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Tauriga Sciences Inc. to Further Expand its Product Offerings With Dark Chocolate [20mg] CBD Infused Round Medallions
Basel, December 4, 2020 — Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi® (ruxolitinib) significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to best available therapy (BAT)1. The results of REACH3, the first successful, randomized Phase III trial in chronic GvHD, were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH). REACH3 is jointly sponsored by Novartis and Incyte.
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Novartis announces first data from REACH3 trial showing Jakavi® (ruxolitinib) significantly improved outcomes in patients with...
DECLARATION OF THE NUMBER OF SHARES AND VOTING RIGHTS
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Virbac : Declaration of the number of shares and voting rights 11/2020
Mechelen, Belgium; 4 December 2020, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises.
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Galapagos increases share capital through subscription right exercises
SAN JOSE, Dec. 04, 2020 (GLOBE NEWSWIRE) -- Anpac Bio-Medical Science Co., Ltd. (“Anpac Bio,” the “Company” or “we”) (ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, announced today the resignation of Ernst & Young Hua Ming LLP ("EY"), which previously was the independent registered public accounting firm of Anpac Bio, on November 3, 2020 and the appointment of Friedman LLP ("Friedman") as the Company's independent registered public accounting firm on December 2, 2020 to conduct the audit for the fiscal year ended December 31, 2020. The appointment of Friedman has been approved by both the audit committee and the board of directors (the "Board") of the Company. The change was not made due to any disagreements with EY.
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Anpac Bio Announces Change of Auditor
WALTHAM, Mass., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the company approved the grant of equity awards to two new employees with grant date of December 1, 2020, as equity inducement awards outside of the company's 2017 Stock Incentive Plan (but under the terms of the 2020 Inducement Stock Incentive Plan) and material to the employees’ acceptance of employment with the company. The equity awards were approved on October 27, 2020 and November 16, 2020, in accordance with Nasdaq Listing Rule 5635(c)(4).
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Apellis Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Basel, December 5, 2020 — Novartis announced analyses from two separate trials with Kymriah® (tisagenlecleucel) in patients with certain advanced lymphomas. In the interim analysis of the investigational Phase II ELARA study, Kymriah led to a complete response (CR) in 65% of patients with relapsed or refractory (r/r) follicular lymphoma (FL) and an overall response rate (ORR) of 83% after at least three months of follow-up. These patients continued to relapse or have refractory disease despite exposure to numerous lines of therapy (median four prior lines of therapy [range 2-13]) prior to Kymriah infusion1. The second analysis – a 40-month median follow-up from the Phase II JULIET trial – reported that the two-year progression-free survival (PFS) rate was 33% in patients with r/r diffuse large B-cell lymphoma (DLBCL), an important finding given these patients have limited treatment options that provide durable responses2. The JULIET study continued to show the effectiveness and well-characterized safety profile of Kymriah for these patients. These results were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH).
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Novartis analyses confirm benefit of Kymriah® with clinically meaningful rates of complete response seen in patients with certain advanced lymphomas
CAMBRIDGE, Mass., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that preclinical data with FTX-6058 for the treatment of sickle cell disease will be presented in three posters at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 5-8, 2020. FTX-6058 is a highly potent small molecule EED inhibitor that induces expression of fetal hemoglobin (HbF). Elevating HbF can compensate for the mutated adult hemoglobin that has been identified as the root cause of several hemoglobinopathies and can ameliorate or eliminate the symptoms of sickle cell disease.
Data support novel approach to develop and manufacture a best-in-class, durable medicine for people living with hemoglobinopathies
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Editas Medicine Announces Preclinical Data and Large-Scale Manufacturing Process for EDIT-301, in Development for the Treatment of Sickle Cell Disease...
