Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company based in the United States, has partnered with the Kenya Medical Research Institute (KEMRI) to conduct a Phase I clinical trial for a new vaccine candidate aimed at preventing mpox and smallpox. The trial will assess the safety, tolerability, and immunogenicity of TNX-801, a live virus-based horsepox vaccine. Under the partnership, Tonix will act as the sponsor, while KEMRI will oversee the clinical trial in Kenya.
“We are excited to advance the development of TNX-801 under this research agreement with KEMRI,” said Seth Lederman, CEO of Tonix Pharmaceuticals. “There is an urgent need for the worldwide availability of a single-dose mpox vaccine with durable protection. TNX-801 has demonstrated promising preclinical results and meets the World Health Organization’s (WHO) newly issued target product profile (TPP) for mpox vaccines. We believe TNX-801 has the potential to help interrupt the spread of mpox globally.”
Tonix announced in September 2024 that TNX-801’s profile aligns closely with the WHO’s preferred TPP for mpox vaccines. The TPP calls for single-dose, durable protection with no need for special equipment, stability at room temperature, and suitability for use in immunocompromised individuals. TNX-801 could also support case-contact vaccination strategies, helping curb outbreaks quickly and effectively.
Kenya has reported five mpox cases to date, the latest involving a 29-year-old woman from Mombasa, who contracted the virus after her husband returned from Rwanda. Health Cabinet Secretary Debra Barasa confirmed that the woman is currently in isolation at Utange Hospital’s Mpox Isolation Centre.
In response to the recent cases, Kenya will begin mpox vaccinations next month once the country receives vaccine doses from the Africa Centres for Disease Control and Prevention (Africa CDC). With this launch, Kenya will become the fourth African country to vaccinate its population against mpox, joining the Democratic Republic of Congo, Rwanda, and Nigeria.
Beyond its targeted protection, TNX-801 has the advantage of scalability and ease of distribution without a complex supply chain. This efficiency could be instrumental for global vaccine distribution, especially in regions with limited healthcare infrastructure.
The partnership between Tonix and KEMRI represents a promising step in tackling mpox and smallpox in Kenya and beyond. With Tonix leading as the sponsor and KEMRI’s established role in research and public health, the trial is set to contribute significantly to ongoing efforts to prevent these infectious diseases in Africa and around the world.
