BioNTech Stock Sinks on Cancer Trial Termination

BioNTech SE shares fell 7.3% Friday after the company announced it would terminate a Phase 2 clinical trial evaluating its investigational individualized mRNA cancer immunotherapy for colorectal cancer.

The company said it decided to end the trial (BNT122-01) testing autogene cevumeran as an adjuvant monotherapy in patients with ctDNA-positive, surgically resected Stage II or Stage III colorectal cancer. BioNTech is developing the therapy jointly with Genentech, a member of the Roche Group.

The decision followed a recommendation from the independent Data Safety Monitoring Board, which identified a numerical imbalance in overall survival between treatment arms. The DSMB noted that further trial continuation was unlikely to change the efficacy outcome and recommended discontinuing treatment and terminating the trial. The futility boundary had been crossed in October 2025.

BioNTech said no new safety signals were identified by the DSMB regarding autogene cevumeran. The trial was designed to assess whether the investigational individualized mRNA cancer immunotherapy as monotherapy could help prevent disease recurrence in high-risk patients compared with watchful waiting.

The company said it will conduct a thorough analysis of the trial data to provide insights into patient population selection and inform the clinical development strategy for potential further investigational mRNA cancer immunotherapies. Results will be shared with the scientific and medical community at an appropriate time.

BioNTech’s Phase 2 clinical trial IMcode003 evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy in adjuvant pancreatic ductal adenocarcinoma is not affected and continues as planned.