BioVaxys Technology Corp. announced that it has entered into an agreement with Bioanalytical Systems, Inc. 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.