RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device, Enabling Clinical Study for Safety and Feasibility – BioSpace

ROSELAND, N.J., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Renovacare, Inc. (Symbol: RCAR; http://www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, today announced that the US Food and Drug Administration (FDA)conditionally approved the Companys Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous stem cells rendered by its CellMist System from donor skin and applied topically with the SkinGun spray device for treatment of burn wounds.

"The FDA conditional approval marks a significant milestone for RenovaCare and our technology for spraying an ultra-gentle mist of a patients own skin cells for the healing of burns and wounds. We are working to complete the FDA's technical requirements so that we may move forward with the next phase of development," stated Alan L. Rubino, the Company's President and Chief Executive Officer.

The clinical trial protocol, conditionally approved on August 5, 2020 by the FDA is an open-label single-arm clinical study that will enroll 14 human burn subjects with partial-thickness second- or- third degree thermal burn wounds. The Company expects to conduct the clinical study at multiple U.S. burn centers.

"This achievement marks the culmination of our innovative stem cell and spray technologies coupled to applied research and development resulting in a formal clinical evaluation of skin stem cells as a therapeutic to facilitate burn wound healing," stated RenovaCare Chief Scientific Officer, Dr. Robin A. Robinson. "I am proud of our RenovaCare Team and their dedication to our mission and commitment to provide effective and expedited patient healing and look forward to commencing this study as quickly as possible."

About RenovaCare RenovaCare, Inc. is developing new generation autologous stem cell therapies for the regeneration of human organs and tissues. The Company's initial product under development targets the bodys largest organ, the skin. The Companys flagship technology, the CellMist System, renders single-cell suspensions of tissue-specific pluripotent cells from donor tissues through sequential protease digestions. The RenovaCare CellMist System facilitates rapid healing of wounds or other afflicted tissues when applied topically as a gentle cell mist using the patented RenovaCare SkinGun. The Companys SkinGun is used to spray a liquid suspension of a patients stem cells the CellMist Solution on to wounds.

RenovaCare is developing its CellMist System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars. In the US alone, this $45 billion market is greater than the spending on high-blood pressure management, cholesterol treatments, and back pain therapeutics.

Development for next-generation biomedical technologies and devices for addressing unmet medical needs and commercialization is taking place at the RenovaCare R&D Innovation Center, located at StemCell Systems in Berlin, Germany. The Innovation Center houses dedicated RenovaCare cell biology laboratories; additional engineering, fabrication, prototyping and performance testing facilities; and product design studios for medical devices and biomedical products. Experienced contract bioengineers, cell biologists, and support staff work under the direction of a team of MD-PhDs who are experts in regenerative medicine, new product development, and clinical translation.

RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the Companys planned or filed submissions to the U.S. Food and Drug Administration will be accepted or cleared by the FDA.

For additional information, please call Amit Singh at: 1-888-398-0202 or visit:https://renovacareinc.com

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Social Media Disclaimer Investors and others should note that we announce material financial information to our investors using SEC filings and press releases. We use our website and social media to communicate with our subscribers, shareholders and the public about the company, RenovaCare, Inc. development, and other corporate matters that are in the public domain. At this time, the company will not post information on social media that could be deemed to be material information unless that information was distributed to public distribution channels first.

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Legal Notice Regarding Forward-Looking Statements No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although RenovaCare, Inc. (the Company) believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words may, will, should, could, expect, anticipate, estimate, believe, intend, or project or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: the timing and success of clinical and preclinical studies of product candidates, the potential timing and success of the Companys product programs through their individual product development and regulatory approval processes, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, obsolescence of the Companys technologies, technical problems with the Companys research, price increases for supplies and components, litigation and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Companys operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Companys ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, and other risks. There can be no assurance that further research and development will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that the Company will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Companys most recent Form 10-Q and Form 10-K filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission athttp://www.sec.gov. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

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RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device, Enabling Clinical Study for Safety and Feasibility - BioSpace

Stem Cell Therapy Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 – Owned

Allosource

Stem Cell Therapy Market: Competitive Landscape

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.

