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Data Bridge Market Research has recently published the Global research Report Titled: Psoriatic Arthritis Treatment Market

The research and analysis conducted in Psoriatic Arthritis Treatment report help clients to predict investment in an emerging market, expansion of market share, or success of a new product with the help of global market research analysis. This report has been designed in such a way that it provides a very evident understanding of the business environment and Psoriatic Arthritis Treatment industry. Nevertheless, this global market research report unravels many business problems very quickly and easily. Due to high demand and the value of market research for the success of different sectors, Psoriatic Arthritis Treatment Market report is provided that covers many work areas.

Global psoriatic arthritistreatment market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market is growing with the healthy CAGR in the above-mentioned forecast period. Factors such as growing number of smokers, alcoholism and obesity are propelling the growth of psoriatic arthritistreatment market globally.

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The Global Psoriatic Arthritis Treatment Market research report assembles data collected from different regulatory organizations to assess the growth of the segments. In addition, the study also appraises the global Psoriatic Arthritis Treatment market on the basis of topography. It reviews the macro- and microeconomic features influencing the growth of the Psoriatic Arthritis Treatment Market in each region. Various methodological tools are used to analyze the growth of the worldwide Psoriatic Arthritis Treatment market.

Prominent Key Players Covered in the report:

GlaxoSmithKline plc, Cumberland Pharmaceuticals Inc, Amneal Pharmaceuticals LLC, ANI Pharmaceuticals, Inc., Novartis AG, Alvogen, Bayer AG,Currax Pharmaceuticals LLC,Mylan N.V., Azurity Pharmaceuticals, Inc., Antares Pharma, Cumberland Pharmaceuticals Inc., Vintage Labs, Pfizer Inc., Samsung Biologics, Amgen Inc, Johnson & Johnson Services, Inc.

Regional Analysis Includes:

Scope of Report:

Psoriatic Arthritis Treatment MarketGlobal industry research report is a professional and in-depth study on the market size, growth, share, trends, as well as industry analysis. The report begins with an overview of the industrial chain structure and describes the upstream. Besides, the report analyses market size and forecast in different geographies, type and end-use segment, in addition, the report introduces market competition overview among the major companies and companys profiles, besides, market price and channel features are covered in the report. Furthermore, market size, the revenue share of each segment and its sub-segments, as well as forecast figures are also covered in this report.

Important Features that are under offering & key highlights of the report:

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Moreover, the report gives production, consumption, sales, and other market forecasts. The document contains the details associate with sales channels, suppliers, traders, dealers, research findings and conclusion, etc for the Psoriatic Arthritis Treatment market. In-depth global market progress and outlook linked with the factors boosting the market are explained in the report.

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Key Questions Answered:

Table Of Contents

Part 01: Executive Summary

Part 02: Scope of the Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers and Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

In conclusion, the Psoriatic Arthritis Treatment Market report is a reliable source for accessing the research data that is projected to exponentially accelerate your business. The report provides information such as economic scenarios, benefits, limits, trends, market growth rates, and figures. SWOT analysis is also incorporated in the report along with speculation attainability investigation and venture return investigation.

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Psoriatic Arthritis Treatment Market revenue to expand at significant CAGR through 2027 - The Daily Chronicle

Rheumatoid Arthritis Drugs Market Scenario 2020-2028:This detailed market study covers Rheumatoid Arthritis Drugs Market growth potentials which can assist the stakeholders to understand key trends and prospects in the Rheumatoid Arthritis Drugs market identifying the growth opportunities and competitive scenarios. The report also focuses on data from different primary and secondary sources and is analyzed using various tools. It helps to gain insights into the markets growth potential, which can help investors identify scope and opportunities. The analysis also provides details of each segment in the global Rheumatoid Arthritis Drugs market

Rheumatoid Arthritis Drugs

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Company profiled in this report based on Business overview, Financial data, Product landscape, Strategic outlook & SWOT analysis: AbbVie Inc., Amgen Inc., Bayer AG, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company

According to the report, the Rheumatoid Arthritis Drugs market report points out national and global business prospects and competitive conditions for Rheumatoid Arthritis Drugs. Market size estimation and forecasts were given based on a detailed research methodology tailored to the conditions of the demand for Rheumatoid Arthritis Drugs. The Rheumatoid Arthritis Drugs market has been segmented as By Type of Molecule (Pharmaceuticals, Biopharmaceuticals), By Drug Class (Non-steroidal Anti-inflammatory Drugs (NSAIDs), Corticosteroids, Analgesics) . Historical background for the demand of Rheumatoid Arthritis Drugs has been studied according to organic and inorganic innovations in order to provide accurate estimates of the market size. Primary factors influencing the growth of the demand Rheumatoid Arthritis Drugs have also been established with potential gravity.

Regional segmentation and analysis to understand growth patterns: The market has been segmented in major regions to understand the global development and demand patterns of this market. By region, the Rheumatoid Arthritis Drugs market has been segmented in North America, Europe, Asia Pacific, Middle East & Africa, and South America. The North America and Western Europe regions are estimated to register a stable demand during the forecast period with market recovery from recent slowdowns.

North America region includes the US, Canada, and Mexico. The US is estimated to dominate this market with a sizeable share followed by Canada, and Mexico. The industrial sector is a major contributor to the US and Canada economies overall. Hence, the supply of advanced materials in production activities is critical to the overall growth of industries in this region.

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Europe region is dominated by Germany, the UK, France, Italy, and Spain. These countries also have a strong influence on the industrial sector resulting in sizeable demand for the Rheumatoid Arthritis Drugs market. Asia Pacific is estimated to register the highest CAGR by region during the forecast period. The presence of some of the high growth economies such as China and India is expected to propel the demand in this region. Besides, this region has witnessed strategic investments by major companies to increase their market presence. The Middle East and Eastern Europe are estimated to be other key regions for the Rheumatoid Arthritis Drugs market with a strong market potential during the forecast period. The rest of the World consisting of South America and Africa are estimated to be emerging markets during the forecast period.

This report provides: 1) An overview of the global market for Rheumatoid Arthritis Drugs market and related technologies.2) Analysis of global market trends, yearly estimates, and annual growth rate projections for compounds (CAGRs).3) Identification of new market opportunities and targeted consumer marketing strategies for the global Rheumatoid Arthritis Drugs market.4) Analysis of R&D and demand for new technologies and new applications5) Extensive company profiles of key players in the industry.

