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Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-1800 as a Potential Vaccine to Prevent COVID-19
TNX-1800 is a Live Virus Vaccine Designed to Elicit Durable T cell Immunity TNX-1800 is a Modified Version of Dr. Edward Jenner’s Vaccine that Eradicated
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"TNX-1800 is a Live Virus Vaccine Designed to Elicit Durable T cell Immunity TNX-1800 is a Modified Version of Dr. Edward Jenner’s Vaccine that Eradicated Smallpox, Engineered to Express SARS-CoV-2 Spike Protein In Animal Testing, TNX-1800 Protected Upper and Lower Airways After Challenge with SARS-CoV-2, Suggesting an Ability to Block Forward Transmission Phase 1 Trial of TNX-1800 for the Prevention of COVID-19 Expected to Start in the First Half of 2022 CHATHAM, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it received the official written response from a Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-18001 (recombinant horsepox virus, live vaccine) as a potential SARS-CoV-2 vaccine to protect against COVID-19. Tonix believes the written response provides a path to agreements on the design of a Phase 1 study and the overall clinical development plan to qualify TNX-1800 as a vaccine to prevent COVID-19. Based on the response, the Company expects to begin a Phase 1 study in the first half of 2022. TNX-1800 is a live virus vaccine based on the horsepox viral vector platform designed to express the SARS-CoV-2 spike protein and to protect against COVID-19, primarily by eliciting a T cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021. The horsepox virus is closely related to the vaccine developed by Dr. Edward Jenner more than 200 years ago that led to the eradication of smallpox. Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, “The pre-IND meeting written response marks an important milestone in the development of TNX-1800. We have obtained FDA concurrence and clear guidance on the proposed manufacturing, nonclinical pharmacology and toxicology studies, and the Phase 1 clinical design.” Dr. Lederman continued, “Operation Warp Speed (OWS) vaccines were available very rapidly and have made a huge contribution to the health of the U.S. population, but they have limitations, particularly in terms of the short duration of protection and the likely requirement for boosters. Concerns about durability of protection have led Pfizer and Moderna, the innovator...