Bio-manufacturing partner BioElpida completes next phase of BVX-0918 GMP production for European clinical study
VANCOUVER, BC, June 8, 2022 /CNW/ — BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (“BioVaxys” or “Company”), today announced that its Lyon, FranceBioVaxys’ biomanufacturing partner, BioElpida (“BioElpida”), has completed the establishment of several OVCAR-3 cell banks as the next step in developing the GMP manufacturing process for BVX-0918, BioVaxys’ vaccine for the treatment of platinum-resistant ovarian cancer.
The OVCAR-3 cell line is mandatory to create the identity tests that will need to be performed on each lot of ovarian cancer vaccine. This test is required by EU regulatory bodies and United States. The cell line is derived from human ovarian adenocarcinoma, established from a patient refractory to cisplatin, a chemotherapy drug used in advanced ovarian cancer. Patients whose tumors are naturally resistant to cisplatin at the time of initial treatment generally have a poor prognosis, which is the target patient population for BVX-0918.
President and COO of BioVaxys Kenneth Kovan stated that “the completion of the OVCAR-3 cell banks is another step towards our ability to produce GMP yields of BVX-0918, and brings us closer to our phase I study in the EU scheduled for later this year. .”
BioVaxys has recently entered into collaborations with the Hospices Civils de Lyons in France and the Deaconesses Research Institute of United States provide the Company with surgically reduced tumors from stage III/IV ovarian cancer patients. Tumor samples from both hospitals are being used to validate the tumor collection protocol, cryoconditioning, cryopreservation, and supply chain logistics for the bioproduction of BVX-0918 for potential patients in the United States and around the world. EU. HCL tumor samples will also be used for process testing and manufacturing “no-load tests“ of BVX-0918, a major milestone leading to the completion of Good Manufacturing Process (“GMP”) production.
BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins — whether viral or tumoral — with haptens makes them more visible to the immune system. This process of haptenization “taught“ a patient’s immune system to recognize and manufacture target proteins more “visible“ as foreign, thereby stimulating a T cell-mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically binding them to a hapten, and injecting them back into the patient to induce an immune response to proteins that are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach for cancer immunotherapy and has been clinically evaluated in regional and disseminated metastatic tumors.
A first-generation, single-hapten vaccine invented by BioVaxys co-founder and medical director David Berd, MD, has shown positive immunological and clinical results in phase I and phase II human trials in more than 600 patients with different types of tumors, as well as no toxicity observed over the years of clinical studies. These studies were conducted under an IND reviewed by the FDA. A first-generation autologous haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had stopped responding to conventional chemotherapy. The results were encouraging: in 24 patients, the median overall survival was 25.4 months with a range of 4.5 to 57.4 months; 8 patients survived more than 2 years. BioVaxys has improved on the first-generation approach by using two haptens (“bi-haptenization”), which the company says will yield superior results.
About BioVaxys Technology Corp.
Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered clinical-stage biotechnology company developing viral and oncology vaccine platforms, as well as immunodiagnostics. The Company is advancing vaccines against SARS-CoV-2, SARS-CoV-1 and a pan-sarbecovirus vaccine based on its haptenized viral protein technology, and plans a clinical trial of its haptenized autologous cell-based vaccine used in combination with anti-PD1 and anti-PDL1 checkpoint inhibitors that will initially be developed for stage III/stage 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 several US and international patent applications related to its cancer vaccines, viral vaccines and diagnostic technologies. Common shares of BioVaxys are listed on the CSE under the ticker symbol “BIOV” and trade on the Frankfurt Stock Exchange (FRA: 5LB) and in the United States (OTCQB: BVAXF).
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This press release contains certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of applicable Canadian and United States securities laws, including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included herein, without limitation, statements relating to the future operating or financial performance of the Company, are forward-looking statements. Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”. and similar expressions or statements that events, conditions or results “will”, “could”, “might” or “should” occur or be achieved. Forward-looking statements in this press release relate to, among other things, the completion of the mouse model study, the regulatory approval of a Phase I study of its vaccine candidate BVX-0320 in humans and the development package of vaccines from BioVaxys, including any haptenized SARS-Cov-2 protein vaccine. 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 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 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 BioVaxys’ vaccines may not prove not effective and/or do not receive the required regulatory approvals. With respect to BioVaxys’ business, there are a number of risks that could affect the development of its biotechnology products, including, but not limited to, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty as to whether its products will complete the long, complex and costly clinical trial and regulatory approval process for new drug approvals required for marketing approval, uncertainty as to whether its autologous cell-based vaccine immunotherapy can be scaled up to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expense, delays, uncertainties and complications generally encountered by biopharmaceutical companies in the development phase, the financial and development obligations in under license agreements in order to protect its rights to its products and technologies, to obtain and protect new intellectual property rights and to avoid infringement of third parties and their dependence on the manufacture by some thirds.
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