The researchers have studied the market in-depth and have developed important segments such as product type, application, and region. Each and every segment and its sub-segments are analyzed based on their market share, growth prospects, and CAGR. Each market segment offers in-depth, both qualitative and quantitative information on market outlook.

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Objectives of this report: To estimate the market size for the Rheumatoid Arthritis Drugs market on a regional and global basis. To identify major segments in the Rheumatoid Arthritis Drugs market and evaluate their market shares and demand. To provide a competitive scenario for the Rheumatoid Arthritis Drugs market with major developments observed by key companies in the historic years. To evaluate key factors governing the dynamics of the Rheumatoid Arthritis Drugs market with their potential gravity during the forecast period.

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Rheumatoid Arthritis Drugs Market: Prospective Growth Trends & Incremental Opportunity Assessment till 2028 - The Daily Chronicle

Market Study Report LLC presents an extensive report on Rheumatoid Arthritis Therapeutics market that offers qualitative information about prevailing trends and a detailed analysis of the growth trajectory of this industry. It also includes a study of the historical data and detailed statistics that will help determine the future scope of the industry in terms of commercialization opportunities.

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The Rheumatoid Arthritis Therapeutics research report provides a detailed assessment of this business sphere. This report also estimates the market share and growth rate attained over the forecast period. The report unravels all the key aspects of Rheumatoid Arthritis Therapeutics market including revenue forecasts, industry size, and sales amassed with respected to each industry segment. The key growth drivers and the restraints of this industry vertical have also been elucidated in the report.

Understanding the Rheumatoid Arthritis Therapeutics market with respect to the regional landscape:

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Rheumatoid Arthritis Therapeutics Market Presents an Overall Analysis, Trends and Forecast to 2025 - The Daily Chronicle

It is worth mentioning this is highly beneficial in cases of arthritis. Further, glucosamine has been able to demonstrate its remarkable ability to lessen collagen breakdown.

(Newswire.net -- September 21, 2020) Orlando, FL -- Arthritis is undeniably a painful condition, and unfortunately, it affects millions and millions of people worldwide. Aside from pain, individuals with this disease also suffer from other symptoms like fatigue.

Experts have time and again warned that there are actually culprits behind fatigue in cases of arthritis. It may be due to depression, which actually goes hand in hand with the disease. The loss of muscle mass may also be a culprit.

It is worth noting that losing muscle tissue burdens the remaining muscles during body movements.

Inactivity is one of the common reasons behind the loss of muscle mass. However, there are those with severe inflammatory arthritis that also suffer from cachexia, which happens when there are decreases in muscle mass and increases in fatigue.

Some other medical conditions increases the odds of fatigue, such as lung disease, heart disease, diabetes, and inflammatory bowel disease. There are also other conditions not linked with arthritis found to result in fatigue.

These are thyroid disease, kidney or liver disease, and chronic fatigue syndrome. Arthritis is often managed through the use of certain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs).

These medications are useful in temporarily easing pain and enhancing mobility. Individuals who are looking for safer pain relievers may take into account the use of supplements like glucosamine, which is a widely studied natural amino sugar.

Over decades, researchers have been carrying out studies to look into the beneficial effects of this remedy. It has been found that it works in enhancing the health and protection of the joint cartilage.

It is worth mentioning this is highly beneficial in cases of arthritis. Further, glucosamine has been able to demonstrate its remarkable ability to lessen collagen breakdown. In individuals with osteoarthritis, this remedy may be helpful in lessening inflammation.

This is due to the fact that inflammation is found to be one of the major culprits of joint cartilage breakdown.

There are many studies looking into the healing goodness of this remedy. Studies have time and again revealed that the use of this remedy worked in lessening pain as well as enhancing function among adults with osteoarthritis.

This therapeutic remedy has also been found helpful in improving overall symptoms, such as stiffness and pain.

Today, formulas like VitaBreeze Glucosamine are widely resorted to by individuals with this condition. While there are many formulas available in the global market today, this one from VitaBreeze is thought widely to be superior over others (www.amazon.com/Glucosamine-Chondroitin-Turmeric-Dietary-Supplement/dp/B00DUMO9X4).

VitaBreeze is a nutraceutical brand that manufactures high-quality natural supplements to help people live a healthy, enjoyable, and longer life. All of the companys products are manufactured in the United States using the finest-quality ingredients that have been carefully selected, tested, and crafted into the firms winning formulas. Visit http://www.VitaBreeze.com to learn more.

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Health Authorities Warn About the Reasons Behind Fatigue in Arthritis - Newswire

The Canine Arthritis Treatment Market study offers an in-depth analysis of the current market trends influencing this business vertical. The study also includes market valuation, market size, revenue forecasts, geographical spectrum and SWOT Analysis of the industry. In addition, the report depicts key challenges and growth opportunities faced by the industry bigwigs, in consort with their product offerings and business strategies.

A collective analysis of Canine Arthritis Treatment Market offering an exhaustive study based on current trends influencing this vertical across various geographies has been provided in the report. Also, this research study estimates this space to accrue considerable income during the projected period, with the help of a plethora of driving forces that will boost the industry trends during the forecast duration. Snippets of these influences, in tandem with countless other dynamics relating to the Canine Arthritis Treatment Market, like the risks that are predominant across this industry along with the growth prospects existing in Canine Arthritis Treatment Market, have also been charted out in the report.

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The report provides extensive data concerning the market share that each one of these companies presently gather throughout this business, followed by the market share that they are anticipated to acquire by the end of the predicted timeframe. Also, the report expounds on details relating to the goods manufactured by these firms, that would help new industry participants and major stakeholders work on their competition and portfolio strategies. In addition, their policymaking process is likely to get easier since the Canine Arthritis Treatment Market report also enumerates an idea of the trends in product prices and the revenue margins of all the major companies partaking in the industry share.

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Canine Arthritis Treatment Market to Witness a Healthy YoY Growth during 2018 2028 - The Daily Chronicle

Given the debilitating impact of COVID-19 (Coronavirus) on the Psoriatic Arthritis Therapeutics market, companies are vying opportunities to stay afloat in the market landscape. Gain access to our latest research analysis on COVID-19 associated with the Psoriatic Arthritis Therapeutics market and understand how market players are adopting new strategies to mitigate the impact of the pandemic.

