Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has announced the enrolment of the first subject in the dose-finding TNX-2100 study, an in vivo skin test to evaluate delayed-type hypersensitivity to SARS-CoV-2. Delayed-type hypersensitivity is a functional T cell immunity measure.
Tonix reports dose-finding results of the TNX-2100 study.
CEO Seth Lederman said, “The SARS-CoV-2 skin test is designed to measure T cell immunity. T cell immunity prevents serious disease and blocks forward transmission in other infectious diseases. Because antibodies are easier to measure, there has been more discussion about antibodies rather than T cells as a biomarker of immunity to SARS-CoV-2. However, T cells, not antibodies, are the body’s major defense against viruses.
The skin test can be potentially be used as a T cell protective immunity biomarker and vaccine durability, as well as a tailored approach for vaccination boosters and a means to stratify COVID-19 vaccine trial participants with a full picture of the immune state. It can also be used as an outcome in COVID-19 vaccination trials and public health monitoring for vaccinations that trigger T cell immunity.
Lederman added, “We believe the TNX-2100 skin test has the potential to address the unmet need for a rapid, sensitive, and specific test that may indicate current or past infection with SARS-CoV-2 and potentially predict protective immunity. We also believe the skin test has the potential to inform strategies to protect individuals and communities from COVID-19.”
Skin test will enable measuring of functional T cell immunity.
Tonix EVP of Translational Medicine, Herbert Harris, commented, “There is continued uncertainty about the durability of protection provided by mRNA vaccines for COVID-19 and the number and frequency of boosters required to maintain protective immunity. This skin test, with its potential to allow for measurement of functional T cell immunity to SARS-CoV-2, could provide a personalized approach to determining the need for a booster. A personalized approach to boosters has advantages over the lock-step boosters-for-everyone strategy, which is expensive, exposes people to unknown risks and is unlikely to be sustainable.”
