BioNTech halts personalized mRNA colorectal-cancer vaccine trial

BioNTech and Roche’s Genentech are terminating the Phase 2 BNT122-01 trial of autogene cevumeran, a personalized mRNA cancer immunotherapy, in high-risk colorectal cancer.

An independent Data Safety Monitoring Board concluded that the study was unlikely to demonstrate efficacy and recommended stopping treatment and ending the trial for futility.

The review found a numerical imbalance in overall survival between the vaccine and control groups; Genentech said more deaths occurred in the vaccine arm in this specific patient population.

The study involved patients with surgically removed Stage II or Stage III colorectal cancer who remained positive for circulating tumor DNA. The vaccine was tested as postoperative monotherapy.

No new safety signal linked to autogene cevumeran was reported. The trial had previously crossed a prespecified futility boundary in October 2025, but follow-up was then considered insufficient for a definitive conclusion.

BioNTech shares fell roughly 7.5%–9% after the announcement. A separate Phase 2 study testing autogene cevumeran in pancreatic cancer, including combination treatment, is continuing.