The report provides both quantitative and qualitative information of global Psoriatic Arthritis Therapeutics market for period of 2018 to 2025. As per the analysis provided in the report, the global market of Psoriatic Arthritis Therapeutics is estimated to growth at a CAGR of _% during the forecast period 2018 to 2025 and is expected to rise to USD _ million/billion by the end of year 2025. In the year 2016, the global Psoriatic Arthritis Therapeutics market was valued at USD _ million/billion.

This research report based on Psoriatic Arthritis Therapeutics market and available with Market Study Report includes latest and upcoming industry trends in addition to the global spectrum of the Psoriatic Arthritis Therapeutics market that includes numerous regions. Likewise, the report also expands on intricate details pertaining to contributions by key players, demand and supply analysis as well as market share growth of the Psoriatic Arthritis Therapeutics industry.

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Psoriatic Arthritis Therapeutics Market Overview:

The Research projects that the Psoriatic Arthritis Therapeutics market size will grow from in 2018 to by 2024, at an estimated CAGR of XX%. The base year considered for the study is 2018, and the market size is projected from 2018 to 2024.

Leading manufacturers of Psoriatic Arthritis Therapeutics Market:

key players and product offerings

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Psoriatic Arthritis Therapeutics Market To Witness A Considerable CAGR Growth Through The Forecast Period 2017 2025 - The Daily Chronicle

According to results of an observational study, nearly half of real-world patients developing a rheumatologic immune-related adverse event (irAE) while undergoing treatment with an immune checkpoint inhibitor (ICI) were able to continue ICI treatment without interruption. These findings were presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020.1

In this presentation, Karolina Benesova, MD, of the department of hematology, oncology, and rheumatology at University HospitalHeidelberg, Germany, described the rationale for, and characteristics of, a registry of real-world patients with cancer who exhibit symptoms of rheumatic disease.

With patient recruitment initiated at the University of Heidelberg in 2018, the MalheuR project (Malignancies and rheumatic diseases) was described as an open-label, nonrandomized, retro- and prospective, noninterventional observational study with a focus on gaining understanding of the inter-relationships between malignant and rheumatic diseases and facilitating the development of standardized guidelines to manage both of these disease processes.

Dr Benesova explained that the MalheuR project has 3 dimensions, each of which represents a possible context of coincidence between malignant and rheumatic diseases:

With 550 patients enrolled in the registry after 2 years, this presentation focused on the 77 patients in the TRheuMa arm. Of these patients, 65 were undergoing treatment with ICI therapy, and 38%, 33%, and 17% were classified as having a diagnosis of non-small cell lung cancer (NSCLC), melanoma, and other malignancy, respectively.

A key approach to facilitating a better understanding of underlying disease processes is the further classification of patients treated with ICI therapy according to the pattern of rheumatic disease that their irAEs resemble.

Thus far, 39% of patients have exhibited irAEs represented by an asymmetric spondyloarthritis/psoriatic arthritis-like pattern, 20% of patients have irAEs characterized by a symmetrical pattern that mostly involve small joints, such as rheumatoid arthritis, and 14% of patients had irAEs resembling polymyalgia rheumatic-like disease, such as symmetrical myalgia of the shoulder and hip girdle.

Also, a growing number of patients with preexisting [rheumatic disease] experience a flare of their disease as an irAE, reported Dr Benesova.

Regarding laboratory parameters, specific findings were reported to be rare, with the presence of autoantibodies mostly absent, although approximately three-quarters of patients had elevated C-reactive protein (CRP) levels. Of note, pathologic arthrosonographic findings were observed 49 of 51 patients evaluated with this method.

In reviewing a previously published therapeutic algorithm for rheumatic irAEs developed in collaboration with oncologists,2 Dr Benesova described how mild-to-moderate rheumatic irAEs, like tendinitis and arthritis, usually respond well to low-dose prednisolone up to 10 mg, NSAIDS, or combination of both.

She also noted that while oncologists usually discontinue ICIs at oral prednisolone levels above 10 mg, such treatment allows for continuation of ICI therapy.

From our experience, rheumatic irAEs respond better to low-dose prednisone than classical [rheumatological diseases], she commented.

The presence of more severe symptoms or organ manifestations typically necessitates high-dose oral prednisolone up to 1 mg/kg daily, and ICIs are withheld. Finally, life-threatening rheumatic irAEs such as severe myositis, while very rare, necessitate treatment with intravenous prednisolone up to 2 mg/kg daily and permanent discontinuation of ICI therapy.

Of the 65 patients receiving ICI therapy, rheumatic irAEs were sufficiently managed with steroids up to 10 mg daily with or without NSAIDS in 42%; ICI discontinuation was necessary in only 15% of patients.

Regarding oncologic outcomes for the patients with melanoma (25 individuals), a complete response (CR) was achieved in 48%, which was longstanding in most patients. For those with a diagnosis of NSCLC (29 individuals), no patient achieved a CR, but a partial response was observed in 69% of patients, with duration of response still under investigation.

In her concluding remarks, Dr Benesova stated that rheumatic irAEs are mostly not severe, well verifiable by imaging and CRP (seldom by autoantibodies), mostly well treatable, and associated with a better oncologic outcome.

Disclosure: Some of the authors of the study reported financial relationships with the pharmaceutical industry. For a full list of disclosures, please refer to the original abstract.

Read more of Cancer Therapy Advisors coverage of the ESMO Virtual Congress 2020 by visiting the conference page.

References

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Tracking Symptoms and Outcomes in Real-World Patients Exhibiting Rheumatic irAEs - Cancer Therapy Advisor

DetailsCategory: Small MoleculesPublished on Sunday, 20 September 2020 11:23Hits: 632

Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic Dermatitis Medicine

INDIANAPOLIS, IN, USA I Septemer 18, 2020 I Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

This opinion marks the first step toward European regulatory approval for baricitinib (marketed as OLUMIANT) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one-two months.

"Due to the limited treatment options currently available for adult patients with AD, we're excited to further explore baricitinib's potential benefit for patients,"said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "At Lilly, we aspire to elevate treatment standards for patients with dermatologic conditions. Today's CHMP opinion brings us closer to providing a new medicine for adults living with AD in Europe."

The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; BREEZE-AD4, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD who have failed or who are intolerant to, or have contraindications to cyclosporine; and BREEZE-AD7, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.

"Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option," said Prof. Thomas Bieber, M.D., Ph.D., M.D.R.A., Professor of Dermatology and Allergy, University Hospital in Bonn, Germany.

