Tonix Pharmaceuticals has announced the enrollment of the first participant in a dose-finding clinical trial of its diagnostic skin test, TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration).
The in vivo diagnostic skin test is designed to measure delayed-type hypersensitivity (DTH) to the SARS-CoV-2 (CoV-2) virus. DTH is a method of measuring functional T cell immunity.
The TNX-2100 test consists of three different synthetic peptides mixtures, TNX-2110, TNX-2120 and TNX-2130, which represent the CoV-2 virus’ different protein components.
TNX-2110 represents multiple protein epitopes from CoV-2, while TNX-2120 and TNX-2130 represent only the spike protein and non-spike proteins, respectively.
The multi-cohort clinical trial will assess the efficacy and safety of the intradermally-injected TNX-2100. The presence, as well as magnitude of DTH reactions, will also be assessed.
The study is expected to be carried out in nearly 90 healthy adults in the US.
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Tonix Pharmaceuticals CEO Seth Lederman said: “In other infectious diseases, T cell immunity prevents serious disease and blocks forward transmission. 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 defence against viruses.
“The skin test has the potential to serve as: 1) a biomarker for T cell protective immunity and durability of vaccine protection; 2) a personalised approach for vaccine boosters; 3) a method to stratify participants in Covid-19 vaccine trials with a more complete picture of immune status; 4) an endpoint in Covid-19 vaccine trials for vaccines that elicit T cell immunity, and 5) public health surveillance.”
After all subjects complete the Day 5 visit, the company plans to conduct an interim analysis to check the presence of DTH reactions and evaluate safety up to 96 hours post-administration.
Following its investigational new drug application, Tonix obtained approval from the US Food and Drug Administration to begin a first-in-human clinical trial of TNX-2100 last month.