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BioVaxys says trial affirms CoviDTH approach to screen for T cell mediated immune response to SARS-CoV-2 is effective in humans

Dr Yvelise Barrios, who has led the two clinical studies in Spain’s Hospital Universitario de Canarias, will be a scientific adviser at BioVaxys

Pfizer - BioVaxys says trial affirms CoviDTH approach to screen for T cell mediated immune response to SARS-CoV-2 is effective in humans
BioVaxys said the results of Dr Barrios' studies support the idea that the company’s planned Phase I/II US study will likewise find 'CoviDTH to be effective and safe in humans'

BioVaxys Technology Corp has revealed that well-known immunologist Dr Yvelise Barrios has joined the company as a scientific adviser to support the development of CoviDTH, a disposable diagnostic tool that screens for T-cell immune response to SARS-CoV-2.

Significantly, Dr Barrios, a specialist in clinical immunology at Spain’s Hospital Universitario de Canarias, in Tenerife, is an authority in the clinical use of delayed-type hypersensitivity (DTH), the mechanism behind BioVaxys’ CoviDTH as an immuno-diagnostic tool.

In June this year, the Clinical Immunology and Vaccines journals both published the results of two clinical studies led by Dr Barrios and her colleagues at Hospital Universitario de Canarias, in Spain on the 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 (NYSE:PFE) mRNA vaccine.

READ: BioVaxys receives FDA guidance for it to prepare Investigational New Drug application for clinical trials of CoviDTH

BioVaxys noted that the studies in people 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.

“The clinical trial proved that an affordable and simple test, which is substantially equivalent to CoviDTH, is effective and safe, and can answer basic immunogenicity questions in large-scale populations,” said the company. 

In a statement, Dr Barrios said: "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,” added Dr Barrios. “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 mounting evidence that an antibody-mediated and T cell-mediated immune response is required for protection against SARS-CoV-2. According to the company, T cell-mediated immunity is a “more reliable correlate of vaccine protection” than antibody titers in seniors, strongly supporting the need for a determination of T cell response in COVID-19 vaccine design and population screening.

BioVaxys chief operating officer Kenneth Kovan said the results of Dr Barrios' studies back the idea that the company’s planned Phase I/II US 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," added Kovan.

Dr Barrios’ lab is the reference laboratory for kidney transplantation of the Canary Islands Province, in Spain. She received her medical degree at La Laguna University, in Spain and conducted her clinical immunology residency at Puerta de Hierro Hospital. She did her post-doctoral studies in phage display expression of antibody fragments in immune technology at Lund University, in Sweden.

“Dr Barrios and her colleagues will be collaborating with BioVaxys on research that explores the use of 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,” said the company. 

Contact the author Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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