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Mount Sinai Leading the Way in Innovative Stem Cell Therapy for COVID-19 Patients – Newswise

Posted: April 11, 2020 at 8:42 pm

Newswise (New York, NY April 9, 2020) Mount Sinai Health System is the first in the country to use an innovative allogeneic stem cell therapy in COVID-19 patients and will play a central role in developing and conducting a rigorous clinical trial for patients with severe acute respiratory distress syndrome, the breathing illness that afflicts people who have severe cases of COVID-19.

The therapy, known as remestemcel-L, has previously been tested in bone marrow transplant patients, who can experience an overactive immune response similar to that seen in severe cases of COVID-19.

Mount Sinai began administering the therapy, known as remestemcel-L, to patients in late March under the Food and Drug Administrations compassionate use program, which allows patients with an immediately life-threatening condition to gain access to an investigational therapy. Ten patients with moderate to severe cases of COVID-19-related acute respiratory distress syndrome (ARDS), most of whom were on ventilators, were given the therapy and doctors saw encouraging results.

We are encouraged by what we have seen so far and look forward to participating in the randomized controlled trial starting soon that would better indicate whether this is an effective therapy for patients in severe respiratory distress from COVID-19, said Keren Osman, MD, Medical Director of the Cellular Therapy Service in the Bone Marrow and Stem Cell Transplantation Program at The Tisch Cancer Institute at Mount Sinai and Associate Professor of Medicine (Hematology and Medical Oncology) at the Icahn School of Medicine at Mount Sinai. Dr. Osman oversaw the treatment of the first Mount Sinai patients with this innovative therapy.

Under the leadership of Annetine Gelijns, PhD, Alan Moskowitz, MD, and Emilia Bagiella, PhD, of Mount Sinais Institute of Transformative Clinical Trials, Mount Sinai will serve as the clinical and data coordinating center for a randomized clinical trial evaluating the therapeutic benefit and safety of this stem cell therapy in 240 patients with COVID-related ARDS in the United States and Canada. The trial will be conducted as a public-private partnership between the Cardiothoracic Surgical Trials Network, which was established as a flexible clinical trials platform by the National Heart, Lung, and Blood Institute, and Mesoblast, the manufacturer of the cells.

The coronavirus pandemic has caused exponential increases of people suffering with acute respiratory distress syndrome, requiring intubation and mechanical ventilation with many dying, said Dr. Gelijns, who is also the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai. We have designed a clinical trial that will expeditiously determine whether the stem cell therapy will offer a life-saving therapy for a group of patients with a dismal prognosis.

We are interested to study the potential of this anti-inflammatory cell therapy to make an impact on the high mortality of lung complications in COVID-19 patients, said CSTN Chairman A. Marc Gillinov, MD. This randomized controlled trial is in line with our mandate to rigorously evaluate novel therapies for public health imperatives.

The therapy consists of mesenchymal stem cells. These cells are found in bone marrow and serve many functions including aiding tissue repair and suppressing inflammation. The therapy was previously tested in a phase 3 trial in children who had an often-fatal inflammatory condition called graft-versus-host disease (GVHD) that can occur after bone marrow transplants.

The inflammation that occurs in GVHD is the result of a cytokine storm, which activates immune cells that attack healthy tissue. A similar cytokine storm that causes damage to the lungs and other organs appears to be taking place in COVID-19 patients who develop acute respiratory distress syndrome, said John Levine, MD, Professor of Medicine (Hematology and Medical Oncology), and Pediatrics, at the Icahn School of Medicine at Mount Sinai, who helped implement the compassionate use of the drug at Mount Sinai.

These stem cells have shown excellent response rates in severe graft-versus-host disease in children, said Dr. Levine, who is also the co-director of the Mount Sinai Acute GVHD International Consortium (MAGIC). Mesenchymal stem cells have a natural property that dampens excessive immune responses.