CAMBRIDGE, Mass., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), is presenting new preclinical data in support of NTLA-5001, the company’s wholly owned Wilms’ Tumor 1 (WT1)-directed T cell receptor (TCR)-T cell therapy candidate for the treatment of acute myeloid leukemia (AML), at the 62nd American Society of Hematology (ASH) Annual Meeting, taking place virtually from December 5-8, 2020. NTLA-5001 capitalizes on how natural T cells recognize and respond to tumors. The target, WT1, is highly overexpressed in AML, a cancer of the blood and bone marrow that is often fatal despite existing treatments (NIH SEER Cancer Stat Facts: Leukemia – AML). The new preclinical data being presented today highlight the faster expansion and superior function of T cells manufactured by Intellia’s proprietary approach, compared to a standard genome editing process. Specifically, NTLA-5001’s lead TCR-T cells resulted in significantly higher anti-tumor activity in mouse models of acute leukemias than that observed in mice treated with cells engineered using the standard process.
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2020 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced positive initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma (MM). Data were presented at an oral session of the American Society of Hematology (ASH) annual meeting. This study utilizes ALLO-647, Allogene's anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen.
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Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL Study of ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory...
- Beta thalassemia: All seven patients were transfusion independent with 3 to 18 months of follow-up after CTX001 infusion -
– Evidence of biologic activity observed in each dose-escalation cohort treated to date –
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Kura Oncology Presents First Clinical Data for Menin Inhibitor KO-539 at American Society of Hematology Annual Meeting
Basel, 5 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from the pivotal phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta®/Venclyxto® (venetoclax)-based combinations in certain people with chronic lymphocytic leukaemia (CLL) and provide more evidence on the potential value of minimal residual disease (MRD). Data were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday 5 December 2020. “These results reinforce the long-term value of fixed-duration, chemotherapy-free Venclexta/Venclyxto-based combinations in CLL, potentially offering patients a significant period of time without treatment following initial therapy,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These data also reflect our ongoing commitment to accelerating clinical advancements for patients by exploring the novel endpoint minimal residual disease as a potential predictor of patient outcomes.” Five-year data from the pivotal phase III MURANO trial continue to show sustained investigator-assessed progression-free survival (PFS) with Venclexta/Venclyxto plus MabThera®/Rituxan® (rituximab). Data, presented in an oral session, showed:
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Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic...
- 9 of 14 Patients Showed Reduction in Tumor Size, Including Two Recently Reported Complete Responses -
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IGM Biosciences Presents First Clinical Data from IGM-2323 in Non-Hodgkin’s Lymphoma at 2020 ASH Annual Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (NASDAQ: MGTA) and bluebird bio, Inc. (NASDAQ: BLUE) today announced an exclusive clinical trial collaboration to evaluate the utility of MGTA-145, in combination with plerixafor, for mobilization and collection of stem cells in adults and adolescents with sickle cell disease (SCD). The data from this clinical trial could provide proof-of-concept for MGTA-145, in combination with plerixafor, as the preferred mobilization regimen for patients with SCD. bluebird bios experience with plerixafor as a mobilization agent in sickle cell disease aligns with Magentas combination therapy approach, utilizing MGTA-145 plus plerixafor with potential to achieve safe, rapid and reliable mobilization of sufficient quantities of high-quality stem cells to improve outcomes associated with stem cell transplantation. Under the collaboration, the stem cells will be fully characterized, and Magenta will undertake preclinical studies to evaluate the ability of these cells to be gene corrected and engrafted in mouse models. The companies will co-fund the clinical trial and Magenta will retain all rights to its product candidate.
We are excited to build upon our leading position in the field of ex-vivo gene therapy and the promising clinical data with LentiGlobin in SCD with a collaboration focused on achieving improved stem cell mobilization, said Dave Davidson, M.D., chief medical officer, bluebird bio. In this initial study, we hope to establish whether the combination of plerixafor with MGTA-145 can generate appropriate CD34+ stem cells with a single round of mobilization. If successful, we hope to evaluate this novel mobilization regimen with LentiGlobin to make another step forward in the treatment of patients with SCD.
Achieving reliable and rapid stem cell mobilization and a simplified collection process can ensure the entire patient experience is optimal with respect to therapeutic outcome. The incorporation of bluebird bios experience in this area of treatment will be immensely valuable in further developing MGTA-145 plus plerixafor to address the remaining unmet needs in gene therapy approaches for diseases like sickle cell disease, said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics. We look forward to collaborating with bluebird bio to evaluate MGTA-145 as the preferred mobilization option for people with sickle cell disease.
SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS), causing red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive events (VOEs). For adults and children living with SCD, this means unpredictable episodes of excruciating pain due to vaso-occlusion as well as other acute complicationssuch as acute chest syndrome (ACS), stroke, and infections, which can contribute to early mortality in these patients.
Currently available mobilization drugs, including granulocyte-colony stimulating factor (G-CSF), a commonly used mobilization agent administered over the course of five to seven days in other transplant settings, is not used in sickle cell disease because it can trigger vaso-occlusive crises and even death in adults and adolescents. Plerixafor is used to mobilize a patients stem cells for collection prior to transplant and while an available treatment option, multiple cycles of apheresis and collection may sometimes be required to generate sufficient stem cells for gene therapy. Magenta is developing MGTA-145, in combination with plerixafor, to be the preferred mobilization regimen for rapid and reliable mobilization and collection of hematopoietic stem cells (HSCs) to improve stem cell transplantation outcomes in multiple disease areas, including genetic diseases such as sickle cell disease, as well as blood cancers and autoimmune diseases.
About Magenta Therapeutics MGTA-145
MGTA-145, in combination with plerixafor, has demonstrated, in a recently completed Phase 1 study in healthy volunteers, it can rapidly and reliably mobilize high numbers of functional stem cells in a single day, without the need for G-CSF. MGTA-145 works in combination with plerixafor to harness a physiological mechanism of stem cell mobilization to rapidly and reliably mobilize HSCs for collection and transplant across multiple indications.
Additionally, as shown in preclinical studies, stem cells mobilized with MGTA-145 can be efficiently gene-modified and are able to engraft, potentially allowing for safer and more efficient mobilization for gene therapy approaches to treat sickle cell disease and other genetic diseases.
Magenta completed its Phase 1 trial of MGTA-145 in healthy volunteers, demonstrating MGTA-145 was well tolerated and enables same-day dosing, mobilization and simplified collection of sufficient stem cells for transplant, meeting all primary and secondary endpoints.
About bluebird bio, Inc.
bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene and cell therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.
bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders: cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using gene and cell therapy technologies including gene addition, and (megaTAL-enabled) gene editing.
bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.
Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.
LentiGlobin and bluebird bio are trademarks of bluebird bio, Inc.
About Magenta Therapeutics
Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with autoimmune diseases, genetic diseases and blood cancers. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients.
Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.
Follow Magenta on Twitter: @magentatx.
Forward-Looking Statement
This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, will, could, should, expects, intends, plans, anticipates, believes, estimates, predicts, projects, seeks, endeavour, potential, continue or the negative of such words or other similar expressions can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation risks set forth under the caption Risk Factors in Magentas Annual Report on Form 10-K filed on March 3, 2020, and in bluebird bios Annual Report on Form 10-K filed on February 18, 2020, as updated by each companys most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta and bluebird bio believe that the expectations reflected in the forward-looking statements are reasonable, neither Magenta nor bluebird bio can guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Magenta or bluebird bio, nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Neither Magenta nor bluebird undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
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Magenta Therapeutics and bluebird bio Announce a Phase 2 Clinical Trial Collaboration to Evaluate Magenta's MGTA-145 for Mobilizing and Collecting...
3 of 4 Patients Evaluable for Efficacy in Dose Escalation Cohorts 2 and 3 Show Objective Response, with 2 Patients Achieving Complete Response
No Observed Events of Any Grade of Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, or Graft-vs-Host Disease
Six Doses of FT516 were Well-tolerated with No FT516-related Grade 3 or Greater Adverse Events Reported by Investigators
Management to Host Virtual Event Entitled The Power of hnCD16 Today at 4:30 PM Eastern Time
SAN DIEGO, Dec. 04, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced positive interim data from the Companys dose escalation Phase 1 study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. FT516 is the Companys universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.
