BioNTech

Autogene cevumeran (BNT122)

In Development

An individualized neoantigen-specific mRNA cancer vaccine, custom-manufactured for each patient's tumor mutations and co-developed with Genentech (Roche) to train the immune system against residual disease after surgery.

Latest update Aug 29, 2026

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Current status

In Phase 2 trials in adjuvant pancreatic ductal adenocarcinoma. The companion Phase 2 trial in adjuvant colorectal cancer was terminated on August 28, 2026 after an independent data safety monitoring board recommended discontinuing treatment - the trial had tripped a futility threshold in October 2025 but was kept running for more data. Phase 1 pancreatic-cancer data showed durable neoantigen-specific T-cell responses that correlated with delayed recurrence; final analysis in the pancreatic indication is now expected in 2027.

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Specifications2

Modality
Individualized mRNA neoantigen vaccine
Lead Readouts
Pancreatic, 2027

colorectal trial terminated Aug 2026

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