15 September 2021 | Wednesday | News
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BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF)("BioVaxys"), announced that CDMO's global partner WuXi Biologics has completed the synthesis of the recombinant SARS-CoV-2 protein for BVX-0320, the company's COVID-19 vaccine candidate, and CoviDTH, its immunodiagnostic product. Both are targeting clinical trials, and BioVaxys has begun preparing an IND submission to the U.S. Food and Drug Administration ("FDA") for a combined Phase I/II clinical study of CoviDTH as a diagnostic to evaluate the immune response of T cells to SARS-CoV-2.
Under the terms of the March 11, 2021 agreement, WuXi Biologics synthesized high yields of fully characterized SARS-CoV-2 protein for BioVaxys' Good Laboratory Practice (GLP) preclinical safety study of its CoviDTH to 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 the planned animal toxicity study of BioVaxys is discretionary and not mandatory for IND filing. However, the Company continues with this CoviDTH study, as it does not interfere with the presentation of the IND and may in fact provide useful data.
BioVaxys CEO and Chief Operating Officer Kenneth Kovansaid, "The production of the recombinant s protein using WuXi Biologics' proprietary cell expression system is an important milestone for Biovaxys, as we not only have high protein production performance, but now also have the ability and knowledge to produce proteins on a large scale with the level of protein purity, consistency and characterization required by the FDA for our commercial-scale clinical studies and 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.