Stem Cell Clinic

FDA Accepts IND for NK Cell Therapy CYNK-001 to Treat Patients with COVID-19 – Cancer Network

By adminApril 8, 2020Stem Cell Treatment

The FDA cleared the investigational new drug (IND) application for the use of CYNK-001 in adults with coronavirus disease 2019 (COVID-19), according to Celularity, the agents manufacturer.1

The company also announced that it will immediately begin a phase I/II clinical study of CYNK-001 in collaboration with Sorrento Therapeutics, which will include up to 86 patients with COVID-19.

We are confident that our strategic relationship with Sorrento will help assure our ability to meet the scale requirements for our efforts in COVID-19, Robert Hariri, MD, PhD, CEO for Celularity, said in a press release.

Individuals who are enrolled in the trial will receive infusions of natural killer (NK) cells, which the company believes could kill cells infected with the virus and address the resulting inflammation caused by the immune system.

Infectious Disease Research Institute (IDRI), a nonprofit based in Seattle, says it is coordinating the trial, which will take place at medical centers in the US.2

To date, efforts to treat COVID-19 cases have been primarily focused on antiviral medications, Corey Casper, MD, MPH, clinical professor of global health and medicine at the University of Washington and interim president and CEO at IDRI, said in a press release. While these are important, patients with serious disease may not respond completely to antiviral medications because they are experiencing damage already inflicted on the bodys vital organs.

CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells. The company suggests that using such cells eliminates the risk of an immune system reaction that other kinds of donor cells can cause.

The therapy is already being tested in patients with acute myeloid leukemia and multiple myeloma in early-stage studies, and as a potential treatment option for various solid tumors.

In January, the FDA cleared Celularitys investigational new drug (IND) application for CYNK-001 in patients with glioblastoma multiforme (GBM).3The clinical trial is anticipated to be the first clinical trial in the US to investigate intratumoral administration of an allogeneic NK cell therapy.

The FDA clearance of our IND validates the versatility of our allogeneic, off-the-shelf, placental-derived NK cell therapy platform to generate novel clinical candidates against a broad range of devastating cancers, Hariri said in a press release. This IND represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme.

According to the company, they expect to initiate first-in-human clinical testing of CYNK-001 administered either intravenously or intratumorally. The study is anticipated to evaluate the safety, feasibility, and tolerability of multiple doses of CYNK-001 in patients with relapsed GBM.

Nonclinical safety and efficacy data were presented at the 2019 Society for Neuro-Oncology (SNO) Annual meeting, demonstrating that a single administration of CYNK-001 was well-tolerated and showed enhancedin vivoanti-tumor activity against GBM.

References:

1. Sorrento to Provide Manufacturing Support to Celularity as CYNK-001 NK Cell Trial for COVID-19 Begins Enrolling Patients [news release]. San Diego, CA. Published April 2, 2020. globenewswire.com/news-release/2020/04/02/2010998/0/en/SORRENTO-TO-PROVIDE-MANUFACTURING-SUPPORT-TO-CELULARITY-AS-CYNK-001-NK-CELL-TRIAL-FOR-COVID-19-BEGINS-ENROLLING-PATIENTS.html. Accessed April 2, 2020.

2. Xconomy National. Celularity to Test Natural Killer Cell Therapy for Cancer Against COVID. Xconomy National website. Published April 2, 2020. xconomy.com/national/2020/04/02/celularity-to-test-natural-killer-cell-therapy-for-cancer-against-covid/. Accessed April 2, 2020.

3. Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cyropreserved NK Cell Therapy [news release]. Warren, NJ. Published January 22, 2020. businesswire.com/news/home/20200122005061/en/Celularity-Announces-FDA-Clearance-Landmark-IND-CYNK-001. Accessed April 2, 2020.

Fate Therapeutics Strikes Multi-Billion Dollar Cell Therapy Deal with Janssen – BioSpace

By adminApril 8, 2020Stem Cell Treatment

Shares of Fate Therapeutics were up more than 21% in premarket trading after the company announced a multi-billion dollar deal with Janssen Biotech to develop cell therapies for the treatment of cancer.

The partnership will leverage San Diego-based Fate Therapeutics induced pluripotent stem cell (iPSC) product platform and Janssens proprietary tumor-targeting antigen binders to create novel CAR NK and CAR T-Cell product candidates that will be developed against up to four tumor-associated antigens for hematologic malignancies and solid tumors. Fate will advance the different candidates through preclinical studies to the point of the filing of an Investigational New Drug Application with the U.S. Food and Drug Administration. When that time comes, Janssen will have the right to exercise its option for an exclusive license for the development and commercialization of collaboration candidates targeting the tumor-associated antigens.

Fates iPSC platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses, according to the company. The companys approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass-produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment, the company said.

Under terms of the agreement, Fate will receive $50 million in upfront cash, as well as a $50 million equity investment by Janssen. Janssen will also cover the funding costs of the R&D of the collaboration candidates. Once Janssen takes over the program, Fate will then be eligible to receive payments of up to $1.8 billion upon the achievement of development and regulatory milestones and up to $1.2 billion upon the achievement of commercial milestones. Fate will also be eligible to receive double-digit royalties on worldwide commercial sales of products targeting the antigens. Additionally, Fate has the right to co-commercialize the candidates should they be approved and share equally in profits and losses, the company said in its announcement.

Scott Wolchko, president and chief executive officer of Fate Therapeutics, touted the partnership with Janssen. He said the collaboration combines Janssens deep domain expertise in oncology, along with their proprietary technologies for targeting and binding certain tumors with Fates iPSC product platform to develop novel off-the-shelf CAR NK and T-cell cancer immunotherapies.

The collaboration strengthens our financial and operating position through a focused effort of developing cell-based cancer immunotherapies utilizing Janssens proprietary antigen-binding domains while enabling us to continue to exploit our deep pipeline of wholly-owned product candidates and further develop our off-the-shelf, iPSC-derived cell-based immunotherapies, Wolchko said in a statement.

