Tonix Pharmaceuticals’ TNX-1800 selected by NIH/NIAID Project NextGen

Tonix Pharmaceuticals Holding announced that the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health, will conduct a Phase 1 clinical trial with TNX-1800, Tonix Pharmaceuticals’ vaccine candidate to protect against COVID-19. Tonix is developing a novel vaccine platform initially targeting COVID-19, smallpox and mpox. The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response. TNX-1800 expresses the spike protein of SARS-CoV-2, was immunogenic, well tolerated and showed promise in protecting animals from challenge with SARS-CoV-2 delivered directly into the lungs. A related horsepox-based vaccine, TNX-8011, protected animals against challenge with monkeypox virus delivered directly into the lungs.4 TNX-801 is also the vector on which TNX-1800 is based and has been shown to be greater than1,000-fold more attenuated than modern vaccinia virus vaccine strains in immunocompromised mice.5 The Phase 1 trial of TNX-1800 is expected to start in the second half of 2024. NIAID will study TNX-1800 by percutaneous administration. “Project NextGen,” is an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19. NIAID will be conducting clinical trials to evaluate several early-stage vaccine candidates. The Phase 1 study involving TNX-1800 is designed to assess safety and immunogenicity in approximately 60 healthy adult volunteers. Upon completion of the trial, NIAID and Tonix Pharmaceuticals will assess the results and determine the next steps for the development of TNX-1800. NIAID will cover the full cost of the clinical trial, including operations and related analysis. Tonix will be responsible for providing clinical trial materials, and upon completion will have the right to rely on the findings in regulatory filings with the U.S. Food and Drug Administration to support the approval of its COVID-19 vaccine and other vaccines based on the RPV platform.