Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has announced that the FDA has approved its IND application to commence the first-in-human clinical trial of its SARS-CoV-2 epitope peptide mixtures TNX-2100 for intradermal delivery.
Study to evaluate DTH to SARS-CoV-2 virus
The study seeks to evaluate delayed-type hypersensitivity (DTH) to the COVID-19 causing the SARS-CoV-2 virus. Notably, DTH is a T Cell immunity measure, and the company anticipates the study to commence in Q1 2022.
Tonix CEO Seth Lederman said, “When fully developed, our proposed skin test has the potential to provide clinicians, patients, employers and public health officials with important diagnostic, safety and predictive information, including the durability of immune responses in vaccinated, convalescent and exposed individuals. One of the goals of clinical development of TNX-2100 will be to study the potential correlation of a positive skin test with protective immunity. A test that measures protective immunity could allow for a personalized approach to determining the need for vaccine boosters which would reduce costs as well as risks associated with unnecessary vaccinations. In contrast, a one-size-fits-all booster strategy would be relatively more expensive and likely unsustainable.”
T Cell immunity vital against SARS-CoV-2 infection
T cell immunity against SARS-CoV-2 is thought to be a key component of protection against COVID-19 infection. Usually, T cell immunity lasts longer relative to antibody immunity and can even exist without a detectable antibody response. For instance, T cell immunity has been discovered in people who do not produce antibodies and in people whose antibody responses have weakened and become unnoticeable over time.
Interestingly, both antibody titers and T cell immunity must be assessed to get a complete picture of the immunological status of an individual. Antigen-specific T cell responses can be detected using skin tests that prompt DTH reactions, which are well-established procedures. Because tiny peptides must be injected into the skin, these tests are known as in vivo diagnostics. A favorable result is indicated by a cutaneous reaction caused by local infiltration of active antigen-specific T lymphocytes around the injection site.