Stem Cell Therapy Market: Segment Analysis

The research report includes specific segments by region (country), by company, by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2019 to 2027. Understanding the segments helps in identifying the importance of different factors that aid the market growth.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

Stem Cell Therapy Market: Regional Analysis

The research report includes a detailed study of regions of North America, Europe, Asia, and South America. The report has been curated after observing and studying various factors that determine regional growth such as economic, environmental, social, technological, and political status of the particular region. Analysts have studied the data of revenue, sales, and manufacturers of each region. This section analyses region-wise revenue and volume for the forecast period of 2015 to 2026. These analyses will help the reader to understand the potential worth of investment in a particular region.

North America(United States, Canada, and Mexico) Europe(Germany, France, UK, Russia, and Italy) Asia-Pacific(China, Japan, Korea, India, and Southeast Asia) South America(Brazil, Argentina, Colombia, etc.) The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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Stem Cell Therapy Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 - Owned

Trumps Unprecedented Attacks on Our Public-Health System – The New Yorker

How worried should we be that the President of the United States recently described as very impressive a woman who claims that doctors make medicine using DNA from aliens? Or that he shows no sign of recognizing the magnitude of the COVID-19 pandemic? Its simply not possible to worry too much.

I thought her voice was an important voice, Donald Trump said, after a reporter asked him why he would retweet the claims of Stella Immanuel, a Houston pediatrician with a long history of bizarre statements about medicine and human sexuality. Immanuel also shares Trumps unfounded enthusiasm for hydroxychloroquine. The drug has been repeatedly discredited as a treatment for this disease. She insists that it is a cure. Its tempting to write off this episode purely as evidence of Trumps disrespect for science. But the problem it represents is much bigger; it is the clearest sign yet that political interests and personal whims have eclipsed the rigor of some of our most important scientific institutions.

Read The New Yorkers complete news coverage and analysis of the coronavirus pandemic.

Twenty years ago, reporting from South Africa, I saw firsthand what happens when a national leader forces his people to subsist on lies and magic. From 2000 to 2005, according to a definitive study by researchers at the Harvard School of Public Health, Thabo Mbeki, then the President of South Africa, let as many as three hundred and thirty thousand of his fellow-citizens die and thirty-five thousand babies be born with H.I.V., by refusing to permit the countrys health service to treat AIDS with antiretroviral drugs. Mbeki and his health minister, Manto Tshabalala-Msimang, insisted that antiviral medicine was the product of a plot by Western pharmaceutical companies to kill Africans. The Harvard study concluded that the drugs were withheld largely because of Mbekis well-known refusal to initially accept that AIDS is caused by a virus, H.I.V.

No single national leader would have been able to prevent the coronavirus pandemic. But Trumps denialism and hostility toward public-health officials has greatly increased Americas share of suffering and death. On Fox & Friends, on Wednesday, he said that the virus is spreading in a relatively small portion of the country, and that children are virtually immune; both statements are false. And, as he has done many times before, he declared at a briefing that the pandemic would just go away.

Trump has had one consistent response to the pandemic: he attacks leading experts when they attempt to tell the truth. Last week, when Deborah Birx, the cordinator of the White House coronavirus task force, characterized the epidemic as extraordinarily widespread, Trump tweeted that she was pathetic. Earlier this year, when Anthony Fauci, the nations leading infectious-disease expert, was asked at a briefing to discuss his view on hydroxychloroquine, Trump prevented him from answering. The Presidents refusal either to lead or to recognize the leadership of others has made it impossible to develop a national plan to combat this virus.

Without such a plan, the nation has been subjected to a giant game of viral roulette. With no coherent system of rapid tests, contact tracing is all but useless. Since we have neither a vaccine nor any general therapy, tests and tracing offer the only near-term hope of controlling the pandemic. States have largely been left to fend for themselves. Last week, seven governors, Republicans and Democrats, formed their own testing coalition.

On Wednesday, Fauci was asked if the United States had the worlds worst COVID-19 outbreak. It is quantitatively, if you look at it, he said. I mean, the numbers dont lie. Trump is asked similar questions nearly every day. And, although the numbers may not lie, the President does. As he put it in a recent tweet, You will never hear this on the Fake News concerning the China Virus, but by comparison to most other countries, who are suffering greatly, we are doing very well. No amount of statistical massaging could make that statement true.

This war on reality has deeply wounded Americas public-health system. In March, under relentless pressure from Trump and his trade adviser, Peter Navarro (who has no medical training), the Food and Drug Administration issued an emergency-use authorization (E.U.A.) for hydroxychloroquine. That allowed doctors to administer the drug to patients who were severely ill, but it was not an approval of the drug for general use. As Janet Woodcock, who runs the F.D.A.s Center for Drug Evaluation and Research, put it in an interview with Stat, We simply said its possible from the in vitro data this may have a beneficial effect and the benefits may outweigh the risks. Few people understood that distinction, and, goaded on by the President, few listened to those who urged caution.