OLUMIANT is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

Lilly has exclusive worldwide development and commercialization rights for baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases under a license and collaboration agreement with Incyte.

Information on the previously approved EU OLUMIANT indication (Rheumatoid Arthritis) can be found here.

Indication and Usage for OLUMIANT (baricitinib) tablets (inthe United States) for RA patients

OLUMIANT(baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

About OLUMIANT

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1OLUMIANT is approved in more than 70 countries. OLUMIANT is developed by Lilly under license from Incyte Corporation.

About Atopic DermatitisAtopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3 AD is a heterogeneous disease both biologically and clinically, but may be characterized by chronic symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5 AD affects approximately one-three percent of adults worldwide.6

Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8

About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

AboutEli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atlilly.comandlilly.com/newsroom.

About IncyteIncyteis aWilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information onIncyte, please visit Incyte.com and follow @Incyte.

1 Olumiant Prescribing Information, 2020.2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.3 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.4Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.5 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.6 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.7 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.8 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

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CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis | Small Molecules | News...

University of Bristol researchers have treated a mouse model of glaucoma using a single gene therapy injection

Pixabay/Arek Socha

Writing in Molecular Therapy, scientists described how CRISPR gene editing was used to inactivate a gene in the ciliary body of the eye, decreasing intraocular pressure.

Visiting senior research fellow at Bristol Medical School, Dr Colin Chu, said the team hoped to advance towards clinical trials of the therapy in the near future.

If it's successful it could allow a long-term treatment of glaucoma with a single eye injection, which would improve the quality of life for many patients whilst saving the NHS time and money," Dr Chu said.

Researchers note that while eye drops are currently used to reduce intraocular pressure in glaucoma patients, the drops may have side effects and there are issues of patient compliance in administering the drops daily.

Gene editing to provide a single but permanent therapeutic alteration is an appealing approach given glaucoma is a chronic disease that requires lifelong intervention, the study authors emphasised.

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Gene therapy as a potential treatment for glaucoma - AOP

A biotech company spun out of the University of Edinburgh will utilise research to develop new gene therapies to target different types of cancer.

The company, Cellinta Limited, was born out of research from scientists at the University of Edinburgh, and received funding through investments from SV Health Investors and Cancer Research UK.

The funding will be used to develop a pipeline of highly selective gene therapies targeting cancer stem cells in a variety of solid tumour types.

It will draw on research led by Professor Steven Pollard at the University of Edinburgh, which delved into stem cell biology, synthetic biology and cancer genomics.

Cellinta has entered into a collaborative research agreement with the University, and retains the option to license intellectual property developed from research conducted there.

Professor Pollard will join the Cellinta team as scientific founder and a senior adviser, while Dr Soraya Bekkali will take the helm as chief executive officer of the new company.

I am delighted to be leading such an exciting company, said Dr Bekkali.

Cellintas approach offers the opportunity to deliver combinations of therapies selectively to cancer stem cells, bypassing the limitations of traditional treatments which often target single genes or redundant signalling pathways, she added.

Meanwhile, Mike Ross managing partner at London-based SV Health Investors has been appointed chairman of Cellinta.

Cellinta represents a unique opportunity to build a leading company based on exciting and innovative science, with the potential to develop first-in-class therapies, said Ross.

We are delighted with the progress the company has made and extremely pleased to appoint Soraya, who has deep experience in gene therapy across various therapeutic areas, as CEO. We look forward supporting Cellinta in its progress as a pioneer in the field, he added.

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University of Edinburgh spinout Cellinta will develop gene therapies for cancer - PharmaTimes

Xtalks Life Science Webinars

TORONTO (PRWEB) September 21, 2020

The International Organization for Standardization (ISO) has recently issued its eagerly awaited guidance on the transportation of cells for therapeutic use (ISO 21973). The ISO document is meant to provide general requirements and points to consider for transportation service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation process. This webinar will discuss the key recommendations and changes that interested parties should review and evaluate when planning their clinical and commercial distribution strategies for cell and gene therapies. Some of the elements to be discussed are documentation, traceability, validation and qualification activities, temporary storage, as well as cleaning and disinfection.

Join Robert Jones, Vice President, BioServices, Cryoport Systems in a live webinar on Thursday, October 1, 2020 at 11am EDT (4pm BST/UK).

For more information or to register for this event, visit Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution.

ABOUT CRYOPORT, INC.

Cryoport, Inc. is redefining temperature controlled supply chain support for the life sciences industry by providing a broad platform of temperature-controlled supply chain solutions, serving the Biopharma, Reproductive Medicine, and Animal Health markets. Our mission is to support life and health on earth by providing reliable and comprehensive solutions for the life sciences industry through our advanced technologies, global supply chain network and dedicated scientists, technicians and supporting team of professionals. Through our purpose-built, proprietary Cryoport Express Shippers; Cryoportal information technology; validated Global Logistics Centers; smart and sustainable temperature-controlled logistics solutions; and biostorage/biobanking services, Cryoport serves clients in life sciences research, clinical trials, and product commercializations. We support life-saving advanced cell and gene therapies and deliver vaccines, protein producing materials, and IVF materials in over 100 countries around the world. For more information, visit http://www.cryoport.com or follow @cryoport on Twitter at http://www.twitter.com/cryoport for live updates.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.comFor information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution, Upcoming Webinar Hosted by Xtalks - PR Web

The first part of the CPhI Annual Report 2020, released ahead of the CPhI Festival of Pharma (taking place online October 5-16) predicts dramatic growth of new mAb production in China. It also forecasts capacity shortages for cell and gene therapies in the US, as well as widespread global adoption of single-use technologies, with only limited continuous bioprocessing.

In the document, CPhI experts from BioPlan Associates (Vicky Qing XIA, senior project manager; Leo Cai Yang, project manager; and Eric Langer, president and managing partner) delve into the rapidly evolving biologics markets. The report highlights implications for contract outsourcing and Chinas continually increasing presence emergence as a hub for both bio innovation and contract services.

The report predicts rapid bio growth in China to continue, forecasting that more than 10 new mAbs likely will be launched each year by 2025. Overall, the authors estimate the total market size will quadruple by 2025, reaching nearly $18b (120b RMB) by that point and rising to more than $28b (190b RMB) by 2030.

