Category Archives: Stem Cell Treatment


Humanigen Appoints Bob Atwill as Head of Asia-Pacific Region – Business Wire

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating cytokine release syndrome (CRS) with lenzilumab, the companys proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, today announced the appointment of Bob Atwill, MBA, to the newly created role of Head of Asia-Pacific, effective immediately. Mr. Atwill will report to Dr. Cameron Durrant, Chief Executive Officer of Humanigen, and will initially serve on a consultancy basis.

Mr. Atwill has more than 30 years of experience in the global healthcare industry across the pharmaceutical, biotechnology and cellular therapy sectors. He began his career at GlaxoSmithKline and Sanofi-Synthlabo prior to holding senior executive and consulting roles at Mesoblast, Benitec Biopharma and a number of other US, European and Australian-listed biotechnology companies. He currently serves as Principal at Eaton Square, a cross-border M&A and capital service provider, in its biotechnology practice, based in the Melbourne office. Mr. Atwill received his MBA from Ashridge Management College in the UK and has participated in Executive/President programs at Yale University and UCLA.

We have several partner-funded clinical trials either underway or in late-stage planning in Australia. Bobs business development and clinical trial expertise, coupled with his deep industry network and relationships with multiple leading hospitals, make him ideally suited to build on our existing work and to help us evaluate and pursue potential strategic partnerships in the region, said Dr. Durrant. Bob has worked in COVID-19 and other virology areas, graft-versus-host disease, immuno-oncology and cell and gene therapy with leading companies, and we believe his scientific and market understanding will be valuable to Humanigens strategic long-term and global growth.

Mr. Atwill said, There has never been a more important time to rapidly commercialize valuable technologies in the healthcare and biotechnology industry, especially those that will have the potential to play a critical role in mitigating the impact of the COVID-19 pandemic. I am honoured to assist in progressing lenzilumab and the Humanigen pipeline in Australia and more broadly across the Asia-Pacific Region.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The companys immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit http://www.humanigen.com.

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations surrounding our operational, research, development or commercialization activities in the Asia Pacific region, and our ability to mitigate the impact of COVID-19 via any of the technologies in our current pipeline. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

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Humanigen Appoints Bob Atwill as Head of Asia-Pacific Region - Business Wire

Organ Transplant Rejection Medications Market: Drug Companies Focus on Improving Long-term Outcome of New Drugs – BioSpace

Organ Transplant Rejection Medications Market: Introduction

According to the report, the globalorgan transplant rejection medications marketwas valued atUS$ 4.7 Bn in 2018and is projected to expand at a CAGR of~3% from 2019 to 2027. Rise in healthcare spending and improvements in healthcare infrastructure, and increase in the global geriatric population are the major factors anticipated to drive the organ transplant rejection Medication market from2019 to 2027.

Rise in Healthcare Spending and Improvement in Healthcare Infrastructure to Drive Global Market

Increase in patient awareness about personal health boosts the demand for medical devices. Patients are more aware and proactive about their health and are willing to seek a physician's advice at an early stage. Increase in per capita disposable income is encouraging people to spend more on healthcare facilities, which, in turn, fuels the global organ transplant rejection medications market. Advertisements have increased public visibility of new technology, thereby generating interest among chronic patients for organ transplant rejection medications.

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Changing demographics in emerging economies such as China, India, Brazil, and South Africa are expected to provide significant opportunities for organ transplant rejection medications. Moreover, public and private healthcare expenditure is expected to increase in these countries, which is likely to drive the organ transplant rejection medications market.

Increase in healthcare expenditure, rise in global per capita income, and improvement in healthcare infrastructure and government reimbursement programs in developed as well as developing countries are likely to propel the organ transplant rejection medications market in the near future.

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Kidney Transplant to Offer Lucrative Opportunities

The report offers detailed segmentation of the global organ transplant rejection medications market based on drug class, transplant type, distribution channel, and region. In terms of drug class, the organ transplant rejection medications market has been segmented into calcineurin inhibitors, antiproliferative agents, mTOR inhibitors, antibodies, and steroids. Based on transplant type, the market has been segmented into kidney transplant, bone marrow transplant, liver transplant, heart transplant, lung transplant, and other transplants. Kidney transplant is a highly preferred treatment for end-stage renal disease (ESRD). It is comparatively more cost-effective than dialysis and is associated with a long-term mortality improvement.

Based on distribution channel, the global organ transplant rejection medications market has been classified into hospital pharmacies, retail pharmacies, and online pharmacies. Hospitals are major clinical settings wherein a large number of surgeries are conducted. This makes hospital pharmacies a prominent segment of the organ transplant rejection medications market.