Trump announced on national television that hydroxychloroquine could be a game changer. It wasnt. Former F.D.A. officials were astonished by the rushed action. I understand the desire to find hope, but we need more evidence than is currently available before we encourage widespread use, Margaret A. Hamburg said at the time. She served as the F.D.A. commissioner for six years under Barack Obama.

In June, when the drugs ineffectiveness had become apparent, the F.D.A. revoked the E.U.A. It was a remarkable retreat. While it is reassuring that the agency finally made a decision based on data, the drug should not have been released for this use in the first place. But, when politics takes precedence, facts no longer matter. Rick A. Bright, one of the nations experts on pandemic preparedness and the chief of BARDA (the Biomedical Advanced Research and Development Authority), had objected to the use of the drug and tried to stop it. He was fired. As the Times reported on Monday, Stephen Hahn, the current F.D.A. commissioner, is not allowed to speak to the press unless Michael Caputo, an assistant secretary of the Department of Health and Human Services, or another official, is also on the line. Caputo has long been associated with Trump, once serving as his driver.

We have recently witnessed an even more pernicious example of an American scientific colossus bowing to Trumps ignorance. In May, the Centers for Disease Control and Prevention issued stringent guidelines to determine when and if schools should reopen this fall. Trump has insisted, against all scientific advice, that all schools should open. He tweeted, I disagree with the @CDCgov on their very tough & expensive guidelines for opening schools. While they want them open, they are asking schools to do very impractical things. I will be meeting with them!!!

Robert Redfield, the director of the C.D.C., immediately issued an update to the guidelines, announcing that it is critically important for our public health to open schools this fall. The reversal was stunning; past C.D.C. directors were not immune to politics, and they understood that a President might overrule them. But there has always been an understanding at the agency that all public-health decisions made there would have to be governed by data.

No agency or scientist is infallible. Early in the pandemic, the C.D.C. failed to introduce accurate test kits; many of the kits it distributed were contaminated and useless. The agency used highly sensitive tests based on PCR technology, which is a kind of molecular copying machine that makes millions (or billions) of copies of a DNA sample. That makes it much easier for clinicians to detect any specific sequence of DNA, including those in the coronavirus. The technology has been used routinely for more than three decades, but it is sensitive to small errors, and there were several in the C.D.C. kits. The misstep delayed accurate data collection throughout the United States at one of the most critical moments in the pandemic.

Originally posted here:
Trumps Unprecedented Attacks on Our Public-Health System - The New Yorker

How European Startups Have Advanced Cancer T-Cell Therapy in… – Labiotech.eu

With the help of a huge 66M Series A round last week, the German startup T-knife is developing cancer T-cell immunotherapies with the help of genetically modified mice. However, this is just one of several cancer T-cell therapy startups making advances this year, with other innovations including off-the-shelf treatments and a potential universal cancer therapy.

The rise of Chimeric Antigen Receptor (CAR) T-cell immunotherapy was a major step forward in the treatment of cancer. CAR T-cell therapy consists of bioengineering a patients immune T cells to produce proteins called CARs. These proteins recognize targets on the surface of cancer cells, letting the T-cells destroy them. However, CAR T-cell therapy is also limited against solid tumors since many cancer targets lie within the cancer cells, beyond the reach of the CAR proteins.

In the last few months, European startups have been making advances in T-cell receptor (TCR) T-cell immunotherapies, which could be better than CAR T-cells at hunting down solid tumors. This is because the protein that is genetically modified on TCR T cells the TCR can recognize targets hidden inside cancer cells by scanning a protein on the cell surface called human leukocyte antigen (HLA).

Last week, the Berlin-based T-knife brought TCR T-cell therapies into the spotlight with a huge 66M Series A round. With the proceeds, the startup aims to take a radical approach to developing TCR T-cell therapies.

While most TCR T-cell therapy developers tweak existing human TCRs in their cell therapies, T-knife sources its cancer-hunting TCRs from mice. The firm genetically modifies mice to produce fully humanized T-cell receptors and injects them with human tumor antigens. The immune system of the mice then reacts to the cancer antigens and produces a variety of T-cell receptors. After picking the best cancer-seeking T-cell receptors from the mouse immune system, T-knife then expresses them in the patients T cells to produce the cell therapy.

