BioNTech Terminates Phase II Colorectal Cancer Trial, Shares Fall

BioNTech SE shares fell on Friday after the company announced it would terminate its Phase II clinical trial of autogene cevumeran in patients with resected colorectal cancer. Here's what you need to know.

BioNTech stock is under bearish pressure. What's behind the BNTX decline?

BioNTech Terminates Phase II Colorectal Cancer Trial

BioNTech is shutting down BNT122-01, a mid-stage study testing its investigational personalized mRNA cancer therapy autogene cevumeran as a monotherapy in colorectal cancer patients who still showed circulating tumor DNA after surgical resection. Roche's Genentech co-developed the therapy with BioNTech, and the two companies jointly made the termination decision.

The trial had already hit a futility threshold in October 2025, but the study's independent safety monitors at the time deemed the data too immature for a definitive conclusion, so BioNTech continued the trial. A recent review changed that picture: the safety committee found a gap in overall survival between patients in the treatment group and those in the untreated group, and concluded that continuing the trial would not meaningfully impact outcomes, recommending the study be terminated.

The trial aimed to test whether the mRNA therapy, used alone without checkpoint inhibitors, could prevent cancer recurrence in this high-risk group better than standard surveillance.

BioNTech co-founder and Chief Medical Officer Özlem Türeci said the result was not what the company had hoped for, but it provides useful insights into treating immunoresistant tumors and will help guide future mRNA cancer research. She said BioNTech remains committed to mRNA as a core part of its oncology strategy, including combination therapies, and thanked those involved in the study.

BioNTech Plans Further Analysis, Other Trials Unaffected

BioNTech said it plans to further analyze the trial data to inform future mRNA cancer therapy development, with results to be shared publicly at a later date. Separately, the company's other autogene cevumeran trial, IMcode003, is unaffected and will continue as planned. That trial combines the drug with checkpoint inhibitors and chemotherapy to treat pancreatic cancer.

BNTX Shares Drop Sharply

BNTX stock movement: As of Friday's writing, BioNTech shares were down 6.94% at $103.68.