Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma.
BioNTech shares dropped as much as 8% Friday morning to around $103 per share after the Germany-based company said it would discontinue a mid-stage colorectal cancer trial of its highly anticipated personalized mRNA cancer immunotherapy.
“BioNTech’s termination of the Phase 2 trial in resected colorectal cancer is a clear setback,” BMO Capital Markets wrote in a note to analysts Friday morning. “We expect the termination to reduce confidence in autogene cevumeran and raise questions about whether vaccine-induced immune responses can prevent recurrence without concurrent checkpoint inhibition or chemotherapy.”
Last week, Moderna and Merck reported positive data from a Phase 3 trial of their own personalized mRNA cancer vaccine intismeran autogene, but the regimen also included the larger partner’s blockbuster checkpoint inhibitor Keytruda. In their trial, participants taking the combination lived longer without melanoma returning, meeting the study’s primary endpoint of recurrence-free survival.
BioNTech’s trial, conversely, was not showing evidence of efficacy. An Independent Data Safety Monitoring Board (DSMB) recommended discontinuing the trial due to futility, according to a Friday press release from BioNTech. Dubbed BNT122-01, the study evaluated whether autogene cevumeran given as monotherapy could help prevent disease recurrence in high-risk patients with colorectal cancer (CRC). The “futility boundary” was crossed in October 2025, the company noted, but at the time the DSMB determined that “the data were not sufficiently mature to support reliable conclusions regarding efficacy, and that follow-up time was insufficient to evaluate the trial’s primary endpoint.”
Based on the data now available, the DSMB “identified a numerical imbalance in overall survival between treatment arms in this specific patient population” and said further continuation of the trial was unlikely to change the efficacy outcome.
BioNTech is also investigating autogene cevumeran in the Phase 2 IMcode003 trial, along with Roche’s checkpoint inhibitor Tecentriq and chemotherapy, for pancreatic ductal adenocarcinoma (PDAC). Data presented in April from a small Phase 1 trial in this indication showed that nearly 90% of trial participants whose immune systems responded to the vaccine were still alive up to six years after receiving the last treatment, according to Memorial Sloan Kettering Cancer Center.
Because the vaccine is not given as a monotherapy for PDAC, BMO said the read-through of the canceled trial to BioNTech’s broader program “is negative but limited.” Still, the analysts continued, the CRC trial discontinuation “represents a clear setback for the company’s individualized neoantigen therapy platform.”
BioNTech’s news is a blow to a resurgent mRNA space still celebrating the Phase 3 win for Merck and Moderna’s own cancer vaccine in melanoma. In addition to the clinical win, the space also saw movement on the regulatory side. On Aug. 5—exactly a year after the Department of Health and Human Services slashed $500 million in funding from mRNA-based programs—Moderna won FDA approval for its flu vaccine, mFLUVISA. The greenlight was a redeeming moment for Moderna, after the agency refused to review its original application in February.
And this week, the FDA greenlit updated mRNA-based vaccines for the 2026-27 season: Moderna’s mNexspike and Spikevax, and Pfizer and BioNTech’s Comirnaty, along with Novavax’s protein-based Nuvaxovid.