As most early-stage biotech in China lack manufacturing facilities, the need for contract manufacturing services is rising quickly, and has been accelerated further by the 2016 MAH reforms, XIA commented.

According to the report, bioprocessing outsourcing in China is currently highly stratified with four tiers and just one domestic company in tier one (WuXi Biologics), with a number of international CDMOs (including BI, Lonza and Merck).

However, by 2025 the report anticipates as many as five more domestic CDMOs may have reached tier one status, with US Food and Drug Administration (FDA) and EU facility approvals. Significantly, pending regulatory changes for contract vaccine production will likely spur further rapid growth amongst the existing tier one CDMOs.

WuXi Biologics in 2019 realized 35.3% of its total revenue of USD 0.57 billion from China, which is ~USD 0.2 billion and would translate to ~35% of the total biopharma outsourcing service market in China1. However, despite sizable growth in revenue, its overall share of the market will now fall, as the mAb market expands rapidly, added XIA.

Langer explained, Because preclinical and clinical pipeline products require flexible manufacturing, SUS lends itself to these scales, but many of these will fail as they progress through the pipeline. This means that while more commercial-scale biologics are going to be made in SUS platforms, or hybrid systems, over the next 2+ years, stainless platforms are, and will remain, critical to bioprocessing as well.

The report also suggested that in the US and European markets will likely ocme under a cell and gene therapy capacity crunch by 2025, seeing CDMOs investing in this area already expanding in an attempt to meet the pipelines impending demand.

However, capacity alone is not the biggest challenge as there is a shortage of both specialized platforms, and trained personnel to operate them. Significantly, for some facilities in these emerging areas the equipment required for expansion and up-scaling may not yet exist, nor are regulatory authorities fully aligned with issues around patient treatments which could slow approvals.

Tara Dougal, head of content at CPhI Festival of Pharma, explained, The cell and gene therapy space is hugely fast-moving and we will run a session on the potential for M&As as both manufacturers and CDMOs try to buy-in expertise rather than build. More generally, our report also points to sustained bio growth in China, almost universal adoption of single use technologies, with continuous processing growing but from a far lower base."

Dougal added that CPhI has engaged Jefferson Institute for Bioprocessing to expand on the topic, exploring current strategies and looking ahead at future approaches.

Langer is scheduled to participate in a panel discussion on M&A activity in the cell and gene sector, taking place at CPhI Festival of Pharma October 6, 2 to 3 pm CET.

The CPhI Festival of Pharma takes place digitally October 5 to 16. For more information about the program or to register, go to https://www.cphi.com/festival-of-pharma/en/home.html.

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CPhI: cell and gene therapy capacity shortages on the horizon - OutSourcing-Pharma.com

HEIDELBERG, Germany, Sept. 21, 2020 /PRNewswire/ -- GeneWerk GmbH, a cell and gene therapy testing laboratory focused on providing preclinical and clinical trial patient sample analysis services, today announced a majority investment from Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector. Ampersand's growth investment will be used to expand GeneWerk's capabilities to meet rapidly growing demand for cell and gene therapy testing services.

GeneWerk provides cell and gene therapy sponsors with patient testing services in compliance with guidance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company is recognized as a leading provider of vector integration site analysis (ISA) services, a method that was developed by GeneWerk's founders and that the FDA and EMA recommend performing after the administration of both integrating and non-integrating cell and gene therapies. The company's test menu also includes vector persistence testing, gene edited off-target analysis, vector copy number (VCN), vector quality control, immune repertoire analysis, and dedicated bioinformatics studies. With a focus on vector safety, characterization, and functionality analysis, the company's 30 employees work in compliance with GCP and in line with GLP standards in a BSL-2 classified state-of-the-art genomics and bioinformatics laboratory in Heidelberg, Germany.

Annette Deichmann, Ph.D., Co-Founder and Co-CEO at GeneWerk commented, "With the benefit of Ampersand as our partner, GeneWerk will strengthen and expand its position in the U.S. and European markets while further investing in our testing capabilities to service cell and gene therapy sponsors and patients." Co-Founder and Co-CEO Manfred Schmidt, Ph.D., then added, "Our partnership with Ampersand solidifies GeneWerk's position in the space and will allow the company to continue to exceed our customers' expectations by facilitating the development of innovative cell and gene therapies. We are very pleased to have Ampersand on board as we take GeneWerk through its next phase of growth." Christof von Kalle, M.D., Co-Founder concluded, "This will greatly further GeneWerk's opportunities to contribute to medical breakthroughs and patient safety."

Marina Pellon-Consunji, Principal at Ampersand said, "GeneWerk is a leading company in its field. Given the exciting developments within the cell and gene therapy market and recent guidance by FDA and EMA, this is an excellent time for an investor with deep experience in cell and gene therapy to partner with the company. We are looking forward to working with the team at GeneWerk to accelerate and continue its success in delivering leading testing services to ensure the safety of patients receiving cutting edge cell and gene therapies."

About GeneWerk GmbHFounded in 2014 by Prof. Dr. Christof von Kalle, Dr. Manfred Schmidt, and Dr. Annette Deichmann with the participation of the German Cancer Research Center (DKFZ) Heidelberg, GeneWerk is a cell and gene therapy testing laboratory focused on providing preclinical and clinical trial patient sample analysis services. The company is recognized as a leading provider of vector integration site analysis (ISA) services, a method that was developed by the company's founders and that the FDA and EMA recommend performing after the administration of both integrating and non-integrating cell and gene therapies. For more information, please visit http://www.genewerk.com.

About Ampersand Capital PartnersFounded in 1988, Ampersand is a middle market private equity firm dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors. Additional information about Ampersand is available at http://www.ampersandcapital.com.

SOURCE Ampersand Capital Partners

http://www.ampersandventures.com

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GeneWerk GmbH Announces Growth Equity Investment from Ampersand Capital Partners - PRNewswire

BOTHELL, Wash., Sept. 21, 2020 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS)("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, today announced it has entered into a definitive agreement to acquire SciSafe, a privately held multi-facility provider of biological materials storage to the cell and gene therapy and pharmaceutical industries. The transaction is expected to close on September 30th.

SciSafe had 2019 unaudited revenue of $6 million and positive EBITDA and is anticipated to be accretive during 2021.

Under the terms of the agreement, BioLife will pay $15 million in cash and $15 million in newly issued shares of BioLife common stock for 100% of the outstanding shares of SciSafe. SciSafe's shareholders are also eligible over the next four years to receive up to 626,000 additional shares of BioLife common stock based on the achievement of annual revenue milestones.

