BioNTech halts Phase 2 colorectal cancer vaccine trial

BioNTech said on August 28, 2026 it is terminating the Phase 2 BNT122-01 trial of its individualized mRNA cancer vaccine autogene cevumeran as an adjuvant monotherapy in surgically resected, ctDNA-positive colorectal cancer, run with Genentech. An independent Data Safety Monitoring Board recommended stopping after finding a numerical imbalance in overall survival between the vaccine and watchful-waiting arms and judging further continuation unlikely to change the outcome, though it reported no new safety signal. BioNTech said the separate Phase 2 IMcode003 trial testing autogene cevumeran in combination with chemotherapy and checkpoint inhibition for pancreatic cancer is unaffected and continues as planned.