BioNTech stops Phase 2 colorectal cancer mRNA vaccine trial after futility findings

BioNTech announced that it is ending its Phase 2 study of a personalized mRNA vaccine for resected colorectal cancer after the trial failed to show the needed benefit. The news sent the company’s shares down about 8% in early trading.

The company said the decision was based on a futility analysis, and analysts noted that the setback could weaken confidence in the vaccine platform when used without a checkpoint inhibitor or chemotherapy.

The announcement comes shortly after Moderna and Merck reported positive Phase 3 results for their own personalized mRNA vaccine combined with Keytruda in melanoma, highlighting a contrast between the two approaches.