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BioNTech Terminates Phase 2 Colorectal Cancer Clinical Trial; Shares Fall

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BioNTech Terminates Phase 2 Colorectal Cancer Clinical Trial; Shares Fall

BioNTech (BNTX) shares slumped Friday after the company said it is terminating a mid-stage clinical trial of an experimental treatment of colorectal cancer, following a new recommendation from the study's independent data safety monitoring board.

The German drugmaker was studying autogene cevumeran, an investigational mRNA-based cancer immunotherapy product, as an adjuvant therapy for patients suffering from resected stage II or stage III colorectal cancer in a phase 2 trial. BioNTech was jointly developing the candidate with Genentech, a member of the Roche Group.

The decision to terminate the trial came after its safety board recommended discontinuing patient treatment and ending the study, according to BioNTech. The independent board, which also oversees the trial's integrity, identified a "numerical imbalance" in overall survival between treatment arms in patients and indicated further continuation was not expected to change the efficacy outcome, the company said Friday.

"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," BioNTech Co-Founder and Chief Medical Officer Ozlem Tureci said in a statement.

BioNTech's Nasdaq-listed shares fell 7.8% in afternoon trade. The stock has gained 8% in value so far this year.

In October, the trial crossed its futility boundary, but the safety board had identified that the trial's data wasn't adequately "mature" to make reliable conclusions regarding its efficacy and there was insufficient follow-up time to evaluate its primary endpoint. BioNTech decided to continue the study at the time with no objection from the board.

The company said Friday intends to continue a separate phase 2 study evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy for adjuvant pancreatic ductal adenocarcinoma, the most common and aggressive type of pancreatic cancer.

Earlier this month, Moderna (MRNA) and Merck (MRK) said a late-stage trial of an experimental skin cancer treatment yielded positive topline results.

On Thursday, BioNTech and Pfizer (PFE) said the US Food and Drug Administration approved the supplemental biologics license application for their 2026-2027 COVID-19 vaccine targeting the XFG variant.

Price: $103.14, Change: $-8.26, Percent Change: -7.41%

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