Inotiv would study the safety, tolerability, and toxicity of purified SARS-CoV-2 s-protein in an intradermal research model
BioVaxys Technology has teamed up with Bioanalytical Systems, doing business as Inotiv, to conduct preclinical toxicology studies for its Covid-T immunodiagnostic.
Inotiv is a contract research organisation (CRO) that offers services to emerging pharmaceutical, drug development and medical research companies.
Under the terms of the agreement, Inotiv would study the safety, tolerability, and toxicity of purified SARS-CoV-2 s-protein in an intradermal research model.
Also, the study will include a series of clinical pathology, immunology, and histopathology evaluations.
WuXi Biologics will provide the fully characterised, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein, which forms the core element of Covid-T immunodiagnostic.
BioVaxys said that the results from the preclinical toxicity study are expected by early summer, and is planning to begin a human trial of Covid-T later this year, subject to FDA approval.
BioVaxys CEO James Passin 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.”
BioVaxys is a Canadian clinical-stage biotechnology company focused on developing viral and oncology vaccine platforms, along with immuno-diagnostics.
Its Covid-T is a low-cost, easy-to-administer and precise tool designed for testing the presence of T cells against SARS-CoV-2, using delayed-type hypersensitivity (DTH).
Also, the test evaluates the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T cell immunity.
In addition to Covid-19, the test has been used for other infectious diseases including tuberculosis, fungal diseases, and mumps, said the company.
BioVaxys president and chief operating officer Ken Kovan said: “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.”