Tonix Pharmaceuticals presents vaccine platform data at Vaccine Congress 2024

Tonix Pharmaceuticals announced data presented at an oral Keynote Talk at the Vaccine Congress 2024 held June 24-25, 2024 in Prague, Czech Republic. The presentation titled, “A New Live Virus, One Dose Vaccine Platform for Mpox, Smallpox and COVID-19”, detailed the Company’s vaccine platform, including TNX-801 vaccine for preventing mpox and smallpox and TNX-1800 for protecting against COVID-19. TNX-801 and TNX-1800 are live replicating attenuated vaccines based on horsepox that are believed to provide immune protection with better tolerability than modern vaccinia viruses. In the presentation, Tonix highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population. The presentation noted that the global mpox outbreak, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade I strain of mpox remains restricted to several Central African countries, including the Democratic Republic of the Congo, where it is currently endemic. Clade I mpox is typically associated with higher case fatality rates than Clade IIb mpox. According to the U.S. Centers for Disease Control and Prevention, and other experts, there is a significant risk that the deadlier Clade I strain may appear in the U.S. Further, the presentation noted that the Bipartisan Commission on Biodefense recently highlighted the renewed dual threats of both a more virulent mpox epidemic as well as smallpox re-introduction from lab accidents or bad actors, while the National Academies of Science, in its review of smallpox preparedness, highlighted the need for new single dose vaccines against smallpox. The keynote presentation also included preclinical data for TNX-1800, demonstrating immunity and tolerability. TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial and cover the full cost, while Tonix provides the vaccine candidate.