BioVaxys Technology Corp. has announced that global CDMO partner WuXi Biologics completed the synthesis of recombinant SARS-CoV-2 s-protein for the BVX-0320 and CoviDTH programs.
BVX-0320 is BioVaxys’ COVID-19 vaccine candidate and CoviDTH its immunodiagnostic product.
Both are headed for clinical trials, with BioVaxys having begun preparing an Investigational New Drug (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.
READ: BioVaxys says trial affirms CoviDTH approach to screen for T cell mediated immune response to SARS-CoV-2 effective in humans
BioVaxys said WuXi Biologics synthesized high yields of fully characterized SARS-CoV-2 s-protein for its Good Laboratory Practice (GLP) preclinical safety study of CoviDTH, which will begin this month.
In the FDA’s official written response in July to the company's request for a Pre-IND Type B review of CoviDTH, BioVaxys said the agency indicated that its planned animal toxicity study is discretionary and not required for IND submission.
However, the company said it is continuing with its study of CoviDTH as it does not interfere with the IND submission and may in fact provide some useful data.
"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,” said BioVaxys president and chief operating officer Kenneth Kovan in a statement.
BioVaxys stressed that it is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.
Contact the author: firstname.lastname@example.org
Follow him on Twitter @PatrickMGraham