Policy & Regulation
BioVaxys announces completion of synthesis of recombinant SARS-CoV-2 s-proteins for BVX-0320 and CoviDTH
14 September 2021 -

Biotechnology company BioVaxys Technology Corp (CSE:BIOV) (FRA:5LB) said on Tuesday that its global CDMO partner WuXi Biologics has completed the synthesis of recombinant SARS-CoV-2 s-protein for BVX-0320 and immunodiagnostic product CoviDTH for clinical trial.

Based in British Columbia, BioVaxys stated that BVX-0320 is the company's COVID-19 vaccine candidate and CoviDTH is its immunodiagnostic product. It has 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.

Pursuant to 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.

The US 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.