BIOVAXYS files FDA pre-IND meeting request and briefing package for COVID-T

BioVaxys Technology Corp., the world leader in haptenized antigen vaccines for antiviral and cancer applications, announced today that it is has filed a pre-IND (Investigational New Drug) meeting request and submitted a briefing package with the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) for Covid-T, its T-cell immune response diagnostic for SARS-CoV-2. The pre-IND meeting is a critical step in the US regulatory approval process, as it affords an opportunity for study sponsor companies to seek clarification from the FDA on clinical trials design, clinical materials manufacturing, and quality control. BioVaxys anticipates a written response to its pre-IND briefing package later this month.

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 induration 24 hours later.  In vivo skin test antigens are considered biological products and are regulated by CBER's Office of Vaccine Research and Review (OVRR). 

In January, the FDA instructed BioVaxys that it can file for a pre-Emergency Use Authorization ("EUA") for Covid-T™. An EUA can be issued after several statutory requirements are met. Among these is a determination by the FDA that the known and potential benefits of a product, when used to diagnose, prevent, or treat serious or life-threatening diseases when certain criteria are met, outweigh the known and potential risks of the product. In the case of biologics being developed for the diagnosis, treatment or prevention of COVID-19, this assessment is made on a case-by-case basis depending on the characteristics of the product, the totality of the available scientific evidence relevant to the product, and the preclinical and human clinical study data on the product.

Pending completion of clinical product development, BioVaxys is not making any express or implied claims that it has sufficient data to file for an EUA to test for T-cell immunity to the SAR–CoV-2 virus.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

About BioVaxys Technology Corp.

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early stage biotechnology company that is developing viral and oncology vaccine platforms, as well as immuno-diagnostics. The Company is advancing a SARS-CoV-2 vaccine based on its haptenized viral protein technology, and is planning a clinical trial of its haptenized autologous cell vaccine used in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors that will initially be developed for ovarian cancer. Also in development is a diagnostic for evaluating the presence or absence of a T cell immune response to SARS-CoV-2, the virus that causes COVID-19. BioVaxys has two issued US patents and two patent applications related to its cancer vaccine, and pending patent applications for its SARS-CoV-2 (Covid-19) vaccine and diagnostic technologies. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trades on the Frankfurt Bourse (FRA: 5LB) and US OTC: LMNGF.