BioVaxys Technology has entered into an agreement with Bioanalytical Systems, Inc. d/b/a Inotiv, a Contract Research Organization (CRO), to conduct preclinical toxicology studies for its Covid-T™ immunodiagnostic. Headquartered in West Lafayette, IN, Inotiv, provides contract research services and monitoring instruments to emerging pharmaceutical companies and some of the world's leading drug development companies and medical research organizations.
Covid-T™ is a low-cost, easy-to-administer, and accurate tool to test for the presence of T cells against SARS-CoV-2, and to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity. Covid-T™ uses Delayed-Type Hypersensitivity (DTH), which is known to be a measure of T cell immunity and has been used for many years for other infectious diseases including tuberculosis, fungal diseases, and mumps. The test is performed by placing a small amount of synthesized test material, e.g., SARS-Cov-2 spike protein, intradermally and inspecting the site for mild localized reddening and hardening of the skin ~24 hours later.
Under the terms of the March 15th, 2021, agreement, Inotiv will evaluate the safety, tolerability, and toxicity of purified SARS-CoV-2 s-protein in an intradermal research model, which will include a battery of clinical pathology, immunology, and histopathology evaluations. The fully characterized, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein will be synthesized by WuXi Biologics and is a core element of the Covid-T immunodiagnostic. BioVaxys anticipates that the preclinical toxicity study results will be available early summer, with the successful completion of the study a critical step towards the initiation of a pivotal human trial of Covid-T later this year, subject to FDA approval. BioVaxys intends to submit its pre-IND meeting request to the FDA for Covid-T early next month.
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"Based on previous preclinical studies conducted with BVX-0320, and the fact that our SARS-CoV-2 vaccine candidate likewise incorporates synthetic s-protein, we have high expectations that this detailed toxicology study of the s-protein with Inotiv will confirm the safety profile of the diagnostic and lead to our planned pivotal clinical study later this year," BioVaxys President and Chief Operating Officer Ken Kovan said.
"We are delighted to work with Inotiv, a leading CRO, to complete a toxicity study, further advancing Covid-T, our novel low cost and scalable skin test for T cell immunity to SARS-CoV-2, the virus that causes Covid-19. We believe that Covid-T will help to solve the world's most pressing public health policy crisis by enabling the rational distribution and allocation of vaccine resources, while preventing unnecessary and wasteful vaccination of people with demonstrable T cell immunity to Covid-19," James Passin, BioVaxys CEO, said.