The mouse immune system is not tolerant of human tumor antigens it sees them like a virus or a pathogen. Thus we can generate a strong immune response in the mice when we immunize them with human tumor antigens, Elisa Kieback, CEO and co-founder of T-knife, told me.

According to Kieback, the companys mouse-derived TCRs can latch onto cancer antigens more strongly and specifically than those of established TCR T-cell therapy biotechs such as Immatics and Adaptimmune. We are letting the mice select the best TCR via a very natural in vivo selection mechanism which means they are less likely to have off-target reactivity, she said.

T-knife exited stealth mode with the Series A round, which was led by the investment firms Versant Ventures and RA Capital Management. The company has already initiated the clinical development of a myeloma treatment and plans to sponsor a solid tumor trial in late 2021.

One drawback of cell therapies based on genetically modifying the patients own T cells is that the process is complex, costly, and must be tailored to each patient. To get around this issue, several European startups have been developing TCR T-cell therapies that use donor immune cells in an off-the-shelf fashion, cutting the costs of the therapy.

One such company is the Norwegian startup Zelluna Immunotherapy, which raised 7.5M in equity funding and grants in June. The company aims to develop a TCR T-cell therapy based on cancer-hunting immune cells called natural killer cells. The company sees these cells as well suited for making off-the-shelf therapies since they have a lower risk of attacking the patients healthy tissue than T cells and are faster at killing cancer cells.

Another off-the-shelf TCR T-cell therapy in the works is being developed by the Dutch biotech Gadeta, which appointed a new CEO in April. It is working with the US company Kite Pharma to engineer T cells that produce TCRs from a rare type of T cell called gamma delta T cells. The TCRs from gamma delta T cells are better at recognizing stress signals on cancer cells than those of the more common type of T cells, called alpha beta T cells.

Gadetas platform combines the key features ofalpha beta T cells, such as the high proliferation and memory capacity, with the anti-tumor specificity and activity of selectedgamma delta receptors, Marco Londei, the companys new CEO, told me. This novel T cell platform is perfectly placed for possible allogeneic off-the-shelf use.

Gadeta is currently preparing to enter phase I testing for the treatment of multiple myeloma.

TC Biopharm has also hinted at promising progress with its own off-the-shelf cancer cell immunotherapy. The Scottish startup collects gamma delta T cells from young, healthy donors and makes them produce CAR proteins like a CAR T-cell therapy.

In some patients, the innate ability to hunt and kill cells is compromised either because of the cancer itself, other pathologies or age, Michael Leek, CEO of TC BioPharm, explained.

This is no ordinary CAR T-cell therapy, however. TC BioPharm also uses the gamma delta T cells TCRs as a safety catch to avoid destroying healthy cells that happen to show a cancer target. The CAR protein recognizes a cancer target on the cell surface, but the gamma delta TCR only allows the cell therapy to kill cells that show signs of stress from cancer. This could make it much safer than current CAR T-cell therapies.

TC BioPharm initiated a phase I clinical trial for the treatment of the blood cancer acute myeloid leukemia last year. The trial has progressed well; all qualifying patients saw a marked response to treatment with reduction of their tumor burden, Leek told me. We hope to progress this therapy to market around 2021-22.

In addition to cancer, TC BioPharm has also joined a growing list of immuno-oncology companies testing the potential of its technology for the treatment of Covid-19, launching a phase I trial in July.

Though TCR T-cell therapies can target more types of cancer than CAR T-cell therapies, they still tend to be specific to particular types of cancers, and ineffective against others. One cancer entity is oftentimes much more heterogeneous than initially thought, Kai Pinkernell, CMO of Munich-based Medigene, told me. Could such a therapy target more than one cancer type?

In June, Medigene initiated a phase I clinical trial of a TCR T-cell therapy candidate for a diverse range of blood cancers. The treatment is designed to hit a target that they all have in common called HA-1. The trial is testing the treatment in patients that recently received a bone marrow stem cell transplant, but whose blood cancer has relapsed.

[Our therapy] would improve the current gold-standard approach, being stem cell transplantation. Interestingly, this could work in many different diseases that were the reason for the transplant, Pinkernell explained.

