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KEMRI, Tonix Pharmaceuticals partner to conduct Phase I clinical trial for TNX-801, an mpox vaccine

The partnership deal will see Tonix Pharmaceuticals, a fully-integrated biopharmaceutical company, design and conduct a Phase I clinical trial of the vaccine designed to prevent Mpox.

NAIROBI, Kenya Nov 13 – The Kenya Medical Research Institute (KEMRI) has entered into an agreement with Tonix Pharmaceuticals to develop and test Monkey pox (Mpox) vaccine in Kenya.

The partnership deal will see Tonix Pharmaceuticals, a fully-integrated biopharmaceutical company, design and conduct a Phase I clinical trial of the vaccine designed to prevent Mpox disease.

Prof. Elijah Songok Director General of KEMRI said the trial which will take place in the country will focus on assessing the vaccine’s safety, tolerability, and immunogenicity.

“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,” he said.

Songok added that Tonix will sponsor the trial, while KEMRI will oversee the execution of the proposed Clinical Study aiming to evaluate the safety of the vaccine.

“ 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,” he stated.

On his part Dr Seth Lederman CEO Tonix Pharmaceuticals highlighted the need for to develop and test the vaccine in order to stop the spread of the disease which has continued to raise global health concerns

“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 TNX-801,” he urged.

Dr Seth Lederman affirmed that Tonix Pharmaceuticals  is committed  to stop the spread of the infectious disease.

“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,” he added.

This agreement comes as the World Health Organization (WHO) declared the recent rise in mpox cases across Africa a Public Health Emergency of International Concern (PHEIC) in August 2024.

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.

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.

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