BioNTech Terminates Mid-Stage Trial of Personalized mRNA Cancer Vaccine for Colorectal Cancer Due to Survival Imbalance
BioNTech, in collaboration with Genentech, has terminated its Phase 2 BNT122-01 trial for autogene cevumeran, a personalized mRNA cancer vaccine designed for colorectal cancer. The decision was made after an independent monitoring board identified a numerical imbalance in overall survival between the two treatment groups, with a Genentech spokesperson confirming more deaths in the vaccine arm. The trial, which enrolled patients with surgically removed Stage II high-risk or Stage III colorectal cancer who still had circulating tumor DNA, had already crossed its futility boundary in October 2025, indicating it was unlikely to show benefit. BioNTech stated that no new safety signals were identified, and the trial tested the vaccine as a monotherapy in a tumor type known to resist immunotherapy. 
