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BioNTech SE terminated the Phase 2 clinical trial (BNT122-01) for autogene cevumeran as an adjuvant monotherapy in…
BNTXBioNTech SE
BioNTech SE terminated the Phase 2 clinical trial (BNT122-01) for autogene cevumeran as an adjuvant monotherapy in patients with ctDNA-positive, surgically resected Stage II or III colorectal cancer. The decision followed a recommendation from the independent Data Safety Monitoring Board, which identified a numerical imbalance in overall survival and concluded that further continuation was unlikely to change efficacy outcomes after the futility boundary was crossed in October 2025. No new safety signals were identified. BioNTech will conduct a thorough analysis of the trial data to inform future development strategies. The Phase 2 IMcode003 trial for autogene cevumeran in pancreatic ductal adenocarcinoma continues as planned. BioNTech SE is a global biopharmaceutical company pioneering novel investigative therapies, particularly mRNA cancer immunotherapies.