 |
VANCOUVER, BC and LYON, France, June 1, 2021 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (US OTCQB: BVAXF) ("BioVaxys" or "the Company") is pleased to announce that its bioproduction partner Bio Elpida of Lyon, France, has initiated construction of a new Good Manufacturing Practice ("GMP") clean room facility needed for producing clinical supply of BVX-0918A, BioVaxys' ovarian cancer vaccine candidate. The design, construction and qualification of the new facility will be dedicated to autologous cancer vaccine production for BioVaxys, allowing for ovarian tumor biopsy reception and treatment within a short time frame. The GMP clean room facility is planned to be completed by the end of this year.
The bioproduction process development consists of two phases. The first phase, which has begun, is a feasibility study and involves the development of production techniques using BioVaxys know-how. After establishing these techniques, Bio Elpida will further develop the required procedures, tests and assays over the next few months so that the product can be produced in compliance with GMP requirements. Bio Elpida will work with BioVaxys to prepare the manufacturing section of the Clinical Trial Application (the "CTA," which is similar to the US IND application) for the EU. Upon acceptance of the CTA, the second phase of the engagement would then commence, which is the manufacturing and testing of clinical samples for administration to patients as part of the EU clinical trial phase I/II planned for Q2 next year.
Bio Elpida President Gilles Devilliers stated that "Bio Elpida is excited and proud to contributing to BioVaxys' pharmaceutical bioproduction process development of BVX-0918A for the European Phase I clinical. The construction of a dedicated GMP clean room facility for cancer vaccine production is well in line with Bio Elpida's strategy to remaining a leader in this specific service offering."
About BioVaxys Technology Corp.
Based in Vancouver, BioVaxys Technology Corp., a British Columbia-registered clinical-stage biotechnology company, is developing viral and oncology vaccines based on its proprietary hapten-conjugated antigen platforms as well as immuno-diagnostics. The Company is developing BVX-0320, its SARS-CoV-2 vaccine candidate, and is advancing a clinical study of BVX-0918A, its cancer vaccine in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors, in late-stage ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T-cell immune response to SARS-CoV-2. BioVaxys has two issued US patents and multiple pending US and international patents related to its cancer vaccine platform, and US/PCT patent applications for its viral vaccine platform 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 the OTCQB Venture Market (OTCQB: BVAXF).
Cautionary Statements 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 legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating 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", "may", "could", or "should" occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys' vaccines, 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 in such forward-looking statements.
These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVayxs' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.
The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
ON BEHALF OF THE BOARD
Signed "James Passin"
James Passin, CEO
+1 646 452 7054
Media Contacts BioVaxys Technology Corp.
Nikita Sashdev
Luna PR
info@lunapr.io
Logo - https://mma.prnasia.com/media2/1522337/BioVaxys_Technology_Corp_Bio_Elpida_Logo.jpg?p=medium600