We are highly encouraged by these Phase 1 data, which clearly demonstrate that off-the-shelf, iPSC-derived NK cells can drive complete responses for cancer patients and that our proprietary hnCD16 Fc receptor can effectively synergize with and enhance the mechanism of action of tumor-targeted antibodies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Importantly, the safety profile of FT516 continues to suggest multiple doses of iPSC-derived NK cells can be administered in the outpatient setting, and supports potential use across multiple lines of therapy, including as part of early-line CD20-targeted monoclonal antibody regimens, for the treatment of B-cell lymphoma.
As of a November 16, 2020 data cutoff, three patients in the second dose cohort of 90 million cells per dose and one patient in the third dose cohort of 300 million cells per dose were available for assessment of safety and efficacy. All four patients were heavily pre-treated, having received at least two prior rituximab-containing regimens. Each patient received two 30-day treatment cycles, with each cycle consisting of fludarabine and cyclophosphamide lympho-conditioning followed by three once-weekly doses of FT516, IL-2 cytokine support, and rituximab.
Safety DataAll four relapsed / refractory patients were administered FT516 in an outpatient setting with no requirement for inpatient monitoring. No dose-limiting toxicities, and no cases of any grade of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease, were observed. The multi-dose, two-cycle treatment regimen was well-tolerated with no FT516-related grade 3 or greater adverse events reported by investigators. In addition, no evidence of anti-product T- or B-cell mediated host-versus-product alloreactivity was detected, supporting the potential to safely administer up to six doses of FT516 in the outpatient setting without patient matching. All grade 3 or greater treatment emergent adverse events were not related to FT516 and were consistent with lympho-conditioning chemotherapy and underlying disease.
Activity DataThree of four relapsed / refractory patients achieved an objective response, including two complete responses (CR), following the second FT516 treatment cycle as assessed by PET-CT scan per Lugano 2014 criteria. A CR was achieved in one patient with diffuse large B-cell lymphoma (DLBCL) who was most recently refractory to a rituximab-containing treatment regimen, and a CR was achieved in one patient with follicular lymphoma (FL) who had previously been treated with four rituximab-containing treatment regimens. Notably, in one patient for which an interim tumor assessment showed a partial response following the first FT516 treatment cycle, the response deepened to a CR following administration of the second FT516 treatment cycle, suggesting that additional FT516 treatment cycles can confer clinical benefit.
M = million; CR = Complete Response; PR = Partial Response; PD = Progressive DiseaseAs of November 16, 2020 database entry. Data subject to cleaning and source document verification.1 Day 29 of the second FT516 treatment cycle as assessed per Lugano 2014 criteria
Dose escalation is continuing in the current dose cohort of 300 million cells per dose in combination with rituximab, and a fourth dose cohort of 900 million cells per dose in combination with rituximab is planned. The Company previously reported that two patients treated in the first dose cohort of 30 million cells per dose in combination with rituximab showed a protocol-defined response assessment of progressive disease. No events of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease were observed in either patient.
About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.
About FT516FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Scientists from the Company have shown in a peer-reviewed publication (Blood. 2020;135(6):399-410) that hnCD16 iPSC-derived NK cells, compared to peripheral blood NK cells, elicit a more durable anti-tumor response and extend survival in combination with anti-CD20 monoclonal antibodies in an in vivo xenograft mouse model of human lymphoma. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in an open-label, multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).
About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.
Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the safety and therapeutic potential of the Companys iPSC-derived NK cell product candidates, including FT516, its ongoing and planned clinical studies, and the expected clinical development plans for FT516. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties or delays in subject enrollment in current and planned clinical trials, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com
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Fate Therapeutics Reports Positive Interim Data from its Phase 1 Study of FT516 in Combination with Rituximab for B-cell Lymphoma - GlobeNewswire
GlobeNewswire
Updated data from the ALLCAR study suggests AUTO1s potential for transformational activity in adult patients with r/r ALL Conference call and webcast to be held Monday, December 7, 2020at 4:00 pm ET / 9:00 pm GMTLONDON, Dec. 05, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced new data highlighting progress on its AUTO1 program, the companys CAR T cell therapy being investigated in the ongoing ALLCAR Phase 1 study in relapsed / refractory adult B-Acute Lymphocytic Leukemia (ALL), during the American Society of Hematology (ASH) All-Virtual Annual Meeting, held between December 5-8, 2020.As of the November 12, 2020 data cut-off date, 20 patients with r/r ALL had received AUTO1. AUTO1 was well tolerated, with no patients experiencing Grade 3 cytokine release syndrome (CRS). Three patients (15%), all of whom had high leukemia burden (>50% blasts), experienced Grade 3 neurotoxicity (NT) that resolved swiftly with steroids.Of the 19 patients evaluable for efficacy, 16 (84%) patients achieved minimum residual disease (MRD)-negative complete response (CR) at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival (EFS) at six and 12 months is 69% and 52% respectively. Median EFS and overall survival (OS) has not been reached at a median follow up of 16.9 months (range up to 30.5 months).The high level of sustained CRs observed with AUTO1 in adult ALL, achieved without subsequent stem cell transplant, point to a potentially transformational treatment for adult ALL, said Dr. Claire Roddie,Consultant Hematologist,UCL Cancer Institute and University College London Hospital. Despite high disease burden and despite this being a heavily pre-treated patient population on study, AUTO1 remains well tolerated. Its encouraging to also observe promising early activity and safety in indolent NHL.Adult ALL is a disease with high unmet need, whereby approximately 60% of patients relapse or are refractory to first line therapy, said Dr. Elias Jabbour, Professor of Leukemia at The University of Texas MD Anderson Cancer Center.AUTO1 is a novel CD19 CAR T candidate with an impressive clinical profile. This profile has the potential to change standard of care as a curative therapy for r/r ALL.Dr.Christian Itin, chairman and chief executive officer of Autolus, addedWe are excited about the long-term remissions observed without a need for an additional stem cell transplant. Remarkably, this outstanding result was achieved with a well-tolerated safety profile in this fragile adult ALL population. We believe the unique characteristics of AUTO1, seen in the ALLCAR study, point to the potential for AUTO1 as a standalone and transformational therapy in r/r ALL. Our Phase 1b/2 pivotal study is under way, however, with the escalating COVID-19 pandemic, enrolment projections have had to be adjusted. We now expect to enroll patients throughout 2021 with a full data set in 2022.In addition to adult ALL, the ALLCAR study was extended to patients with indolent B cell Non-Hodgkin Lymphoma (NHL) (Cohort 1), high grade B-NHL (Cohort 2) and chronic lymphocytic leukemia(CLL) (Cohort 3). As of the data cut-off date ofNovember 12, 2020, four patients in Cohort 1 had been infused with AUTO1.AUTO1 was well tolerated, with no patients experiencing Grade 2 CRS and no patients experiencing NT of any grade. All four patients achieved a Complete Metabolic Response (CMR).Investor call on Monday December 7, 2020 Management will host a conference call and webcast on Monday, December 7, 2020 at4:00 pm ET/9:00 pm GMT to discuss the ASH data. To listen to the webcast and view the accompanying slide presentation, please go to:https://www.autolus.com/investor-relations/news-and-events/events.The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 9188389. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 9188389.About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information please visit http://www.autolus.com. About AUTO1 AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety - while maintaining similar levels of efficacy - compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. AUTO1 is currently being evaluated in two Phase 1 studies, one in pediatric ALL and one in adult ALL. The company has also now progressed the program to a potential pivotal study, AUTO1-AL1.About AUTO1-AL1 pivotal study The AUTO1-AL1 study will enroll patients with relapsed / refractory ALL. The study will have a short Phase1b component prior to proceeding to a single arm Phase 2 study. The primary end point is overall response rate and the key secondary end points include duration of response, MRD negative CR rate and safety. The study will enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the US,UKandEurope.Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of AUTO3 and the future clinical development of AUTO3 including progress, expectations as to the reporting of data, conduct and timing. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 3, 2020, as amended, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.Contact: Lucinda Crabtree, PhD Vice President, Investor Relations and Corporate Communications +44 (0)7587 372 619 l.crabtree@autolus.comJulia Wilson +44 (0) 7818 430877 j.wilson@autolus.comSusan A. Noonan S.A. Noonan Communications +1-212-966-3650 susan@sanoonan.com
