BioNTech Terminates Phase 2 Clinical Trial for Colorectal Cancer Immunotherapy Autogene Cevumeran

BioNTech SE has announced the termination of its Phase 2 clinical trial (BNT122-01) evaluating autogene cevumeran, an investigational individualized mRNA cancer immunotherapy, as an adjuvant monotherapy for patients with circulating tumor DNA-positive, surgically resected Stage II (high risk) or Stage III colorectal cancer. The decision, made in consultation with Genentech, follows a recommendation from the independent Data Safety Monitoring Board due to a numerical imbalance in overall survival between treatment arms and the unlikelihood of further trial continuation changing the efficacy outcome.