestock farming, but with meat that we print out ourselves instead of it coming from pasture. In this way, we ensure the nutrition of the growing world population and reduce the ecological footprint of our diet. At the same time, our diet becomes healthier without having to sacrifice taste.

Lars Jaeger is a Swiss-German author and investment manager. He writes on the history and philosophy of science and technology and has in the past been an author on hedge funds, quantitative investing, and risk management.

Previous contributions: Rudi Bogni, Peter Kurer, Rolf Banz, Dieter Ruloff, Werner Vogt, Walter Wittmann, Alfred Mettler, Robert Holzach, Craig Murray, David Zollinger, Arthur Bolliger, Beat Kappeler, Chris Rowe, Stefan Gerlach, Marc Lussy, Nuno Fernandes, Richard Egger, Maurice Pedergnana, Marco Bargel, Steve Hanke, Urs Schoettli, Ursula Finsterwald, Stefan Kreuzkamp, Oliver Bussmann, Michael Benz, Albert Steck, Martin Dahinden, Thomas Fedier, Alfred Mettler,Brigitte Strebel, Mirjam Staub-Bisang, Nicolas Roth, Thorsten Polleit, Kim Iskyan, Stephen Dover, Denise Kenyon-Rouvinez, Christian Dreyer, Kinan Khadam-Al-Jame, Robert Hemmi,Anton Affentranger,Yves Mirabaud, Katharina Bart, Frdric Papp, Hans-Martin Kraus, Gerard Guerdat, MarioBassi, Stephen Thariyan, Dan Steinbock, Rino Borini,Bert Flossbach, Michael Hasenstab, Guido Schilling, Werner E. Rutsch,Dorte Bech Vizard, Adriano B. Lucatelli, Katharina Bart, Maya Bhandari, Jean Tirole, Hans Jakob Roth,Marco Martinelli, Thomas Sutter,Tom King,Werner Peyer, Thomas Kupfer, Peter Kurer,Arturo Bris,Frederic Papp,James Syme, DennisLarsen, Bernd Kramer, Ralph Ebert, Armin Jans,Nicolas Roth, Hans Ulrich Jost, Patrick Hunger, Fabrizio Quirighetti,Claire Shaw, Peter Fanconi,Alex Wolf, Dan Steinbock, Patrick Scheurle, Sandro Occhilupo, Will Ballard, Michael Bornhaeusser, Nicholas Yeo, Claude-Alain Margelisch, Jean-Franois Hirschel, Jens Pongratz, Samuel Gerber, Philipp Weckherlin, Anne Richards, Antoni Trenchev, Benoit Barbereau, Pascal R. Bersier, Shaul Lifshitz, Klaus Breiner, Ana Botn, Martin Gilbert, Jesper Koll, Ingo Rauser, Carlo Capaul, Claude Baumann, Markus Winkler, Konrad Hummler, Thomas Steinemann, Christina Boeck, Guillaume Compeyron, Miro Zivkovic, Alexander F. Wagner, Eric Heymann, Christoph Sax, Felix Brem, Jochen Moebert, Jacques-Aurlien Marcireau, Ursula Finsterwald, Claudia Kraaz, Michel Longhini, Stefan Blum, Zsolt Kohalmi, Karin M. Klossek, Nicolas Ramelet, Sren Bjnness, Lamara von Albertini, Andreas Britt, Gilles Prince, Darren Willams, Salman Ahmed, Stephane Monier, and Peter van der Welle, Beat Wittmann, Ken Orchard, Christian Gast, Didier Saint-Georges, Jeffrey Bohn, Juergen Braunstein, Jeff Voegeli, Fiona Frick, Stefan Schneider, Matthias Hunn, Andreas Vetsch, Fabiana Fedeli, Marionna Wegenstein, Kim Fournais, Carole Millet, Ralph Ebert, Lars Jaeger, Swetha Ramachandran, Brigitte Kaps, Thomas Stucki, Teodoro Cocca, Neil Shearing, Claude Baumann, Guy de Blonay, Tom Naratil, Oliver Berger, Robert Sharps, Tobias Mueller, Florian Wicki, Jean Keller, Fabrizio Pagani, Niels Lan Doky, Michael Welti, Karin M. Klossek, Ralph Ebert, Johnny El Hachem, Judith Basad, Katharina Bart, Thorsten Polleit, Beat Wittmann,Bernardo Brunschwiler, Peter Schmid, Karam Hinduja, Stuart Dunbar, Zsolt Kohalmi, Lars Jaeger, Raphal Surber, Santosh Brivio, Grard Piasko, Mark Urquhart, Olivier Kessler, Bruno Capone, and Peter Hody.

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Laid off from ImmunoGen, an ex-Genzyme and Shire exec heads to an ARCH upstart – Endpoints News

Saturday, October 10th, 2020

ImmunoGen CBO Blaine McKee got laid off after the company had a big Phase III failure last March, but by the time his official exit came around in December, he already landed a plum new gig. ARCH Venture Partners had tapped the longtime executive to run a biotech willing to spend a lot of cash in an area that had gone under-invested: kidney disease.

Now that biotech is emerging from stealth mode with 12 employees, $51 million in Series A funding from ARCH and UCB Venture and two new methods of directly attacking a disease and an organ that drug developers have long only tried to mitigate from the side. Theyve also got a new name: Walden Biosciences.

Its horribly served, poorly served, there hasnt been much innovation for years, McKee told Endpoints News. Were not looking to slow the progression of renal diseases, were not looking to make a modest impact on renal disease, we want to full on stop or reverse the progression of renal disease.

Although a couple recent upstarts have altered the picture, for years the majority of drugs in biotech pipelines have treated the chronic conditions that often trigger kidney diseases, CSO Alex Duncan noted. Thats been on particularly acute display over the past year, as AstraZeneca gradually rolled out what theyve billed as unprecedented data on their SGLT2 diabetes drug Farxiga. Those data showed a 40% reduction in risk of kidney progression or cardiovascular death, but that was in patients regardless of diabetes status and in some ways an outlier.

Pharma has tended to focus on, well, lets treat the diabetes and we should be able to treat the kidney disease, Duncan, a Medimmune and AstraZeneca vet who last worked at the cancer biotech Agenus, told Endpoints. Well, that hasnt happened.

McKee, a longtime Genzyme executive who ran corporate development for Shire before the Takeda buyout, will direct a platform culled from the labs of Jochen Reiser and Sanja Sever at Massachusetts General Hospital and Harvard. Although they have yet to nominate lead candidates, their approach can be split into two different biological mechanisms.

