Tonix Pharma eyes clinical trials for monkeypox vax in Kenya

KENYA – Tonix Pharmaceuticals Holding Corp. (TNXP) has selected the Kenya Medical Research Institute (KEMRI) for monkeypox vaccine trials in a bid to increase access to potential monkeypox treatment in Africa as the current disease outbreak constitutes a global health emergency.   

Tonix Pharma is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease involving immunology and central nervous system (CNS) and infectious disease product candidates.

The US-based pharmaceutical firm has partnered with the Kenya Medical Research Institute 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.

Tonix Chief Executive Officer (CEO) Seth Lederman announced that the Phase I study in Kenya will begin in the first half of 2023 with the Kenya Medical Research Institute leading the study, reaffirming that Tonix will support regulatory filings and other logistics.

CEO Lederman explained that if monkeypox cases arise in Kenya, the collaborative parties will then launch a Phase II clinical trial which might serve as a barometer of efficacy since there are no monkeypox cases reported in the country so far.

The recent global outbreak of monkeypox has exemplified the need to be prepared with a vaccine that is efficacious, that provides for durable immunity and that blocks forward transmission. Tonix’s live virus vaccine technology is designed to achieve these outcomes.

In addition, the partnership between Tonix Pharmaceuticals Holding Corp and the Kenya Medical Research Institute cements Kenya as a vaccine research hub and significantly contributes to the country’s efforts for local vaccine production.

According to a new global study published by medical journal The Lancet, local vaccine production can earn Kenya billions of shillings each year in additional investments, savings and revenue citing its strategic advantages in traditional research capacity as well as distribution logistics.

The recent Lancet study has ranked Kenya as a top candidate in Africa for vaccine manufacturing globally ahead of India and South Africa after assessing the case for investing in clinical trials and manufacturing capacity for three middle-income countries including India, Kenya and South Africa.

“New products developed and manufactured in Kenya would benefit all 21 countries in the Common Market for Eastern and Southern Africa (COMESA),” said Lancet in the study backed by American private university Duke University and the Bill & Melinda Gates Foundation.

Meanwhile, Kenya has partnered with the American biotechnology firm Moderna to set up the first mRNA manufacturing facility in Africa which is expected to produce up to 500 million doses of vaccines each year.

Moderna intends to invest up to US$500 million in building this new facility which will focus on drug substance manufacturing on the continent of Africa for Africa. The state-of-the-art mRNA facility could also be expanded to include fill/finish and packaging capabilities of its COVID-19 vaccine at the site as early as 2023.

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