- Excellent emerging safety and tolerability profile with BVX-1021
VANCOUVER, BC, Nov. 16, 2022 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") is pleased to announce that interim results of its ongoing preclinical of BVX-1021, the Company's vaccine for SARS-CoV-1 ("SARS1"), which is being evaluated in collaboration with Ohio State University ("Ohio State") to develop a vaccine pan-sarbecovirus, shows an excellent emergent tolerability profile with no observed side effects or notable clinical observations.
BVX-1021 is the subject of an ongoing research collaboration between Ohio State and BioVaxys that is evaluating the company's novel approach for a "universal vaccine" that can treat a broad range of sarbecoviruses. Sarbecoviruses are a family of viruses that includes all variants of Covid-19, the SARS-CoV-1 virus responsible for the 2003 global SARS pandemic, and a wide range of other potentially dangerous zoonotic viruses. The collaboration is evaluating the combination of BioVaxys BVX-0320 and BVX-1021 in a guinea pig model; BVX-1021 is a hapten-modified recombinant S1 subunit of the spike protein of SARS1 virus, while BVX-0320 is a hapten-modified recombinant S1 subunit of the spike protein of SARS-CoV-2 ("SARS2"), the virus What causes Covid-19.
Three weeks after administration of BVX-1021 in the guinea pig animal model, no toxicities, changes in body weight, or injection site reactions were observed.
Dr. David Berd, BioVaxys Medical Director, said: "Although preclinical results in animal models are not always duplicated in humans, the emerging tolerability and clean toxicity profile hold great promise for clinical evaluation."
The next step in the study is follow-up immunization of test animals with BVX-0320, the company's Covid-19 vaccine candidate, currently underway in Ohio State. The main endpoints of the study are the development of virus-neutralizing antibodies against the live SARS2 virus and other sarbecoviruses, including SARS-related coronaviruses from bats and pangolins. The presence of neutralizing antibodies in the animal model would strongly suggest that BVX-1021 would confer an additional immune response to all sarbecoviruses in those fully vaccinated against Covid-19, as well as those with natural immunity.
BioVaxys President and COO Kenneth Kovan stated: "These interim data further support our efforts to develop a safe and well-tolerated solution for sarbecoviruses such as SARS-1, SARS-CoV-2 and their variants that The emerging in vivo safety and tolerability profile of BVX-1021 mirrors what our SARS-CoV-2 vaccine, BVX-0320, shows, and is further evidence of the feasibility of our haptenized antigen vaccine platform. in different viruses".
About BioVaxys Technology Corp.
Headquartered in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered early-stage biotechnology company developing platforms for viral and oncology vaccines, as well as immunodiagnostics. The company is advancing the development of vaccines against SARS-CoV-2, SARS-CoV-1, and a sarbecovirus vaccine in general based on its haptenized viral protein technology, and is planning a clinical trial of its cellular vaccine. autologous haptenized drug used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for stage III and IV ovarian cancer. Also in development is CoviDTH®, a diagnostic to assess the presence or absence of a T-cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and multiple US and international patent applications related to its cancer vaccines, antiviral vaccines and diagnostic technologies. BioVaxys common shares trade on the CSE under the stock symbol "BIOV" and are listed on the Frankfurt Bourse (FRA: 5LB) and in the United States (OTCQB: BVAXF).
Signed "James Passin"
James Passin, CEO 1 646 452 7054
Cautionary Note Regarding Forward-Looking Information
This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities law, including the United States Private Securities Litigation Reform Act of 1995. All statements except statements of historical fact, including herein, without limitation, statements relating to the Company's future operating or financial performance, are forward-looking statements. Forward-looking statements are often, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "estimates," "potential," "possible" and similar expressions, or statements that the events, conditions or results "may", "may", "could" or "should" occur or be achieved. Forward-looking statements in this news release pertain to, among other things, the completion of the mouse model study, regulatory approval for a Phase I study of its vaccine candidate BVX-0320 in humans, and the overall development of vaccines for BioVaxys, including any haptenized SARS-Cov-2 protein vaccine. There can be no guarantee that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements reflect the beliefs, opinions and projections as of the date the statements are made and are based on a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, which, while are considered reasonable by the company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies, including, primarily but not limited to, the risk that BioVayxs vaccines will not be effective and/or will not receive approvals required regulations. With respect to BioVaxys' business, there are a number of risks that could affect the development of its biotech products, including, but not limited to, the need for additional capital to finance clinical trials, its lack of operating history, uncertainty as to whether its products will complete the lengthy, complex and costly clinical trial and regulatory approval process for new drug approvals required for marketing approval, uncertainty as to whether your autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether their vaccine products will be commercially accepted and profitable, the costs, delays, and uncertainties and complications that are often encountered by development-stage biopharmaceutical companies, financial and development obligations under license agreements to protect their rights to its products and technologies, obtaining and protection of new intellectual property rights and the prevention of third party infringement and their reliance on third party manufacturing.
The company does not undertake any obligation to update forward-looking statements of beliefs, opinions, projections or other factors, should they change, except as required by law.
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