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Fate Therapeutics Strikes Multi-Billion Dollar Cell Therapy Deal with Janssen - BioSpace

Beam Therapeutics Licenses SIRION Biotech’s LentiBOOST Technology for its CAR-T pipeline – Business Wire

By adminApril 8, 2020Stem Cell Treatment

MARTINSRIED, Germany--(BUSINESS WIRE)--SIRION Biotech GmbH announced today that Beam Therapeutics licensed rights to use SIRION Biotechs LentiBOOST for use in their CAR-T cell products.

CAR-T cell therapy represents a promising and future-defining shift in cancer treatment. Beam Therapeutics is developing a new generation of CAR-T product candidates using its proprietary base editing technology.

Under the terms of this agreement, SIRION agreed to provide Beam with non-exclusive access to its proprietary lentiviral transduction enhancer LentiBOOST for clinical development and commercialization of Beams portfolio of CAR-T programs. SIRION will be entitled to undisclosed upfront and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success.

Dr. Christian Thirion, CEO and founder of SIRION Biotech GmbH explains: LentiBOOST was engineered to improve lentiviral transduction of difficult cell types like T-cells and hematopoietic stem cells. This technology enables robust upscaling of the T-cell production process, and helps to reduce manufacturing costs by lowering the amount of lentiviral vectors needed for production of the cell product while at the same time improving clinical efficacy by increasing vector copy numbers (VCN) per cell. We are delighted that the LentiBOOST technology may help Beam further enhance the clinical success of its CAR-T pipeline.

LentiBOOST is used in an increasing number of clinical trials in the US and in Europe and the technology is more and more considered as a gold standard in manufacturing of cell products. Our non-exclusive licensing strategy makes our technology available to a wide range of companies and research hospitals to boost the efficiency of their various clinical programs, says SVP of Business Development & Licensing, Dr. Sabine Ott.

About SIRION Biotech GmbH

SIRION Biotech was founded in 2005 to lead the next generation of viral vector technologies for gene and cell therapy as well as vaccine development. Now SIRION offers one of the worlds most comprehensive viral vector technology platforms based on lenti-, adeno-, and adeno-associated viruses which expedites gene therapy research and advances drug development. SIRION is becoming a partner of choice in this growing sector. LentiBOOST has been used in a number of clinical trials from early stage clinical Phase 1/2 through late stage clinical Phase 3 trials and demonstrated clinical success in improving transduction of the therapeutic vector.

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Beam Therapeutics Licenses SIRION Biotech's LentiBOOST Technology for its CAR-T pipeline - Business Wire

COVID-19 Impact on Stem Cell Therapy Identify Which Types of Companies Could Potentially Benefit or Loose out From the Impact of COVID-19 – Science…

By adminApril 8, 2020Stem Cell Treatment

Complete study of the global Stem Cell Therapy market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Stem Cell Therapy industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Stem Cell Therapy production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

Key companies operating in the global Stem Cell Therapy market include _, Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR Pharmaceutical, Pharmicell, Medi-post, Anterogen, Molmed, Takeda (TiGenix)

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Segmental Analysis

The report has classified the global Stem Cell Therapy industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Stem Cell Therapy manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Stem Cell Therapy industry.

Global Stem Cell Therapy Market Segment By Type:

Autologous, Allogeneic

Global Stem Cell Therapy Market Segment By Application:

, Musculoskeletal Disorder, Wounds & Injuries, Cornea, Cardiovascular Diseases, Others

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Stem Cell Therapy industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key questions answered in the report:

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TOC

1 Market Overview of Stem Cell Therapy1.1 Stem Cell Therapy Market Overview1.1.1 Stem Cell Therapy Product Scope1.1.2 Market Status and Outlook1.2 Global Stem Cell Therapy Market Size Overview by Region 2015 VS 2020 VS 20261.3 Global Stem Cell Therapy Market Size by Region (2015-2026)1.4 Global Stem Cell Therapy Historic Market Size by Region (2015-2020)1.5 Global Stem Cell Therapy Market Size Forecast by Region (2021-2026)1.6 Key Regions Stem Cell Therapy Market Size YoY Growth (2015-2026)1.6.1 North America Stem Cell Therapy Market Size YoY Growth (2015-2026)1.6.2 Europe Stem Cell Therapy Market Size YoY Growth (2015-2026)1.6.3 China Stem Cell Therapy Market Size YoY Growth (2015-2026)1.6.4 Rest of Asia Pacific Stem Cell Therapy Market Size YoY Growth (2015-2026)1.6.5 Latin America Stem Cell Therapy Market Size YoY Growth (2015-2026)1.6.6 Middle East & Africa Stem Cell Therapy Market Size YoY Growth (2015-2026)1.7 Coronavirus Disease 2019 (Covid-19): Stem Cell Therapy Industry Impact1.7.1 How the Covid-19 is Affecting the Stem Cell Therapy Industry1.7.1.1 Stem Cell Therapy Business Impact Assessment Covid-191.7.1.2 Supply Chain Challenges1.7.1.3 COVID-19s Impact On Crude Oil and Refined Products1.7.2 Market Trends and Stem Cell Therapy Potential Opportunities in the COVID-19 Landscape1.7.3 Measures / Proposal against Covid-191.7.3.1 Government Measures to Combat Covid-19 Impact1.7.3.2 Proposal for Stem Cell Therapy Players to Combat Covid-19 Impact 2 Stem Cell Therapy Market Overview by Type2.1 Global Stem Cell Therapy Market Size by Type: 2015 VS 2020 VS 20262.2 Global Stem Cell Therapy Historic Market Size by Type (2015-2020)2.3 Global Stem Cell Therapy Forecasted Market Size by Type (2021-2026)2.4 Autologous2.5 Allogeneic 3 Stem Cell Therapy Market Overview by Type3.1 Global Stem Cell Therapy Market Size by Application: 2015 VS 2020 VS 20263.2 Global Stem Cell Therapy Historic Market Size by Application (2015-2020)3.3 Global Stem Cell Therapy Forecasted Market Size by Application (2021-2026)3.4 Musculoskeletal Disorder3.5 Wounds & Injuries3.6 Cornea3.7 Cardiovascular Diseases3.8 Others 4 Global Stem Cell Therapy Competition Analysis by Players4.1 Global Stem Cell Therapy Market Size (Million US$) by Players (2015-2020)4.2 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Stem Cell Therapy as of 2019)4.3 Date of Key Manufacturers Enter into Stem Cell Therapy Market4.4 Global Top Players Stem Cell Therapy Headquarters and Area Served4.5 Key Players Stem Cell Therapy Product Solution and Service4.6 Competitive Status4.6.1 Stem Cell Therapy Market Concentration Rate4.6.2 Mergers & Acquisitions, Expansion Plans 5 Company (Top Players) Profiles and Key Data5.1 Osiris Therapeutics5.1.1 Osiris Therapeutics Profile5.1.2 Osiris Therapeutics Main Business and Companys Total Revenue5.1.3 Osiris Therapeutics Products, Services and Solutions5.1.4 Osiris Therapeutics Revenue (US$ Million) (2015-2020)5.1.5 Osiris Therapeutics Recent Developments5.2 NuVasive5.2.1 NuVasive Profile5.2.2 NuVasive Main Business and Companys Total Revenue5.2.3 NuVasive Products, Services and Solutions5.2.4 NuVasive Revenue (US$ Million) (2015-2020)5.2.5 NuVasive Recent Developments5.3 Chiesi Pharmaceuticals5.5.1 Chiesi Pharmaceuticals Profile5.3.2 Chiesi Pharmaceuticals Main Business and Companys Total Revenue5.3.3 Chiesi Pharmaceuticals Products, Services and Solutions5.3.4 Chiesi Pharmaceuticals Revenue (US$ Million) (2015-2020)5.3.5 JCR Pharmaceutical Recent Developments5.4 JCR Pharmaceutical5.4.1 JCR Pharmaceutical Profile5.4.2 JCR Pharmaceutical Main Business and Companys Total Revenue5.4.3 JCR Pharmaceutical Products, Services and Solutions5.4.4 JCR Pharmaceutical Revenue (US$ Million) (2015-2020)5.4.5 JCR Pharmaceutical Recent Developments5.5 Pharmicell5.5.1 Pharmicell Profile5.5.2 Pharmicell Main Business and Companys Total Revenue5.5.3 Pharmicell Products, Services and Solutions5.5.4 Pharmicell Revenue (US$ Million) (2015-2020)5.5.5 Pharmicell Recent Developments5.6 Medi-post5.6.1 Medi-post Profile5.6.2 Medi-post Main Business and Companys Total Revenue5.6.3 Medi-post Products, Services and Solutions5.6.4 Medi-post Revenue (US$ Million) (2015-2020)5.6.5 Medi-post Recent Developments5.7 Anterogen5.7.1 Anterogen Profile5.7.2 Anterogen Main Business and Companys Total Revenue5.7.3 Anterogen Products, Services and Solutions5.7.4 Anterogen Revenue (US$ Million) (2015-2020)5.7.5 Anterogen Recent Developments5.8 Molmed5.8.1 Molmed Profile5.8.2 Molmed Main Business and Companys Total Revenue5.8.3 Molmed Products, Services and Solutions5.8.4 Molmed Revenue (US$ Million) (2015-2020)5.8.5 Molmed Recent Developments5.9 Takeda (TiGenix)5.9.1 Takeda (TiGenix) Profile5.9.2 Takeda (TiGenix) Main Business and Companys Total Revenue5.9.3 Takeda (TiGenix) Products, Services and Solutions5.9.4 Takeda (TiGenix) Revenue (US$ Million) (2015-2020)5.9.5 Takeda (TiGenix) Recent Developments 6 North America Stem Cell Therapy by Players and by Application6.1 North America Stem Cell Therapy Market Size and Market Share by Players (2015-2020)6.2 North America Stem Cell Therapy Market Size by Application (2015-2020) 7 Europe Stem Cell Therapy by Players and by Application7.1 Europe Stem Cell Therapy Market Size and Market Share by Players (2015-2020)7.2 Europe Stem Cell Therapy Market Size by Application (2015-2020) 8 China Stem Cell Therapy by Players and by Application8.1 China Stem Cell Therapy Market Size and Market Share by Players (2015-2020)8.2 China Stem Cell Therapy Market Size by Application (2015-2020) 9 Rest of Asia Pacific Stem Cell Therapy by Players and by Application9.1 Rest of Asia Pacific Stem Cell Therapy Market Size and Market Share by Players (2015-2020)9.2 Rest of Asia Pacific Stem Cell Therapy Market Size by Application (2015-2020) 10 Latin America Stem Cell Therapy by Players and by Application10.1 Latin America Stem Cell Therapy Market Size and Market Share by Players (2015-2020)10.2 Latin America Stem Cell Therapy Market Size by Application (2015-2020) 11 Middle East & Africa Stem Cell Therapy by Players and by Application11.1 Middle East & Africa Stem Cell Therapy Market Size and Market Share by Players (2015-2020)11.2 Middle East & Africa Stem Cell Therapy Market Size by Application (2015-2020) 12 Stem Cell Therapy Market Dynamics12.1 Industry Trends12.2 Market Drivers12.3 Market Challenges12.4 Porters Five Forces Analysis 13 Research Finding /Conclusion 14 Methodology and Data Source14.1 Methodology/Research Approach14.1.1 Research Programs/Design14.1.2 Market Size Estimation14.1.3 Market Breakdown and Data Triangulation14.2 Data Source14.2.1 Secondary Sources14.2.2 Primary Sources14.3 Disclaimer14.4 Author List

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COVID-19 Impact on Stem Cell Therapy Identify Which Types of Companies Could Potentially Benefit or Loose out From the Impact of COVID-19 - Science...

Nurses life-saving stem cell transplant leaves her with an addiction to Monster Munch just like her don – The Sun

By adminApril 8, 2020Stem Cell Treatment

A NURSEs life-saving stem cell transplant caused her to inherit her donors addiction for pickled onion flavour Monster Munch.