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One sneaky player prop trend to watch for - Yahoo Sport Australia
A new research document is added in DBMR database of 350 pages, titled as Global Cancer Nanomedicine Market Size, Share, Growth, Trends, Industry By Type (Inorganic Nanoparticles, Organic Nanoparticles), Agent Type (Diagnostic Agents, Therapeutic Agents, Drug Delivery Agents), Mechanism (Targeting Tumor Cells, Nanocarrier Drug Complex, Drug Release Systems), Cancer Type (Breast Cancer, Pancreatic Cancer, Brain Cancer, Lung Cancer, Others), Imaging Technique (Positron Emission Tomography, Single Photon Emitted Tomography, Magnetic Resonance Imaging (MRI)), Phase (Research, Preclinical, Phase-I, Phase-I/II, Phase-II, Phase-III) Country and Forecast with detailed analysis, Competitive landscape, forecast and strategies. Latest analysis highlights high growth emerging players and leaders by market share that are currently attracting exceptional attention. The identification of hot and emerging players is completed by profiling 50+ Industry players; some of the profiled players are Alnylam Pharmaceuticals, Inc., Amgen Foundation, Inc., Arrowhead Pharmaceuticals, Inc., AstraZeneca, Cadila Pharmaceuticals, etc. The study conducted for Cancer Nanomedicine industry also analyses the market status, size, share, growth rate, future trends, market drivers, opportunities and challenges, risks and entry barriers, sales channels, and distributors with the help of SWOT analysis and Porters Five Forces Analysis.
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Data Bridge Market Research analyses the Cancer Nanomedicine Market to grow at a CAGR of 12.50% in the forecast period. The growing usages of nanomedicine in drug delivery technology will further create various opportunities for the growth of the market.
The Cancer Nanomedicine Market report encompasses the general idea of the global Cancer Nanomedicine market including definition, classifications, and applications. Further, it includes the all-inclusive comprehension of several factors such as drivers, constraints, and major micro markets. The report is a wide-ranging source of widespread facts and figures for business strategists as it offers the historical &futuristic data such as demand & supply data, cost, revenue, profit, supply chain value, and so on. Furthermore, it entails the key market features, comprising production, revenue, price, capacity, gross margin, market share, consumption, gross, production rate, demand/supply, cost, capacity utilization rate, export/import, and CAGR (compound annual growth rate). In addition the report encompasses global Cancer Nanomedicine market segmentation on the basis of diverse facets like product/service type, application, technology, end-users, and major geographic regions North America, Europe, Asia-Pacific and Latin America. Apart from this, the researcher market analyst and experts present their outlook or insights of product sales, market share, and value along with the possible opportunities to grow or tap into in these regions.
Overview:
Surging volume of patients suffering from cancer, and other chronic disorders, increasing number of geriatric population across the globe, increasing development of nanotechnology-based drugs as well as therapies, adoption of advanced technologies are some of the factors which will likely to enhance the growth of the cancer nanomedicine market in the forecast period of 2020-2027. On the other hand, surging levels of investment on research and development activities along with introduction of advanced diagnostics procedure which will further bring immense opportunities for the growth of the cancer nanomedicine market in the above mentioned forecast period.
Low rate of adoption along with increasing side effects associated with the consumption of nanoparticles, stringent regulatory framework for approvals of drugs are acting as market restraints for the growth of the cancer nanomedicine market in the above mentioned forecast period.
According to this report Global Cancer Nanomedicine Market will rise from Covid-19 crisis at moderate growth rate during 2020 to 2027. Cancer Nanomedicine Market includes comprehensive information derived from depth study on Cancer Nanomedicine Industry historical and forecast market data. Global Cancer Nanomedicine Market Size To Expand moderately as the new developments in Cancer Nanomedicine and Impact of COVID19 over the forecast period 2020 to 2027.
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Cancer Nanomedicine Market report provides depth analysis of the market impact and new opportunities created by the COVID19/CORONA Virus pandemic. Report covers Cancer Nanomedicine Market report is helpful for strategists, marketers and senior management, And Key Players in Cancer Nanomedicine Industry.
