MAINZ, Germany, August 28, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that it has decided to terminate the Phase 2 clinical trial (BNT122-01; NCT04486378) evaluating autogene cevumeran (BNT122/RO7198457), an investigational individualized mRNA cancer immunotherapy, as an adjuvant monotherapy in patients with circulating tumor DNA (“ctDNA”)-positive, surgically resected Stage II (high risk) or Stage III colorectal cancer (“CRC”). Autogene cevumeran is being jointly developed by BioNTech and Genentech, a member of the Roche Group. The decision to terminate the clinical trial was made in consultation with Genentech.
The decision follows a new recommendation from the independent Data Safety Monitoring Board (“DSMB”) which is responsible for overseeing the safety and integrity of the trial. As previously reported, the futility boundary was crossed in October 2025. At that time, the DSMB concluded that the data were not sufficiently mature to support reliable conclusions regarding efficacy, and that follow-up time was insufficient to evaluate the trial’s primary endpoint. Therefore, in the absence of safety concerns and with no objection from the DSMB, BioNTech decided to continue the trial in accordance with the protocol.
In its most recent review of the available data of this trial, the DSMB identified a numerical imbalance in overall survival between treatment arms in this specific patient population and noted that further trial continuation was unlikely to change the efficacy outcome. Therefore, the DSMB recommended discontinuing treatment of patients in this trial and terminating the clinical trial. No new safety signals were identified by the DSMB regarding autogene cevumeran. BioNTech has informed investigators and relevant regulatory authorities accordingly.
The BNT122-01 clinical trial was designed to assess whether an investigational individualized mRNA cancer immunotherapy as monotherapy, i.e. without supportive checkpoint inhibitor treatment, could help prevent disease recurrence in this high-risk patient population, compared with watchful waiting, the current standard of care. CRC is a biologically complex disease and an immunologically “cold” tumor type, that is historically largely unresponsive to immunotherapy and associated with a high risk of metastatic relapse, marking an area of significant unmet medical need.
“Any decision concerning clinical trials is made with utmost care, keeping patients as our highest priority,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “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 with immune-suppressive microenvironments and will help inform the further development of investigational mRNA cancer immunotherapies. We remain committed to mRNA as a key pillar in our oncology strategy and our novel-novel combination approaches. We are deeply grateful to the patients, families, investigators and site teams whose participation has made this important research possible.”
As is standard procedure, BioNTech will be conducting a thorough analysis of the trial data aiming to provide insights into the patient population selection and informing the clinical development strategy for potential further investigational mRNA cancer immunotherapies. The results of the trial will be shared with the scientific and medical community at an appropriate time.
The Phase 2 clinical trial IMcode003 (NCT05968326) evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy in adjuvant pancreatic ductal adenocarcinoma (“PDAC”) is not affected and continues as planned.
