Clinical Trial Affirms CoviDTH Diagnostic Approach to screen for T cell-mediated immune response to SARS-CoV-2 is safe and effective in humans

BioVaxys Technology Corp. is pleased to announce that Immunologist Yvelise Barrios, MD, PhD, a specialist in Clinical Immunology at Hospital Universitario de Canarias, Tenerife, Spain, has joined BioVaxys as a Scientific Adviser to support development of CoviDTH, the Company's 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. Dr. Barrios is a leading expert in the clinical use of delayed type hypersensitivity ("DTH"), the mechanism behind CoviDTH, as an immuno-diagnostic tool.

In June, the medical research journals Clinical Immunology and Vaccines both published the results of two clinical studies [1,2] led by Dr. Barrios and her colleagues at Hospital Universitario de Canarias in Spain on use of the DTH reaction to measure cellular immune responses to SARS-CoV-2 in patients after infection and in individuals vaccinated with the Pfizer mRNA vaccine. These studies in human volunteers by Dr. Barrios and her colleagues are the first publications of the results obtained using the classical DTH response to the SARS-CoV-2 s-spike protein ("s protein") to assess T cell immune responses in vaccinated individuals, and proved that this affordable and simple test, which is substantially equivalent to CoviDTH, is effective and safe, and can answer basic immunogenicity questions in large-scale populations. 

Dr. Barrios stated, "The use of this test will provide clinicians with a fundamental tool to answer immunogenicity questions basic to understanding how long T cell immune responses are detectable in exposed and vaccinated individuals. This simple method is also ideal for those groups of patients that do not have easy access to troublesome in vitro studies, such as the young and pediatric population, being extremely useful because it can be interpreted by any non-specialist medical doctor. The study of cellular immune responses in Covid-vaccinated individuals will also provide insight to optimize dosing and type of vaccines in different scenarios of selected groups of patients such as immunodeficient and transplant patients." 

There is significant evidence that an antibody-mediated and T cell-mediated immune response is required for protection against SARS-CoV-2 [3,4] and also that T cell-mediated immunity is a more reliable correlate of vaccine protection than antibody titers in seniors [5], strongly supporting the need for a determination of T cell response in COVID-19 vaccine design and population screening.

Kenneth Kovan, President and Chief Operating Officer of BioVaxys, stated, "The results of Dr. Barrios' studies infer that our planned US Phase I/II study will likewise find CoviDTH to be effective and safe in humans. This is obviously extremely exciting news for us, as the clinical data from this study has shown that CoviDTH has the potential to answer basic SARS-CoV-2 immunogenicity questions in large-scale populations."

Dr. Barrios is a specialist in Clinical Immunology at Hospital Universitario de Canarias, with a clinical focus on histocompatibility, autoimmune diseases and allergy, and is senior Immunology consultant for primary immunodeficiency diseases. Her lab is the Reference Laboratory for kidney transplantation of the Canary Islands Province in Spain. Dr. Barrios received her medical degree at La Laguna University, Tenerife, Spain and conducted her Clinical Immunology Residency at Puerta de Hierro Hospital. She received her PhD on Active Immunotherapy in B-cell Tumors, from Universidad Autonoma, Madrid, and did her post-doctoral in phage display expression of antibody fragments in Immunotechnology at Lund University in Sweden.

Dr. Barrios and her colleagues will also be collaborating with BioVaxys on research that explores the use of the DTH reaction to measure cellular immune response in a population exposed to different variants of SARS-CoV-2, as well as evaluating the potential use of M and N proteins in CoviDTH. 

References:

[1] 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.

[2] 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.

[3] Sariol, A.; Perlman, S. Lessons for COVID-19 Immunity from Other Coronavirus Infections. J. Immun. 53, 248–263

[4] Tay, M.Z.; Poh, C.M.; Rénia, L.; Macary, P.A.; Ng, L.F.P. The trinity of COVID-19: Immunity, inflammation and intervention. Nat. Rev. Immunol. 2020,20, 363–374.

[5] Haq, K.; E McElhaney, J. Immunosenescence: Influenza vaccination and the elderly. Curr. Opin. Immunol. 29, 38–42

About BioVaxys Technology Corp.

Based in Vancouver, BioVaxys Technology Corp. is a British Columbia-registered, early 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 planning 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 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 two issued US patents and two 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 trades on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF).