BioNTech Ends Colorectal Cancer Vaccine Trial

BioNTech is ending a mid-stage trial of its personalized mRNA cancer vaccine, autogene cevumeran, after an independent monitoring committee concluded that continuing the study was unlikely to demonstrate effectiveness. The decision allows the company and its partner Genentech to stop investing in the study, which evaluated patients with high-risk, mid-stage colorectal cancer who had surgery, chemotherapy, and persistent cancer DNA in their blood.

The committee identified an unexplained numerical imbalance in overall survival between the study groups, though neither BioNTech nor the panel disclosed the exact figures. BMO Capital Markets analyst Evan Seigerman described the update as more concerning than a standard trial stoppage due to that survival imbalance. Following the announcement, BioNTech shares listed in the United States fell 7.5%, according to Reuters, after having risen 20% days earlier when Merck and Moderna reported positive mRNA results in melanoma.

BioNTech stated that the decision will not affect its separate autogene cevumeran study in pancreatic cancer, which combines the vaccine with Roche's Tecentriq and has results expected in 2031. For nearer-term data, the company expects interim results later this year from BNT113 for head and neck cancer. Reuters also reported that the setback will likely accelerate BioNTech's shift toward antibody-drug conjugates and bispecific cancer therapies, including the drug pumitamig.