BioVaxys has signed an agreement with Bioanalytical Systems (Inotiv) to conduct preclinical toxicity studies for its Covid-T immunodiagnostic programme.
Covid-T is an easy-to-administer and accurate tool used to test the presence of T cells against SARS-CoV-2.
It uses delayed-type hypersensitivity (DTH) and evaluates the efficiency of any SARS-CoV-2 vaccine candidate in stimulating T-cell immunity.
DTH measures immunity of T-cell and has been used for many years for other infectious diseases like tuberculosis, fungal diseases, and mumps.
By placing a small amount of synthesised test material such as SARS-Cov-2 spike protein, intradermally, the test is conducted by inspecting the site for mild localised reddening and hardening of the skin for about 24 hours later.
Inotiv will be responsible for evaluating the safety, tolerability, and toxicity of purified SARS-CoV-2 s-protein in an intradermal research model that will include a battery of clinical pathology, immunology and histopathology evaluations.
Chinese company WuXi Biologics will synthesise the fully characterised, Good Laboratory Practice (GLP) grade SARS-CoV-2 s-protein.
BioVaxys president and chief operating officer Ken Kovan said: “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.”
Results of the preclinical toxicity study are expected to be available this year.
The company plans to submit its pre-IND meeting request to the FDA for Covid-T early next month. Subject to FDA approval, a pivotal human trial of Covid-T will begin later this year.