The US Food and Drug Administration has put a clinical hold on BioNTech’s investigational new drug (IND) application and Phase I/II clinical trial examining the company’s pipeline malaria vaccine.
In a letter sent to the US Securities and Exchange Commission (SEC) on 4 March, the FDA confirmed that it had paused the company’s mRNA-vaccine trial with the company set to address unnamed changes.
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Following the announcement the company’s stock is predicted to drop slightly from $111.56 per share at market close on 3 March to $109.97 in pre-market opening estimates today (5 March). The company had planned to announce the primary readout from the trial of BNT165e in September of this year.
The SEC filing reads: “BioNTech has complied with the hold by the FDA and, in accordance with the clinical trial protocol, had proactively paused the study. BioNTech is taking actions to address the FDA’s requests and will work with the FDA to assess the next steps.”
The Phase I/II trial (NCT06069544) has enrolled 177 healthy volunteers into a trial to test the safety, efficacy and pharmacokinetics (PK) of its mRNA-based vaccine for P. falciparum malaria in healthy malaria-naive adults at five sites across the US. The vaccine is described by BioNTech as a combination of distinct mRNA vaccines, BNT165c and BNT165d.
Research by GlobalData’s Pharmaceutical Intelligence Centre estimates that if the vaccine makes it to market, it could bring in $25m in sales by the end of 2030. The market is set to largely be dominated by GSK’s Mosquirix vaccine, and Shanghai Fosun Pharmaceutical’s Artesunate. Both are set to bring in $100m and $155m respectively by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
The World Health Organization (WHO) estimates that there were around 263 million malaria cases in 2023 and 597,000 deaths. Cases were spread across 83 countries, but 94% of these were in Africa, which also saw 95% of malaria deaths. Of those deaths, children comprise approximately 76%.
The announcement follows after the company struck a deal with Coalition for Epidemic Preparedness Innovations (CEPI) in a bid to expand its end-to-end African vaccine system with CEPI committing up to $145m to establish an mRNA vaccine R&D, clinical and commercial-scale manufacturing site at the company’s facility in Kigali, Rwanda.
BioNTech made its name in the mRNA field after it co-developed a Covid-19 vaccine with Pfizer. mRNA vaccines were heavily utilised during the Covid-19 pandemic, with the 2023 Nobel Prize in Physiology or Medicine being awarded jointly to Katalin Karikó and Drew Weissman who discovered mRNA vaccines. mRNA vaccines are now being investigated beyond infectious diseases, with ongoing trials investigating personalised cancer vaccines.
Elsewhere in the field of malaria vaccines, competitors Novartis and Medicines for Malaria Venture (MMV) have reported positive data from the Phase II/III CALINA trial of Coartem. Meanwhile, The WHO has called for country commitment to combat neglected tropical diseases, after the agency lost its biggest source of funds in the US.
