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Vancouver, British Columbia, September 30, 2021/PRNewswire/ - BioVaxys Technology Corp.
(CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") announced today that it has While compiling the IND application documents, the in vivo animal toxicology research in the CoviDTH program was initiated
.
In accordance with the terms of the agreement in March 2021, the Global Contract Research Organization ("CRO") Inotiv, Inc.
Inotiv (NASDAQ: NOV) (market value: $79.
5 million) is headquartered in West Lafayette, Indiana, and is able to provide contract research services for emerging pharmaceutical companies and some of the world's leading drug development companies and medical research organizations
.
The U.
S.
Food and Drug Administration ("FDA") stated in its July 2021 written response to BioVaxys's application for pre-IND Category B review using CoviDTH as a diagnostic tool to assess the T cell immune response to the new coronavirus.
Conduct animal toxicity studies on CoviDTH, and BioVaxys can start its clinical development plan through a phase I/II joint study
.
Although animal toxicity studies can be conducted on their own, it will not interfere with the IND schedule, and BioVaxys believes that the study will provide useful data when it is completed next month
CoviDTH™ is the world's first and only low-cost disposable bedside diagnostic tool for screening patients who have been vaccinated or exposed to the new coronavirus for T cell responses to the new coronavirus
.
Recently released clinical studies1,2 have confirmed that the use of the delayed hypersensitivity (DTH) skin test behind CoviDTH is a feasible and safe in vivo method for evaluating natural and vaccinated individuals exposed to the new coronavirus.
Ken Kovan, President and Chief Operating Officer of BioVaxys, said: “Based on the millions of people who have been vaccinated with the new coronavirus vaccine based on the expression of the new coronavirus s The toxicology studies will also confirm the safety of CoviDTH
.
"
In order to provide greater certainty, BioVaxys makes no explicit or implicit statement about its current ability to treat the new coronavirus
.
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
About BioVaxys Technology Corp.
BioVaxys Technology Corp.
( headquartered in Vancouver, is an early-stage biotechnology company registered in British Columbia, Canada.
It is engaged in the development of virus and tumor vaccine platforms and immunodiagnostic technologies
.
The company is advancing a new coronavirus vaccine based on its hapten virus protein technology, and plans to carry out clinical trials that use its hapten autologous cell vaccine in combination with anti-PD1 and anti-PDL-1 checkpoint inhibitors.
Cautionary statement regarding forward-looking information
This press release contains certain "forward-looking information" and "forward-looking statements" (collectively referred to as "forward-looking statements") as defined in relevant Canadian and U.
S.
securities regulations (including the Private Securities Litigation Reform Act of 1995)
.
Except for statements about historical facts, all statements contained in this article, including but not limited to statements related to the company's future operations or financial performance, are forward-looking statements
These forward-looking statements reflect the views, opinions and forecasts as of the date of the statement, and are based on certain assumptions and estimates
.
The main assumption is that BioVaxys will successfully develop and test vaccines.
Unless required by law, the company has no obligation to update forward-looking statements regarding views, opinions, forecasts or other factors (such as changes)
.
Logo: https://mma.
Source: BioVaxys Technology Corp.
