BioVaxys and BioElpida Sign Termsheet for Bioproduction of BVX-0918A under Clinical Requirements
22 February 2021
BioVaxys Technology Corp. announced that there is a Termsheet ("Termsheet") with BioElpida SAS ("BioElpida") based in Lyon , France has signed to collaborate on setting up the clinical manufacturing process and aseptic packaging for BXV-0918A, BioVaxy's vaccine against Stage III / Stage IV ovarian cancer. The completion of the development of the GMP-compliant organic production process is planned for this year. The EU phase I / II clinical trial is scheduled for early 2022, subject to approval by the European Medicines Agency ("EMA").
BioElpida is a biotech contract development and manufacturing ("CDMO") company that uses single-use bioprocesses to develop and manufacture biological and cell-based products. BioElpida’s expertise ranges from research and development to pharmaceutical manufacturing and clinical batch release to Intermediate steps such as process development, feasibility studies, analytical method validation, aseptic filling and other bioproduction services. BioElpida's facility is certified for clinical bioproduction by France's National Safety Agency for Medicines and Health Products (ANSM).
The two companies are working towards a final agreement by the end of March this year. The completion of the development of the GMP-compliant organic production process is planned for this year. The EU phase I / II clinical trial is scheduled for early 2022, subject to approval by the European Medicines Agency ("EMA").
Kenneth Kovan , President and Chief Operating Officer of BioVaxys , stated, “In addition to their expertise in bioproduction, the BioElpida team is very familiar with our haptenized protein approach, having previously worked on process development for the 'first generation' clinical delivery. of the haptenized tumor cell vaccines. "
BioVaxys recently announced that it is partnering on the clinical program for its ovarian cancer vaccine with Spanish biopharmaceutical company ProCare Health Iberia SAS, which plans to submit a clinical trial ("CTA") application for BVX-0918A later this year to the European Medicines Agency ("EMA") for approval for use in hardship cases in stage III and IV ovarian cancer. ProCare Health will hold the marketing rights for BVX-0918A in the EU and UK, while BioVaxys will commercialize its ovarian cancer vaccine in North America and the rest of the world.
There remains a significant unmet therapeutic need for the treatment of ovarian cancer worldwide. Over 300,000 women worldwide are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer being the leading cause of death from gynecological cancers in the United States (American Cancer Society Facts & Figures 2020). For 2020 in the USAan estimated 21,750 new cases of ovarian cancer with 13,940 deaths expected (National Cancer Institute, Surveillance and Epidemiology Program, 2020). The majority of women with stage III or IV cancer ultimately develop relapsing disease that does not respond to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have a limited life expectancy even with multiple salvage therapies. This large group of non-responders or those who relapse after first-line therapy are the primary target market for BioVaxys.
The global ovarian cancer drug market was valued at $ 1.2 billion in 2017 and is projected to reach $ 4.6 billion by 2026, with an average annual growth rate (CAGR) of 18.29% ( www.medgadget.com /2020/11/ovarian-cancer-drugs-2020-global-market-to-reach-us-4-6-bn-and-growing-at-cagr-of-18-29-by-2026.html ).
About BioVaxys Technology Corp.
In Vancouver resident BioVaxys Technology Corp . is a in British Columbia Registered early stage biotechnology company developing viral and oncological vaccine platforms and immunodiagnostics. The company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology and plans to conduct a clinical trial of its haptenized autologous cell vaccine in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors for ovarian cancer to be developed. Also under development is 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 U.S. patents and two patent applications related to its cancer vaccine and pending patent applications for its SARS-CoV-2 (COVID-19) vaccine and diagnostic technologies. BioVaxys' common stock is listed on the CSE under the symbol "BIOV" and is traded on the Frankfurt Stock Exchange (FRA: 5LB) and the US OTC: LMNGF.
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This press release contains certain "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") as used in theapplicable Canadian and US securities laws, including the United States Private Securities Litigation Reform Act of 1995. All statements contained herein that are not historical facts, particularly statements about the company's future operational or financial performance, are forward-looking statements. Forward-looking statements are often, but not always, identified by words such as "expects," "predicts," "believes," "intends," "estimates," "potentially", "possible" and similar expressions, or statements that will occur , Conditions or results "occur", "may", "could" or "should" or be achieved.There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.
These forward-looking statements reflect the beliefs, opinions and projections at the time the statements were made and are based on a number of assumptions and estimates, including, but not limited to, the belief that BioVaxys will be successful in vaccine development and testing. While Company believes these assumptions and estimates are reasonable, they are inherently subject to significant business, economic, competitive, political and social uncertainties and uncertainties, including the risk that BioVayxs' vaccines will not prove effective and / or not provide the necessary ones received regulatory approvals. There are a number of risks associated with BioVaxys' business,
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ON BEHALF OF THE MANAGEMENT BOARD
Signed "James Passin"
James Passin , CEO
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