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VANCOUVER, BC, Dec. 2, 2022 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") is pleased to announce the success of the sterile, bacteria-free trial production of BVX-0918, the Company's bi-haptenized autologous ovarian cancer vaccine.
The complete fabrication of BVX-0918 from an ovarian tumor of a cancer patient now validates the production protocols that had been developed over the past few months for successful tumor cell extraction, cryo-packaging, and cryopreservation. -preservation of tumor cells, the identification of ovarian cancer cells as components of the vaccine using specially developed monoclonal antibodies and flow cytometry, the sterility processes and the development of the double haptenization process of the ovarian tumor cells used in the vaccine.
Production protocols have reduced the time required to haptenize tumor cells by fifty percent, having established a semi-automated technique to mechanically extract tumor cells from a tumor mass, thus saving time for GMP manufacturing.
Next steps include further optimization of the vaccine production process, completion of the protocol for the manufacture of BVX-0918 according to good manufacturing practices, followed by transfer of the production protocol to scale-up manufacturing and validation. of good manufacturing practices for the presentation of a CTA to the regulatory authorities of the EU. The CTA is the European equivalent of the FDA's Investigational New Drug Application, or IND, which is filed to seek approval of a clinical study.
BioVaxys President and COO Kenneth Kovan stated: "BioVaxys has successfully reached a major manufacturing milestone by establishing the process for taking ovarian cancer cells surgically removed from a cancer patient, conjugating two haptens, and manufacturing a sterile and bacteria-free complete vaccine The next steps consist of product characterization according to GMP and the application of analytical methods to validate that each step of the production of BVX-0918 is carried out under GMP conditions to the satisfaction of the regulatory authorities We have completed the clinical study protocol, and our EU clinical development and commercialization partner, Procare Health Iberia, has selected a CRO and has already begun meeting with potential Spanish investigators for the Phase I study."
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
Government and media relations
JB
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. The forward-looking statements in this press release pertain to, among other things, the completion of the animal model study, regulatory approval for a Phase I study of its vaccine candidate BVX-1021 in humans, and the overall development of vaccines for BioVaxys, including any haptenized SARS-Cov-2 or SARS-CoV 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 efficacious products and, if so, whether your 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 licensing agreements to protect your 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
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