Several people were instrumental in quickly and efficiently working through the complex application process for each patient to gain compassionate use of the therapy. Three key players involved were Stacey-Ann Brown, MD, MPH, Assistant Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine) at the Icahn School of Medicine at Mount Sinai; Tiffany Drummond, Assistant Director of Regulatory Affairs at The Tisch Cancer Institute at Mount Sinai; and Camelia Iancu-Rubin, PhD, Director of the Cellular Therapy Laboratory at the Icahn School of Medicine at Mount Sinai.

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality carefrom prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 onU.S. News & World Report's"Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally byU.S. News & World Report.

For more information, visithttps://www.mountsinai.orgor find Mount Sinai onFacebook,TwitterandYouTube.

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Mount Sinai Leading the Way in Innovative Stem Cell Therapy for COVID-19 Patients - Newswise

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Chimeric Antigen Receptor (CAR) T-Cell Therapy Market 2020: Professional Survey & Competitive Dynamics Mustang Bio Inc., iCell Gene Therapeutics,…

Posted: April 11, 2020 at 8:42 pm

Global Chimeric Antigen Receptor (CAR) T-Cell Therapy Market 2020 is analyzed in details, to provide accurate and useful insights and market data that players can perform strong growth in the future. Experts and Chimeric Antigen Receptor (CAR) T-Cell Therapy industry analysts, which makes it legitimate and dependable compile the analysis. Readers have a thorough inspection of historical and futuristic Chimeric Antigen Receptor (CAR) T-Cell Therapy market scenarios to have a good understanding of other issues that are important with the market competition. The report offers Chimeric Antigen Receptor (CAR) T-Cell Therapy information on key players, key sections, market dynamics and assorted niches. It is a complete collection of Chimeric Antigen Receptor (CAR) T-Cell Therapy research and in-depth analysis of the market.

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Chimeric Antigen Receptor (CAR) T-Cell Therapy Market 2020: Professional Survey & Competitive Dynamics Mustang Bio Inc., iCell Gene Therapeutics,...

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Moving toward Nonchemotherapy-Based Approaches in Follicular Lymphoma – Cancer Network

Posted: April 11, 2020 at 8:42 pm

Nonchemotherapy-based approaches, including PI3K inhibitors and a more widespread use of allogeneic stem cell transplant, are being explored as treatments for patients with follicular lymphoma, according to Michael L. Grossbard, MD, who added that CAR T-cell therapy is also being evaluated.

As time has gone by, we have tried to move more toward nonchemotherapy brute force approaches to managing follicular lymphoma, said Grossbard, a professor in the Department of Medicine, chief of the Hematology and Medical Oncology Inpatient Service at Tisch Hospital, NYU Langone Healths Perlmutter Cancer Center.

Grossbard, who is also section chief of Hematology at NYU Langone Healths Perlmutter Cancer Center, spoke withOncLive,CancerNetworks sister publication, about these recent developments in the field of follicular lymphoma.

Follicular lymphoma is easy to get into remission with a lot of the new therapies we have, but there is a continuous period of relapse. Patients are not cured with their initial therapy Grossbard explained. Maintenance rituximab (Rituxan) is very helpful because you can use a targeted monoclonal antibody to prolong remissions, which may not have an impact on long-term survival, but prolonging remissions for patients is really important. For a patient, not having disease means a lotemotionally and psychologicallyin terms of quality of life.

According to Grossbard, minimal residual disease (MRD) may help measure the length of remission for a patient; however, there are no studies in follicular lymphoma that currently show that achievement of MRD is critical.

There are a lot of studies that have looked at MRD in follicular lymphoma. Some of those studies go back more than 20 years, which originally showed that the only modality we had to get patients to an MRD-negative state was transplant, said Grossbard. Now, with rituximab and other targeted therapies, we can actually achieve that MRD-negative state with more minimalist approaches.

Another treatment option that Grossbard highlighted were PI3K inhibitors, which are yet another targeted therapy for follicular lymphomas.