In one path, theyll look to target a protein known as soluble urokinase plasminogen activator receptor, or simply: suPAR. Researchers have known for years that the protein, when overproduced elsewhere in the body, can flow through the blood and cause harmful inflammation in the kidney. Theyve subsequently largely used it as a biomarker. But Walden says they can use antibodies to basically neutralize suPARs before they reach the kidney, returning it to normal levels an approach akin to the antibodies now being developed to neutralize SARS-CoV-2 before it enters cells.

In the second path, theyll look to activate a protein called dynamin. The protein helps support the physical structure of the kidney itself, and in a 2015 Nature Medicine paper, Sever and Reiser describe how a small molecule that continually activates the receptor can help maintain the kidneys structure and ameliorate disease in animals. The approach, Duncan said, could allow patients to keep on meds they would have discontinued because of renal side effects.

Even with the damage that might be being caused from conditions outside of the kidney, we can make the proper filtration apparatus inside, Duncan said.

As they look to push the two programs, Walden will be boosted by a key regulatory change, McKee said. The FDA in 2018 changed their guidelines to allow companies to use the reduction of protein in the urine as an acceptable endpoint for accelerated approval. That, he said, could shave off years of development time.

He said thats what helped other VCs enter the field over the last 5 years, including Third Rock with GoldFinch in 2016 and Versant with Chinook in 2019.

Theyll be looking to put their first drug into the clinic in 2022.

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5 Deadly Pre-existing Conditions You Could Have Due To COVID-19 – Brumpost – Brumpost

Saturday, October 10th, 2020

The COVID-19 is a respiratory disease caused by SARS-COV-2 virus which is a strain of virus that came from Wuhan in China late December of the year 2019 and has caused a devastating effect on almost everyone on earth forcing businesses to be closed, events to be canceled and economies to be completely shattered since its spread earlier this year 2020.

This is a very new disease and because of that, there is much to learn about the disease which scientists ae constantly working on in order to understand more about it so as to be able to fight it even much more efficiently. Meanwhile in their researches, scientists have been able to realize the roles played by pre-existing conditions in determining the severity of the disease on patients who contracts the coronavirus.

In order to assess the situations which can determine the fatality of the coronavirus infection, scientists have been able to further carry out much more researchers on pre-existing conditions which can cause serious complications.

The research was recently carried out by Penn State University which published in the journal PLOS One took a look at a variety of pre-existing conditions.

A team of researchers reviewed data on almost 500 COVID-19 cases and determined the following five cases are the deadliest pre-existing conditions when it comes to the coronavirus disease.

While an early diagnose of cancer might mean catching the malignant cells when theyre still fresh out, the American Cancer Society writes that doctors are still learning about the possible risks of COVID-19 infection for cancer patients.

The body further warned that all patients who are undergoing chemotherapy or stem cell (bone marrow) treatments should be extra careful and avoid infections at all cost because their immune system can be severely weakened by the treatment.

And for more specific information on cancer and coronavirus, be aware thatThis Type of Cancer Increases Your Risk of Severe COVID by 60 Percent.

While some diabetes can be lifelong, having the illness doesnt mean youre susceptible to catching the COVID-19 but the problem people with diabetes face is primarily a problem of worse outcomes stated the American Diabetes Association.

If your diabetes is being manage safely and regularly that puts you in a much better position but if the blood sugar level are constantly fluctuating or other diabetes-related complications can happen.

Since COVID-19 is a viral disease, this makes it also risky for diabetic patients as it can cause inflammation or internal swelling which is an already risky situation of above-target blood sugars.

Viruses also make patients more likely to experiencediabetic ketoacidosis(DKA). And if youre concerned about this condition,This Quick Trick Can Determine Your Diabetes Risk, Study Says.

Having a high blood pressure can be risky to your lifestyle causing stress and doctors have described this as the silent killer because it can often be present with no symptoms at all.

Meanwhile, early analysis of data from the outbreak of COVID-19 both in the US and China showed that having high blood pressure is the most commonly shared pre-existing condition among those hospitalized with 3- to 50 percent of patients havign it.

Hypertension is very deadly as it can weaken the patients immune system and because of this, patients hit by the COVID-19 are likely to exhibit more severe symptoms.

Patients with congestive heart failure which is a progressive, chronic weakening of the heart which causes the ventricles to lose their strength and their ability to pump sufficient blood throughout the body are 2.03 times more likely to die from COVID-19.

Studies carried out in China suggested that about 20% of the COVID-19 patients in Wuhan which is the epicenter of the original outbreak in December demonstrated a cardiac effect called myocardial injury.

However, analysis by the University of Oxford also stresses that its important thatheart failure patientsare not written off. For patients with known heart failure, continuation of current therapy is crucial, the experts warn.

Those who are constant smokers as well as older people or those living with obesity and diabetes are at a much more higher risk for chronic kidney disease and this disease also runs as an heredity which is more common in African-Americans, Native Americans and Asian-Americans.

COVID aside, chronic kidney disease is especially dangerous as it doesnt cause any symptoms untilmost of your kidney is destroyed.

As many cases of COVID-19 is being reported, patients with this disease are much more vulnerable and can lead to fatal severity if they contract the COVID-19.

Patients with chronic kidney disease (CKD) have ahigher rate of all-type infectionsand cardiovascular disease than the general population, a June paper in theClinical Kidney Journalsums up. A markedly altered immune system and immunosuppressed state may predispose CKD patients to infectious complications. Likewise, they have a state of chronic systemic inflammation that may increase their morbidity and mortality. This research found that the risk for severe COVID-19 is three times higher in those with CKD than those without it.

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The Crypto Daily Movers and Shakers October 10th, 2020 – Sports Grind Entertainment

Saturday, October 10th, 2020

Photograph: Rex/Shutterstock

Rebekah Powers was 11 when members of her faith group, the People of Praise, gathered around as she sat on a chair and laid their hands on her to pray. Powers sister had shown a gift for speaking in tongues, a defining trait of the followers of the small charismatic Christian community, and Rebekah was expected to do the same.

Related: McConnell hits out at Guardian and other media over Amy Coney Barrett scrutiny

But after what seemed like an eternity, she proved unable to produce a sound.

I couldnt get it, and I stayed there an hour and a half before they gave up and finally said, You just have blockage. You need to just work on your sin and be more open, she said.

The 41-year-old had a rebellious spirit and left People of Praise when she turned 18. It has taken decades of therapy and hard work to overcome the intense feelings of shame and fear of damnation that she said marked her childhood. The Christian faith group, based in South Bend, Indiana, dominated every aspect of her early life, she said.

