BioVaxys announces that CoviDTH Demonstrates Safety and Tolerability in Broad Ranging In Vivo Clinical Pathology, Immunology, and Histopathology Evaluation, Supporting Planned Clinical Development of CoviDTH
BioVaxys Technology Corp. (OTCQB: BVAXF) announced positive results from its in vivo study demonstrating the safety and tolerability of CoviDTH, a diagnostic tool for T-cell response to SARS-CoV-2. Conducted with Inotiv, the study showed no adverse effects at doses significantly higher than human levels, except for mild localized redness. The FDA indicated that animal toxicity studies were not required, allowing BioVaxys to move forward with a combined Phase I/II clinical development program. CoviDTH is noted as a cost-effective, point-of-care diagnostic tool validated by recent clinical studies.
- Successful in vivo study confirms safety and tolerability of CoviDTH.
- Study doses were 5x-10x higher than expected human dosage with no significant adverse effects.
- FDA deemed animal toxicity studies for CoviDTH unnecessary, facilitating quicker clinical trials.
- None.
VANCOUVER, BC, Nov. 9, 2021 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company"), announced today that results from its in vivo animal research study support the safety and tolerability of CoviDTH at two intradermal dose levels across a battery of clinical pathology, immunology, and histopathology evaluations.
The objective of the study was to determine the potential toxicity and toxicokinetic profile of SARS-CoV-2 Spike Protein when administered two times via intradermal injection in a rabbit model, and to determine the persistence or reversibility of any toxic effects over a one-week recovery period.
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, Sánchez-Machín I, Poza-Guedes P, González-Pérez 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, Sánchez-Machín I, Matheu V. Eur J Immunol 2021 51,S1, 338. Abstract P-0814 doi: 10.1002/eji.202170200
About BioVaxys Technology Corp.
Based in Vancouver, BioVaxys Technology Corp. (www.biovaxys.com) is a British Columbia-registered, clinical 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 preparing for 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 Stage III/Stage IV ovarian cancer. Also in development is CoviDTH®, 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 multiple issued US patents and pending 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 trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).
ON BEHALF OF THE BOARD
Signed "James Passin"
James Passin, CEO
+1 646 452 7054
Cautionary Statements Regarding Forward Looking Information
This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. Forward-looking statements in this news release relate to, among other things, completion of the murine model study, regulatory approval for a Phase I study of its BVX-0320 Vaccine Candidate in humans and the overall development of BioVaxys' vaccines, including any haptenized SARS-Cov-2 protein vaccine. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements.
These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties.
The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Media Contacts BioVaxys Technology Corp.
Gina Cestari, Senior VP
6 Degrees Public Relations
+1 917 797 7904
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