Key Segmentation:
By Type (Inorganic Nanoparticles, Organic Nanoparticles)
By Agent Type (Diagnostic Agents, Therapeutic Agents, Drug Delivery Agents)
By Mechanism (Targeting Tumor Cells, Nanocarrier Drug Complex, Drug Release Systems)
By Cancer Type (Breast Cancer, Pancreatic Cancer, Brain Cancer, Lung Cancer, Others)
By Imaging Technique (Positron Emission Tomography, Single Photon Emitted Tomography, Magnetic Resonance Imaging (MRI))
By Phase (Research, Preclinical, Phase-I, Phase-I/II, Phase-II, Phase-III)
Leading Players operating in the Cancer Nanomedicine Market are:
Complete Report is Available (Including Full TOC, List of Tables & Figures, Graphs, and Chart)@ https://www.databridgemarketresearch.com/covid-19-impact/global-cancer-nanomedicine-market
The Cancer Nanomedicine market report also entails the vigorous evaluation about the growth plot and all opportunities &risk related to of global Cancer Nanomedicine market during the forecast period. In addition, the report comprises the key events and most recent innovations in the industry together with the prospective trends technological progresses within the global Cancer Nanomedicine market that can impact its expansion graph. Entailing the pivotal data on the markets statistics and dynamics, the report will serve as a valued asset in term of decision-making and guidance for the businesses and companies already active within industry or looking forward to enter into it.
Global Cancer Nanomedicine Market Scope and Market Size
Cancer nanomedicine market is segmented on the basis of type, agent type, mechanism, cancer type, imaging technique, and phase. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.
Based on type, cancer nanomedicine market is segmented into inorganic nanoparticles, and organic nanoparticles. Inorganic nanoparticles have been further segmented into synthesis of gold nanoparticle. Organic nanoparticles have been further segmented into polymeric nanoparticle, and lipid organic nanoparticles.
On the basis of agent type, cancer nanomedicine market is segmented into diagnostic agents, therapeutic agents, and drug delivery agents. Diagnostic agents have been further segmented into cancer biomarkers, diagnostic device and nanoprobes, and quantum dots. Diagnostic device and nanoprobes have been further sub segmented into biosensors, and microarrays. Therapeutic agents have been further segmented into photodynamic therapy, and photo thermal therapy.
Based on mechanism, cancer nanomedicine market is segmented into targeting tumor cells, nanocarrier drug complex, and drug release systems. Targeting tumor cells have been further segmented into passive targeting, and active targeting. Nanocarrier drug complex have been further segmented into liposomes, dendrimers, micelles, and inorganic nanocarriers.
On the basis of cancer type, cancer nanomedicine market is segmented into breast cancer, pancreatic cancer, brain cancer, lung cancer, and others.
Based on imaging technique, cancer nanomedicine market is segmented into positron emission tomography, single photon emitted tomography, and magnetic resonance imaging (MRI).
Cancer nanomedicine market has also been segmented based on the phase into research, preclinical, phase-I, phase-I/II, phase-II, and phase-III.
Geographically, the following regions together with the listed national/local markets are fully investigated:
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Reason to Buy
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Also, Research Report Examines:
Table of Content:
Market Overview: The report begins with this section where product overview and highlights of product and application segments of the global Cancer Nanomedicine Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product
Competition by Company: Here, the competition in the Worldwide Cancer Nanomedicine Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.
Company Profiles and Sales Data:As the name suggests, this section gives the sales data of key players of the global Cancer Nanomedicine Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the global Cancer Nanomedicine Market.
Market Status and Outlook by Region:In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the global Cancer Nanomedicine Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.
Application or End User:This section of the research study shows how different end-user/application segments contribute to the global Cancer Nanomedicine Market.
Market Forecast:Here, the report offers a complete forecast of the global Cancer Nanomedicine Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.
Research Findings and Conclusion:This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.
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Cancer Nanomedicine Market to Build Excessive Revenue at Healthy Growth rate at 12.50% up to 2027 - PharmiWeb.com
Sensors that track everything from infection in the lungs to WiFi usage on a busy university campus are poised to enhance our understanding of, and approach to improving, human health at many levels a trend that has been accelerated by the challenges of the Covid-19 pandemic, researchers and experts said at the 2020 SENSE.nano Symposium.