Next week, Amy Coney Barrett, a conservative appellate court judge who is a prominent member of the 1,700-member strong People of Praise, will sit before the Senate judiciary committee to face questions about her judicial philosophy as part of her controversial confirmation to take a seat on the supreme court. A successful appointment, replacing the liberal Ruth Bader Ginsburg, will cement a conservative dominance on the powerful body.

Democrats have already stated that neither Barretts Catholic faith nor her membership in the People of Praise which has never publicly been discussed or disclosed, but has been examined in press reports will be raised in their questioning of the nominee.

Mitch McConnell, the Senate majority leader who is seeking to confirm Barrett before the end of October, has nevertheless said that media reports and some remarks by senators about a newly discovered public statement by Barrett in opposition to Roe v Wade, were disgusting attacks on faith. He said they risked a return to the tropes of the 1960s, when it was feared by some anti-Catholic bigots that John F Kennedy would act in the interest of the pope instead of the US.

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Our coastal elites are so disconnected from their own country that they treat religious Americans like strange animals in a menagerie, McConnell said in a statement.

But Powers, who is one of a handful of former People of Praise members who contacted the Guardian to describe their difficult experience in the group (using her married name), and some religious scholars who have studied charismatic Christian communities, say Barretts membership in this specific religious community does raise legitimate questions. They want to examine how views that are integral to the groups core beliefs from its treatment of women to the separation of church and state might influence her. They are also distinct from most mainstream Catholic faith.

In the bi-weekly and hours-long meetings that defined Powers childhood, intense prayer and discussions centered on obedience and driving out sin. Powers, who does not know Barrett, frequently witnessed people speaking in tongues and frenzied calls for evil spirits to be expelled, episodes that usually led to exorcisms.

The brainwashing and the groupthink, the female subjugation it was so devaluing

Rebekah Powers

In the strict hierarchy exercised by the group, Powers parents were often asked to take in other members into their home, even though her own family were using food stamps to get by. As a child and teenager, Powers father served as her spiritual head and worked multiple jobs, including being asked to tend to the lawns of the communitys properties, free of charge.

Women who are married, like Barrett, count their husbands as their heads.

We were Catholic, but the Catholicism was on the side. Our life, all of our friends, all of the randoms who were living in our household, were the [People of Praise] community. It was God, she said. The brainwashing and the groupthink, the female subjugation of being there to serve and listen to your spiritual head. It was so devaluing. To me, it instilled such problems.

Powers experiences are in line with a handbook called The Spirit and Purpose of the People of Praise, which was obtained by the Guardian and confirms that people who seek to be members of the group are prayed with for the release of charismatic gifts specifically, speaking in tongues and the gift of prophecy. It also states: Obedience to authority and submission to headship are active responses to the gifts of God.

Although Barrett has not discussed the issue, there is evidence that the former Notre Dame law professor served as a trustee for a school affiliated with the group; lived in the home of a prominent co-founder when she was in law school; and announced the birth of her children in People of Praises magazine, which has removed references to Barrett and her family since she joined the federal bench in 2017.

The Washington Post reported this week that Barrett served as a handmaid as late as 2010, a leadership position for women in the community, according to a directory.

Barretts father, Mike Coney, who has served in a leadership position in the People of Praise, described his own decision to join the group in a 2018 testimonial at his Catholic church, describing how he had initially unwillingly attended a charismatic seminar as a young man. When prayed with for a greater outpouring of the Holy Spirit, nothing happened. Then later that night I began to speak in tongues. More importantly, I was filled with an insatiable appetite for reading scripture and spiritual books, he wrote.

Thomas Csordas, an anthropology professor at the University of California San Diego who has studied the issues around communities like People of Praise, said it was wrong to focus attention on whether the group could be a considered a cult in the spirit of Jim Joness Peoples Temple. It was much more appropriate, he said, to examine what he called the intentional community of People of Praise and its nature of being conservative, authoritarian, hierarchical, and patriarchal.

I think theyre potentially more dangerous and much more sophisticated [than a cult], he said. It is not the kind of group where submission of women to men means that they have to stay barefoot and pregnant. Instead, they have to be lawyers and judges and submissive to men at the same time. They have to be able to have a career and seven kids at the same time.

Far from taking her cues from the People of Praise, Csordas said, Barretts biography showed she was not a mindless devotee of a cult, but rather part of the elite of the intentional charismatic covenant community, reflecting her previous status as a handmaiden and trustee of the school, and her fathers leadership role.

Related: Revealed: Amy Coney Barrett lived in home of secretive Christian groups co-founder

Contrary to a situation in which people might worry she might be told what to think or told by her husband. Being that far into the community means, no, she is going to be teaching other people. She already knows what to think because of the patriarchal structure she was raised in, which mirrors conservative Catholic views and the views of her judicial mentor, Antonin Scalia.

Massimo Faggioli, a professor of theology at Villanova University, said that even if senators declined to question Barrett about her faith, the issues deserved to be aired in other forums because groups like People of Praise, he said, does reject a secular view of separation between church and state.

I dont think we should put her Catholicism on trial, but the Catholic conservative legal movement is putting liberalism on trial. They want to change a certain understanding of the liberal order of individual rights, and that is coming from the religious worldview of Catholic groups, he said.

Maybe not in the Senate, but in the public square.

A spokesman for People of Praise has said it would be inappropriate to discuss Barrett. He has also said the organization is an ecumenical community that strives to allow men and women with a wide variety of political and religious views to live together in harmony.

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Coronavirus Tracker: Bexar Co. cases surpass 59,000; Texas hospitalizations trending in the wrong direction – KENS5.com

Saturday, October 10th, 2020

Facts, not fear: KENS 5 is tracking the latest numbers from the coronavirus (COVID-19) pandemic in San Antonio and across Texas.

SAN ANTONIO We're tracking the latest numbers from the coronavirus pandemic in San Antonio and across Texas. Here are the latest numbers reported by Bexar and surrounding counties:

How Bexar County is trending

We've tracked how many coronavirus cases have been confirmed in Bexar County from the time officials began reporting cases in March 2020. The graphic below shows the number of cases since June and charts those daily case numbers along a 7-day moving average to provide a more accurate picture of the overall coronavirus case curve in our area and the direction we're trending amid the pandemic.

On Wednesday, San Antonio Mayor Ron Nirenberg announced 214 additional coronavirus cases in Bexar County, sending the local total over 59,000. In all, 59,153 residents have been diagnosed with COVID-19.

Nirenberg also said there were no additional virus-related deaths in the county. In all, 1,168 county residents have died from coronavirus complications.

