FDA puts BioNTechs malaria vaccine on clinical hold
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/