The FDA has placed a clinical hold on BioNTech's Phase I/IIa trial evaluating their investigational RNA-based malaria vaccine candidate BNT165e135. Here are the key details:
Clinical Hold Details
The FDA informed BioNTech of the clinical hold on their Investigational New Drug (IND) application and related Phase I/IIa trial for BNT165e13.
BNT165e is an RNA-based vaccine candidate being developed for prevention of P. falciparum malaria in healthy malaria-naive adults34.
BioNTech has complied with the hold and proactively paused the study13.
The company is taking actions to address the FDA's requests and will work with the agency to assess next steps13.
Trial Information
The trial was evaluating the safety, tolerability, immunogenicity and efficacy of BNT165e34.
It was expected to enroll around 177 participants across multiple sites in the United States34.
The estimated study completion date was September 20254.
BNT165e is a multi-antigen malaria vaccine combining three distinct RNAs (BNT165c and BNT165d)34.
Impact and Next Steps
BioNTech's stock was predicted to drop slightly following the announcement5.
The company had planned to announce the primary readout from the trial in September 20255.
BioNTech will work with the FDA to address their requests and determine how to move forward with the development program13.
This clinical hold represents a setback for BioNTech's malaria vaccine development efforts, though the company appears committed to working with regulators to resolve any issues and continue advancing the program when possible.
Sources:
1. https://markets.businessinsider.com/news/stocks/biontech-reports-fda-clinical-hold-on-phase-i-iia-trial-of-bnt165e-1034440269
3. https://www.benzinga.com/general/biotech/25/03/44148407/fda-places-clinical-hold-on-biontechs-early-phase-trial-for-rna-based-malaria-vaccine
4. https://clinicaltrials.biontech.com/trials/BNT165-02
5. https://www.clinicaltrialsarena.com/news/fda-puts-clinical-hold-on-biontechs-malaria-vaccine-trial/