The US Food and Drug Administration (FDA) has approved Tonix Pharmaceuticals’ investigational new drug (IND) application to begin a first-in-human clinical trial of its diagnostic skin test, TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration).
The test is designed to measure the SARS-CoV-2 (CoV-2) virus-specific delayed-type hypersensitivity (DTH), a method of measuring T cell immunity.
TNX-2100 comprises three different synthetic peptide mixtures, TNX-2110, TNX-2120 and TNX-2130, which represent different protein components in the CoV-2 virus.
TNX-2120 represents only the spike protein while TNX-2110 and TNX-2130 represent multiple protein epitopes from CoV-2 and non-spike proteins, respectively.
As part of the procedure, the three tests are expected to be given at separate locations on the forearm of individuals who have pre-existing T cell immunity to peptides in that mixture.
Each test is expected to provide a DTH response after about 48 hours.
The company expects to begin the first-in-human study of the diagnostic skin test in the first quarter of next year.
Tonix Pharmaceuticals CEO and president 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 personalised approach to determining the need for vaccine boosters which would reduce costs as well as risks associated with unnecessary vaccinations.”
Simultaneously, the company is developing a live Covid-19 virus vaccine, TNX-1800, to produce primarily T cell immunity.
Positive immune response and challenge studies in non-human primates have already been completed.
Based on the written responses from the FDA to a pre-IND meeting, Tonix expects to commence a Phase I study of TNX-1800 in humans in the second half of next year.
Last year, the US FDA approved Abiomed’s investigational device exemption (IDE) to begin a clinical study for the Impella ECP heart pump.