Claire Stewart, 49, had never tasted the snack before the treatment but as she recovered she developed cravings for it.

She started sending bemused husband David out to buy as many bags as he could.

She said: He thought it might be a passing urge like you get when youre pregnant, but those crisps became my favourite food.

Id never eaten them before. I preferred chocolate!

The mystery was solved when she met donor Keely Jackson, 37, whose bone marrow was matched with hers by charity Anthony Nolan.

Claire, of Middlesbrough, who needed a transplant to treat a rare blood cancer, gave nurse Keely thank you gifts and a pack of Monster Munch.

Claire said: Keely gave me the strangest look like I was playing some trick on her.

She told me shed always been a secret pickled onion Monster Munch addict.

RAIN ON OUR PARADEEaster weekend washout to hit after Britain basks in mini heatwave

'BLAST' PANIC'Explosions' heard as cops launch dramatic 'gun and drug' raid in London

'DEVASTATED'NHS nurse, 29, dies from coronavirus as pals pay tribute to 'amazing' medic

STAY STRONGCoronavirus survivors give hope for PM promising 'if we can beat it, so can he'

DRUG RAPGang leader named 'The General' jailed despite 150-mile move to halt life of crime

DEADLiest dayUK suffers worst leap in coronavirus deaths yet with 786 recorded in 24hrs

Id seemingly inherited this peculiar obsession from someone whose DNA I now share.

Keely, from Wakefield, West Yorks, said: Ive got a Monster Munch friend for life!

Rebecca Pritchard, of Anthony Nolan, said: From time to time, recipients do report developing tastes shared with their donor.

She added: While all of our activities are restricted at this time, we can still help people like Claire, with blood cancer, by joining the Anthony Nolan register online or donating to our emergency appeal.

Anthony Nolan needs to raise an extra 10,000 every month that the coronavirus pandemic goes on to continue to fund their work. Visit http://www.anthonynolan.org/coronavirusemergencyappeal.

GOT a story? RING The Sun on 0207 782 4104 or WHATSAPP on 07423720250 or EMAIL exclusive@the-sun.co.uk

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Nurses life-saving stem cell transplant leaves her with an addiction to Monster Munch just like her don - The Sun

Covid-19 Impact on Cell Freezing Media for Cell Therapy Market (2020-2026) – Science In Me

By adminApril 8, 2020Stem Cell Treatment

The report titled Global Cell Freezing Media for Cell Therapy Market is one of the most comprehensive and important additions to QY Researchs archive of market research studies. It offers detailed research and analysis of key aspects of the global Cell Freezing Media for Cell Therapy market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the global Cell Freezing Media for Cell Therapy market. Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the global Cell Freezing Media for Cell Therapy market is carefully analyzed and researched about by the market analysts.

Key companies operating in the global Cell Freezing Media for Cell Therapymarket include_BioLife Solutions, Thermo Fisher Scientific, Merck, GE Healthcare, Zenoaq, WAK-Chemie Medical, Biological Industries, Akron Biotechnology

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Segmental Analysis :

The report has classified the global Cell Freezing Media for Cell Therapy industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Cell Freezing Media for Cell Therapy manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Cell Freezing Media for Cell Therapy industry.

Global Cell Freezing Media for Cell Therapy Market Segment By Type:

With FBS, Without FBS

Global Cell Freezing Media for Cell Therapy Market Segment By Applications:

Human Embryonic Stem Cells, CAR-T Cell Therapy, Neural Stem Cell Therapy, Mesenchymal Stem Cell Therapy, Hematopoietic Stem Cell Transplantation, Other

Critical questions addressed by the Cell Freezing Media for Cell Therapy Market report

