US pharmaceutical firm Tonix selects Kenya for Monkeypox vaccine trials

Tonix is set to start the study in the first half of 2023, in partnership with the Kenya Medical Research Institute (KEMRI).

“Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, today announced a collaboration with the Kenya Medical Research Institute (KEMRI) to plan, seek regulatory approval for and conduct a Phase 1 clinical study in Kenya to develop TNX-8011 as a vaccine to protect against monkeypox and smallpox,” said the company in a statement.

KEMRI Director General and CEO Prof. Samuel Kariuki welcomed the study, saying: “KEMRI is excited to plan this clinical trial with Tonix, and ultimately to lead the trial.”

“Monkeypox has spread in Central and West Africa, and there’s a concern that we could begin seeing cases in the Eastern and Central Africa or from foreign travellers,” added Prof. Kariuki.

Dr. Seth Lederman, the CEO of Tonix announced that Phase I of the study will begin in the first half of next year, with KEMRI leading the study and Tonix supporting regulatory filings and other logistics.

Kenya has no reported cases of the virus so far. Dr. Lederman, however, noted that if monkeypox cases arise in Kenya, then a Phase II clinical trial might serve as a barometer of efficacy.

Monkeypox is spreading around the world, with at least 16,000 infections documented in over 40 countries. The disease, which causes smallpox-like skin lesions, is caused by infection with monkeypox virus, a virus closely related to variola virus that causes smallpox.

The World Health Organisation has declared Monkeypox a public health emergency of international concern.

Scientists say monkeypox is spreading mainly through sexual experiences, putting sexual health clinics on alert for new cases.

The global outbreak of monkeypox surfaced on 7 May in the United Kingdom. So far this year  in Africa, cases have been recorded only in Cameroon, Nigeria, and the Central African Republic.

Tonix said it has been working on monkeypox and smallpox for close to a decade. Dubbed TNX-801, the vaccine has previously been given to eight non-human primates and then delivered a lethal dose of monkeypox into their lungs via the intratracheal route.

Dr. Lederman said that all eight were protected and did not develop lesions in the study.