Videos from the event are now available online, so anyone can view the presentations and panel discussions featuring leaders from research and industry, representatives of MIT-launched startup companies, and current MIT graduate students.
Held online earlier this semester, the symposium offered a glimpse at how sensing technologies are being used to sense and quantify life at all scales, from subcellular up to large populations. It was the fourth annual meeting organized by SENSE.nano around significant themes relevant to disciplines and industries with a focus on sensors, sensing systems, and sensing technologies.
Delivering SENSE.nano as a virtual, online event permitted more than 600 individuals from 250 organizations to join us for the three half-days of the symposium, says Vladimir Bulovi, founding faculty director of MIT.nano and Fariborz Maseeh Professor of Emerging Technology. Over 80 percent of attendees were from industry, fulfilling our goal of relating academic discoveries to practitioners who can broadly scale these ideas.
Professor Elazer Edelman, director of the Institute for Medical Engineering and Science and Edward J. Poitras Professor in Medical Engineering and Science at MIT, gave the opening keynote on the first day of the 2020 SENSE.nano Symposium.
See the full agenda and watch videos of the speakers and sessions.
The event featured sessions on sensing at four levels: cell and subcellular, organs, body systems, and populations. The focus was on life as a system. The functions of the body and how we interact as human beings was celebrated across the scales at SENSE.nano 2020, says Brian W. Anthony, associate director of MIT.nano and faculty lead for the Industry Immersion Program in Mechanical Engineering. The SENSE event helped to highlight what is happening at these different scales, made explicit some connections across research domains, and hopefully also made explicit some opportunities.
Several of the presentations focused on applications for the current pandemic. Speakers discussed rapid antigen detection for infectious pathogens, detecting Covid-19-related changes in the voice using mobile phones, and understanding how pandemic misinformation propagates through social media, among other topics. One panel discussion offered insights into how the pandemic is affecting workspace design, clinical testing, and child development; another panel discussion offered insight into unique needs and opportunities for commercial innovations.
Elazer Edelman, director of the MIT Institute for Medical Engineering and Science (IMES) and keynote speaker on day one of the symposium, offered a historical perspective on sensing the body through the lens of his care for a cardiovascular patient who developed Covid-19. From Leonardo da Vincis glass models of heart circulation to the 19 pieces of equipment collecting data from the cardiovascular patients hospital bed, health care has been transformed by a marriage between medicine and science and engineering technology at all scales that has actually changed our lives, Edelman said.
Researchers working at the cutting edge of sensing technology must commit to sharing their findings, cautioned Edelman, who also serves as the Edward J. Poitras Professor in Medical Engineering and Science at MIT. The most important thing, I think, is to realize that engineers like us, scientists like us, clinicians like us, have a responsibility to the community, not simply to the clinic or the hospital. The most important thing we can do, therefore, is get all of our technology as quickly as possible out into the general population.
Digital technology is finally becoming mature enough and is giving us the tools to revolutionize how healthcare will be delivered, said Brendan Cronin, director of Digital Healthcare Group at Analog Devices and keynote speaker on day two of the symposium. Nano sensors will be used to diagnose illness faster and be used to invent new medicine in the case of synthetic biology, smart devices will routinely monitor our bodies and the environment and help manage our disease in a semi- or autonomous way, [and] doctors will routinely use digital tools to predict acute events rather than react to them, he said.
Sensing technologies face many of the same challenges of acceptance, equity, and ease of use that are found throughout health care, researchers suggested in another panel discussion. Sensors and sensing systems need to be developed with guidance from users on exactly what information or decisions they need to make with this data, while taking advantage of ubiquitous technologies such as mobile phones, they noted. Speakers also cautioned against developing technologies and systems that replicate the biases against people of color and women that have led to unequal care in the past.
The symposium was sponsored by MIT.nano, the MIT Industrial Liaison Program, MIT Institute for Medical Engineering and Science, and the MIT Clinical Research Center.
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Sensing the body at all scales - MIT News