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Table of Contents1 Cell Freezing Media for Cell Therapy Market Overview1.1 Cell Freezing Media for Cell Therapy Product Overview1.2 Cell Freezing Media for Cell Therapy Market Segment by Type1.2.1 With FBS1.2.2 Without FBS1.3 Global Cell Freezing Media for Cell Therapy Market Size by Type (2015-2026)1.3.1 Global Cell Freezing Media for Cell Therapy Market Size Overview by Type (2015-2026)1.3.2 Global Cell Freezing Media for Cell Therapy Historic Market Size Review by Type (2015-2020)1.3.2.1 Global Cell Freezing Media for Cell Therapy Sales Market Share Breakdown by Type (2015-2026)1.3.2.2 Global Cell Freezing Media for Cell Therapy Revenue Market Share Breakdown by Type (2015-2026)1.3.2.3 Global Cell Freezing Media for Cell Therapy Average Selling Price (ASP) by Type (2015-2026)1.3.3 Global Cell Freezing Media for Cell Therapy Market Size Forecast by Type (2021-2026)1.3.3.1 Global Cell Freezing Media for Cell Therapy Sales Market Share Breakdown by Application (2021-2026)1.3.3.2 Global Cell Freezing Media for Cell Therapy Revenue Market Share Breakdown by Application (2021-2026)1.3.3.3 Global Cell Freezing Media for Cell Therapy Average Selling Price (ASP) by Application (2021-2026)1.4 Key Regions Market Size Segment by Type (2015-2020)1.4.1 North America Cell Freezing Media for Cell Therapy Sales Breakdown by Type (2015-2026)1.4.2 Europe Cell Freezing Media for Cell Therapy Sales Breakdown by Type (2015-2026)1.4.3 Asia-Pacific Cell Freezing Media for Cell Therapy Sales Breakdown by Type (2015-2026)1.4.4 Latin America Cell Freezing Media for Cell Therapy Sales Breakdown by Type (2015-2026)1.4.5 Middle East and Africa Cell Freezing Media for Cell Therapy Sales Breakdown by Type (2015-2026) 2 Global Cell Freezing Media for Cell Therapy Market Competition by Company2.1 Global Top Players by Cell Freezing Media for Cell Therapy Sales (2015-2020)2.2 Global Top Players by Cell Freezing Media for Cell Therapy Revenue (2015-2020)2.3 Global Top Players Cell Freezing Media for Cell Therapy Average Selling Price (ASP) (2015-2020)2.4 Global Top Manufacturers Cell Freezing Media for Cell Therapy Manufacturing Base Distribution, Sales Area, Product Type2.5 Cell Freezing Media for Cell Therapy Market Competitive Situation and Trends2.5.1 Cell Freezing Media for Cell Therapy Market Concentration Rate (2015-2020)2.5.2 Global 5 and 10 Largest Manufacturers by Cell Freezing Media for Cell Therapy Sales and Revenue in 20192.6 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Cell Freezing Media for Cell Therapy as of 2019)2.7 Date of Key Manufacturers Enter into Cell Freezing Media for Cell Therapy Market2.8 Key Manufacturers Cell Freezing Media for Cell Therapy Product Offered2.9 Mergers & Acquisitions, Expansion 3 Global Cell Freezing Media for Cell Therapy Status and Outlook by Region (2015-2026)3.1 Global Cell Freezing Media for Cell Therapy Market Size and CAGR by Region: 2015 VS 2020 VS 20263.2 Global Cell Freezing Media for Cell Therapy Market Size Market Share by Region (2015-2020)3.2.1 Global Cell Freezing Media for Cell Therapy Sales Market Share by Region (2015-2020)3.2.2 Global Cell Freezing Media for Cell Therapy Revenue Market Share by Region (2015-2020)3.2.3 Global Cell Freezing Media for Cell Therapy Sales, Revenue, Price and Gross Margin (2015-2020)3.3 Global Cell Freezing Media for Cell Therapy Market Size Market Share by Region (2021-2026)3.3.1 Global Cell Freezing Media for Cell Therapy Sales Market Share by Region (2021-2026)3.3.2 Global Cell Freezing Media for Cell Therapy Revenue Market Share by Region (2021-2026)3.3.3 Global Cell Freezing Media for Cell Therapy Sales, Revenue, Price and Gross Margin (2021-2026)3.4 North America Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)3.4.1 North America Cell Freezing Media for Cell Therapy Revenue YoY Growth (2015-2026)3.4.2 North America Cell Freezing Media for Cell Therapy Sales YoY Growth (2015-2026)3.5 Asia-Pacific Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)3.5.1 Asia-Pacific Cell Freezing Media for Cell Therapy Revenue YoY Growth (2015-2026)3.5.2 Asia-Pacific Cell Freezing Media for Cell Therapy Sales YoY Growth (2015-2026)3.6 Europe Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)3.6.1 Europe Cell Freezing Media for Cell Therapy Revenue YoY Growth (2015-2026)3.6.2 Europe Cell Freezing Media for Cell Therapy Sales YoY Growth (2015-2026)3.7 Latin America Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)3.7.1 Latin America Cell Freezing Media for Cell Therapy Revenue YoY Growth (2015-2026)3.7.2 Latin America Cell Freezing Media for Cell Therapy Sales YoY Growth (2015-2026)3.8 Middle East and Africa Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)3.8.1 Middle East and Africa Cell Freezing Media for Cell Therapy Revenue YoY Growth (2015-2026)3.8.2 Middle East and Africa Cell Freezing Media for Cell Therapy Sales YoY Growth (2015-2026) 4 Global Cell Freezing Media for Cell Therapy by Application4.1 Cell Freezing Media for Cell Therapy Segment by Application4.1.1 Human Embryonic Stem Cells4.1.2 CAR-T Cell Therapy4.1.3 Neural Stem Cell Therapy4.1.4 Mesenchymal Stem Cell Therapy4.1.5 Hematopoietic Stem Cell Transplantation4.1.6 Other4.2 Global Cell Freezing Media for Cell Therapy Sales by Application: 2015 VS 2020 VS 20264.3 Global Cell Freezing Media for Cell Therapy Historic Sales by Application (2015-2020)4.4 Global Cell Freezing Media for Cell Therapy Forecasted Sales by Application (2021-2026)4.5 Key Regions Cell Freezing Media for Cell Therapy Market Size by Application4.5.1 North America Cell Freezing Media for Cell Therapy by Application4.5.2 Europe Cell Freezing Media for Cell Therapy by Application4.5.3 Asia-Pacific Cell Freezing Media for Cell Therapy by Application4.5.4 Latin America Cell Freezing Media for Cell Therapy by Application4.5.5 Middle East and Africa Cell Freezing Media for Cell Therapy by Application 5 North America Cell Freezing Media for Cell Therapy Market Size by Country (2015-2026)5.1 North America Market Size Market Share by Country (2015-2020)5.1.1 North America Cell Freezing Media for Cell Therapy Sales Market Share by Country (2015-2020)5.1.2 North America Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2015-2020)5.2 North America Market Size Market Share by Country (2021-2026)5.2.1 North America Cell Freezing Media for Cell Therapy Sales Market Share by Country (2021-2026)5.2.2 North America Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2021-2026)5.3 North America Market Size YoY Growth by Country5.3.1 U.S. Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)5.3.2 Canada Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026) 6 Europe Cell Freezing Media for Cell Therapy Market Size by Country (2015-2026)6.1 Europe Market Size Market Share by Country (2015-2020)6.1.1 Europe Cell Freezing Media for Cell Therapy Sales Market Share by Country (2015-2020)6.1.2 Europe Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2015-2020)6.2 Europe Market Size Market Share by Country (2021-2026)6.2.1 Europe Cell Freezing Media for Cell Therapy Sales Market Share by Country (2021-2026)6.2.2 Europe Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2021-2026)6.3 Europe Market Size YoY Growth by Country6.3.1 Germany Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)6.3.2 France Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)6.3.3 U.K. Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)6.3.4 Italy Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)6.3.5 Russia Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026) 7 Asia-Pacific Cell Freezing Media for Cell Therapy Market Size by Country (2015-2026)7.1 Asia-Pacific Market Size Market Share by Country (2015-2020)7.1.1 Asia-Pacific Cell Freezing Media for Cell Therapy Sales Market Share by Country (2015-2020)7.1.2 Asia-Pacific Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2015-2020)7.2 Asia-Pacific Market Size Market Share by Country (2021-2026)7.2.1 Asia-Pacific Cell Freezing Media for Cell Therapy Sales Market Share by Country (2021-2026)7.2.2 Asia-Pacific Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2021-2026)7.3 Asia-Pacific Market Size YoY Growth by Country7.3.1 China Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.2 Japan Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.3 South Korea Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.4 India Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.5 Australia Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.6 Taiwan Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.7 Indonesia Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.8 Thailand Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.9 Malaysia Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.10 Philippines Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)7.3.11 Vietnam Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026) 8 Latin America Cell Freezing Media for Cell Therapy Market Size by Country (2015-2026)8.1 Latin America Market Size Market Share by Country (2015-2020)8.1.1 Latin America Cell Freezing Media for Cell Therapy Sales Market Share by Country (2015-2020)8.1.2 Latin America Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2015-2020)8.2 Latin America Market Size Market Share by Country (2021-2026)8.2.1 Latin America Cell Freezing Media for Cell Therapy Sales Market Share by Country (2021-2026)8.2.2 Latin America Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2021-2026)8.3 Latin America Market Size YoY Growth by Country8.3.1 Mexico Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)8.3.2 Brazil Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)8.3.3 Argentina Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026) 9 Middle East and Africa Cell Freezing Media for Cell Therapy Market Size by Country (2015-2026)9.1 Middle East and Africa Market Size Market Share by Country (2015-2020)9.1.1 Middle East and Africa Cell Freezing Media for Cell Therapy Sales Market Share by Country (2015-2020)9.1.2 Middle East and Africa Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2015-2020)9.2 Middle East and Africa Market Size Market Share by Country (2021-2026)9.2.1 Middle East and Africa Cell Freezing Media for Cell Therapy Sales Market Share by Country (2021-2026)9.2.2 Middle East and Africa Cell Freezing Media for Cell Therapy Revenue Market Share by Country (2021-2026)9.3 Middle East and Africa Market Size YoY Growth by Country9.3.1 Turkey Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)9.3.2 Saudi Arabia Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026)9.3.3 U.A.E Cell Freezing Media for Cell Therapy Market Size YoY Growth (2015-2026) 10 Company Profiles and Key Figures in Cell Freezing Media for Cell Therapy Business10.1 BioLife Solutions10.1.1 BioLife Solutions Corporation Information10.1.2 BioLife Solutions Description, Business Overview and Total Revenue10.1.3 BioLife Solutions Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.1.4 BioLife Solutions Cell Freezing Media for Cell Therapy Products Offered10.1.5 BioLife Solutions Recent Development10.2 Thermo Fisher Scientific10.2.1 Thermo Fisher Scientific Corporation Information10.2.2 Thermo Fisher Scientific Description, Business Overview and Total Revenue10.2.3 Thermo Fisher Scientific Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.2.5 Thermo Fisher Scientific Recent Development10.3 Merck10.3.1 Merck Corporation Information10.3.2 Merck Description, Business Overview and Total Revenue10.3.3 Merck Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.3.4 Merck Cell Freezing Media for Cell Therapy Products Offered10.3.5 Merck Recent Development10.4 GE Healthcare10.4.1 GE Healthcare Corporation Information10.4.2 GE Healthcare Description, Business Overview and Total Revenue10.4.3 GE Healthcare Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.4.4 GE Healthcare Cell Freezing Media for Cell Therapy Products Offered10.4.5 GE Healthcare Recent Development10.5 Zenoaq10.5.1 Zenoaq Corporation Information10.5.2 Zenoaq Description, Business Overview and Total Revenue10.5.3 Zenoaq Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.5.4 Zenoaq Cell Freezing Media for Cell Therapy Products Offered10.5.5 Zenoaq Recent Development10.6 WAK-Chemie Medical10.6.1 WAK-Chemie Medical Corporation Information10.6.2 WAK-Chemie Medical Description, Business Overview and Total Revenue10.6.3 WAK-Chemie Medical Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.6.4 WAK-Chemie Medical Cell Freezing Media for Cell Therapy Products Offered10.6.5 WAK-Chemie Medical Recent Development10.7 Biological Industries10.7.1 Biological Industries Corporation Information10.7.2 Biological Industries Description, Business Overview and Total Revenue10.7.3 Biological Industries Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.7.4 Biological Industries Cell Freezing Media for Cell Therapy Products Offered10.7.5 Biological Industries Recent Development10.8 Akron Biotechnology10.8.1 Akron Biotechnology Corporation Information10.8.2 Akron Biotechnology Description, Business Overview and Total Revenue10.8.3 Akron Biotechnology Cell Freezing Media for Cell Therapy Sales, Revenue and Gross Margin (2015-2020)10.8.4 Akron Biotechnology Cell Freezing Media for Cell Therapy Products Offered10.8.5 Akron Biotechnology Recent Development 11 Cell Freezing Media for Cell Therapy Upstream, Opportunities, Challenges, Risks and Influences Factors Analysis11.1 Cell Freezing Media for Cell Therapy Key Raw Materials11.1.1 Key Raw Materials11.1.2 Key Raw Materials Price11.1.3 Raw Materials Key Suppliers11.2 Manufacturing Cost Structure11.2.1 Raw Materials11.2.2 Labor Cost11.2.3 Manufacturing Expenses11.3 Cell Freezing Media for Cell Therapy Industrial Chain Analysis11.4 Market Opportunities, Challenges, Risks and Influences Factors Analysis11.4.1 Market Opportunities and Drivers11.4.2 Market Challenges11.4.3 Market Risks11.4.4 Porters Five Forces Analysis 12 Market Strategy Analysis, Distributors12.1 Sales Channel12.2 Distributors12.3 Downstream Customers 13 Research Findings and Conclusion 14 Appendix14.1 Methodology/Research Approach14.1.1 Research Programs/Design14.1.2 Market Size Estimation14.1.3 Market Breakdown and Data Triangulation14.2 Data Source14.2.1 Secondary Sources14.2.2 Primary Sources14.3 Author Details14.4 Disclaimer