Hospitalizations in the county dropped ever so slightly on Wednesday. 203 residents were receiving treatment for coronavirus symptoms, which is three fewer than on Tuesday. And the number of patients using ventilators (39) and in ICU (84) are also slight drops from Tuesday's numbers.

Coronavirus in Texas

The number of Texans who have tested positive for the coronavirus since the pandemic began grew by 4,121 cases on Wednesday, according to the Texas Department of State Health Services.

3,776 of those are new diagnoses over the last 24 hours, while the other 345 cases stem from a number of backlogs in several counties and groups of previously unreported cases in some areas. More details can be found at the top of this page.

In total, 777,556 coronavirus cases have been confirmed in Texas.

State health authorities, meanwhile, reported an additional 119 virus-related deaths on Wednesday. At least 16,230 Texans have passed away from COVID-19 complications.

The state also saw a sharp uptick in hospitalizations on Wednesday. There were 125 more Texans receiving treatment for coronavirus symptoms in the last 24 hours, for a total of 3,519 currently hospitalized; it's been nearly a month since the figure was that high.

The state estimates that 692,123 Texans have recovered, while 70,813 Texans remain ill with COVID-19.

Meanwhile, the Texas Education Agency updated its online coronavirus database to show that there have been 9,857 cumulative cases among staff and students across the state as of Sept. 27. More information can be found here.

Latest Coronavirus Headlines

Coronavirus symptoms

The symptoms of coronavirus can be similar to the flu or a bad cold. Symptoms include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell sore throat, congestion or runny nose, nausea or vomiting and diarrhea, according to the Centers for Disease Control.

Most healthy people will have mild symptoms. A study of more than 72,000 patients by the Centers for Disease Control in China showed 80 percent of the cases there were mild.

But infections can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death, according to the World Health Organization. Older people with underlying health conditions are most at risk.

But infections can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death, according to the World Health Organization. Older people with underlying health conditions are most at risk.

Experts determined there was consistent evidence these conditions increase a person's risk, regardless of age:

The CDC believes symptoms may appear anywhere from two to 14 days after being exposed.

Human coronaviruses are usually spread...

Help stop the spread of coronavirus

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Ligand Announces its Captisol Business is Positioned for Major Growth and Forecasts 2021 Captisol Material Sales of $200 Million – Business Wire

Thursday, September 24th, 2020

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that recent new contracting with partners and investments in manufacturing capacity have contributed to its Captisol business operating at the highest levels in the history of the technology and position Captisol for major growth. Significant new clinical and regulatory developments with Evomela and Kyprolis, among other drugs, are reinforcing the role the proprietary technology serves in enabling important medicines. During 2020, Ligand has facilitated the successful installation of equipment to allow production at significantly higher levels to support anticipated demand. In addition to manufacturing at partner Hoviones facilities in Ireland and Portugal, Ligand has now added final step processing capacity for Captisol in both the United States and England. Ligand also introduces guidance for 2021 Captisol material sales of approximately $200 million.

The global medical need for Captisol-enabled drugs has never been higher, said John Higgins, Chief Executive Officer of Ligand. Our recently expanded operating team has successfully positioned our Captisol technology for the substantial growth we now expect in 2021 and beyond. There is significant ongoing investment by our partners for over 30 Captisol-enabled medicines in clinical development. We have entered into more contracts this year than any other year and are proud to be working closely with Gilead under our recently extended 10-year supply contract. We continue to be pleased with the momentum relating to Captisol, as it is a critical component in multiple life-saving medicines.

Recent Captisol technology business highlights include the following:

Ligands forecast for 2021 Captisol material sales of approximately $200 million is based on information it has on anticipated demand from its major partners given growth in existing and new markets, clinical requirements for Captisol-enabled development programs and binding orders from certain commercial or pre-commercial partners. The 2021 Captisol outlook compares with the Companys guidance for 2020 Captisol material sales of approximately $90 million.

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Gileads VEKLURY, Amgens KYPROLIS, Baxter Internationals NEXTERONE, Acrotech Biopharma L.L.C.s and CASI Pharmaceuticals EVOMELA, Melinta Therapeutics BAXDELA and Sage Therapeutics ZULRESSO. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including 37 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.

About Ligand Pharmaceuticals

Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligands OmniAb technology platform is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. The Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. The Vernalis Design Platform (VDP) integrates protein structure determination and engineering, fragment screening and molecular modeling, with medicinal chemistry, to help enable success in novel drug discovery programs against highly challenging targets. Ab Initio technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Icagen has established deep biological expertise focused on ion channels and transporters and has a strong track record in ion channel drug discovery from screening to lead optimization. Ligand has established multiple alliances, licenses and other business relationships with the worlds leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier, Gilead Sciences and Baxter International. For more information, please visit http://www.ligand.com.

Follow Ligand on Twitter @Ligand_LGND.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as plans, believes, expects, anticipates, and will, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligands expectation that Captisol demand will increase significantly in 2021 and beyond (particularly for sales to Gilead and to partners in Gileads consortium) and Ligands ability to supply Captisol to Gilead and other partners, including Ligands ability to increase supply capacity; the timing of initiation, enrollment and expected results with respect to the planned clinical trial of CE-Iohexol; and guidance regarding Ligands 2020 and 2021 Captisol material sales. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligands business, including, without limitation: Ligand may not receive expected revenue from Captisol sales; the COVID-19 pandemic has disrupted Ligands and its partners business, including delaying manufacturing, preclinical studies and clinical trials and product sales, and impairing global economic activity, all of which could materially and adversely impact Ligands results of operations and financial condition; Ligand may not achieve its Captisol material sales guidance for 2020 and/or 2021; remdesivir may be later shown to not be effective or safe for the treatment of COVID-19 and/or the FDA (and/or equivalent agencies in other countries) may revise or revoke its emergency use authorization for remdesivir for the treatment of COVID-19 in patients hospitalized with moderate or severe disease if the FDA (and/or another such agency) determines that authorization no longer meets the statutory criteria for issuance; alternative COVID-19 therapies or vaccines may be approved or the risk of coronavirus infection could significantly diminish, any of which could materially and adversely affect the commercial opportunity for remdesivir; Gilead may terminate the supply agreement without cause upon 30 days prior written notice; Ligand may be unable to scale-up the supply of Captisol or at acceptable prices; Ligand is currently dependent on Hovione as a single source sole supplier for certain Captisol manufacturing functions and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; Amgen, Acrotech Biopharma or other Ligand partners may not execute on their sales and marketing plans for marketed products for which Ligand has an economic interest; Ligand or its Captisol partners may not be able to protect their intellectual property and patents covering certain products and technologies may be challenged or invalidated; Ligand's Captisol partners may terminate agreements or development or commercialization of products; Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements; Ligand and its Captisol partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for product candidates, or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, which could result in increased costs and delays, or limit the ability to obtain regulatory approval; unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's or its Captisol partners product(s) could delay or prevent regulatory approval or commercialization; and ongoing or future litigation could expose Ligand to significant liabilities and have a material adverse effect on the company. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at http://www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at http://www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

a Monahan, et al. Biology of Blood and Marrow Transplantation, September 2020

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Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations – BioSpace

