Palm Beach, FL – May 20, 2021 – In the race against emerging coronavirus variants, researchers are looking beyond antibodies for clues to lasting protection from COVID-19. Concerns about coronavirus variants that might be partially resistant to antibody defenses have spurred renewed interest in other immune responses that protect against viruses. In particular, scientists are hopeful that T cells — a group of immune cells that can target and destroy virus-infected cells — could provide some immunity to COVID-19, even if antibodies become less effective at fighting the disease.  Researchers are now picking apart the available data, looking for signs that T cells could help to maintain lasting immunity. Alongside antibodies, the immune system produces a battalion of T cells that can target viruses. Some of these, known as killer T cells, seek out and destroy cells that are infected with the virus. Others, called helper T cells are important for various immune functions, including stimulating the production of antibodies and killer T cells.  An article in Nature.com addressed the subject saying: “T cells do not prevent infection, because they kick into action only after a virus has infiltrated the body. But they are important for clearing an infection that has already started. In the case of COVID-19, killer T cells could mean the difference between a mild infection and a severe one that requires hospital treatment, says Annika Karlsson, an immunologist at the Karolinska Institute in Stockholm. “If they are able to kill the virus-infected cells before they spread from the upper respiratory tract, it will influence how sick you feel,” she says. They could also reduce transmission by restricting the amount of virus circulating in an infected person, meaning that the person sheds fewer virus particles into the community.”   Active biotech companies in the market this week include Agenus Inc. (NASDAQ: AGEN), BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV), Onconova Therapeutics, Inc. (NASDAQ: ONTX), Novavax, Inc. (NASDAQ: NVAX), GlaxoSmithKline plc (NYSE: GSK).

Nature.com continued:  “We know the antibodies are likely less effective, but maybe the T cells can save us,” says Daina Graybosch, a biotechnology analyst at investment bank SVB Leerink in New York City. “It makes sense biologically. We don’t have the data, but we can hope.”  The article concluded: “Some coronavirus vaccine developers are already looking at ways to develop next-generation vaccines that stimulate T cells more effectively. Antibodies detect only proteins outside cells, and many coronavirus vaccines target a protein called spike that decorates the surface of the virus. But the spike protein is “quite variable”, suggesting that it might be prone to mutating, says Karlsson, and raising the risk that emerging variants will be able to evade antibody detection.”

BioVaxys Technology Corp. (OTCQB: BVAXF) (CSE: BIOV.CNQ) BREAKING NEWS:  BIOVAXYS ANNOUNCES APPOINTMENT OF POLICY ADVISOR  – BioVaxys Technology Corp. (“BioVaxys”), a biotechnology company that is advancing viral and oncology vaccine platforms as well as immuno-diagnostic products, today announced the appointment of Adam Coutts, PhD, as Policy Advisor.

Dr. Coutts is a Senior Research Fellow at Magdalene College, University of Cambridge and a Research Associate in the Department of Sociology, University of Cambridge.  Dr. Coutts’ research focuses on the social and political determinants of health looking at how non-health sector public policies affect the health and wellbeing of vulnerable groups and how government interventions can be used to help them. Dr. Coutts holds a PhD from the Department of Sociology, University of Cambridge and has held post-doctoral fellowships at Cambridge, and the Department of Politics and International Relations, University of Oxford, Nuffield College.  Dr. Coutts is also a research associate at the Centre for Business Research, Cambridge

James Passin, BioVaxys CEO, stated, “We are honored to onboard Dr. Coutts as a Policy Advisor to BioVaxys. Dr. Coutts’ expertise and experience in public health policy, bringing together academic, policy decision makers and multilateral agencies with those working on- the-ground to deliver healthcare, will prove critical as BioVaxys advances CoviDTH, a novel skin test for T cell immunity to Covid-19, through regulatory and commercial development. We believe that CoviDTH can offer a transformative approach to public health policy in low-income contexts especially in humanitarian and conflict settings, where resources and access are limited. This approach provides a tool to help governments optimize the distribution and targeting of vaccines which will accelerate the lifting of restrictions and lockdown policies.”

Dr. Coutts stated, “CoviDTH provides a low-cost and reliable solution to help mitigate the impacts of the pandemic in fragile and humanitarian settings where health systems are already severely strained, and funds and access are challenging. To end the pandemic, everyone, everywhere need the protection of affordable and effective products like CoviDTH.”  Continued…. Read this full release and more news for BioVaxys Technology at:  https://www.financialnewsmedia.com/news-biov/    

Other recent developments in the biotech industry include:

Agenus Inc. (NASDAQ: AGEN) and Bristol-Myers Squibb Company (NYSE: BMY) announced that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted a global exclusive license to Agenus’ proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target. AGEN1777 is an Fc-enhanced antibody in late preclinical development designed to target major inhibitory receptors expressed on T and NK cells to improve anti-tumor activity. In preclinical studies this approach has shown significant potential in tumor models where anti-PD-1 or anti-TIGIT monospecific antibodies alone are ineffective.

Under the agreement, Bristol Myers Squibb will become solely responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide. Agenus will receive a $200 million upfront payment and up to $1.36 billion in development, regulatory and commercial milestones in addition to tiered double-digit royalties on net product sales. Agenus will retain options to conduct clinical studies under the development plan, to conduct combination studies with certain other Agenus pipeline assets, and also, upon commercialization, to co-promote AGEN1777 in the US. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.  Agenus expects to file an Investigational New Drug (“IND”) application for the development of AGEN1777 with the U.S. Food and Drug Administration in the second quarter of 2021. Bristol Myers Squibb intends to advance the research and development of AGEN1777 in immuno-oncology (“I-O”) for high priority tumor indications including non-small cell lung cancer.

Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced data from a preclinical study of the company’s combination quadrivalent seasonal flu vaccine (NanoFlu) and COVID-19 vaccine candidate (NVX-CoV2373). The NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses to both influenza and SARS-CoV-2.

The manuscript, titled ‘Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M Adjuvant,’ studied a combination vaccine comprising a quadrivalent nanoparticle influenza vaccine formulated together with a recombinant SARS-CoV-2 spike protein vaccine and Matrix-M adjuvant. The combination vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus. Clinical studies of the combination vaccine are expected to begin by the end of the year.

Onconova Therapeutics, Inc. (NASDAQ: ONTX) recently announced that the first patient has been dosed in an investigator-initiated Phase 2 study to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC). The patient was dosed at the EB House Austria, a center of expertise for epidermolysis bullosa at the University Hospital Salzburg, Austria. Additional sites are anticipated to be opened in the UK and in the US to study this rare and genomically driven devastating disease.

In this open-label investigator-initiated study, 12 patients will receive either oral or intravenous rigosertib at the clinician’s discretion given the various clinical manifestations of the disease, which may dictate the need for either oral or intravenous administration of rigosertib. These patients have skin desquamation making intravenous access difficult, or may form esophageal strictures, which make oral administration difficult. Patients will receive either oral rigosertib in four-week cycles (three weeks on, one week off) for up to 13 cycles, with 560 mg of oral rigosertib in the morning and again in the afternoon, for a total of 1,120 mg/day. Alternatively, patients will receive intravenous (IV) rigosertib as a 72-hour IV infusion on days 1, 2 and 3 of eight 2-week cycles, and on days 1, 2 and 3 of nine 4-week cycles thereafter, with each 24-hour infusion consisting of 1,800 mg of rigosertib.

GlaxoSmithKline plc (NYSE: GSK) and Vir Biotechnology, Inc. (NASDAQ: VIR) recently announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorization application. The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.

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