Another TCR T-cell therapy player aims to go even further with widening the range of treatments. In January, the London-based Ervaxx recently rebranded as Enara Bio entered a partnership agreement with the University of Cardiff to overcome a common limitation of TCR therapies: the HLA molecules that TCRs scan vary widely between patients, so TCR T-cell therapies need to be personalized to different patients.

To get around this obstacle, Enara Bio and a research group led by Andrew Sewell, Professor of Immunology at Cardiff University, are developing a type of TCR T-cell therapy that doesnt scan HLA, but rather a protein called MR1, which is the same from patient to patient and is found on a wide range of cancer cells.

We have various T-cell receptors that respond to most cancers without the need for a specific human leukocyte antigen that we are exploring, Sewell told me.

By accessing a wide range of cancers and patients, this cancer immunotherapy could work universally with no need for personalization. The team aims to test the therapy in humans at the end of this year.

While a universal cancer therapy is an intriguing concept, Pinkernell thinks that we should be cautious in our expectations of seeing such a therapy. The timing of the drug in the therapy of a cancer, or best window of application is not easy to find, he said.

T-knifes Kieback echoed the skepticism. For now, rather highly tumor-, target-, and patient-specific therapies will be required and emerge, she said. Londei of Gadeta agreed and pointed out the complexity of cancer disease development. Key challenges are understanding how tumors escape immunotherapies and how to find combination therapies to overcome this problem, for different types of tumors, he added.

Sewell has a slightly more optimistic take. I think it is a bit strong to say that there is potential for universal therapies, but we can definitely build T cells that recognize most cancers from all individuals. I feel that there is a prospect for immunotherapy to be successfully treating most cancers within the next 25 years.

Part of the reason for the unclear potential of TCR T-cell therapy is that it is at an early stage in the clinical pipeline. The most advanced TCR T-cell therapy programs havent yet gone beyond phase II, such as that of Adaptimmunes lead candidate. However, the size of T-knifes recent Series A round demonstrates that investors are interested in the future of the technology, so its going to be worth keeping an eye on the TCR T-cell startup scene in the coming years.

Images from Shutterstock

Tags: Ervaxx, Gadeta, Medigene, T-knife, TC BioPharm, TCR, Zelluna Immunotherapy

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How European Startups Have Advanced Cancer T-Cell Therapy in... - Labiotech.eu

Stem Cell And Platelet Rich Plasma Prp Alopecia Therapies Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook, Competitive…

New Jersey, United States,- The most recent Stem Cell And Platelet Rich Plasma Prp Alopecia Therapies Market Research study includes some significant activities of the current market size for the worldwide Stem Cell And Platelet Rich Plasma Prp Alopecia Therapies market. It presents a point by point analysis dependent on the exhaustive research of the market elements like market size, development situation, potential opportunities, and operation landscape and trend analysis. This report centers around the Stem Cell And Platelet Rich Plasma Prp Alopecia Therapies business status, presents volume and worth, key market, product type, consumers, regions, and key players.

The COVID-19 pandemic has disrupted lives and is challenging the business landscape globally. Pre and Post COVID-19 market outlook is covered in this report. This is the most recent report, covering the current economic situation after the COVID-19 outbreak.

Key highlights from COVID-19 impact analysis:

Unveiling a brief about the Stem Cell And Platelet Rich Plasma Prp Alopecia Therapies market competitive scope:

The report includes pivotal details about the manufactured products, and in-depth company profile, remuneration, and other production patterns.

The research study encompasses information pertaining to the market share that every company holds, in tandem with the price pattern graph and the gross margins.

Stem Cell And Platelet Rich Plasma Prp Alopecia Therapies Market, By Type

Stem Cell And Platelet Rich Plasma Prp Alopecia Therapies Market, By Application

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Covid-19 roundup: Pfizer-backed BioNTech plans to seek FDA OK for a new vaccine ‘as early as’ October ahead of the election – Endpoints News

BioNTech execs say theyre on track to get their late-stage data on a Covid-19 vaccine partnered with Pfizer into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they wont be wasting any time in hustling that over to the FDA.

I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful, said Ugur Sahin, BioNTechs CEO and co-founder.

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Covid-19 roundup: Pfizer-backed BioNTech plans to seek FDA OK for a new vaccine 'as early as' October ahead of the election - Endpoints News

BeyondSpring Initiates Expanded Access Program with Plinabulin for Patients Suffering from CIN in the U.S. – GlobeNewswire

August 11, 2020 08:00 ET | Source: BeyondSpring, Inc.

