BioNTech Terminates Phase 2 Autogene Cevumeran mRNA Cancer Vaccine Trial in Colorectal Cancer

The US FDA approved Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine for adults 65+ and high-risk individuals 5-64. The approval is based on clinical, real-world, and manufacturing data. The vaccine targets the XFG variant and will be available in the US from autumn 2026.

Moderna (MRNA) and BioNTech (BNTX) are focusing on cancer vaccines post-pandemic. Moderna's cancer vaccine showed strong Phase 3 results, boosting its shares. BioNTech's pumitamig, in development with Bristol Myers Squibb, aims to challenge Merck's Keytruda. BioNTech's market cap is $26B, while Moderna's is $60B. Both are valued on pipeline progress, with Moderna offering near-term certainty and BioNTech potential upside if pumitamig succeeds.

BioNTech halted its BNT122-01 trial for colorectal cancer due to survival imbalance. Moderna and Merck recently reported positive melanoma trial results. BioNTech's IMcode003 trial for pancreatic cancer showed 90% survival rate in responders, per Memorial Sloan Kettering.

BioNTech terminated its phase 2 BNT122-01 trial of autogene cevumeran in colorectal cancer due to a DSMB recommendation, citing an imbalance in overall survival and unlikely efficacy. The trial tested the mRNA immunotherapy as a monotherapy. No new safety concerns were identified. The decision does not impact other trials, including a phase 2 study in pancreatic cancer.

BioNTech and Genentech terminated a Phase II trial for autogene Cevumeran, an mRNA cancer immunotherapy, in colorectal cancer patients due to efficacy concerns. The Data Safety Monitoring Board recommended termination after finding no significant efficacy. The decision does not affect another ongoing trial for pancreatic cancer. BioNTech plans to analyze the data and share findings with the scientific community.

BioNTech's stock dropped 10% after terminating a clinical trial for a colorectal cancer vaccine, impacting its oncology pipeline and raising doubts about its mRNA cancer treatment strategy. Moderna also fell 6%, while Pfizer remained stable. The setback highlights the risks in experimental cancer programs and may lead to a repricing of BioNTech's pipeline risk.