We understand more about B cells gone awry, which are the essence of what lymphoma is. The B-cell receptor pathway is triggered by the number of enzymes in a cascade, Grossbard explained. One of those [enzymes] is PI3K, and by blocking that particular enzyme, we can block the growth and proliferation of B cells and cause the killing of lymphoma cells.

However, in order to determine which type of PI3K inhibitor a patient should receive, Grossbard indicated that there are no clear guidelines to be followed, as it depends on personal experience and comfort with the drugs. He recommends becoming familiar with 1 or more of them in order to see where they fit into a patients treatment course.

For patients with heavily pretreated follicular lymphomas, Grossbard indicated that allogeneic transplant opens an option for potential cure, even in later stages and those with more advanced and refractory disease. However, this therapy option is typically not recommended unless a patient has been extensively pretreated.

Patients who have been through multiple chemotherapy regimens, multiple biological therapy regimens, and still have a good performance status and a tolerable amount of comorbid disease would fall into that sweet spot of considering allogeneic stem cell transplant, said Grossbard. Still, even though we do a lot better with managing toxicities than we used to, there are significant potential adverse events of graft-versus-host disease and other complications of allogenic transplant.

When asked about the status of venetoclax (Venclexta) in follicular lymphoma, a BCL2 inhibitor, Grossbard suggested that there is still a lot that is unknown. Venetoclax is currently approved for use in chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia.

In theory, venetoclax should be a marvelous drug for follicular lymphoma, but the response rates in follicular lymphoma with single-agent venetoclax have been a little more disappointing than we would have anticipated, Grossbard said. Venetoclaxs place in follicular lymphoma still remains to be defined.

This article was adapted from an article that originally appeared on OncLive, titled Follicular Lymphoma Moves Toward Chemo-Free Regimens.

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Animal Stem Cell Therapy Market Forecast 2020-2025, Latest Trends and Opportunities – Express Journal

Posted: April 11, 2020 at 8:42 pm

Growth Analysis Report onAnimal Stem Cell Therapy Market size | Industry Segment by Applications (Veterinary Hospitals and Research Organizations), by Type (Dogs, Horses and Others), Regional Outlook, Market Demand, Latest Trends, Animal Stem Cell Therapy Industry Share & Revenue by Manufacturers, Company Profiles, Growth Forecasts 2025.Analyzes current market size and upcoming 5 years growth of this industry.

TheAnimal Stem Cell TherapyMarketAnalysis report attempts to offer foremost and deep understandings into the current market scenario and the advanced development dynamics. The report onAnimal Stem Cell Therapy Marketaims to provides the extensive view of the market landscape. The comprehensive research will enable the well-established as well as the emerging players to expand their business approaches and achieve their targeted goals.

This report on Animal Stem Cell Therapy Market covers the manufacturers data including shipment, revenue, gross profit, business distribution etc., these data help the consumer know about the competitors better. This report also covers topmost regions and countries of the world, which shows a regional development status, including Animal Stem Cell Therapy market size, volume and value as well as price data.

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Animal Stem Cell Therapy Market Forecast 2020-2025, Latest Trends and Opportunities - Express Journal

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Cell Therapy Market Size Analysis, Top Manufacturers, Shares, Growth Opportunities and Forecast to 2026 – Science In Me

Posted: April 11, 2020 at 8:42 pm

New Jersey, United States:The new report has been added by Market Research Intellect to provide a detailed overview of the Cell Therapy Market. The study will help to better understand the Cell Therapy industry competitors, the sales channel, Cell Therapy growth potential, potentially disruptive trends, Cell Therapy industry product innovations and the value / volume of size market (regional / national level, Cell Therapy- Industrial segments), market share of the best actors / products.

Information has been added to the report to provide a realistic view of the industry based on data from Cell Therapy manufacturers, i.e. H. Shipping, price, sales, gross profit, business distribution, etc., SWOT analysis, consumer preference, current developments and trends, drivers and limiting factors, company profile, investment opportunities, analysis of the demand gap, market size value / volume, services and products, Porters five models , socio-economic factors, official regulations in the Cell Therapy branch. Market participants can use the report to take a look at the future of the Cell Therapy market and make significant changes to their operating style and marketing tactics in order to achieve sustainable growth.

