Business
Tonix Pharmaceuticals Announces IND Clearance for Skin Test (TNX-2100) to Measure SARS-CoV-2 Exposure and T Cell Immunity
First-in-Human Study Expected to be Initiated in the First Quarter of 2022 An Approved Test Would Lead to Identification of People Requiring Vaccine Boosters
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"First-in-Human Study Expected to be Initiated in the First Quarter of 2022 An Approved Test Would Lead to Identification of People Requiring Vaccine Boosters CHATHAM, N.J., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a first-in-human clinical study for TNX-2100 (SARS-CoV-2 epitope peptide mixtures for intradermal administration), a skin test to measure delayed-type hypersensitivity (DTH) to SARS-CoV-2 (CoV-2), the virus that causes COVID-19. DTH is a measure of T cell immunity. Tonix expects to initiate the clinical study in the first quarter of 2022. “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,” stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “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 to SARS-CoV-2 is believed to provide an important element of protection against serious COVID-19 illness after infection with SARS-CoV-2. T cell immunity persists longer than antibody immunity and is sometimes present in the absence of a measurable antibody response. For example, T cell immunity has been detected in some individuals who do not make antibody responses and in others after their antibody responses have waned and become undetectable over time. A complete picture of a patient’s immune status would require assessment of both antibody titers and T cell immunity. Skin tests that elicit DTH responses are well-established methods for the detection of antigen-specific T cell responses. Tests of this ...