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WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.
BioVaxys Technology, a Canadian clinical-stage biopharmaceutical company, announced on March 15, 2021 that it has entered into an agreement with WuXi Biologics, the contract development and manufacturing organization business unit of Wuxi AppTec, to produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.
Under the terms of the agreement, WuXi will produce high yields of fully characterized SARS-CoV-2 s-protein for BioVaxys’ preclinical safety study of its Covid-T diagnostic, BioVaxys said in a company press release. The recombinant s-protein will be created and expressed using WuXi Biologics’ proprietary vector, allowing BioVaxys to secure the level of purity, consistency, and protein characterization expected by FDA.
The s-protein will also be used in BVX-0320, which is being prepared for a clinical study this year.
“Establishing a bioproduction method for a steady supply of purified and fully characterized s-protein from a validated process will enable us to quickly transition from having the GLP material for the upcoming Covid-T animal toxicity study to having a steady source [of] the GMP-grade s-protein for clinical trials later this year,” said Ken Kovan, BioVaxys president and chief operating officer, in the press release. “Now that we know the gene sequences, a further major benefit of our relationship with WuXi will be our ability to quickly source the s-protein of newly emerging SARS-CoV-2 variants for use in a planned multi-valent version of BVX-0320 and line extensions of Covid-T.”