Mike Rice, Chief Executive Officer of BioLife Solutions, commented, "This acquisition enables BioLife to offer even more value to our cell and gene therapy customers through an established business with an excellent reputation, marquee customers and seasoned team. Through SciSafe, we are accelerating profitable growth by expanding into the high growth biostorage segment with a robust quality system, a scalable business model and strong financial performance. We anticipate several vertical integration cost synergies including using SciSafe facilities for cGMP storage of our biopreservation media products, leveraging our CBS facility to manufacture walk-in freezer rooms for SciSafe and deploying our evo Smart Shippers and evoIS cloud app for the thousands of annual inbound and outbound biologic materials shipments managed by SciSafe."

Garrie Richardson, President of SciSafe, remarked, "I'm thrilled to be joining forces with BioLife. With BioLife's stellar reputation in the cell and gene therapy market, key customer relationships, financial resources and commitment to fund our growth, the SciSafe team is poised to deliver significant high-margin incremental revenue to BioLife's growing enterprise."

Benefits of the Transaction

Entry into the fast-growing biostorage segment

Cross-selling opportunities

Potential vertical integration cost synergies

Financial Impact of SciSafe Acquisition

BioLife expects the acquisition of SciSafe to impact the Company's financial performance as follows:

About SciSafeFounded in 2010, SciSafe offers dedicated pharmaceutical and biological specimen storage in its four fully cGMP-compliant state-of-the-art sample management facilities. SciSafe has built flourishing relationships with over 300 of the world's leading and most admired organizations. Clients have repeatedly chosen to store their most valued and irreplaceable biological samples because they trust SciSafe to care for them as if they were their own. SciSafe values and respects its long-term client relationships. With over 60 years combined experience specifically in life sciences, SciSafe personnel fully appreciate the vital requirements of all areas of specimen storage and cold chain management. For more information, please visit http://www.scisafe.com.

About BioLife SolutionsBioLife Solutions is a leading supplier of a portfolio of class-defining cell and gene therapy bioproduction tools and services. Our tools portfolio includes our proprietaryCryoStorfreeze media and HypoThermosolshipping and storage media, ThawSTARfamily of automated, water-free thawing products, evocold chain management system, and Custom Biogenic Systemshigh capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit http://www.biolifesolutions.com, and follow BioLife on Twitter.

Cautions Regarding Forward Looking Statements Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning the expected financial performance of the company following the completion of its acquisition of SciSafe, the expected synergies between the company and SciSafe, the company's ability to realize all or any of the anticipated benefits associated with the acquisition of SciSafe, the company's ability to implement its business strategy and anticipated business and operations, including following the acquisition of SciSafe, the potential utility of and market for the company's and SciSafe's products and services, guidance for financial results for 2020 and 2021, including regarding SciSafe's revenue, and potential revenue growth and market expansion, including with consideration to our acquisition of SciSafe. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding unexpected costs, charges or expenses resulting from the company's acquisition of SciSafe or the 2019 acquisitions, charges or expenses resulting from the acquisition of SciSafe; market adoption of the company's products (including the company's recently acquired products) or SciSafe's products; the ability of the SciSafe acquisition to be accretive on the company's financial results; the ability of the company to implement its business strategy; uncertainty regarding third-party market projections; market volatility; competition; litigation; the impact of the COVID-19 pandemic; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media & Investor Relations Roderick de Greef Chief Financial Officer (425) 686-6002 [emailprotected]

SOURCE BioLife Solutions, Inc.

http://www.biolifesolutions.com

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BioLife Solutions to Acquire SciSafe, a High-Growth Biostorage Service Provider to the Cell and Gene Therapy Industry - PRNewswire

This article was originally published here

Curr Gene Ther. 2020;20(2):127-141. doi: 10.2174/1566523220999200731003206.

ABSTRACT

Suppression of TP53 function is nearly ubiquitous in human cancers, and a significant fraction of cancers have mutations in the TP53 gene itself. Therefore, the wild-type TP53 gene has become an important target gene for transformation research of cancer gene therapy. In 2003, the first anti-tumor gene therapy drug rAd-p53 (recombinant human p53 adenovirus), trade name Gendicine, was approved by the China Food and Drug Administration (CFDA) for treatment of head and neck squamous cell carcinoma (HNSCC) in combination with radiotherapy. The recombinant human TP53 gene is delivered into cancer cells by an adenovirus vector constructed to express the functional p53 protein. Although the only currently approved used of Gendicine is in combination with radiotherapy for treatment of HNSCC, clinical studies have been carried out for more than 20 other applications of Gendicine in treating cancer, including treatment of advanced lung cancer, advanced liver cancer, malignant gynecological tumors, and soft tissue sarcomas. Currently more than 30,000 patients have been treated with Gendicine. This review provides an overview of the clinical applications of Gendicine in China. We summarize a total of 48 studies with 2,561 patients with solid tumors, including 34 controlled clinical studies and 14 open clinical studies, i.e., clinical studies without a control group. There are 11 studies for head and neck cancer, 10 for liver cancer, 6 for malignant gynecological tumors, 4 for non-small cell lung cancer, 4 for soft tissue sarcoma, 4 for malignant effusion, 2 for gastrointestinal tumors, and 7 for other types of cancer. In all the reported clinical studies, the most common side effect was self-limited fever. Intratumoral injection and intra-arterial infusion were the most common routes of administration. Overall, Gendicine combined with chemotherapy, radiotherapy, or other conventional treatment regimens demonstrated significantly higher response rates compared to standard therapies alone. Some of the published studies also showed that Gendicine combination regimens demonstrated longer progression-free survival times than conventional treatments alone. To date, Gendicine has been clinically used in China for treatment of cancers other than HNSCC for more than ten years, mainly for patients with advanced or unresectable malignant tumors. However, the establishment of standard treatment regimens using TP53 gene therapy is still needed in order to advance its use in clinical practice.