- NCCN Guideline Updates Highlight Need for Maximum CIN Prevention and Resource Allocation for COVID-19 Patients -

- First Patient Dosed in the U.S. Avoided Grade 4 Neutropenia in Cycle 2 with Plinabulin and Pegfilgrastim, Despite Experiencing Grade 4 Neutropenia in Cycle 1 with Pegfilgrastim Alone -

NEW YORK, Aug. 11, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has initiated an Expanded Access Program (EAP) to enable doctors across the U.S. to use BeyondSprings late-stage asset, Plinabulin, to prevent cancer patients chemotherapy-induced neutropenia (CIN), both alone and in combination with G-CSFs (the current standard of care), during the COVID-19 pandemic. Dr. Emad Ibrahim enrolled the first patient at Redlands Community Hospital in California on July 28, 2020.

In response to COVID-19, the National Comprehensive Cancer Network (NCCN) recently updated its treatment guidelines for the prophylaxis of CIN, with the objective of preserving hospital and ER resources for COVID-19 patients and maximizing protection for cancer patients against CIN development. This is designed to help necessitate healthcare interactions, and avoidance of hospital / ER visits will also minimize cancer patients risk of contracting COVID-19. In light of these NCCN guideline updates, BeyondSpring initiated an Expanded Access Program to enable the use of Plinabulin by oncologists to better protect cancer patients against CIN with the use of myelosuppressive chemotherapies under the current COVID-19 challenges.

Dr. Emad Ibrahim enrolled the first patient under this EAP at Redlands Community Hospital in California:

The recent updates to the NCCN guidelines aim to protect cancer patients from developing CIN in the most effective way possible and enable the healthcare system to reserve precious resources for COVID-19 patients, said Ramon Mohanlal, BeyondSprings Chief Medical Officer and Executive Vice President, Research and Development. In our CIN studies, Plinabulin, in combination with Pegfilgrastim, provided superior protection against CIN, compared to the standard of care alone. The observation in this first EAP patient who completely avoided Grade 4 CIN when given Plinabulin and Pegfilgrastim is a significant achievement for us. At BeyondSpring, we strive to play our part in serving patients and healthcare providers to the highest degree while working through the many challenges imposed by COVID-19.

Preventing CIN during chemotherapy is extremely important, as this will enable cancer patients to receive the full regimen of chemotherapy and achieve treatment goals. The onset of CIN is the No. 1 reason for treatment modifications, such as downgrading the strength of chemotherapy or stopping chemotherapy altogether. When a patient develops CIN, the treating physician is required to delay the next round of chemotherapy until a patients white blood cell count recovers. These changes can have a profoundly negative impact on patient outcomes.

For more information on BeyondSprings Plinabulin Expanded Access Program, please visit http://www.beyondspringpharma.com/EAP/. Supplies may be limited.

If you are a physician in the U.S. who would like to request Plinabulin EAP access for your patient, please email expandedaccess@beyondspringpharma.com.

About BeyondSpring Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSprings first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen doses decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a pipeline drug, Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSprings extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed molecular glue that uses the protein degradation pathway.

About Plinabulin Plinabulin, BeyondSprings lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem andCell Reports, 2019). Plinabulins CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSprings most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts Caitlin Kasunich / Raquel Cona KCSA Strategic Communications 212.896.1241 / 212.896.1276 ckasunich@kcsa.com / rcona@kcsa.com

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BeyondSpring Initiates Expanded Access Program with Plinabulin for Patients Suffering from CIN in the U.S. - GlobeNewswire

Cell Isolation-Cell Separation Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 – Owned

Bio-Rad Laboratories

Cell Isolation-Cell Separation Market: Competitive Landscape

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.

Cell Isolation-Cell Separation Market: Segment Analysis

The research report includes specific segments by region (country), by company, by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2019 to 2027. Understanding the segments helps in identifying the importance of different factors that aid the market growth.

