KEMRI Partners withTonix Pharmaceuticals to Develop TNX-801 Mpox Vaccine in Kenya.

Tonix Pharmaceuticals, in collaboration with the Kenya Medical Research Institute (KEMRI), announced plans to conduct a Phase I clinical trial for TNX-801, an investigational mpox vaccine (formerly known as monkeypox), in Kenya. The trial aims to evaluate the vaccine’s safety, tolerability, and immunogenicity, marking a critical step in combating the rising threat of mpox outbreaks worldwide.

This announcement follows the World Health Organization’s (WHO) declaration in August 2024 declaring the surge in mpox cases across Africa as a Public Health Emergency of International Concern (PHEIC). The cases of the newly identified Clade Ib mpox have also been reported in non-endemic regions such as Sweden, Thailand, Singapore, and India, highlighting the pandemic potential of the virus.

The Ag. Director General of KEMRI, Prof. Elijah Songok said, “KEMRI is proud to partner with Tonix Pharmaceuticals in this crucial endeavor to address the global health threat posed by mpox. As an Institute at the forefront of medical research in Africa, we recognize the importance of developing innovative solutions that are accessible and effective. The planned clinical trial of TNX-801 reflects our ongoing commitment to advancing scientific research that not only benefits Kenya but also contributes to global efforts to prevent and manage emerging infectious diseases. Together, we aim to make significant strides in ensuring the safety and well-being of communities at risk.”

On his part, the Chief Executive Officer (CEO) of Tonix Pharmaceuticals, Dr. Seth Lederman, expressed his optimism about the collaboration, stating, “we are excited to move forward with this important trial in partnership with KEMRI. Given the continued spread of mpox and the recent global health concerns, there is an urgent need for a durable, single-dose vaccine like TNX801. Preclinical data has been highly encouraging, and we believe TNX-801 aligns with the World Health Organization’s (WHO) preferred characteristics for mpox vaccines. Our goal is to contribute to the global effort to halt the spread of this infectious disease.”

The trial will be funded by Tonix, while KEMRI team led by Prof. Matilu Mwau from the Busia-based, Center for Infectious and Parasitic Diseases Control Research (CIPDCR) will oversee the execution of this ground breaking clinical trials. This partnership highlights the importance of collaboration in advancing medical research and addressing emerging public health challenges.

TNX-801 is a live-attenuated horsepox virus vaccine that is being developed to provide immune protection against mpox. It is designed to be safer and better tolerated than older smallpox vaccines derived from vaccinia viruses. Preclinical studies have shown that TNX-801 can protect animals from lethal mpox virus challenges with a single dose, reducing viral shedding and preventing clinical disease. TNX-801’s stability at ambient temperatures and its ease of administration without special equipment also make it an attractive candidate for large-scale vaccination programs, particularly in resource-limited settings.