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North America to Lead Organ Transplant Rejection Medications Market

North America was the largest market for organ transplant rejection medications in 2018, due to presence of the maximum number of living as well as deceased donors and better organ-preserving practices in the region. However, high costs and complex procedures would adversely affect the organ transplant rejection medications market during the forecast period. The organ transplant rejection medications market in Asia Pacific is projected to expand at a relatively high CAGR of4.1%during the forecast period. Transplantation procedures vary substantially from region to region and country to country, due to factors such as difference in the rate of end-organ damage, economic differences in terms of ability to provide transplants or other treatments, cultural differences that can support or hinder organ donation and transplant, and reporting of legal transplants across regions.

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Major Market Players

The report provides profiles of leading players operating in the global organ transplant rejection medications market. These includeGlaxoSmithKline plc, Novartis AG, F. Hoffmann-La Roche Ltd., Astellas Pharma, Inc., Pfizer, Inc., AbbVie, Inc., Allergan plc, Bristol-Myers Squibb Company (BMS), and Sanofi.

Novartis AG is a leading company that specializes in the development and manufacture of branded as well as generic pharmaceutical and biopharmaceutical drugs. It is evaluating the experimental Facilitating Cell Therapy (FCR001), which involves taking stem cells of a kidney donor and grafting them in the transplant recipients bone marrow. This combination would trick the recipients immune system by accepting the donated kidney as its own.

Pfizer, Inc. is a global pharmaceutical company that develops, manufactures, and markets prescription medicines in 11 therapeutic segments, including cardiovascular, oncology, neuroscience, pain, and infectious diseases. The company offers a range of medicines and vaccines as well as consumer healthcare products for the prevention and treatment of infectious and chronic diseases for all age groups.

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Organ Transplant Rejection Medications Market: Drug Companies Focus on Improving Long-term Outcome of New Drugs - BioSpace

Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 – Chelanpress

Global Stem Cell Therapy Market Analysis with forecast period 2020 to 2025 provides an in-depth analysis of market growth factors, future assessment, country-level analysis, Stem Cell Therapy industry distribution, and competitive landscape analysis of major industry players. The research report of global Stem Cell Therapy market report offers the extensive information about the top most makers and sellers who are doing great and are directly working right in the market now and which have great market area according to the country and region and other aspects that affect the growth of any company or industry. The report exhibits both Stem Cell Therapy market quantitative as well as qualitative data with tables and figures displayed in the form of bar graphs, and pie charts.

A leading research firm, Adroit Market Research added a latest industry report on Global Stem Cell Therapy Market consisting of 110+ pages during the forecast period and Stem Cell Therapy Market report offers a comprehensive research updates and information related to market growth, demand, opportunities in the Market.

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Global Stem Cell Therapy market study includes a thorough analysis of the overall competitive landscape and the company profiles of leading market players involved in the global Stem Cell Therapy market. Moreover, crucial specifics such as growth drivers as well as the expected growth rate of the Stem Cell Therapy market during the forecast period are included in the report. The report also details the potential growth aspects along with the restraints of this industry vertical. Further, the presented study offers accurate insights pertaining to the different segments of the global Stem Cell Therapy market such as the market share, value, revenue, and how each segment is expected to fair post the COVID-19 pandemic.

Read complete report with TOC at:https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market

Global Stem Cell Therapy market report estimates the revenue, industry size, types, applications, players share, production volume, and consumption to get an understanding of the demand and supply chain of the market. The report encompasses technical data, raw materials, volumes, and manufacturing analysis of the global Stem Cell Therapy market. The research study delivers future projections for prominent opportunities based on the analysis of the subdivision of the market. The study meticulously unveils the market and contains substantial details about the projections with respect to industry, remuneration forecast, sales graph, and growth prospects over the forecast timeline.

Global Stem Cell Therapy market is segmented based by type, application and region.

Based on Type, the market has been segmented into:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

Based on application, the market has been segmented into:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal Disorders Wounds & Injuries Cardiovascular Diseases Gastrointestinal Diseases Immune System Diseases Other Applications

The market overview section highlights the Stem Cell Therapy Market definition, taxonomy, and an overview of the parent market across the globe and region wise. To provide better understanding of the global Stem Cell Therapy Market, the report includes in-depth analysis of drivers, restraints, and trends in all major regions namely, Asia Pacific, North America, Europe, Latin America and the Middle East & Africa, which influence the current market scenario and future status of the global Stem Cell Therapy Market over the forecast period.

Key Highlights Questions of Stem Cell Therapy Market: What will be the size of the global Stem Cell Therapy market in 2025? Which product is expected to show the highest market growth? Which application is projected to gain a lions share of the global Stem Cell Therapy market? Which region is foretold to create the most number of opportunities in the global Stem Cell Therapy market? Will there be any changes in market competition during the forecast period? Which are the top players currently operating in the global Stem Cell Therapy market?

