By Sriparna Roy and Bhanvi Satija
Aug 28 (Reuters) – BioNTech SE 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 U.S. listed shares down 7% 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.
The independent committee, responsible for overseeing the safety and integrity of the 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.
Patients in the study had received at least three months of standard chemotherapy before being randomized to receive BioNTech’s individualized cancer vaccine or undergo watchful waiting, as per the study’s design.
The German vaccine maker, which is partnering with Roche’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.
BioNTech’s failure comes days after Merck and Moderna 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.
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.
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)
Comments