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Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-801 as a Potential Vaccine to Prevent Mpox and Smallpox
Phase 1/2 Clinical Trial of TNX-801 for the Prevention of Mpox and Smallpox to Commence Following Submission of an IND TNX-801 is Based on a Proprietary Live
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Phase 1/2 Clinical Trial of TNX-801 for the Prevention of Mpox and Smallpox to Commence Following Submission of an IND TNX-801 is Based on a Proprietary Live Virus Vaccine Platform Designed to Stimulate Durable T-Cell Immunity TNX-801 Vaccination Protected Animals from a Lethal Challenge with Monkeypox in Preclinical Testing CHATHAM, N.J., Aug. 21, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it received the official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-8011 (recombinant horsepox virus, live vaccine) as a potential vaccine to protect against mpox disease (formerly known as monkeypox) and smallpox. Tonix believes the FDA feedback provides a path to agreement on the design of a Phase 1/2 study and the overall clinical development plan. The Phase 1/2 clinical trial will assess the safety, tolerability, and immunogenicity of TNX-801, following the submission and clearance of an IND. “The FDA’s response to the pre-IND meeting marks an important milestone in the development of TNX-801 since we have FDA concurrence on the proposed manufacturing, toxicology studies, and the Phase 1/2 clinical design,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “TNX-801 is believed to be closely related to Edward Jenner’s original smallpox vaccine.2-10 Jenner’s live virus smallpox vaccine – the first vaccine - remains one of the most effective vaccines in history, since it typically provided lifetime immunity with a single dose, prevented forward transmission of the smallpox virus, and ultimately eradicated the disease. TNX-801 has an attenuated phenotype relative to modern vaccinia viruses, which comprise a group of vaccine viruses that evolved from Jenner’s vaccine during passage in man and animals for over 100 years. When live virus vaccinia vaccination was routinely practiced in Africa, mpox was kept out of the human population.”2,11 TNX-801 is a live replicating attenuated vaccine based on horsepox that is believed to protect against smallpox and mpox, primarily by eliciting a T-cell response evidenced by the “take”. The “take” is a functiona...