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Covid-19 Impact on Cell Freezing Media for Cell Therapy Market (2020-2026) - Science In Me

CYTOVIA Therapeutics and MACROMOLTEK to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19) – GlobeNewswire

By adminApril 8, 2020Stem Cell Treatment

NEW YORK and AUSTIN, Texas, April 07, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics (Cytovia), an emerging biopharmaceutical company developing Natural Killer (NK) immunotherapies for cancer and infectious diseases, announced today that it is expanding its programs to help urgently address the current SAR CoV2 (COVID-19) crisis.

Natural Killer cells are a first line of defense not only against tumor cells but also against severe acute infectious diseases. Using a bi-functional approach has the potential to minimize virus escape from the immune response thereby inhibiting the intensification of the inflammation leading to Acute Respiratory Syndrome (ARS). The activation of NK cells through the NKp46 receptor aims to destroy the virus-infected cells while the other arm can either block the entry of the virus into epithelial cells or neutralize circulating viruses.

Dr Daniel Teper, co-founder, Chairman and CEO of Cytovia said: Our goal is to bring the best candidate to clinical trials by the end of the year 2020 and make it available to patients in 2021. As we become more prepared for potential next waves of the pandemic, physicians will need therapeutic options to strengthen the immune response and prevent rapid worsening of the disease. We expect that our novel approach might also be applied in the future to other severe acute infectious diseases, an area that still has significant unmet medical needs. Partnering with Macromoltek will fast-track this process.

Dr Monica Berrondo, co-founder and CEO of Macromoltek added: Our computational approach to antibody design allows to fast track the development of optimal therapeutic candidates in weeks rather than months. In the fight against SARS CoV2, time is of the essence. We are delighted to be part of a multi-disciplinary team passionate about winning the race against the virus with novel therapeutic solutions.

Cytovia will lead a highly coordinated team of scientific collaborators in order to achieve aggressive timelines for its COVID-19 therapeutic program. Cytovia will leverage its own proprietary bi-functional technology, developed by co-founder Dr Kadouche, NK activating antibodies licensed last month from Yissum, the technology transfer company of the Hebrew University of Jerusalem, and novel antibodies neutralizing or blocking SARS CoV2, designed by Macromoltek, a computational antibody discovery company. The selected bi-functional antibodies will further benefit from the Fast to Clinic approach implemented by STC Biologics, a Boston, MA based antibody development and manufacturing company.

About Cytovia TherapeuticsCytovia aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and applies precision medicine tools to develop the right therapy for the right patient at the right stage of the disease. Cytovia has secured access to multiple advanced technologies, including an induced pluripotent stem cell (iPSC) platform for NK cell therapy, gene editing of Chimeric Antigen Receptors (CAR) to enhance targeting of NK cells, and NK engager multi-functional antibodies. Cytovia partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF) and the Hebrew University of Jerusalem. Learn more at http://www.cytoviatx.com.

About MacromoltekMacromoltek, a computationalde novodrug design company, rapidly producesaccurate and credible antibody designs. They have built a proprietary platform that enables design against difficult targets inaccessible by traditional methods. A Y Combinator cohort company, they are already designing antibodies for several large biopharmas and smaller biotechs. https://www.macromoltek.com

Media and Investor Contacts

Cytovia TherapeuticsSophie Badr(Media)sophiebadre21@gmail.com929.317.1565

Anna Baran Djokovic (Investors)Anna@cytoviatx.com

MacromoltekLisa Hendricksonlhendrickson@sparkcity.co917.912.9424

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CYTOVIA Therapeutics and MACROMOLTEK to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19) - GlobeNewswire

What You Need to Know About the FDA’s Approval of Opdivo-Yervoy for Hepatocellular Carcinoma – Curetoday.com

By adminApril 8, 2020Stem Cell Medicine

The Food and Drug Administration approved the dual immunotherapy of Opdivo and Yervoy for the treatment of patients with advanced hepatocellular carcinoma. Heres what you need to know.

This is the only dual immunotherapy approved by the FDA in this setting of patients with HCC and was based on the results of the phase 1/2 CheckMate-040 trial. The overall trial was to look at Opdivo in patients with advanced HCC, with the Opdivo and Yervoy cohort showing a duration of responses that lasted from 4.6 to 30.5 months with 88% of responses lasting at least 6 months, 56% at least 12 months and 31% at least 24 months, according to a Bristol Myers Squibb spokesperson.

HCC is an aggressive disease in need of different treatment approaches, Dr. Anthony B. El-Khoueiry, lead investigator and phase 1 program director at the Keck School of Medicine, University of Southern California (USC) and the USC Norris Comprehensive Cancer Center, said in the original press release regarding the approval. As the incidence of liver cancer rises in the United States, HCC has become the most common and aggressive from of the disease with relapsed patients in need of new treatments after the first line of treatment fails. This is why the FDA granted accelerated approval to the Opdivo and Yervoy combination for this patient group previously treated with Nexavar, a chemotherapy for liver cancers.

The CheckMate-040 trial is a phase 1/2, dose-escalation/dose expansion, open-label study of Opdivo in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis C or B. Researchers envaulted the Opdivo-Yervoy combination in 49 patients with advanced HCC, 33% of these patients responded to this treatment with 8% demonstrating a complete response and 24% exhibiting a partial response after a minimal follow up of 28 months. Overall response was reported in 35% of patients.

According to a Bristol Myers Squibb spokesperson, the Opdivo-Yervoy combination acts on the CTLA-4 and PD-1 immune checkpoints that while beneficial alone there is evidence that the mechanisms can work together to produce a greater effect in patients. In the case of Yervoy, it may help the patients immune system to activate more T cells that help fight cancer cells while Opdivo assists in already active T cells discovering cancer cells. The researchers believe the combination can work to discover and then deploy newly activated T cells in the fight against cancer.

However, according to a Bristol Myers spokesperson, this combination therapy can cause the immune system to attack normal organs and tissues which can lead to serious complications and may happen more often on this combination therapy.