1.Cell Isolation/Cell Separation Market, By End User:

Research Laboratories and Institutes Hospitals and Diagnostic Laboratories Cell Banks Biotechnology and Biopharmaceutical Companies

2.Cell Isolation/Cell Separation Market, By Application:

Biomolecule Isolation Cancer Research Stem Cell Research Tissue Regeneration In Vitro Diagnostics Therapeutics

3.Cell Isolation/Cell Separation Market, By Technique:

Centrifugation-Based Cell Isolation Surface Marker-Based Cell Isolation Filtration-Based Cell Isolation

4.Cell Isolation/Cell Separation Market, By Cell Type:

Human Cells Differentiated Cells Stem Cells Animal Cells

5.Cell Isolation/Cell Separation Market, By Products:

Consumables Reagents, Kits, Media, and Sera Beads Disposables Instruments Centrifuges Flow Cytometers Magnetic-Activated Cell Separator Systems

Cell Isolation-Cell Separation Market: Regional Analysis

The research report includes a detailed study of regions of North America, Europe, Asia, and South America. The report has been curated after observing and studying various factors that determine regional growth such as economic, environmental, social, technological, and political status of the particular region. Analysts have studied the data of revenue, sales, and manufacturers of each region. This section analyses region-wise revenue and volume for the forecast period of 2015 to 2026. These analyses will help the reader to understand the potential worth of investment in a particular region.

North America(United States, Canada, and Mexico) Europe(Germany, France, UK, Russia, and Italy) Asia-Pacific(China, Japan, Korea, India, and Southeast Asia) South America(Brazil, Argentina, Colombia, etc.) The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Why purchase this report

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Contact us:

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Cell Isolation-Cell Separation Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 - Owned

Stem Cell Manufacturing Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 – Owned

Osiris Therapeutics

Stem Cell Manufacturing Market: Competitive Landscape

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.

Stem Cell Manufacturing Market: Segment Analysis

The research report includes specific segments by region (country), by company, by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2019 to 2027. Understanding the segments helps in identifying the importance of different factors that aid the market growth.

Global Stem Cell Manufacturing Market, By Product

Stem Cell Lines Culture Media Instruments Consumables

Global Stem Cell Manufacturing Market, By Application

Drug Discovery and Development Clinical Applications Cell and Tissue Banking Applications Life Science Research

Stem Cell Manufacturing Market: Regional Analysis

The research report includes a detailed study of regions of North America, Europe, Asia, and South America. The report has been curated after observing and studying various factors that determine regional growth such as economic, environmental, social, technological, and political status of the particular region. Analysts have studied the data of revenue, sales, and manufacturers of each region. This section analyses region-wise revenue and volume for the forecast period of 2015 to 2026. These analyses will help the reader to understand the potential worth of investment in a particular region.

North America(United States, Canada, and Mexico) Europe(Germany, France, UK, Russia, and Italy) Asia-Pacific(China, Japan, Korea, India, and Southeast Asia) South America(Brazil, Argentina, Colombia, etc.) The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Why purchase this report

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080 UK: +44 (203)-411-9686 APAC: +91 (902)-863-5784 US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

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Stem Cell Manufacturing Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 - Owned

Stem Cell Banking Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 – Owned

China Cord Blood Corporation

Stem Cell Banking Market: Competitive Landscape

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2015 to 2019.

Stem Cell Banking Market: Segment Analysis

The research report includes specific segments by region (country), by company, by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2019 to 2027. Understanding the segments helps in identifying the importance of different factors that aid the market growth.

Global Stem Cell Banking Market, by Service:

Analysis Storage Collection & Transportation Processing

Global Stem Cell Banking Market, by Application:

Leukemia Diabetes Autism Cerebral Palsy Thalassemia Others

Stem Cell Banking Market: Regional Analysis

The research report includes a detailed study of regions of North America, Europe, Asia, and South America. The report has been curated after observing and studying various factors that determine regional growth such as economic, environmental, social, technological, and political status of the particular region. Analysts have studied the data of revenue, sales, and manufacturers of each region. This section analyses region-wise revenue and volume for the forecast period of 2015 to 2026. These analyses will help the reader to understand the potential worth of investment in a particular region.

North America(United States, Canada, and Mexico) Europe(Germany, France, UK, Russia, and Italy) Asia-Pacific(China, Japan, Korea, India, and Southeast Asia) South America(Brazil, Argentina, Colombia, etc.) The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Why purchase this report

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080 UK: +44 (203)-411-9686 APAC: +91 (902)-863-5784 US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

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Stem Cell Banking Market 2020 by Manufacturers, Regions, Type and Application, Forecast to 2027 - Owned