BioNTech halts mRNA colorectal cancer vaccine trial after safety review (updated)

Roche Holding AG

28/08/2026 14:39

Trial stopped after review deems it unlikely to succeed
Separate study for pancreatic cancer patients to continue 
Setback comes after Merck-Moderna's recent success in melanoma patients 
U.S.-listed shares of German firm fall more than 7% 
Adds analyst comments in paragraphs 6,7 and 10
By Bhanvi Satija and Sriparna Roy
Aug 28 (Reuters) - BioNTech SE 22UAy.DE said it will end a mid-stage study of its experimental mRNA cancer vaccine after an independent committee found the treatment was unlikely to help colorectal cancer patients live longer, sending the company's U.S.-listed shares 7.5% lower on Friday.
The trial was testing whether the immunotherapy, autogene cevumeran, prevented a recurrence in patients with high-risk, mid-stage colorectal cancer who had already undergone surgery but still had traces of cancer DNA in their blood. 
BioNTech's trial failure comes days after Merck MRK.N and Moderna MRNA.O said their mRNA-based vaccine helped prevent the return and spread of melanoma in a trial of more than 1,000 patients whose tumors were removed surgically but who had a high risk of recurrence.
That success had raised hopes for similar mRNA-based vaccines, lifting shares of BioNTech 20% on the day. 
The committee responsible for overseeing the safety and integrity of BioNTech's trial identified a "numerical imbalance" in overall survival between the patient groups in the study. It said continuing the trial was unlikely to show the vaccine was effective. 
Analysts said the "numerical imbalance" likely meant more deaths occurred in the vaccine group than the control group.
BioNTech did not respond to a request for comment.
"Today's update is more concerning than a conventional futility stop given the numerical (overall survival) imbalance, although the magnitude remains unclear," BMO Capital Markets analyst Evan Seigerman said in a note.
The trial evaluated whether the vaccine alone, given after surgery and three months of chemotherapy, could prevent recurrence in high-risk patients compared to standard watchful waiting.

CHALLENGES FOR MRNA VACCINES IN SOME TUMORS
BioNTech, a German vaccine maker, which is partnering with Roche's ROPC.S Genentech for the mRNA-based cancer vaccine, said that its decision to drop the study would not affect its other trial involving pancreatic cancer patients. Data from this study is expected in 2031.
Analysts said the failure is a negative signal for mRNA vaccines in "cold" tumors historically resistant to immunotherapy, like colorectal and pancreatic cancers, unlike "hot" tumors such as melanoma where Moderna succeeded. 
This could also dim prospects for BioNTech's remaining pancreatic trial, despite its use of combination therapy with Roche's Tecentriq, analysts said.
BioNTech's vaccine, autogene cevumeran, is personalized to deliver instructions that teach the immune system to recognize each patient's specific tumor cells. The Merck-Moderna vaccine is similarly designed to target mutations unique to an individual patient's tumor.
The setback will likely accelerate BioNTech's strategic shift toward its non-mRNA pipeline, particularly its antibody-drug conjugates (ADCs) and bispecific cancer therapies, such as the experimental drug pumitamig.

        BioNTech is also developing other mRNA-based cancer therapies, including BNT113 for head and neck cancer. Interim data from this study is expected later this year.

 (Reporting by Sriparna Roy in Bengaluru and Bhanvi Satija in London; Editing by Shilpi Majumdar and Elaine Hardcastle)
 ((Sriparna.Roy@thomsonreuters.com;))