Biotechs Working Closely & Feverishly With CDC for COVID-19 Vaccine Development

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Apr 07, 2020, 08:50 ET

PALM BEACH, Florida, April 7, 2020 /PRNewswire/ -- Many companies searching for an effective therapy or vaccine for the present world health crisis are focusing on creating a vaccine from the immune system. Key to the race to develop a vaccine for the new coronavirus is a technology that uses the virus' genetic code to essentially persuade your body to make its own vaccine. This technique is faster than egg-based manufacturing, which produces the majority of annual flu vaccines… And it's enabling a possible vaccine for the new coronavirus to be developed in record time. A recent article in USA Today said: ""It's quicker to get started," said Clem Lewin, who is working on vaccine candidates for the manufacturer Sanofi Pasteur. "All you need is the blueprint for the protein." Testing still will take time. Scientists must determine whether any of several vaccine candidates fight the virus effectively. If so, they need to determine the proper dose. This tinkering is what could take a year or more. The article continued: "When the first potential vaccine from the manufacturer Moderna was injected into people on March, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he believed the coronavirus vaccine was being developed at a record pace. It took sixty-three days to go from identifying a virus's genetic sequence to testing a vaccine in people. Active biotech and pharma companies in the markets this week include: Q BioMed Inc. (OTCQB: QBIO), Vir Biotechnology, Inc. (NASDAQ: VIR), Co-Diagnostics, Inc. (NASDAQ: CODX), RedHill Biopharma Ltd. (NASDAQ: RDHL), Immunomedics, Inc. (NASDAQ: IMMU).

The manufacturers pursuing coronavirus vaccines are working closely with the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Agency. Several manufacturers pursuing a vaccine for the latest coronavirus have been aided by a technological innovation. The method that Moderna, Sanofi and others are pursuing is different from traditional vaccinations, in which a weakened or dead version of the virus is introduced into the body, triggering it to create antibodies that would attack the live virus should the person be exposed to it. "Essentially, the patient makes their own vaccine," says the narrator of a Moderna video about the vaccine. "This cuts out the middleman." Fauci said volunteers would be given two injections of the potential coronavirus vaccine… The individuals will be followed for one year — both for safety and whether it induces the kind of response that we predict would be protective," Fauci said.

Q BioMed Inc. (OTCQB:QBIO) BREAKING NEWS: Q BioMed Enters into a Financial Restructuring of Approximately $7,800,000 Consisting of $4,000,000 New Cash and a minimum of $3,800,000 of Debt Conversion - Q BioMed, a commercial stage biotech company, announced today the entering of a significant financial transaction with its lead investor, Yorkville Advisors Global ("YA"). Under the agreement, on closing, YA will have converted a minimum of $3,800,000 into common stock and preferred stock and may convert an additional $500,000 which would be the total debt held by them. As part of the agreement, YA will fund up to an additional $4,000,000 in new capital over the next 2 weeks.

This restructuring of the debt and new capital transforms the Company's balance sheet creating significant positive shareholder equity, a requirement for a Nasdaq listing. The new capital injection will provide enough runway for the Company to implement its full commercial plan as it brings its FDA approved non-opioid, Strontium89 Chloride USP Injection drug to market.

Denis Corin, QBioMed CEO said, "In addition to the rollout of our Strontium89 drug, this funding allows us to advance other key pipeline assets such as our infectious disease platform including a potential treatment for COVID-19, influenza and others, liver cancer therapy Uttroside B and our rare disease drug development in non-verbal autism spectrum disorders."

Along with the revenue expected from Strontium89 sales and the significant non-dilutive grant funding available from the Mannin platform, Q BioMed does not anticipate needing more capital until the first quarter of 2021, if not well beyond. Read this entire release and more news for QBIO at: https://www.financialnewsmedia.com/news-qbio/

Other recent developments in the biotech industry include:Vir Biotechnology, Inc.

(NASDAQ: VIR) and GlaxoSmithKline plc (NYSE: GSK) recently announced they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

Co-Diagnostics, Inc. (NASDAQ: CODX) recently announced that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2. The Company's test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the virus that causes COVID-19, and is available for purchase from the Company's Utah-based ISO-13485:2016 certified facility.

Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs in March 2020 as a result of the FDA's policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the Company had initiated sales of its CE-IVD test to the European Community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.

RedHill Biopharma Ltd. (NASDAQ: RDHL) recently announced that it has received authorization from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee (EC) for an expanded access program (EAP) allowing immediate compassionate use of its investigational drug, opaganib (Yeliva®, ABC294640), in Italy for patients with confirmed coronavirus (COVID-19) infection with life-threatening clinical manifestations.

Approximately 160 patients are planned to be treated in three major hospitals in northern Italy, one of the current major epicenters of the pandemic. "The approved opaganib expanded access program allows physicians in the three major hospitals in Italy to treat patients at high risk of developing pneumonia and those with pneumonia, including acute respiratory distress syndrome, secondary to SARS-CoV-2 infection," said Mark L. Levitt, MD, Ph.D., medical director at RedHill. "RedHill is working diligently to evaluate the potential of opaganib as a treatment for COVID-19 to help patients worldwide in urgent need of a treatment option. I would like to thank our partners at Cosmo Pharmaceuticals for their immense assistance supporting the process in Italy."

Immunomedics, Inc. (NASDAQ: IMMU) recently announced that its Phase 3 confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC), during its recent routine review of the ASCENT study.

"It is my distinct honor to have served as Chairperson of the independent DSMC for this important study," remarked Julie R. Gralow, MD, Jill Bennett Endowed Professor of Breast Cancer, University of Washington School of Medicine; Member, Fred Hutchinson Cancer Research Center. "Triple-negative breast cancer (TNBC) is a disease with extremely limited treatment options beyond classic chemotherapy. The remarkable results we observed across multiple endpoints in the ASCENT study warranted early discontinuation of the trial and are indicative of a potential major advance in the treatment of this devastating disease that affects younger women and African American women at higher rates. I look forward to the release of the full and final analyses of these study data when they are available for public presentation."

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