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The report examines the competitive environment scenario observed with key players in Cell Therapy sales, the profile of their business, their earnings, their sales, their business tactics, and the forecasting situations of the Cell Therapy sales industry. According to studies, the Cell Therapy sales market is very competitive and diverse due to global and local suppliers.

The Cell Therapy Sales Market Report mainly contains the following Manufacturers:

Market Competition

The competitive landscape of the Cell Therapy market is examined in detail in the report, with a focus on the latest developments, the future plans of the main players and the most important growth strategies that they have adopted. The analysts who compiled the report have created a portrait of almost all of the major players in the Cell Therapy market, highlighting their key commercial aspects such as production, areas of activity and product portfolio. All companies analyzed in the report are examined on the basis of important factors such as market share, market growth, company size, production, sales and earnings.

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Assessment of sales channels

innovation trends

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market size and forecast

The geographic department provides data that give you an overview of the turnover of companies and sales figures for the growth activity Cell Therapy for electrical meters. Here are the strengths of the geographic divisions: North America (United States, Canada and Mexico), Europe (Germany, Spain, France, Great Britain, Russia and Italy and more), Asia-Pacific (China, Japan, Korea, India and Southeast Asia) and more ), South America (Brazil, Argentina, Colombia), the Middle East and Africa (Saudi Arabia, United Arab Emirates, Egypt, Nigeria and South Africa) and ROW.

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1 Introduction of Cell Therapy Market1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Cell Therapy Market Outlook4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Cell Therapy Market, By Deployment Model5.1 Overview

6 Cell Therapy Market, By Solution6.1 Overview

7 Cell Therapy Market, By Vertical7.1 Overview

8 Cell Therapy Market, By Geography8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Cell Therapy Market Competitive Landscape9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix11.1 Related Research

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Cell Therapy Market Size Analysis, Top Manufacturers, Shares, Growth Opportunities and Forecast to 2026 - Science In Me

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

Posted: April 11, 2020 at 8:42 pm

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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Celularity Expands Strategic Collaboration with United Therapeutics Corporation to COVID-19 Infection and Acute Respiratory Distress Syndrome -…

Posted: April 11, 2020 at 8:42 pm

WARREN, N.J., April 9, 2020 /PRNewswire/ --Celularity Inc. ("Celularity" or the "Company"), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the expansion of its existing collaborative license agreement with United Therapeutics Corporation's (Nasdaq: UTHR) wholly-owned subsidiary, Lung Biotechnology PBC, to include the treatment of COVID-19 and Acute Respiratory Distress Syndrome (ARDS).

This announcement builds on recent pioneering work by Celularity for the use of its proprietary CYNK-001 for the treatment of the SARS-CoV-2 virus that causes the coronavirus disease, COVID-19, and extends this application of the technology to ARDS. The U.S. Food and Drug Administration recently cleared Celularity's investigational new drug application (IND 019650) to evaluate CYNK-001's safety, tolerability, and efficacy for the treatment of COVID-19.

ARDS, the most devastating complication of COVID-19, is a serious inflammatory lung injury that causes hypoxemia, or below-normal oxygen level in the blood. Hypoxemia can lead to multi-organ system failure and death. Recent findings indicate that ARDS may develop in as many as 17-29% of COVID-19 patients who are hospitalized with pneumonia.

Celularity founder and Chief Executive Officer, Dr. Robert Hariri, said, "This promising, novel approach to treating COVID-19 and the pulmonary complications associated with this infection may unlock a powerful new therapeutic option for patients. The exceptional expertise in pulmonary disease, cellular medicine, and manufacturing makes this strategic collaboration particularly well suited to tackle this urgent, global medical crisis."

