Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) Receives IND Clearance For TNX-2100 and Partners To Advance TNX-1700

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced that the FDA had cleared its IND application to commence first-in-human clinical trials for TNX-2100, a skin test to ascertain delayed-type hypersensitivity (DTH) to the COVID-19 causing SARS-CoV-2 virus.

Tonix to commence TNX-2100 study in Q1 2022

TNX-2100 is a SARS-CoV-2 epitope peptide blend for intradermal delivery. TDH is a T cell immunity measure. T Cell immunity to the virus can offer a vital element to COVID-19 illness protection following SARS-CoV-2 infection.  Notably, T cell immunity can persist longer relative to antibody immunity, and sometimes it is present in the absence of evaluable antibody response. The Company plans to commence the clinical study in Q1 2022.

CEO Seth Lederman said, “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.”

Tonix partners with Columbia University to advance TNX1700

Tonix has also announced a research partnership with Columbia University focusing on advancing recombinant trefoil factor family 2 (rTFF2)-based treatment candidate TNX-1700 in colorectal and gastric cancers.  The Company licensed global rights for the development and commercialization of products associated with Columbia’s rTFF2 tech in 20219 and recently issued major patent claims recently in the  US.

Lederman said, “Tonix is excited to enter into this new research agreement, which continues our work with Columbia University on the development of TNX-1700 rTFF2-based therapies as monotherapy and for enhancing the performance of anti-PD1 checkpoint inhibitors in treating gastric and colorectal cancers – two tumor types that are known to be notoriously unresponsive to anti-PD1 treatment. In our previous work with Columbia University, we have shown that TNX-1700 detoxifies the tumor microenvironment and potentiates anti-PD1 therapy in a mouse model of colorectal cancer.”