BioVaxys Technology Corp. announced that it has started its planned in vivo animal toxicology study of CoviDTH in parallel with the preparation of an IND submission. Under the terms of a March 2021 agreement, global contract research organization ("CRO") Inotiv Inc. ("Inotiv") is evaluating the safety, tolerability, and toxicity of the purified recombinant SARS-CoV-2 s-protein that is a principal constituent of CoviDTH in an intradermal research model, which will include a battery of clinical pathology, immunology, and histopathology evaluations. The Inotiv study will be utilizing purified recombinant SARS-CoV-2 s-protein recently produced by BioVaxys bioproduction partner, WuXi Biologics. In its July 2021 Written Response 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. Although the animal tox study is discretionary, it will not interfere with the IND timing and BioVaxys believes it may provide useful data when the study is completed next month. 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 in vaccinated patients, or those exposed to SARS-CoV-2. 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. For greater certainty, BioVaxys is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time. 1The Beauty of Simplicity: Delayed-Type Hypersensitivity Reaction to Measure Cellular Immune Responses in RNA-SARS-Cov-2 Vaccinated Individuals. Barrios Y, Franco A, Sánchez-Machín I, Poza-Guedes P, González-Pérez R, Matheu V.Vaccines (Basel). 2021 Jun 1;9(6):575. doi: 10.3390/vaccines9060575. 2A 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. 3Long term follow-up of in vivo cellular immune response to SARS-CoV-2 using delayed-type hypersensitivity cutaneous test. Barrios Y, Sánchez-Machín I, Matheu V. Eur J Immunol 2021 51,S1, 338. Abstract P-0814 doi: 10.1002/eji.202170200.