VANCOUVER, BC, Sept. 14, 2021 /CNW/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys"), announced today that global CDMO partner WuXi Biologics, has completed the synthesis of recombinant SARS-CoV-2 s-protein for BVX-0320, the company's COVID-19 vaccine candidate, and CoviDTH, its immunodiagnostic product. Both are headed for clinical trials, with BioVaxys having begun preparing an IND submission to the US Food and Drug Administration ("FDA") for a combined Phase I/II clinical study of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2.
Under the terms of the March 11th, 2021 agreement, WuXi Biologics synthesized high yields of fully characterized, SARS-CoV-2 s-protein for BioVaxys' Good Laboratory Practice (GLP) preclinical safety study of its CoviDTH which will begin this month. In its official Written Response in July to the Company's request for a Pre-IND Type B review of CoviDTH, the FDA has indicated that BioVaxys' planned animal toxicity study is discretionary and not required for IND submission. However, the Company is continuing with this study of CoviDTH as it does not interfere with the IND submission and may in fact provide useful data.
BioVaxys President & Chief Operating Officer Kenneth Kovan commented that "The production of the recombinant s-protein using WuXi Biologics' proprietary cell expression system is a significant milestone for Biovaxys, as we not only have a high production yield of protein, but also now have the ability and know-how to produce protein in large scale with the level of purity, consistency and protein characterization required by the FDA for our clinical studies and commercial-scale yields."
For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.
About BioVaxys Technology Corp.
Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, a diagnostic for evaluating 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 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 shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).