BioNTech SE (Nasdaq: BNTX) has terminated a Phase 2 clinical trial evaluating autogene cevumeran, an investigational individualized mRNA cancer immunotherapy, in patients with colorectal cancer (CRC), the company announced based on a recommendation from an independent oversight board.

The trial, designated BNT122-01, was assessing autogene cevumeran as an adjuvant monotherapy in patients with circulating tumor DNA-positive, surgically resected Stage II or Stage III CRC. The therapy is being jointly developed by BioNTech and Genentech, a member of the Roche Group.

The independent Data Safety Monitoring Board (DSMB) identified a numerical imbalance in overall survival between treatment arms and concluded that further continuation was unlikely to change the efficacy outcome. No new safety signals were identified. The trial had previously crossed a futility boundary in October 2025, though the DSMB had at that time determined data were not sufficiently mature to draw reliable efficacy conclusions.

"While this outcome is not what we had envisioned for mRNA as a monotherapy in colorectal cancer, it provides scientific insight into the challenges of treating immunotherapy-insensitive tumor types," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech.

The trial was designed to compare the therapy against watchful waiting, the current standard of care, in a patient population at high risk of metastatic relapse. CRC is described in the company's statement as historically largely unresponsive to immunotherapy.

BioNTech said it will conduct a thorough analysis of the trial data and share results with the scientific and medical community. A separate Phase 2 trial, IMcode003, evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy in pancreatic ductal adenocarcinoma, is not affected and continues as planned.