Tonix Pharmaceuticals Presented Data on TNX-801 Mpox Vaccine at World Vaccine Congress–Europe 2025

Core Insights - TNX-801 is an investigational live virus vaccine candidate aimed at providing long-lasting protection against mpox and smallpox, showing favorable safety and immunogenicity in preclinical studies [1][3][4] - The data presented at the World Vaccine Congress in Amsterdam supports the advancement of TNX-801 towards clinical development [2][3] Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated biotechnology company with a focus on developing treatments for central nervous system disorders, immunology, rare diseases, and infectious diseases [5][6] - The company has received FDA approval for Tonmya, a non-opioid analgesic for fibromyalgia, marking a significant milestone in the treatment of this condition [6] Vaccine Development - TNX-801 is based on horsepox virus and has demonstrated durable immune protection for at least 14 months post-vaccination in various preclinical models [3][4] - The vaccine has shown strong neutralizing antibody responses and protection against clinical disease and mortality in non-human primate, rabbit, and murine models [3][4] - Tonix is collaborating with the Kenya Medical Research Institute to seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya [4] Competitive Landscape - TNX-801 is positioned as a next-generation orthopoxvirus vaccine, potentially offering advantages over existing vaccines like Jynneos, which requires two doses and has a shorter duration of protection [4] - The investigational vaccine aims to provide a more durable T-cell immune response and can be manufactured at scale with a lower dose compared to non-replicating vaccines [4]