Grant for TNX-801 Vaccine Development

MCDC is a consortium of industrial, academic, and non-profit entities that supports the U.S. government in meeting military requirements for medical products to protect against chemical, biological, radiological and nuclear (CBRN) threats. TNX 801 is in development as an mpox and smallpox vaccine with the potential to be delivered via innovative alternative methods to improve patient compliance, ease of use and tolerability. The MCDC grant will allow for further comprehensive market analyses, target market identification and commercialization planning, including for both private and government markets.

“We are excited by the opportunity to collaborate with MCDC and are thankful for their support of our vaccine candidate,” said Seth Lederman, M.D., President, and Chief Executive Officer of Tonix. “TNX 801 offers an appealing target product profile, requiring just a single dose for durable, long-term protection, with favorable shipping and storage requirements. With a significant global unmet need, TNX 801 is in a strong position to make a potential impact towards preventing mpox and controlling mpox epidemics.”

TNX 801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th century vaccinia live-virus vaccines in animals. TNX 801 has previously been shown to protect animals against lethal challenge with intratracheal clade I monkeypox virus. An outbreak of clade I mpox was declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO) in August of 2024 and reaffirmed in February 2025. Starting from an outbreak in the Democratic Republic of the Congo, clade I mpox has spread to sixteen Central African Countries and outside of Africa, including in China, Thailand, Singapore, India, England, parts of Europe and the Middle East, Canada and the United States.