BioVaxys Technology Corp said it has started its planned in vivo animal toxicology study of CoviDTH in parallel with the preparation of an IND submission.
The Vancouver-based, clinical-stage biotechnology company developing viral and oncology vaccine platforms, as well as immuno-diagnostics also provided an update regarding a March 2021 agreement with Inotiv Inc, a global contract research organization.
As part of the terms, 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.
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According to the company, the test work will include a battery of clinical pathology, immunology, and histopathology evaluations. The Inotiv study utilizes purified recombinant SARS-CoV-2 s-protein recently produced by WuXi Biologics, the firm's bioproduction partner.
In the press release, BioVaxys highlighted a written response it had received from the US Food and Drug Administration (FDA), regarding 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.
In the correspondence, 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.”
However, BioVaxys believes it may provide useful data and will not interfere with the IND timing when the study is completed next month.
CoviDTH is described as 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.
BioVaxys also noted that recently published clinical studies 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.
"Based on the millions of people who have received COVID-19 vaccines that are based on in vivo cellular expression of SARS-CoV-2 s-spike protein, as well as the human DTH studies, we are confident that the toxicology study with Inotiv of the s-protein will likewise confirm the safety profile of CoviDTH," BioVaxys’ President and Chief Operating Officer, Ken Kovan said in a statement.
The company also reiterated it is not making any express or implied claims that it has the ability to treat the SAR-CoV-2 virus at this time.
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