PMID:32951572 | DOI:10.2174/1566523220999200731003206

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Applications of Recombinant Adenovirus-p53 Gene Therapy for Cancers in the Clinic in China - DocWire News

Management to Highlight Progress in Bone Marrow Transplant (BMT) and Chimeric Antigen Receptor T Cell (CAR T) Business Collaborations

Tel Aviv, Israel, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative technology which enables the functional selection of cells facilitating safer and more efficacious cell and gene therapies, today announced that the leadership will be presenting at the Cell & Gene Meeting on the Mesa, which is being held from October 12th 16th. In addition to providing an overview of the Company, the management team will provide a progress update on the clinical and development programs and an overview of the Companys business strategy. Management will be virtually meeting cell and gene therapy companies to support collaborations.

This is one of the most prestigious meetings for our industry, and despite it being virtual this year due to the COVID-19 pandemic, it will not dampen our enthusiasm commented Dr. Yarkoni. We have successfully adjusted our operations, and we continue to make significant progress with our Israel and U.S.-based clinical trials. We are also taking meaningful steps to accelerate nearer-term revenue opportunities as we are collaborating with several partners that are looking to leverage our technology platform to help improve their products, especially in high-growth areas such as CAR T, NK (natural killers) and MSCs. We are looking forward to sharing the progress we have made and also look forward to meeting with current and potential partners developing cell and gene therapies.

To schedule a meeting with the Companys Chief Executive Officer, Dr. Shai Yarkoni or Chief Operating Officer, Amos Ofer, please request a meeting through the meeting portal and/or contact the Company direct at shai@cellect.co or amoso@cellect.co. The presentation will be available on the Companys website prior to the commencement of the meeting. The Cell & Gene Meeting on the Mesa is the sectors foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the functional selection of cells that aims to improve the robustness, safety and efficacy of a variety of cell and gene therapies. The Companys technology can be used by researchers, clinical community and pharma companies in a wide variety of applications including next generation Car T, NK, MSC and gene therapies.

The Company is also developing its own product that is an improved BMT which is in a current clinical trial for cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Companys expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as believe, expect, intend, plan, may, should, could, might, seek, target, will, project, forecast, continue or anticipate or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellects expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Companys history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Companys ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Companys ability to obtain regulatory approvals; the Companys ability to obtain favorable pre-clinical and clinical trial results; the Companys technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Companys clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Companys ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Companys industry; unforeseen scientific difficulties may develop with the Companys technology; the Companys ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Companys ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading Risk Factors in Cellect Biotechnology Ltd.s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SECs website, http://www.sec.gov, and in the Companys periodic filings with the SEC.

ContactCellect Biotechnology Ltd.Eyal Leibovitz, Chief Financial Officerwww.cellect.co+972-9-974-1444

Or

EVC Group LLCMichael Polyviou(732) 933-2754mpolyviou@evcgroup.com

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Cellect Biotechnology to Present at the 2020 Cell & Gene Meeting on the Mesa - GlobeNewswire

Cell and Gene Therapy Market Research Report is a Proficient and In-Depth Study on the Existing State of Cell and Gene Therapy Industry. This Report Focuses on the Major Drivers, Restraints, Opportunities and Threats for Key Players. It also Provides Granular Analysis of Market Share, Segmentation, Revenue Forecasts and Regional Analysis till 2025.

The recent study on Cell and Gene Therapy market offers an all-inclusive analysis of this vertical, with emphasis on the growth driving factors as well as facets such as consumption and production. Constraints and potential threats expected to restrain the expansion along with solutions to overcome the challenges are discussed at length. Moreover, insights of the market share along with estimates reflecting the CAGRs of the listed segments are highlighted in the document.

In hindsight of the COVID-19 pandemic, the report investigates the prevalent business strategies employed by leading organizations and offers tactics for stakeholders to adapt to the industry changes over the forecast period.

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Cell and Gene Therapy Market Report 2020 Industry Capacity, Manufactur - News by aeresearch

T-knife GmbH, a next-gen adoptive T-cell company, and Catalent, have signed an agreement to provide technology transfer and CGMP clinical manufacturing of T-knifes T1367 T-cell receptor (TCR) program.

T1367 is an autologous T-cell receptor-based cell therapy derived from T-knifes proprietary humanized T-cell receptor (HuTCR) mouse platform and specifically targets MAGE-A1 positive tumors in cancer patients. The therapy is expected to be manufactured for clinical trials in both the EU and U.S.

Catalent will undertake transfer of T-knifes platform process for T-cell receptor-based cell therapy at its site in Gosselies, Belgium, with the goal of manufacturing clinical batches for European trials in 2021. T-knife will also prepare for the transfer of the TCR manufacturing platform to Catalents Houston, TX, facility for clinical trials in North America in the future.

The product candidates based on our proprietary HuTCR platform require sophisticated, state-of-the-art manufacturing capabilities and deep cell and gene therapy know-how, said Michael Buchholz, Director Manufacturing of T-knife. We are convinced that Catalent is the right partner for T-knife to ensure premier manufacturing of our pipeline programs, covering all stages from clinical trials to market.

Catalent is well-suited to support T-knife with focused technology transfer and process industrialization in both Gosselies and Houston, commented Manja Boerman, Ph.D., President, Cell & Gene Therapy, Catalent. Emerging and innovative treatments like T1367 are moving rapidly to the clinic. Catalent is committed to continual investment and expansion to support our clients as they continue on the journey to commercialization.

Catalents 25,830 sq.-ft. facility in Gosselies, Belgium, provides clinical through commercial-scale cell therapy manufacturing, for both autologous and allogeneic cell therapy treatments. An additional large-scale commercial manufacturing plant is currently under construction at the site and expected to be fully commissioned in 2021. The companys clinical manufacturing site in Houston is under qualification and expected to be fully commissioned in 2020.

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T-knife, Catalent Sign Tech Transfer And Mfg. Pact For Cell Therapy - Contract Pharma

DUARTE, Calif.--(BUSINESS WIRE)--City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, today announced that it has licensed intellectual property relating to its pioneering chlorotoxin chimeric antigen receptor (CLTX-CAR) T cell therapy to Chimeric Therapeutics Limited, an Australian biotechnology company.

The therapy is currently being used in a phase 1 clinical trial at City of Hope to treat glioblastoma (GBM), a type of brain tumor. The first patient in the trial was recently dosed; Behnam Badie, M.D., chief of City of Hopes Division of Neurosurgery and The Heritage Provider Network Professor in Gene Therapy, is leading this innovative, first-of-its-kind trial.

Chimeric has acquired the exclusive worldwide rights to develop and commercialize certain patents relating to City of Hopes CLTX-CAR T cells, as well as to further develop the therapy for other cancers.

