In a promising development, Tonix Pharmaceuticals and the Kenya Medical Research Institute (KEMRI) have announced a partnership to conduct clinical trials for TNX-801, a vaccine candidate aimed at preventing mpox (formerly known as monkeypox). This joint effort comes as the World Health Organization (WHO) recently declared the spread of mpox across Africa a Public Health Emergency of International Concern.
The trial, which will be based in Kenya, aims to evaluate the safety, tolerability, and immunogenicity of TNX-801. Tonix Pharmaceuticals will sponsor the trial, while KEMRI will oversee its execution. TNX-801, a live-attenuated horsepox virus vaccine, is designed for safe and effective immune protection against mpox, providing stability at ambient temperatures and ease of administration—essential qualities for vaccination efforts in resource-limited regions.
Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, expressed optimism about the collaboration.
“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 said.
“We are thrilled to partner with KEMRI and contribute to the global effort to halt the spread of this infectious disease.”
Prof. Elijah Songok, Director General of KEMRI, emphasized the significance of the collaboration.
“KEMRI is proud to partner with Tonix Pharmaceuticals to address the global health threat posed by mpox,” he noted. “This clinical trial reflects our commitment to advancing scientific research that benefits not only Kenya but also global health initiatives.”
The TNX-801 vaccine has shown promising preclinical results, offering protection against lethal mpox challenges in animals. If successful, it could provide a much-needed solution to manage the spread of the Clade Ib mpox strain, which has primarily affected African countries but has also been reported in non-endemic regions like Sweden and India.
The planned clinical trials reflect the commitment of both institutions to advance medical research aimed at containing and ultimately preventing mpox.