Tuesday, September 15th, 2020

Sept. 14, 2020 10:45 UTC

BOTHELL, Wash. & KENILWORTH, N.J.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced two new strategic oncology collaborations.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200914005237/en/

The companies will globally develop and commercialize Seattle Genetics ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in phase 2 clinical trials for breast cancer and other solid tumors. The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Mercks anti-PD-1 therapy KEYTRUDA (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. Under the terms of the agreement, Seattle Genetics will receive a $600 million upfront payment and Merck will make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6 billion.

Separately, Seattle Genetics has granted Merck an exclusive license to commercialize TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics will receive $125 million from Merck as an upfront payment and is eligible for progress-dependent milestones of up to $65 million.

Collaborating with Merck on ladiratuzumab vedotin will allow us to accelerate and broaden its development program in breast cancer and other solid tumors, including in combination with Mercks KEYTRUDA, while also positioning us to leverage our U.S. and European commercial operations, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The strategic collaboration for TUKYSA will help us reach more patients globally and benefit from the established commercial strength of one of the worlds premier pharmaceutical companies.

These two strategic collaborations will enable us to further diversify Mercks broad oncology portfolio and pipeline, and to continue our efforts to extend and improve the lives of as many patients with cancer as possible, said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. We look forward to working with the team at Seattle Genetics to advance the clinical program for ladiratuzumab vedotin, which has shown compelling signals of efficacy in early studies, and to bring TUKYSA to even more patients with cancer around the world.

Ladiratuzumab Vedotin Collaboration Details

Under the terms of the agreement, Seattle Genetics and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs. The companies have agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin on a 50:50 basis worldwide. Merck will pay Seattle Genetics $600 million upfront and make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics will be eligible to receive up to $2.6 billion in milestone payments, including $850 million in development milestones and $1.75 billion in sales milestones.

The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide. The companies will co-commercialize in the U.S. and Europe. Seattle Genetics will be responsible for marketing applications for approval in the U.S. and Canada, and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in Europe and in countries outside the U.S. and Canada, and will record sales in countries outside the U.S., Europe and Canada. Including the upfront payment, equity investment proceeds and potential milestone payments, Seattle Genetics is eligible to receive up to $4.2 billion.

The closing of the equity investment is contingent on completion of review under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

TUKYSA Collaboration Details

Under the terms of the agreement, Merck has been granted exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics retains commercial rights and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial.

Merck will also co-fund a portion of the TUKYSA global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan. Seattle Genetics will continue to lead ongoing TUKYSA global development planning and operational execution. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territory.

Seattle Genetics will receive from Merck $125 million as an upfront payment and is eligible to receive progress-dependent milestones of up to $65 million. Seattle Genetics will also receive $85 million in prepaid research and development payments to be applied to Mercks global development funding obligations. In addition, Seattle Genetics would receive tiered royalties on sales of TUKYSA in Mercks territory.

The financial impact of these collaborations is not included in Seattle Genetics 2020 guidance.

Seattle Genetics Conference Call Details

Seattle Genetics management will host a conference call to discuss these collaborations today at 6:00 a.m. Pacific Time (PT); 9:00 a.m. Eastern Time (ET). The event will be simultaneously webcast and available for replay from the Seattle Genetics website at http://www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or +1 412-717-9224 (international). The conference ID is 10147850.

About Ladiratuzumab Vedotin

Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1. Most metastatic breast cancers express LIV-1, which also has been detected in several other cancers, including lung, head and neck, esophageal and gastric. Ladiratuzumab vedotin utilizes Seattle Genetics proprietary ADC technology and consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker. This novel ADC is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response by induction of immunogenic cell death.

About TUKYSA (tucatinib)

TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth. TUKYSA in combination with trastuzumab and capecitabine was approved by the U.S. Food and Drug Administration (FDA) in April 2020 for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. In addition, TUKYSA received approval in Canada, Singapore, Australia and Switzerland under the Project Orbis initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners. A marketing application is under review in the European Union.

TUKYSA is being evaluated in several ongoing clinical trials and additional studies are planned. Current trials include the following:

For additional information, visit http://www.clinicaltrials.gov.

TUKYSA Important Safety Information

Warnings and Precautions

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in 2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Use in Specific Populations

For more information, please see the full Prescribing Information for TUKYSA here.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

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Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations - BioSpace

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Alexion and Caelum Biosciences Announce Start of Phase 3 Studies of CAEL-101 in AL Amyloidosis – Business Wire

Tuesday, September 15th, 2020

BOSTON & BORDENTOWN, N.J.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Caelum Biosciences today announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis. The CARES clinical program includes two parallel Phase 3 studies one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival.

In AL amyloidosis, misfolded amyloid proteins can build up in many organs throughout the body, including the heart and kidneys, causing significant damage to these organs and impairing their function. While current treatments address the bone marrow disorder that creates the misfolded amyloid proteins, there are no approved therapies for the significant organ damage the disease causes, said John Orloff, M.D., Executive Vice President and Head of Research and Development at Alexion. CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from these organs. Data from Phase 1 studies suggest that this treatment approach may improve organ function and long-term survival. We look forward to investigating this further in the Phase 3 clinical program.

AL amyloidosis is particularly devastating when it affects the heart, with median survival in these patients of less than one year following diagnosis, said Michael Spector, President and Chief Executive Officer of Caelum. Long-term survival data from AL amyloidosis patients treated with CAEL-101 in the Phase 1a/1b study showed that 78 percent were still alive after a median follow-up time of more than three years. We recognize the urgent need for new treatments that address the organ damage caused by AL amyloidosis and are working together with the AL amyloidosis community and Alexion to advance the Phase 3 clinical program as quickly as possible.

About the CARES Phase 3 Clinical Program

The CARES clinical program consists of two parallel double-blind, randomized, event-driven global Phase 3 studies, which are evaluating the efficacy and safety of CAEL-101 in AL amyloidosis patients who are newly diagnosed and nave to standard of care (SoC) treatment (cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy). One study is enrolling approximately 260 patients with Mayo stage IIIa disease and one study is enrolling approximately 110 patients with Mayo stage IIIb disease. The studies will be conducted at approximately 70 sites across North America, the United Kingdom, Europe, Israel, Japan, and Australia.