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About Us :Adroit Market Research is an India-based business analytics and consulting company. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

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Global Stem Cell Therapy Market 2020: Growth, Demand, Service, Types, Applications, Key Players and Industry Forecast till 2025 - Chelanpress

Fate Therapeutics: 2Q Earnings Snapshot – Albany Times Union

Aug. 5, 2020Updated: Aug. 5, 2020 4:53p.m.

SAN DIEGO (AP) _ Fate Therapeutics Inc. (FATE) on Wednesday reported a loss of $28.1 million in its second quarter.

On a per-share basis, the San Diego-based company said it had a loss of 35 cents.

The results fell short of Wall Street expectations. The average estimate of nine analysts surveyed by Zacks Investment Research was for a loss of 20 cents per share.

The clinical-stage biotech company that develops stem cell treatments posted revenue of $5.5 million in the period, which also missed Street forecasts. Nine analysts surveyed by Zacks expected $20.3 million.

Fate Therapeutics shares have climbed 68% since the beginning of the year. In the final minutes of trading on Wednesday, shares hit $32.84, an increase of 70% in the last 12 months.

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This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on FATE at https://www.zacks.com/ap/FATE

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Fate Therapeutics: 2Q Earnings Snapshot - Albany Times Union

Fate Therapeutics: 2Q Earnings Snapshot – The Pioneer

Updated 4:53pm EDT, Wednesday, August 5, 2020

SAN DIEGO (AP) _ Fate Therapeutics Inc. (FATE) on Wednesday reported a loss of $28.1 million in its second quarter.

On a per-share basis, the San Diego-based company said it had a loss of 35 cents.

The results fell short of Wall Street expectations. The average estimate of nine analysts surveyed by Zacks Investment Research was for a loss of 20 cents per share.

The clinical-stage biotech company that develops stem cell treatments posted revenue of $5.5 million in the period, which also missed Street forecasts. Nine analysts surveyed by Zacks expected $20.3 million.

Fate Therapeutics shares have climbed 68% since the beginning of the year. In the final minutes of trading on Wednesday, shares hit $32.84, an increase of 70% in the last 12 months.

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This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on FATE at https://www.zacks.com/ap/FATE

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Fate Therapeutics: 2Q Earnings Snapshot - The Pioneer

CF Foundation, Longwood team on new incubator for companies with cutting-edge CF treatments – Endpoints News

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertexs line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

CF Foundation has committed up to $20 million to the effort, although the companies selected could also receive funding through Longwoods traditional early-stage VC efforts.

This is new, so well have to see how it plays out in practice, Longwood partner David Steinberg toldEndpoints News.

The idea for the incubator emerged last October at Harvard Medical School, where Longwood was holding their biannual meeting with non-profits and patient groups. At the time, the CF Foundation was preparing to launch its $500 millionPath to a Cureinitiative. Trikafta, the third of Vertexs three small-molecule CF drugs, was about to hit market, but although the new drug meant 90% of CF patients could now be treated, that still left 10% untreated. Armed with royalties from Vertex, the Pathinitiative would try to back technologies that could treat that last group of patients and ultimately, perhaps, lead to a cure.

The CF Foundation had long backed academic work and particular programs at established companies Vertex kept up their early CF work in part because the foundation was funding it but it had never tried to found new ones. But such an early-stage approach made particular sense for what the foundation was now trying to accomplish, foundation CEO Mike Boyle told Endpoints.

Cystic fibrosis involves a malfunctioning transport protein in the lungs, called CFTR. Vertexs drugs either help that protein fold in the right way or guide it to the right place. Theremaining 10% of patients, though, either have a protein misfolded in such a way it doesnt respond to existing small molecules or they simply dont have the protein at all.

That meant patients would have to be treated with technologies that can target the gene: gene therapy, gene editing, and RNA drugs, among others. Boyle said the foundation is in early talks with 17 biotechs, mostly small, with such platforms. Many larger companies with these platforms are focused in other areas.

One of the challenges right now is that there are easier targets for gene therapy than CF, Boyle said.

Its difficult to get gene therapy into the lungs, where the immune response is unique and cells turn over at a higher rate than in other parts of the body. But the incubator could allow Longwood and the foundation to steer companies that are just starting out to this challenge in exchange for the funding they need to get off the ground. Those startups would also have access to the foundations scientific advisors, their CF lab in Boston and their CF clinical trial network.

In addition to specific therapies, the incubator may also invest in drug delivery technology, such as exosomes, that could make delivering DNA, RNA or other types of drugs to the lungs.

There is precedent for the approach. The Gates Foundations venture arm has long invested in early-stage immunology platforms in exchange for a commitment from the companies to focus part of their work on infectious disease and not just cancer or autoimmune disorders.

Boyle said theyre hoping to launch companies within a couple years, but theyre also continuing to solicit partnerships with academic centers and more established biotechs. The incubators $20 million is just a small portion of Paths $500 million vault.

This is the beginning of the process, Boyle said. We are open for business.

