Accelerated Development of COVID-19 Vaccines to Combat Potential for Possible Future Viral Pathogens and Variants

PALM BEACH,  Fla., Sept. 22, 2021 /PRNewswire/ -- The U.S. government, via the American Rescue Plan, is investing more than $3 billion to accelerate the discovery, development and manufacturing of antiviral medicines as part of the government's whole-of-government strategy to develop the next generation of COVID-19 treatments. Through collaboration within the U.S. Department of Health and Human Services (HHS), including the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), this plan – called the Antiviral Program for Pandemics – will respond to the urgent need for antivirals to treat COVID-19 by spurring the availability of medicines to prevent serious illness and save lives. It also will build sustainable platforms for discovery and development of antivirals for other viruses with pandemic potential, helping better prepare the nation to face future viral threats.  In a recent report, the HHS said that the government: "… remains committed to identifying effective treatment options that can prevent people diagnosed with COVID-19 from progressing to serious illness and death. Highly effective oral antiviral medicines that can be taken at home early in the course of infection, similar to antiviral treatment for influenza, would save lives both here and abroad and prevent overwhelming surges in hospitalizations. This plan will support research to identify and accelerate availability of breakthrough treatment options to ensure the public has access to viable medicines."    Active biotech and pharma companies in the markets this week include:  Q BioMed Inc. (OTCQB: QBIO), Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), Moderna, Inc. (NASDAQ: MRNA), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), CytoDyn Inc. (OTCQB: CYDY).

U.S. Department of Health and Human Services is saying "New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives," said Dr. Anthony Fauci, chief medical adviser to the President and NIAID Director. "Through multidisciplinary collaborations among leading scientists in academia and industry, this investment from the American Rescue Plan to create the Antiviral Program for Pandemics will help inspire medical innovation and build on the extraordinary success we have seen in developing the COVID-19 vaccines. The remarkable and rapid development of vaccines and testing technology has shown how agile scientific discovery can be when we combine the resources of public agencies, private entities, and our nation's most brilliant and creative minds," said Dr. Francis S. Collins, NIH Director. "We will leverage these same strengths as we construct a platform for the discovery and development of effective antivirals that will help us defeat COVID-19 and better prepare us for potential future viral pathogens."

Q BioMed Inc. (OTCQB:QBIO) BREAKING NEWS:  Q BioMed Inc. Updates on Covid-19 Therapeutic Development and Clinical Trials - MAN-19 therapeutic program heading to clinical trial in early 2022 - Q BioMed Inc., a commercial stage biotechnology acceleration company, is pleased to provide an update on its partner asset MAN-19 for the treatment of Acute Respiratory Distress Syndrome (ARDS), a condition caused by viral infections in the lungs including COVID-19. 

The MAN-19 therapeutic is a recombinant fusion protein that treats the patient, instead of targeting the virus. It is not a cure for COVID-19, but it strengthens a patient's blood vessels and protects them against ARDS, breathing problems, sepsis and other infections that may cause the body's organs to begin shutting down. It is designed to keep COVID-19 patients out of the ICU and off a ventilator. Initial manufacturing and preclinical testing has shown promise, and pending upcoming toxicology testing, the drug is poised for clinical trials to start in 2022. If the drug proves both safe and effective, our goal is to have it available for use by patients by early 2023.

Dr. George N. Nikopoulos, CEO of Mannin Research Inc. said, "We are very encouraged by our progress and the results of the preclinical work to date. Our next steps are to complete the final toxicology studies, data aggregation and achieve approval of a Phase 1 clinical trial."

Dr. Nikopoulos also notes, "We know that we have a promising solution for COVID-19 patients suffering from ARDS. This is even more meaningful to me personally, as I have seen the need for novel therapeutics for hospitalized COVID-19 patients, having recently recovered from severe COVID-19 myself."

Denis Corin CEO of Q BioMed said, "This platform was the first co-development deal we did and it is very gratifying to see the hard work and diligence come to fruition. With proof-of-concept complete and clinical trials planned in 2022, we believe there is a significant return on investment in the near term and major milestones to be achieved. The market for this kind of treatment in the current pandemic climate is substantial and global. COVID-19 is not going away any time soon. As a result, there is a need to develop more effective treatments. We believe that our technology will play a role in the broader treatment landscape and not only for COVID-19, but also for other infectious diseases that cause ARDS.

QBioMed believes that licensing and milestone revenue opportunities for this and related indications in kidney and ophthalmological diseases are possible in the next few months. Conservative estimates based on milestones could reach $200M over the next 24 months.

Partnering with other companies in Canada and Europe, and with the support of what is expected to be more than $20 million USD in funding from Q BioMed and other non-dilutive sources, has resulted in an accelerated drug development timeline.

Q BioMed has committed approximately $10M to the development of the Tie2 platform in exchange for a 50% residual interest in any profits generated from the sale or sub-licensing of the assets, including other candidates for diseases such: glaucoma, kidney diseases, and cardiovascular disease.  CONTINUED…  Read this entire release and more news for QBIO at:  https://www.financialnewsmedia.com/news-qbio/

Other recent developments in the biotech industry include:

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, recently announced that it has discontinued its Phase 3 study of mupadolimab for COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations. The discontinuation is not related to any safety or efficacy issues observed in study patients. The Company will continue to advance the development of mupadolimab in oncology, where it is currently being studied in a Phase 1/1b clinical trial.

"Since the initiation of our Phase 3 study, it has been confirmed that COVID-19 vaccines are highly effective, particularly in terms of preventing serious disease and hospitalizations; the patient population we intend to treat with mupadolimab," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are prioritizing resources on mupadolimab in oncology and intensifying our efforts in our cancer programs."

Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, recently announced Health Canada has approved the New Drug Submission (NDS-CV) for SPIKEVAX™ (elasomeran mRNA vaccine), which has been known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals 12 years of age and older.

"Health Canada's approval of our COVID-19 vaccine is an important milestone as it is our first full approval for Spikevax. I would like to thank Health Canada for their hard work throughout the process," said Stéphane Bancel, Chief Executive Officer of Moderna. "I would also like to thank the Government of Canada for the partnership they have built with us and for their confidence in our mRNA platform in addressing the COVID-19 pandemic."

Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19, recently announced impressive results from an independent study conducted under real-world field conditions by INMEGEN (The Institute of National Genomics Medicine, Mexico).

Key highlights include: For the population tested with COVISTIX™ (n=783), sensitivity and specificity were 81% (CI95% 76.0-85.0) and 96.0% (CI95% 94.0-98.0), respectively. In contrast, the sensitivity of the Panbio comparator test (n=2202) was measured at 62% (CI95%: 58.0-64.0%) and specificity at 99.0% (CI95%: 0.99-1.00).

CytoDyn Inc. (OTCQB: CYDY) a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, recently announced the treatment of the first patient in its pivotal Phase 3 COVID-19 trial in Brazil for patients with severe symptoms. An interim analysis will be conducted 28 days following the enrollment of 245 patients, which is 40% of the total number of patients to be enrolled in the trial.

As previously announced, this pivotal Phase 3 trial for severe COVID-19 patients is being conducted by Academic Research Organization ("ARO") Albert Einstein Israelite Hospital. This trial is intended to provide Brazil's regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19. The trial will be conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support.

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