In the CheckMate-040 trial serious side effects were seen in 59% of patients on the treatment, including pyrexia, diarrhea, anemia, increased aspartate aminotransferase, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin and pneumonitis in more than 4% of patients. The most common of these side effects was rash, pruritus, musculoskeletal pain, diarrhea, cough, decreased appetite, fatigue, pyrexia, abdominal pain, headache, nausea, dizziness, hypothyroidism and weight decrease reported in more than 20% of patients.

The approval for the Opdivo-Yervoy combination was granted on March 10th, 2020.

Read CUREs original coverage of the approval.

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What You Need to Know About the FDA's Approval of Opdivo-Yervoy for Hepatocellular Carcinoma - Curetoday.com

MSC-based therapies from Mesoblast, Cynata advance to tackle COVID-19 ARDS – BioWorld Online

By adminApril 8, 2020Stem Cell Medicine

PERTH, Australia Australian stem cell therapy company Mesoblast Ltd. announced that the FDA gave it the green light to test its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19).

Were going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesnt destroy your lungs at the same time, Mesoblast CEO Silviu Itescu told BioWorld.

What people are dying of is acute respiratory distress syndrome, which is the bodys immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs, Itescu said.

The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomized controlled trial.

The company is in active discussions with various governments, regulatory authorities, medical institutions and pharmaceutical companies.

Recently published results from an investigator-initiated clinical study conducted in China reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients. A post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS.

Remestemcel-L is being developed for various inflammatory conditions and is believed to counteract the inflammatory processes implicated in those diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in more than 1,100 patients in various clinical trials.

The stem cell therapy was successful in a phase III trial for steroid-refractory acute graft-vs.-host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS.

Cynata in preclinical ARDs studies

Fellow Aussie regenerative medicine company Cynata Therapeutics Ltd. is studying the utility of its Cymerus MSCs as a treatment for ARDS associated with COVID-19 with the Critical Care Research Group at Prince Charles Hospital in Brisbane, Australia.

Acute respiratory distress syndrome is a huge problem worldwide and is prevalent aside from COVID-19, but suddenly it is on the front page because people are dying of this. The data behooves us to see if MSC treatment can rescue people from this, Cynata CEO Ross Macdonald told BioWorld.

The Critical Care Research Group has long seen the need to improve interventions in patients who have ARDS, and they have an interest in MSCs and came to us, he said.

ARDS is an inflammatory process leading to the build-up of fluid in the lungs and respiratory failure. It can occur due to infection, trauma and inhalation of noxious substances. ARDS often affects previously healthy individuals and accounts for roughly 10% of all ICU admissions, with almost 25% of patients requiring mechanical ventilation. Survivors of ARDS are often left with severe long-term illness and disability.

The study will investigate Cynatas Cymerus MSCs as a treatment for ARDS, in combination with extracorporeal membrane oxygenation (ECMO). ECMO circulates blood through an artificial lung, oxygenating the blood before putting it back into the bloodstream of a patient. ECMO has emerged as a treatment adjunct to support the vital organs in patients with severe ARDS, which can provide short- to medium-term mechanical pulmonary support.

MSC therapy could be used as a possible treatment for ARDS due to the ability of MSCs to reduce inflammation, enhance clearance of pathogens and stimulate tissue repair.

The study will first seek to determine if Cymerus MSC treatment improves oxygenation in sheep with ARDS supported by ECMO, and to evaluate the effects on lung mechanics, blood flow, inflammation and lung injury, as well as safety.

If the study is successful, the data would support progression to a clinical trial of Cymerus MSCs in humans with ARDS undergoing ECMO support.

The study is being funded by the Queensland State Government, the National Health and Medical Research Council (NHMRC), the Intensive Care Society UK, and the Prince Charles Hospital Foundation.

If the FDA or TGA wants us to step in, were all ears. Our product is manufactured in the United States, and supply is not an issue. In theory, were ready to go, Macdonald said.

He was quick to point out that what differentiates Cynatas stem cell product from competitors is that its MSCs are derived from induced pluripotent stem cells (iPSCs), and most stem cell companies rely on multiple donors to donate either bone marrow or adipose tissue as their primary tissue sources. From those sources they derive a small number of MSCs, which represent the starting material of their manufacturing process.

Cynatas Cymerus MSC therapy comes from a single donor and can be produced in limitless quantities, giving it the potential to create a new standard, Macdonald said. The platform technology is based on versatile stem cells known as mesenchymoangioblasts (MCAs), which are a precursor of mesenchymal stem cells.

That process allows the company to make MSCs derived from iPSCs in large amounts without losing their potency, and that forms the basis for the companys platform technology, which it calls Cymerus.

Cynata is gearing up for three phase II trials with its Cymerus MSCs in graft-vs.-host disease (GVHD), critical limb ischemia and osteoarthritis.

Mesoblasts remestemcel-L is being studied in clinical trials across several inflammatory conditions, including in elderly patients with lung disease and adults and children with steroid-refractory aGVHD, heart failure and chronic low back pain due to intervertebral disc degeneration.

The FDA recently accepted Mesoblasts BLA for priority review for remestemcel-L for children with aGVHD. It has a PDUFA date of Sept. 30 for the product branded as Ryoncil.

Mesoblast shares (ASX:MSB) were up nearly 34% to AU$1.78 from AU$1.32 per share by market close April 6.

Cynatas shares (ASX:CYP) were trading at AU86 cents on April 7.

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MSC-based therapies from Mesoblast, Cynata advance to tackle COVID-19 ARDS - BioWorld Online

CYTOVIA Therapeutics and MACROMOLTEK to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19) | DNA RNA and Cells | News…

By adminApril 8, 2020Stem Cell Medicine

DetailsCategory: DNA RNA and CellsPublished on Tuesday, 07 April 2020 18:50Hits: 403

NEW YORK, NY and AUSTIN, TX, USA I April 07, 2020 I Cytovia Therapeutics (Cytovia), an emerging biopharmaceutical company developing Natural Killer (NK) immunotherapies for cancer and infectious diseases, announced today that it is expanding its programs to help urgently address the current SAR CoV2 (COVID-19) crisis.

SOURCE: Cytovia Therapeutics