In each study, participants are being randomized in a 2:1 ratio to receive either CAEL-101 plus SoC or placebo plus SoC once weekly for four weeks. This will be followed by a maintenance dose administered every two weeks until the last patient enrolled completes at least 50 weeks of treatment. Patients will continue follow-up visits every 12 weeks.

The primary study objectives are overall survival and the safety and tolerability of CAEL-101. Key secondary objectives will assess functional improvement in the six-minute walk test (6MWT), quality of life measures (Kansas City Cardiomyopathy Questionnaire Overall Score & Short Form 36 version 2 Physical Component Score) and cardiac improvement (Global Longitudinal Strain, or GLS).

Phase 2 Study Results

The Phase 2 open-label dose escalation study was conducted to investigate higher doses of CAEL-101 than had been evaluated in Phase 1 studies with a primary objective to identify the best dose to advance into Phase 3 development. The study evaluated the safety and tolerability of CAEL-101 in 13 AL amyloidosis patients at three study sites who received up to 1000 mg/m2 of CAEL-101 (two times the Phase 1 dose) administered in combination with SoC treatment. The study met its primary objectives, supporting the safety and tolerability of CAEL-101 and the selection of the 1000 mg/m2 dose for the Phase 3 study.

Phase 1a/1b Long-Term Follow-Up Results Presented at ISA 2020

As previously reported, the Phase 1a/1b study of CAEL-101 was the first clinical trial to demonstrate improvement in cardiac function via GLS after treatment with an amyloid fibril targeted therapy in AL amyloidosis patients with amyloid cardiac involvement. New long-term follow-up data from the Phase 1a/1b study will be presented at the virtual International Symposium on Amyloidosis (ISA), September 14 to 18, 2020, in the poster titled, Long term follow-up of patients with AL amyloidosis treated on a phase 1 study of Anti-Amyloid Monoclonal Antibody CAEL-101 (Abstract #342, Divaya Bhutani, M.D., et. al, Columbia University Medical Center). These data demonstrate 78 percent survival (15/19) at a median follow-up of more than three years (37 months) in AL amyloidosis patients treated with CAEL-101 as well as durable organ response among evaluable patients, further supporting the advancement of CAEL-101 into Phase 3 development.

About CAEL-101

CAEL-101 is a first-in-class monoclonal antibody (mAb) designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis. The antibody is designed to bind to misfolded light chain protein and amyloid and shows binding to both kappa and lambda subtypes. In a Phase 1a/1b study, CAEL-101 demonstrated improved organ function, including cardiac and renal function, in 27 patients with relapsed and refractory AL amyloidosis who had previously not had an organ response to standard of care therapy. CAEL-101 has received Orphan Drug Designation from both the U.S. Food and Drug Administration and European Medicine Agency as a therapy for patients with AL amyloidosis.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded immunoglobulin light chains produced by plasma cells aggregate and form fibrils that deposit in tissues and organs. This deposition can cause widespread and progressive organ damage and high mortality rates, with death most frequently occurring as a result of cardiac failure. Current standard of care includes plasma cell directed chemotherapy and autologous stem cell transplant, but these therapies do not address the organ dysfunction caused by amyloid deposition, and up to 80 percent of patients are ineligible for transplant.

AL amyloidosis is a rare disease but is the most common form of amyloidosis. There are approximately 22,000 patients across the United States, France, Germany, Italy, Spain and the United Kingdom. AL amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused by cardiac amyloidosis.

About Alexion

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: http://www.alexion.com.

[ALXN-P]

About Caelum Biosciences

Caelum Biosciences, Inc. (Caelum) is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Caelums lead asset, CAEL-101, is a novel antibody for the treatment of patients with amyloid light chain (AL) amyloidosis. In 2019, Caelum entered a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 3 CAEL-101 data. Caelum was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit http://www.caelumbio.com.

Forward-Looking Statement

This press release contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Alexion and Caelum, including statements related to: the safety and efficacy CAEL-101 as a treatment for AL amyloidosis; CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from the heart, kidney and other organs; data from the Phase 1 studies suggest that the treatment approach may improve organ function and long-term survival and enrollment of the Phase 3 trials. Forward-looking statements are subject to factors that may cause Alexion's and Caelums results and plans to differ materially from those expected by these forward looking statements, including for example: the anticipated safety profile and the benefits of the CAEL-101 may not be realized (and the results of the clinical trials may not be indicative of future results); the inability to enroll and complete the Phase 3 trial; results of clinical trials may not be sufficient to satisfy regulatory authorities; results in clinical trials may not be indicative of results from later stage or larger clinical trials (or in broader patient populations); the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us to discontinue sales of the product (or halt trials, delay or prevent us from making regulatory approval filings or result in denial of approval of our product candidates); the severity of the impact of the COVID-19 pandemic on Alexions or Caelums business, including on commercial and clinical development programs; unexpected delays in clinical trials; unexpected concerns regarding products and product candidates that may arise from additional data or analysis obtained during clinical trials or obtained once used by patients following product approval; future product improvements may not be realized due to expense or feasibility or other factors; delays (expected or unexpected) in the time it takes regulatory agencies to review and make determinations on applications for the marketing approval of our products; inability to timely submit (or failure to submit) future applications for regulatory approval for our products and product candidates; inability to timely initiate (or failure to initiate) and complete future clinical trials due to safety issues, IRB decisions, CMC-related issues, expense or unfavorable results from earlier trials (among other reasons); future competition from biosimilars and novel products; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to satisfactorily address matters raised by regulatory agencies regarding our products and product candidates; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; the adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and challenges against us; the risk that third party payors (including governmental agencies) will not reimburse for the use of our products at acceptable rates or at all; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; adverse impacts on supply chain, clinical trials, manufacturing operations, financial results, liquidity, hospitals, pharmacies and health care systems from natural disasters and global pandemics, including COVID-19 and a variety of other risks set forth from time to time in Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended June 30, 2020 and in their other filings with the SEC. Alexion disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.

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Alexion and Caelum Biosciences Announce Start of Phase 3 Studies of CAEL-101 in AL Amyloidosis - Business Wire

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Braunstein Reflects on the Rise of Quadruplet Therapies in Multiple Myeloma – OncLive

Wednesday, September 9th, 2020

Triplet therapies have become the accepted standard of care in multiple myeloma, according toMarc J. Braunstein, MD, PhD, who added that emerging quadruplet therapies are also generating excitement in the field.

