Tonix reports TNX-801 vaccine shows promise against mpox

CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a clinical-stage biotech with a strong financial health score of 2.13 according to InvestingPro, presented new data on Thursday showing its TNX-801 vaccine candidate demonstrates significantly less virulence than traditional smallpox vaccines while providing robust protection against mpox and rabbitpox in animal studies.

According to the company’s presentation at the Vaccine Congress 2025 in Vienna, TNX-801 is up to 100,000-fold less virulent than licensed vaccinia strains in interferon receptor knockout mice. The recombinant horsepox-derived vaccine also produced strong antibody responses in multiple animal models after a single dose. With a robust current ratio of 12.31 and more cash than debt on its balance sheet, Tonix appears well-positioned to advance its clinical programs.

The company reported that all vaccinated macaques survived lethal Clade I mpox challenge without developing lesions, while rabbits remained fully protected for 14 months after vaccination.

A key finding highlighted in the presentation was that subcutaneous administration of TNX-801 provided equivalent protection to the traditional percutaneous route, which the company says could reduce administration-site complications such as bacterial infections and scarring.

"TNX-801 delivers durable immunity without safety concerns of live virus vaccines," said Sina Bavari, Executive Vice President of Infectious Disease Research and Development at Tonix, who presented the findings.

The World Health Organization and Centers for Disease Control and Prevention continue to classify mpox as an ongoing public health concern.

Tonix is also developing TNX-102 SL for fibromyalgia, with an FDA decision expected by August 15, 2025, and TNX-1500 for organ transplant rejection and autoimmune diseases.

The information was based on a company press release statement. TNX-801 remains an investigational product that has not been approved for any indication.

In other recent news, Tonix Pharmaceuticals Holding Corp. has reported significant advancements in its pharmaceutical and vaccine development efforts. The company published results from its Phase 3 RESILIENT trial for TNX-102 SL, a fibromyalgia treatment, in the journal Pain Medicine. The study showed statistically significant improvements in reducing fibromyalgia pain and other related symptoms compared to a placebo. Tonix has also submitted a New Drug Application with an FDA decision expected by August 2025. Additionally, Tonix announced promising preclinical results for its TNX-801 mpox vaccine, which demonstrated protection in animal studies. Furthermore, Tonix has initiated a Phase 2 trial for TNX-102 SL to evaluate its effectiveness in treating acute stress reactions, supported by a $3 million grant from the U.S. Department of Defense. The company also reported encouraging data from animal studies for its cancer treatment candidate mTNX-1700, which showed increased survival in gastric cancer models. In financial news, Tonix revealed plans to raise up to $225 million through stock offerings, which may have implications for the company’s future funding strategy.

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