The Kenya Medical Research Institute (KEMRI) has announced a partnership with Tonix Pharmaceuticals, a U.S.-based biopharmaceutical company, to conduct a clinical trial on an investigational vaccine for mpox. The Phase I trial of TNX-801, designed to prevent the disease, will take place in Kenya, focusing on its safety, tolerability, and immunogenicity.
KEMRI Director-General, Elijah Songok, emphasized the importance of the trial in advancing scientific research that not only benefits Kenya but also supports global health efforts to combat emerging infectious diseases. The vaccine, TNX-801, is a live-attenuated horsepox virus, which Tonix has developed to provide immunity against mpox. It is designed to be more tolerable and safer compared to older smallpox vaccines that use vaccinia viruses.
TNX-801 also offers the advantage of stability at ambient temperatures, making it easier to distribute and administer, even in resource-limited regions. Under the agreement, Tonix will sponsor the trial, while KEMRI will manage its implementation.
Seth Lederman, CEO of Tonix Pharmaceuticals, highlighted the need for a durable, single-dose vaccine in response to the rising global concern over mpox. Data from the Africa Centers for Disease Control and Prevention show a dramatic 545% increase in confirmed cases in 2024 compared to the previous year, with Central Africa being the hardest hit.
This trial comes after the World Health Organization declared the surge in mpox cases across Africa a Public Health Emergency of International Concern in August 2024.