As seen in the up-front setting, there has been an explosion of therapies, not just for patients with relapsed/refractory multiple myeloma who progress after induction therapy, but also for patients who progress after multiple lines of therapy, said Braunstein, an assistant professor in the Department of Medicine at NYU Long Island School of Medicine. In the field, we appreciate that clonal resistance is truly what leads to shorter remission over time. Now that we have more therapies to offer, we are seeing several new combinations.

In a special episode of OncLiveOn Air, Braunstein, who is also the course co-director of the Hematology-Oncology System and co-director of the Autologous Stem Cell Transplant Program at NYU Winthrop Hospital of NYU Langone Healths Perlmutter Cancer Center, highlighted pivotal research on the use of triplet and quadruplet regimens in the up-front and relapsed/refractory settings presented during the 2020 ASCO Virtual Scientific Program.

VRd Remains the Standard of Care in Newly Diagnosed Multiple Myeloma

Carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) did not improve progression-free survival (PFS) in patients with newly diagnosed multiple myeloma, according to results of the phase 3 ENDURANCE (E1A11) trial (NCT01863550).1

In the randomized analysis, investigators compared the use of KRd with that of bortezomib (Velcade), lenalidomide, and dexamethasone (VRd) in treatment-nave patients with multiple myeloma who had an ECOG performance score of 0, 1, or 2. Patients also had to have acceptable hematological parameters and organ function and measurable disease in serum, urine, or bone marrow to be included. If they had grade 2 or higher peripheral neuropathy or New York Heart Association III or IV heart failure or myocardial infarction less than 6 months before study start, they could not participate.

The first co-primary end point of the trial was PFS for the induction randomization and the second co-primary end point was overall survival (OS) for the second randomization. Key secondary end points included overall response rate, minimal residual disease negativity rate per flow cytometry, time to progression, OS, and toxicity.

In the field, this trial was patiently awaited for some time because we were eager to see the head-to-head comparison of a triplet regimen that includes either the protostome inhibitor bortezomib or carfilzomib in combination with lenalidomide and dexamethasone, the 2 most common up-front regimens in the space, explained Braunstein.

A total of 1087 patients were randomized 1:1 to receive VRd (n = 542) or KRd (n = 545). Patients on the VRd arm received 1.3 mg/m2of bortezomib on days 1, 4, 8, and 11 for cycles 1-8 and the same dose on days 1 and 8 for cycles 9-12; 25 mg of daily lenalidomide on days 1-14; and 20 mg of dexamethasone in on days 1, 2, 4, 5, 8, 9, 11, and 12 for cycles 1-4, and then 10 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 for cycles 5-8, followed by 10 mg on days 1, 2, 8, and 9 for cycles 9-12. Treatment cycles were repeated every 3 weeks for 12 cycles.

Patients on the KRd arm received 20 mg/m2of carfilzomib on days 1 and 2 and 36 mg/m2on days 8, 9, 15, and 16 of cycle 1 followed by 36 mg/m2on days 1, 2, 8, 9, 15, and 16 for cycles 2-9; 25 mg of lenalidomide on days 1-21, and 40 mg of dexamethasone on days 1, 8, 15, and 22 for cycles 1-4 and 20 mg on days 1, 8, 15, and 22 for cycles 5-12. This treatment cycle was repeated every 4 weeks for 9 total cycles.

Results showed a median PFS of 34.4 months (95% CI, 30.1not evaluable) in the VRd arm compared with 34.6 months (95% CI, 28.8-37.8) in the KRd arm (HR, 1.04; 95% CI, 0.83-1.31; P = .742). In addition, on the VRd arm, 21 patients (4.0%) experienced a stringent complete response (sCR), 57 (10.8%) achieved a CR, 263 had a very good partial response (VGPR), and 103 patients had a partial response (PR). On the KRd arm, 31 patients (5.9%) achieved a sCR, 65 (12.4%) had a CR, 292 patients (55.5%) experienced a VGPR, and 68 (12.9%) had a PR. The median OS from induction randomization was not yet reached in either arm.

Moreover, treatment-related adverse effects (TRAEs) were mostly grade 3-5 and consisted of peripheral neuropathy, dyspnea, hypertension, heart failure, and acute kidney injury. The TRAEs of interest were cardiac, pulmonary, and renal, as well as peripheral neuropathy.

One of the criticisms of this study is that it did not include patients with high-risk multiple myeloma who, in prior studies, showed a benefit with carfilzomib, Braunstein noted. Notably, approximately 27% of patients in each group went on to receive autologous stem cell transplant, which was not planned according to the design of the study.

Based on these data, the investigators concluded that VRd should remain the standard of care.

Isatuximab/KRd for Newly Diagnosed, High-Risk Multiple Myeloma

Isatuximab-irfc (Sarclisa) plus KRd can be safely administered in patients with high-risk multiple myeloma, inducing deep responses, according to results from the interim analysis of the GMMG-concept trial presented during the meeting; this was the first study to investigate the quadruplet regimen in this patient population.2

In the multicenter, open-label, phase 2 analysis, investigators evaluated the efficacy of isatuximab, an anti-CD38 monoclonal antibody, in combination with KRd in patients with high-risk, newly diagnosed multiple myeloma. Patients could have received up to 1 cycle of anti-myeloma treatment prior to inclusion. They had to show acceptable organ function in order to participate.

The primary end point of the trial was minimal residual disease (MRD) negativity by flow cytometry to a sensitivity of 10-5and the secondary end point was PFS. Tertiary end points included ORR, duration of MRD negativity, OS, and quality-of-life (QOL) assessment.

This was an investigator-initiated study that ultimately evaluated a quadruplet regimen, which is the trend that we are pursuing these days in terms of up-front therapy, noted Braunstein.

In the analysis, 153 patients were randomized 1:1 based on transplant eligibility. In arm A, 117 transplant-eligible patients received 6 cycles of isatuximab plus KRd induction, 4 cycles of isatuximab plus KRd consolidation, and isatuximab plus KR maintenance. In arm B, 36 transplant-ineligible patients received the same course of treatment with 2 additional cycles of isatuximab plus KRd induction.

The interim analysis reported on a total of 50 patients: 46 in arm A and 4 in arm B. Results showed an ORR of 100% with the quadruplet, a VGPR or greater of 90%, a CR/sCR of 46%. In arm A, 41 of 46 patients achieved a VGPR or greater, while all patients in arm B achieved a VGPR. MRD was assessed in a total of 33 patients in arm A during induction and results showed that 20 patients were MRD negative, 11 were MRD positive, and 2 were not evaluable.

