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.
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.