Under the amended collaborative agreement, Celularity will seek regulatory approval for CYNK-001 in COVID-19, and Lung Biotechnology will seek regulatory approval for CYNK-001 in ARDS. Lung Biotechnology has global rights under the amended collaborative agreement to commercialize CYNK-001 in COVID-19 and ARDS. The collaboration will be governed by a Joint Steering Committee to oversee development and commercialization activities. Financial terms were not disclosed.

Celularity's CYNK-001 is the only cryopreserved allogeneic, off-the-shelf Natural Killer (NK) cell therapy being developed from placental hematopoietic stem cells and is being investigated as a potential treatment option for various hematologic cancers and solid tumors, and is the first cell therapy granted an IND to treat COVID-19. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and virally infected cells and interacting with adaptive immunity. CYNK-001 cells derived from the postpartum placenta have been shown to be well-tolerated in early clinical trials and are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

Media and Investor RelationsMedia Contact:Factory PR[emailprotected]

Investor Relations Contact:John R. Haines, Executive Vice President[emailprotected]

About Celularity: Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory, infectious, and age-related diseases. To learn more, please visit http://www.celularity.com.

Forward-Looking Statements: This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks, and uncertainties that may cause actual results, the outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of the original issue. Celularity expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

SOURCE Celularity Inc.

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More Therapeutic Ideas for the Coronavirus: Too Much Inflammation? – Science Magazine

Posted: April 11, 2020 at 8:42 pm

So today Id like to talk about some of the other anti-coronativirus possibilities that I havent gone into yet these posts will never make a comprehensive list, but at least I can cover some of the more interesting ideas, I hope.

Interleukin-6 is an interesting story. This preprint from German researchers presents some evidence that IL-6 levels correlate with the likelihood of severe respiratory symptoms in coronavirus-infected patients: the more IL-6, the worse the outlook. That makes sense, because the protein is already well-established as a big player in immune and inflammation pathways. The question is whether in some patients the immune response gets out of hand; theres a very real chance that many of the worst outcomes are as much a problem with a patients reaction to the viral infection rather than the infection per se. There were early indications of this in the epidemic; this is the cytokine storm that you hear about so much these days, and the remedy for such a situation is to try to turn the immune signaling back down.

Anti-IL-6 antibody therapies have been developed for just that purpose, for patients with autoimmune disorders who need to turn the dial down in just that manner. Rheumatoid arthritis patients generally have elevated IL-6, for example, and tocilizumab (brand name Actemra) was approved by the FDA in 2010 as a therapy. Its since picked up other indications, such as use in cytokine release syndrome, a similar over-stimulation that can show up as a complication in the new CAR-T engineered T-cell therapies for cancer. So its use in the current epidemic seems like a reasonable idea. Its been approved for that purpose in China, there are anecdotal reports from there, from Italy and from other areas, and there are trials underway or planned in China, Switzerland, the US, Belgium, Greece, and Denmark at the very least. Theres another anti IL-6 antibody that was approved in 2017 (sarilumab, brand name Kevzara), and that one is also going into coronavirus trials.

Update: via the comments, there also siltuximab (brand name Sylvant), an antibody which targets the IL-6 protein itself rather than receptor, as the two above do. Its also being looked at in the clinic, and itll be interesting to see if there are different effects, since some of these proteins have functions beyond those mediated by their receptors.

A similar possibility is anakinra (brand name Kineret), which targets the IL-1 system. Interleukin-1 is also a big player in the immune response, and unraveling its complexities is an ongoing project, since there are 11 related interleukins in that family (isnt immunology great?) But they generally work through a limited set of IL receptors, and theres even a natural antagonist protein (IL-1R) that blocks one of them. Anakinra is a modified version of that antagonist, and its also in trials (in fact, its an arm of some of the same trials investigating the IL-6 antibody).And there are other ways to target the response. Heres a proposal to use antagonists of the alpha-1 adrenergic receptor such as prazosin, and heres oneto try low-molecular weight heparin. Sphingosine kinase 2 is involved in inflammation signaling, and an investigational inhibitor of the enzyme (opaganib) is being tried in Italy. Ruxolitinib (brand name Jakavi) is a Janus kinase inhibitor that also affects these pathways and is being looked at as well. Theres even a technique to filter out such signaling molecules from the blood thats getting a look.

Obviously turning down the inflammation response if there arent signs of overstimulatory trouble would (youd think) be a bad idea. Many of these drugs carry warning labels on them already about not using them during acute infections or noting that they can increase the risk of one. But if overstimulation of the immune response really is the problem, this approach could be just whats needed. Picking out the patients that will benefit will be the tricky part!

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More Therapeutic Ideas for the Coronavirus: Too Much Inflammation? - Science Magazine

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Convalescent plasma therapy useful in treating COVID-19 – Anadolu Ajans

Posted: April 11, 2020 at 8:42 pm

ANKARA

Apheresis therapy can be widely beneficial in treating patients with the novel coronavirus, the president of the World Apheresis Association said Wednesday.

Speaking on convalescent plasma therapy, Fevzi Altuntas said this therapy is being successfully applied in many scientific areas of therapeutic apheresis in Turkey.

What is apheresis?

Apheresis is a science that deals with the processing of blood outside of the body to cure a disease and obtaining the desired blood component or stem cell or cellular therapy products, Altuntas said.

Apheresis is a treatment method that has been successfully applied in treating a wide range of diseases that concern a lot of disciplines such as blood diseases, nephrology, neurology, intensive care, emergency medicine, microbiology and clinical infection, he said.

Stressing that apheresis therapy is not applied only for plasma production in patients with the coronavirus, he said in the pandemic, apheresis is also applied for removal of the virus, the released cytokines and chemicals, replacing the coagulation proteins consumed and the collection of plasma of people who have recovered from COVID-19 disease for transfer.

Turkey started applying convalescent plasma therapy faster than many developed countries, he said.

"This situation sums up the success that our country has reached in the field of apheresis science."

What is convalescent plasma therapy?

This passive antibody therapy is aimed at transferring antibodies to a person for the purpose of protecting and treating against disease, Altuntas underlined.

The aim of the therapy is to take antibodies from the blood of a person who has recovered from a virus and transfer them to a sick person, he said.

In this way, the virus in the patient is expected to be deactivated.

Process of therapy

Commenting on the process of therapy, Altuntas said all donors must be diagnosed with COVID-19.

Donors should have no complaints and feel good for at least 14 days after recovery, he said, stressing that legally, people between the ages of 18-60 can be donors.

He went on to say that immunized plasmas are collected from individuals who meet these criteria and stored in blood banks.

Product collection in apheresis center

Speaking on how to collect products at an apheresis center, Altuntas said the apheresis process will take an average of 60-80 minutes. Approximately 200-600 cc of plasma will be collected with apheresis devices.

Also, the donor will be kept under surveillance for 15 minutes after the transaction is completed, he said, adding an appointment for a new plasma donation will be made again with the consent of the donor.

What will happen to collected products?

Touching on the process after collecting the products, Altuntas said barcoding will be done by the Turkish Red Crescent, also known as Kizilay, for the collected products.

Barcoded products will be stored at minus 18-25 degrees or below in a separate storage cabinet, he said, adding convalescent plasma will be transplanted to severe and critical COVID-19 patients.

Finally, 200-400 ml of convalescent plasma will be transplanted to selected patients, he said.

"I invite everyone recovering from this disease to become a volunteer plasma donor. This is not only a social responsibility but a national duty.

Our examples of social solidarity such as plasma donation are crucial to overcoming this fight together healthfully," he added.

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Convalescent plasma therapy useful in treating COVID-19 - Anadolu Ajans

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Cell Therapy Technologies Market Size, Key Trends, Challenges and Standardization, Research, Key Players, Economic Impact and Forecast to 2026 -…

Posted: April 11, 2020 at 8:42 pm

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Cell Therapy Technologies Market Size, Key Trends, Challenges and Standardization, Research, Key Players, Economic Impact and Forecast to 2026 -...

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