BioNTech ends Phase 2 trial of autogene cevumeran in colorectal cancer

BioNTech SE said on August 28, 2026 that it is stopping the Phase 2 study known as BNT122-01 (NCT04486378), which had been testing autogene cevumeran (BNT122/RO7198457) as a standalone treatment for patients whose colorectal cancer had been surgically removed but who still tested positive for circulating tumor DNA, covering high-risk Stage II and Stage III disease.¹ The therapy is an experimental mRNA cancer treatment tailored to each individual patient.

Autogene cevumeran is being co-developed with Genentech, part of the Roche Group, and the termination decision was made together with that partner.¹

The move follows a new recommendation from the trial's independent Data Safety Monitoring Board. The board had previously flagged that the trial crossed a futility boundary in October 2025, but at that time judged the data too immature and follow-up too short to assess the main efficacy measure, so BioNTech continued the study as planned since there were no safety concerns.¹

In its latest review, the DSMB spotted a numerical gap in overall survival between the treatment groups in this patient population and said continuing the trial further was unlikely to change the efficacy result, leading it to recommend stopping treatment and ending the trial.¹ No new safety issues with autogene cevumeran were reported by the board.¹ BioNTech has notified investigators and the relevant regulatory bodies.¹

The company plans to analyze the trial data in detail to better understand patient selection and to guide future development of mRNA cancer immunotherapies, with results to be shared with the scientific community at a later date.¹

Separately, a different Phase 2 study, IMcode003 (NCT05968326), which tests autogene cevumeran alongside checkpoint inhibition and chemotherapy in pancreatic cancer, is not affected and will continue as planned.¹