Inotiv, Inc. to Evaluate BioVaxys’ CoviDTH

BioVaxys Technology Corp. has announced their plans to work with Inotiv, Inc. This comes with BioVaxys Technologies plans to start their in vivo animal toxicology study of CoviDTH in parallel with the preparation of an IND submission. This plan came with a contract announced back in march to have Inotiv, a global contract research organization, evaluate the safety, tolerability, and toxicity of the purified recombinant SARS-CoV-2 s-protein. This protein is a principal constituent of BioVaxys’ CoviDTH- an experimental diagnostic for COVID-19.

The Inotiv study will utilize a purified recombinant s-protein produced by WuXi Biologics, who is BioVaxys’ bioproduction partner. Indiana-based Inotive provides contract research services to start up and emerging pharmaceutical companies, drug development companies, and medical research organizations.

CoviDTH is a low cost, disposable, diagnostic approach to identify a T-cell immune response to the presence of SARS-CoV-2. They had recently published clinical studies which validated the use of the delayed type hypersensitivity (DTH) cutaneous test behind CoviDTH as a feasible and safe in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals. They also validated that the DTH response is highly durable, persisting for at least one year after either COVID-19 exposure or vaccine administration.

BioVaxys President and Chief Operating Officer Ken Kovan stated, “Based on the millions of people who have received COVID-19 vaccines that are based on in vivo cellular expression of SARS-CoV-2 s-spike protein, as well as the human DTH studies, we are confident that the toxicology study with Inotiv of the s-protein will likewise confirm the safety profile of CoviDTH.”

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