Preclinical data demonstrate the efficacy of TNX‐801 vaccination against mpox virus challenge in a non-human primate model

Phase 1 trial with TNX-801 for the prevention of mpox and smallpox is expected to start in the second half of 2023

“Tonix’s live virus vaccine technology is designed to help protect against emerging infectious diseases by providing durable protection, and can be widely deployed without the need for sterile injection or ultra-cold shipping and storage,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Our lead vaccine candidate, TNX-801, is a live virus vaccine in development to protect against monkeypox (‘mpox’) and smallpox. We believe TNX-801 is closer in genetic structure and properties to the smallpox vaccines used in the U.S. and Europe before 1900 than the modern vaccinia smallpox vaccines. Relative to modern vaccinia vaccines, TNX-801 has reduced virulence in animals, and we believe it has the potential for widespread use to protect against mpox and smallpox.”

The presentation, titled, “TNX-801: A Live Attenuated Orthopoxvirus (Horsepox) Vaccine for Mpox and Smallpox,” describes the history of live virus vaccines and the rationale for the development of the Company’s Recombinant Pox Virus (RPV) platform. The presentation demonstrates that non-human primates vaccinated with TNX-801 were fully protected with sterilizing immunity from a lethal challenge.

The presentation, titled, “The Development of Horsepox virus as a vaccine platform: Evaluation of TNX-1800 as a SARS-CoV-2 Vaccine,” describes TNX-1800, a live virus vaccine based on the horsepox viral vector platform, which was developed to protect against COVID-19. The presentation shows that in animal testing, TNX-1800 protected upper and lower airways after challenge with SARS-CoV-2, suggesting an ability to block forward transmission. TNX-1800 is an example of the ability of Tonix’s adaptable vaccine platform to protect against emerging threats and future pandemics.