live horsepox virus vaccine (TNX-801) / Tonix - LARVOL DELTA

Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress Washington 2025 (GlobeNewswire) - The presentation titled, 'A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine', highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals from mpox and rabbitpox and was well tolerated, even in immunocompromised animals....NX-801 was generally well tolerated, even in immunocompromised animals. The new data show durable six-month protection against a lethal challenge with rabbitpox virus and protection of immunocompromised animals against a lethal challenge with monkeypox clade IIa virus."

Preclinical • Infectious Disease

Tonix Pharmaceuticals Announces Grant by Medical CBRN Defense Consortium (MCDC) for Development of TNX-801, the Company’s Single-Dose Mpox and Smallpox Vaccine Candidate (GlobeNewswire) - "Tonix Pharmaceuticals Holding Corp...today announced it has been awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801 (recombinant horsepox virus, live vaccine)...The MCDC grant will allow for further comprehensive market analyses, target market identification and commercialization planning, including for both private and government markets."

Financing • Infectious Disease

Recombinant chimeric horsepox virus (TNX-801) is attenuated relative to vaccinia virus strains in both in vitro and in vivo models. (PubMed, mSphere) - "The two FDA-approved vaccines, ACAM-2000 and JYNNEOS, have important advantages and disadvantages...Here, we show that TNX-801 is >10- to 1,000-fold attenuated in in vitro and in vivo models including human primary cells and immunocompromised murine models than vaccine strains utilized in smallpox eradication. The natural attenuation of TNX-801 and its ability to induce protective immunity via a single vaccination are promising and warrants further development."

Journal • Preclinical • Infectious Disease • IFNAR1

Treatment and Vaccination for Smallpox and Monkeypox. (PubMed, Adv Exp Med Biol) - "For this reason, new antivirals (cidofovir, brincidofovir, and tecovirimat) and new vaccines (ACAM2000, LC16m8 and Modified Vaccine Ankara MVA) were developed...Further antivirals (NIOCH-14 and ST-357) and vaccines (VACΔ6 and TNX-801) are being developed in Russia and the USA. In conclusion, further research for treatment and prevention of orthopox infections is needed and is already in progress. After a brief introduction, this chapter presents the smallpox and mpox disease and thereafter full overviews on antiviral treatment and vaccination including the passive immunization with vaccinia immunoglobulins."

Journal • Review • Infectious Disease

Single Dose of Recombinant Chimeric Horsepox Virus (TNX-801) Vaccination Protects Macaques from Lethal Monkeypox Challenge. (PubMed, Viruses) - "The vaccine was well tolerated and protected animals from the development of lesions and severe disease. These encouraging data support the further development of TNX-801."

Journal • Infectious Disease