FDA Places Clinical Hold On BioNTech's Early-Phase Trial For RNA-Based Malaria Vaccine

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The FDA placed a clinical hold on BioNTech’s Phase 1/2a trial for its investigational RNA-based malaria vaccine, BNT165e.
BioNTech paused the study and is working with the FDA to address its requests and determine next steps.
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On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on BioNTech SE’s BNTX Investigational New Drug application (IND) and the related Phase 1/2a trial evaluating the safety, tolerability, immunogenicity, and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.

The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2).

Also Read: BioNTech Positioned For Solid Growth Amid Oncology Transition: Analyst

The trial was expected to enroll around 177 participants and conclude in September 2025. BioNTech has proactively paused the study, the SEC filing noted, and is taking actions to address the FDA’s requests and will work with the FDA to assess the next steps.

In October, the FDA imposed a partial clinical hold on BioNTech’s partner, OncoC4 Inc.’s Phase 3 PRESERVE-003 trial. Varying outcomes between patients with squamous and non-squamous non-small cell lung cancer triggered the partial hold.

Also in August, the FDA lifted the partial clinical hold on MediLink Therapeutics’ Phase 1 trial for BNT326/YL202, a HER3-targeting antibody-drug conjugate.

The decision, announced on August 15, follows the submission of a complete response that includes data analysis, updated documentation, and additional risk mitigation measures.

Price Action: BNTX stock is up 3.11% at $113.06 at the last check Wednesday.

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