Covid diagnostic tool backgroundBioVaxys announces that CoviDTH Demonstrates Safety and Tolerability in Broad Ranging In Vivo Clinical Pathology, Immunology, and Histopathology Evaluation, Supporting Planned Clinical Development of CoviDTH
Conducted together with global contract research organization Inotiv, Inc. ("Inotiv"), the Good Laboratory Practice ("GLP") study successfully met all objectives and demonstrated the safety, tolerability, and lack of toxicity of the purified recombinant SARS-CoV-2 s-protein that is a principal constituent of CoviDTH. The highest dose tested in the study was 5x-10x higher than the probable dose in humans, with no adverse effects except some mild localized redness.
In its Written Response this summer to BioVaxys on the Company's request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2, the US Food and Drug Administration ("FDA") indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study. "The battery of analyses provides further evidence of the safety and tolerability of CoviDTH," stated BioVaxys President and Chief Operating Officer Ken Kovan, adding that "Although the animal tox study is deemed discretionary by the FDA, we believe the data will be very supportive of our IND. Preparation of the IND is ongoing as we finalize GMP production plans."
CoviDTH is the world's first and only low cost, disposable, point-of-care diagnostic tool that screens for a T-cell response to SARS-CoV-2, the virus that causes Covid-19. Recent published clinical studies1,2 have validated the use of the delayed-type hypersensitivity (DTH) cutaneous test behind CoviDTH as a feasible and safe in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals and also that the DTH response is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration.3
- The Beauty of Simplicity: Delayed-Type Hypersensitivity Reaction to Measure Cellular Immune Responses in RNA-SARS-Cov-2 Vaccinated Individuals. Barrios Y, Franco A, Snchez-Machn I, Poza-Guedes P, Gonzlez-Prez R, Matheu V.Vaccines (Basel). 2021 Jun 1;9(6):575. doi: 10.3390/vaccines9060575.
- A Novel Application of Delayed-Type Hypersensitivity Reaction to Measure Cellular Immune Response in SARS-CoV-2 Exposed Individuals. Barrios Y, Franco A, Sanchez-Machin I, Poza-Guedes P, Gonzalez-Perez R, Matheu V.Clin Immunol. 2021 May;226:108730. doi: 10.1016/j.clim.2021.108730. Epub 2021 Apr 16.
- Long term follow-up of in vivo cellular immune response to SARS-CoV-2 using delayed-type hypersensitivity cutaneous test. Barrios Y, Snchez-Machn I, Matheu V. Eur J Immunol 2021 51,S1, 338. Abstract P-0814 doi: 10.1002/eji.202170200