BioNTech Terminates Phase 2 Trial Of Autogene Cevumeran In Colorectal Cancer
(RTTNews) - BioNTech SE (BNTX), a biotechnology company focused on developing individualized cancer immunotherapies, announced the termination of its Phase 2 BNT122-01 trial evaluating autogene cevumeran as an adjuvant monotherapy in patients with ctDNA-positive, surgically resected high-risk Stage II or Stage III colorectal cancer.
The decision follows a recommendation from the independent Data Safety Monitoring Board (DSMB), which reviewed the latest available trial data and identified a numerical imbalance in overall survival between the treatment arms.
The DSMB concluded that further continuation of the trial was unlikely to change the efficacy outcome and recommended discontinuing treatment and terminating the study.
The trial had previously crossed its futility boundary in October 2025. At that time, the DSMB determined that the data were not sufficiently mature to support reliable efficacy conclusions and that additional follow-up was needed to assess the primary endpoint.
No new safety signals related to autogene cevumeran were identified, and the decision was not driven by safety concerns.
The BNT122-01 trial was designed to evaluate whether individualized mRNA cancer immunotherapy alone could prevent disease recurrence in high-risk colorectal cancer patients compared with watchful waiting, the current standard of care.
BioNTech said it will conduct a detailed analysis of the trial data to assess patient selection and inform the development strategy for potential future mRNA cancer immunotherapies.
The company said the outcome provides scientific insight into the challenges of treating immunotherapy-insensitive tumors such as colorectal cancer, particularly those with immune-suppressive tumor microenvironments.
BioNTech reiterated that mRNA remains a key pillar of its oncology strategy, including novel combination approaches.
Separately, the Phase 2 IMcode003 trial evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy in the adjuvant treatment of pancreatic ductal adenocarcinoma is not affected and will continue as planned.
BNTX has traded between $79.52 and $124.00 over the past year.
BNTX is trading down 7.45% at $103.10.
