TNX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpoxTNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple preclinical modelsData support advancement of TNX-801 toward clinical development CHATHAM, N.J., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company") presented data in an oral presentation at the World Vaccine Congress–Europe 2025, held October 14–16, 2025, in Amsterdam, the Netherlands. A copy of the Company's presentation, titled "Safety, Durability and Protection of a Single-Dose TNX-801 Mpox Vaccine," is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com."Vaccines remain a cornerstone of pandemic preparedness and biodefense," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "The data presented in Amsterdam support the potential of TNX-801 as a next-generation orthopoxvirus vaccine candidate with the ability to confer durable protection. We believe TNX-801 has the potential to strengthen global readiness for emerging and re-emerging poxvirus threats."TNX-801 is a live, attenuated, minimally replicative investigational vaccine candidate based on horsepox virus and is being developed to protect against mpox (monkeypox) and smallpox. Preclinical data presented by Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research at Tonix Pharmaceuticals, demonstrated that TNX-801 produced durable immune protection following a single dose and was well tolerated across multiple routes of administration, including percutaneous, subcutaneous, and intramuscular delivery. TNX-801 elicited strong neutralizing antibody responses and protected animals from clinical disease and mortality following mpox challenge in non-human primate, rabbit, and murine models. Immunogenicity and durability were observed for at least 14 months post-vaccination."We are encouraged by the consistency and durability of the TNX-801 data across multiple preclinical models," said Dr. Sina Bavari. "We are also excited by the opportunity to evaluate microneedle patch technology as a novel delivery platform to simplify administration and expand vaccine accessibility in future development stages."About TNX-801*TNX-801 (recombinant horsepox virus) is an, attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner's vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 is based on synthesized horsepox which is believed to be more closely related to Dr. Jenner's vaccine than 20th century vaccinia viruses. Smallpox vaccines descended from Jenner's vaccine used prior to 1900 would be called horsepox by modern nomenclature.. Tonix has received 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-801 as a potential vaccine to protect against mpox disease and smallpox. Tonix has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The Company believes TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines. The FDA-approved non-replicating mpox vaccine Jynneos® requires two doses and provides a relatively short duration of protection. FDA also recently approved ACAM2000, a live, replicating vaccinia vaccine for prevention of mpox. ACAM200 is a clone from DryVax®, a 20th century vaccinia vaccine derived from the NYCBH strain. Pre-clinical results from an mRNA vaccine recently showed some protection from a Clade I monkeypox challenge, but with multiple break-through lesions in vaccinated animals.Tonix Pharmaceuticals Holding Corp.*Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain ...Full story available on Benzinga.com