With regard to safety, the most common hematologic treatment-emergent AEs (TEAEs) reported were grade 3 or 4 and consisted of leukopenia (26%), neutropenia (34%), lymphopenia (28%), anemia (10%), and thrombocytopenia (14%).

Any-grade nonhematologic TEAEs included upper-respiratory tract infections (18%), pyrexia (12%), rash (16%), peripheral sensory neuropathy (16%), nasopharyngitis (10%), hypertension (12%), cardiac failure (4%), and infusion reaction (32%). No deaths were reported on the study.

We now have doublet, triplet, and quadruplet up-front regimens for patients with newly diagnosed multiple myeloma, Braunstein said. The more agents you combine synergistically to target the plasma cell clones, the deeper response rates you can achieve and that consistently correlates with longer remissions.

Belantamab Mafodotin Triplet for Relapsed/Refractory Multiple Myeloma

Belantamab mafodotin in combination with bortezomib and dexamethasone (B-Vd) demonstratedan acceptable safety profile, according to preliminary findings from a cohort of the phase 1/2 DREAMM-6 trial also presented during the meeting.3

In the 2-part, open-label, phase 1/2 study, investigators evaluated the safety and efficacy of the addition of belantamab mafodotin to B-Vd, 2 standard-of-care doublet regimens, in patients with relapsed/refractory multiple myeloma who have previously received at least 1 line of therapy. To be eligible for the trial, patients had to have measurable disease, acceptable organ function, and an ECOG performance status of 0 to 2. Those who underwent previous autologous stem cell transplant and those who were not candidates for transplant were permitted, along with those who were refractory to bortezomib.

The primary end points of the trial were safety, tolerability, and ORR as defined by the International Myeloma Working Group Uniform Response Criteria. Key secondary end points included preliminary clinical activity, further safety/tolerability examination, pharmacokinetic assessments, and the health-related QOL impact of the combination.

In arm A, belantamab mafodotin was combined with lenalidomide and dexamethasone (B-Rd) and, in arm B, belantamab mafodotin was combined with B-Vd.Part 1 was a dose-escalation phase and part 2 is an ongoing dose-expansion phase for each of the arms with either single (day 1) or split dosing (day 1 and 8) for belantamab mafodotin at 2.5 mg/kg or 3.4 mg/kg.

Results on 18 patients who received the 2.5-mg/kg dose of B-Vd experienced an ORR of 78% (95% CI, 52.4%-93.6%). In addition, patients demonstrated a clinical benefit rate of 83% (95% CI, 58.6%-96.4%) and the VGPR was 50%. The duration of response with the combination had not yet been reached.

Moreover, 89% of patients experienced grade 3 or 4 AEs. Dose reductions were required in 72% of patients because of AEs and all patients experienced a dose interruption or delay due to keratopathy and/or thrombocytopenia. Notably, all toxicities were found to be clinically manageable.

I believe belantamab mafodotin offers a unique therapeutic approach, which is very much needed in [patients with] refractory multiple myeloma, Braunstein concluded.

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Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients – GlobeNewswire

Wednesday, September 9th, 2020

Basel, 8 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) 510k clearance for the cobas BKV Test on the cobas 6800 and 8800 Systems. The test was previously granted FDA Breakthrough Device designation demonstrating the improved treatment or diagnosis of life-threatening diseases or conditions for transplant patients. The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options.

BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications. Infection can occur without symptoms and happen early in life. After primary infection, the virus can remain inactive, only to possibly reactivate in immunocompromised individuals such as transplant recipients.

Our diagnostic tests can help clinicians greatly improve patient treatment plans and make quick adjustments for personalised healthcare, said Thomas Schinecker, CEO Roche Diagnostics. This FDA clearance allows Roche to offer healthcare professionals a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus and BK virus so they can simultaneously monitor and improve care for transplant patients who are at risk for these common infections or viral reactivations which can cause further illness or death.

The cobas BKV Test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas 6800 and cobas 8800 Systems. Along with the previously approved cobas EBV and CMV Tests, the cobas BKV Test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international units, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of BKV DNA.

About the cobas BKV TestThe cobas BKV Test was previously granted Breakthrough Device Designation by the FDA, together with the cobas EBV Test.

The cobas BKV Test is a real-time polymerase chain reaction (PCR) test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.

The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.

The fully automated cobas BKV Test and the cobas CMV and cobas EBV Tests can run on the cobas 6800/8800 Systems simultaneously, providing absolute automation with proven performance and flexibility, leading to time savings and increased efficiency.

About BK polyomavirus BK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation. Infection can occur early in life, often with no symptoms. After primary infection, the virus can remain inactive throughout life, only to possibly reactivate in immunocompromised individuals, such as patients who receive solid-organ transplants. For kidney transplant patients, BKV infection is considered the most common viral complication, causing polyomavirus nephropathy (PVN) in up to 10 percent of kidney transplant recipients, and about 50 percent of PVN-affected patients will experience transplant graft failure.1 BKV is also associated with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.2

About the cobas 6800/8800 SystemsWhen every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. The systems provide up to 96 results in about three hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift.*

Both systems make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.*

These real-time PCR systems serve the areas of infectious disease, donor screening, sexual health, transplant, respiratory and antimicrobial stewardship.

Through an ever-increasing worldwide install base of cobas 6800/8800 Systems, labs are quickly and easily processing millions of tests per month to meet the changing demands of their communities, their customers, and the patients relying on the results of each assay. Globally, labs know and trust that a Roche assay guarantees high precision, accuracy, and traceability to World Health Organization standards.

Today, rapid advancements in healthcare technology, a shortage of skilled workers, industry-wide consolidation, and the proven need to be ready for the next outbreak have health systems looking to lay a reliable foundation for the future. With proven performance, absolute automation, and unmatched flexibility delivering unparalleled throughput 24/7cobas 6800/8800 Systems are designed to ensure a labs long-term sustainability and success now, more than ever.

Learn more now: http://www.cobas68008800.com or http://diagnostics.roche.com.*May vary based on workflow demands

About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve peoples lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the worlds largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit http://www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References[1] Jamboti, J. S. (2016) BK virus nephropathy in renal transplant recipients. Nephrology, 21: 647 654. doi: 10.1111/nep.12728. [2] Hirsch HH, Randhawa PS; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13528. doi:10.1111/ctr.13528

Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Roche receives FDA clearance for BK virus quantitative test on cobas 6800/8800 Systems to support better care for transplant patients - GlobeNewswire

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