Contract development and manufacturing organization (CDMO) WuXi Biologics has completed the synthesis of recombinant SARS-CoV-2 s-protein for BVX-0320, BioVaxys Technology’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 U.S. 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 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.
 
Kenneth Kovan, president and chief operating officer, BioVaxys, said, “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.