Tonix Secures MCDC Grant To Develop TNX-801: A Promising Mpox And Smallpox Vaccine

Tonix Pharmaceuticals Holding Corp. has received a grant from the Medical CBRN Defense Consortium (MCDC) to advance the development of TNX-801, a live recombinant horsepox virus vaccine. MCDC, a partnership of academic, industrial, and non-profit organizations, collaborates with the U.S. government to address medical needs related to chemical, biological, radiological, and nuclear (CBRN) threats. The funding will support in-depth market analysis, identification of target markets, and commercialization planning for TNX-801 in both private and government sectors.

Seth Lederman, M.D., President and Chief Executive Officer of Tonix, commented, “We are excited by the opportunity to collaborate with MCDC and are thankful for their support of our vaccine candidate. TNX-801 offers an appealing target product profile, requiring just a single dose for durable, long-term protection, with favourable 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 a synthesized horsepox strain. Research indicates that it can offer single-dose immune protection against mpox, with superior tolerability compared to traditional 20th-century vaccinia-based vaccines. Previous studies have demonstrated that TNX-801 protects animals from fatal intratracheal exposure to clade I monkeypox virus. The vaccine’s potential to be administered via alternative delivery methods aims to enhance ease of use, patient compliance, and overall tolerability.

TNX-801 development stands vital because of the escalating mpox outbreak. In August 2024, the World Health Organization declared the clade I mpox outbreak a Public Health Emergency of International Concern level and repeated this status in February 2025. The outbreak first emerged in the Democratic Republic of the Congo before spreading to 16 Central African nations and moving further to China, Thailand, Singapore, India, the United Kingdom, different regions of Europe and the Middle East, Canada and the United States.