City of Hope is excited to enter into this agreement with Chimeric as it supports our innovative research in CAR T cell therapy and our commitment to extend these therapies to more patients, particularly those with GBM and other solid tumors that are difficult to treat, said Christine Brown, Ph.D., The Heritage Provider Network Professor in Immunotherapy and deputy director of City of Hopes T Cell Therapeutics Research Laboratory. Chimeric shares our goal of providing effective CAR T cell therapies to more patients with current unmet medical needs.

Led by Brown and Michael Barish, Ph.D., chair of City of Hopes Department of Developmental and Stem Cell Biology, and Dongrui Wang, Ph.D., a recent graduate of City of Hopes Irell & Manella Graduate School of Biological Sciences, the team developed and tested the first CAR T cell therapy using CLTX, a component of scorpion venom, to direct T cells to target brain tumor cells. The research was published this past March in Science Translational Medicine.

Chimeric is excited to join City of Hope in its quest to find more effective cancer therapies. This is an exceedingly rare opportunity to acquire a promising technology in one of the most exciting areas of immuno-oncology today, said Paul Hopper, executive chairman of Chimeric. Furthermore, the CLTX-CAR T cell therapy has completed years of preclinical research and development, and recently enrolled its first patient in a phase 1 clinical trial for brain cancer.

CARs commonly incorporate a monoclonal antibody sequence in their targeting domain, enabling CAR T cells to recognize antigens and kill tumor cells. In contrast, the CLTX-CAR uses a synthetic 36-amino acid peptide sequence first isolated from death stalker scorpion venom and now engineered to serve as the CAR recognition domain.

In this recent study, City of Hope researchers used tumor cells in resection samples from a cohort of patients with GBM to compare CLTX binding with expression of antigens currently under investigation as CAR T cell targets. They found that CLTX bound to a greater proportion of patient tumors, and cells within these tumors.

CLTX binding included the GBM stem-like cells thought to seed tumor recurrence. Consistent with these observations, CLTX-CAR T cells recognized and killed broad populations of GBM cells while ignoring nontumor cells in the brain and other organs. The study team demonstrated that CLTX-directed CAR T cells are highly effective at selectively killing human GBM cells without off-tumor targeting and toxicity in cell-based assays and in animal models.

City of Hope, a recognized leader in CAR T cell therapies for GBM and other cancers, has treated more than 500 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world it currently has 30 ongoing CAR T cell clinical trials, including CAR T cell trials for HER-2 positive breast cancer that has spread to the brain, and PSCA-positive bone metastatic prostate cancer. It was the first and only cancer center to treat GBM patients with CAR T cells targeting IL13R2, and the first to administer CAR T cell therapy locally in the brain, either by direct injection at the tumor site, through intraventricular infusion into the cerebrospinal fluid, or both. In late 2019, City of Hope opened a first-in-human clinical trial for patients with recurrent GBM, combining IL13R2-CAR T cells with checkpoint inhibitors nivolumab, an anti-PD1 antibody, and ipilimumab, blocking the CTLA-4 protein.

Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.

"City of Hope is delighted to license this technology to Chimeric, said Sangeeta Bardhan Cook, Ph.D., City of Hope director of the Office of Technology Licensing. We are impressed with the ability of their executive team to push and bring therapies to market expeditiously. At City of Hope, our mission is to transform the future of health care. We believe Chimeric has the vision to offer innovative therapies to cancer patients.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope has been ranked among the nations Best Hospitals in cancer by U.S. News & World Report for 14 consecutive years. Its main campus is located near Los Angeles, with additional locations throughout Southern California. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

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City of Hope Enters Licensing Agreement With Chimeric to Develop Its Pioneering Chlorotoxin CAR T Cell Therapy - Business Wire

AUSTIN, Texas--(BUSINESS WIRE)--Genprex, Inc. (Genprex or the Company) (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced it has named Thomas C. Gallagher, Esq. as the Companys Senior Vice President of Intellectual Property and Licensing. Mr. Gallagher has extensive experience in the area of biotechnology intellectual property (IP) law, business development, and licensing transactions with industry and academic institutions.

Mr. Gallagher will play a critical role in advancing our expanding intellectual property estate by spearheading IP strategy, which is an important element of the Companys overall success and value creation. A seasoned biotech executive, he will provide significant support as we execute on broadening our research and development programs, explore opportunities for partnerships on our existing programs, and opportunistically acquire new technologies to further expand our pipeline, said Rodney Varner, President and Chief Executive Officer of Genprex.

Mr. Gallagher has more than 20 years of experience as an intellectual property attorney. Prior to joining Genprex, he served as Principal at the Fenagh Group, an IP and licensing consultancy providing clients in the healthcare sector guidance on all aspects of patent and trademark portfolio management, intellectual property due diligence, freedom-to-operate analysis and related transactional work. He has also served as Senior Vice President of Intellectual Property and Licensing at Kadmon Corporation, LLC, a biopharmaceutical company based in Manhattan. Prior to joining Kadmon, he served as in-house IP counsel at Neostem Inc. (now Caladrius Biosciences, Inc.), a company focused on stem cell biology. Previously, he held several positions at ImClone Systems Incorporated, most recently as Vice President of Intellectual Property and Licensing. While at ImClone, he was responsible for all aspects of intellectual property and led the IP function in multiple due diligence undertakings by major pharmaceutical companies, which resulted in a $2 billion strategic investment, the highest-valued biotech deal ever at the time, and the eventual sale of the company to Eli Lilly and Company for $6.5 billion.

Mr. Gallagher is experienced in both patent prosecution and litigation, as well as intellectual property issues relating to business development and licensing matters. His patent litigation experience includes European litigation and opposition proceedings. In addition to a law degree, Mr. Gallagher holds a Masters degree in molecular biology. Before becoming an attorney, Mr. Gallagher worked as a molecular biologist in France, Spain and the United States.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprexs technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Companys lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZenecas Tagrisso) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Companys web site at http://www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprexs product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Companys future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of GPX-001, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates, whether we identify and succeed in acquiring other technologies and whether patents will ever be issued under patent applications that are the subject of our license agreements or otherwise. These and other risks and uncertainties are described more fully under the caption Risk Factors and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Genprex Names Seasoned IP Executive, Thomas C. Gallagher, as Senior Vice President of Intellectual Property and Licensing - Business Wire