Social image: Mike Boyle, Cystic Fibrosis Foundation via YouTube

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CF Foundation, Longwood team on new incubator for companies with cutting-edge CF treatments - Endpoints News

Fate Therapeutics: 2Q Earnings Snapshot – CT Post

Updated 4:53pm EDT, Wednesday, August 5, 2020

SAN DIEGO (AP) _ Fate Therapeutics Inc. (FATE) on Wednesday reported a loss of $28.1 million in its second quarter.

On a per-share basis, the San Diego-based company said it had a loss of 35 cents.

The results fell short of Wall Street expectations. The average estimate of nine analysts surveyed by Zacks Investment Research was for a loss of 20 cents per share.

The clinical-stage biotech company that develops stem cell treatments posted revenue of $5.5 million in the period, which also missed Street forecasts. Nine analysts surveyed by Zacks expected $20.3 million.

Fate Therapeutics shares have climbed 68% since the beginning of the year. In the final minutes of trading on Wednesday, shares hit $32.84, an increase of 70% in the last 12 months.

_____

This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on FATE at https://www.zacks.com/ap/FATE

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Fate Therapeutics: 2Q Earnings Snapshot - CT Post

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 – BioSpace

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK Cells NK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001 CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19 The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact:

Name:Dani Frank

Email:celularity@factorypr.com

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SOURCE Celularity

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 - BioSpace

Stem Cell Therapy Market Report Aims To Outline and Forecast , Organization Sizes, Top Vendors, Industry Research and End User Analysis By 2026 -…

Detailed Analysis & SWOT analysis, Stem Cell Therapy Market Trends 2020, Stem Cell Therapy Market Growth 2020, Stem Cell Therapy Industry Share 2020, Stem Cell Therapy Industry Size, Stem Cell Therapy Market Research, Stem Cell Therapy Market Analysis, Stem Cell Therapy market Report speaks about the manufacturing process. The process is analyzed thoroughly with respect three points, viz. raw material and equipment suppliers, various manufacturing associated costs (material cost, labor cost, etc.) and the actual process of whole Enterprise Stem Cell Therapy Market.

Stem Cell Therapy market 2020 is a professional and in-intensity look at on the modern state of the key-word industry. The document provides a simple review of the key-word marketplace together with definitions, classifications, programs and chain shape. The key-word enterprise evaluation is supplied for the worldwide marketplace which include improvement records, competitive landscape evaluation, and principal local development popularity.

Ask for a Sample Report 2020

The Stem Cell Therapy marketplace file elaborates Stem Cell Therapy industry evaluation with various definitions and category, Product kinds & its packages and chain shape. Stem Cell Therapy market document presentations the manufacturing, sales, charge, and market proportion and boom rate of every type as following.

2020 Short Detail of this Stem Cell Therapy market report:

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

In the last several years, global stem cell therapy market developed fast at a average growth rate of 46.81%.

Market Analysis and Insights: Global Stem Cell Therapy Market

In 2019, the global Stem Cell Therapy market size was USD 403.6 million and it is expected to reach USD 1439.9 million by the end of 2026, with a CAGR of 19.7% during 2021-2026.

Global Stem Cell Therapy Scope and Market Size

Stem Cell Therapy market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Stem Cell Therapy market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.

Segment by Type, the Stem Cell Therapy market is segmented into Autologous, Allogeneic, etc.

Segment by Application, the Stem Cell Therapy market is segmented into Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases, Others, etc.

Regional and Country-level Analysis

The Stem Cell Therapy market is analysed and market size information is provided by regions (countries).

The key regions covered in the Stem Cell Therapy market report are North America, Europe, China, Japan, Southeast Asia, India and Central & South America, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of revenue for the period 2015-2026.

Competitive Landscape and Stem Cell Therapy Market Share Analysis

Stem Cell Therapy market competitive landscape provides details and data information by vendors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by player for the period 2015-2020. Details included are company description, major business, company total revenue and the revenue generated in Stem Cell Therapy business, the date to enter into the Stem Cell Therapy market, Stem Cell Therapy product introduction, recent developments, etc.

The major vendors include Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix), etc.

This report focuses on the global Stem Cell Therapy status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Stem Cell Therapy development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

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Stem Cell Therapy Market by Product Type:

Stem Cell Therapy Market by Applications:

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Next part of the Stem Cell Therapy Market analysis report speaks about the manufacturing process. The process is analysed thoroughly with respect three points, viz. raw material and equipment suppliers, various manufacturing associated costs (material cost, labour cost, etc.) and the actual process. Stem Cell Therapy market competition by top manufacturers, with production, price, and revenue (value) and market share for each manufacturer as per following;

Top Manufacturer Included in Stem Cell Therapy Market:

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Awa – PharmiWeb.com

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK CellsNK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

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Email:celularity@factorypr.com

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