BioNTech stock fell sharply on Friday after the company announced it had scrapped a clinical trial for its mRNA cancer vaccine, marking the second setback in months.
The German biotech and partner Genentech have ended a Phase 2 trial to determine the efficacy of their personalized vaccine candidate, autogene cevumeran, in colorectal cancer.
BioNTech's American depositary receipts slumped 7.7% to $102.87 on Friday, while shares of Genentech parent Roche fell 2.1% in the U.S.
The decision dealt another blow to the vaccine candidate's commercial prospects. Earlier this year, BioNTech and Genentech halted development of autogene cevumeran as a treatment for bladder cancer, citing a rapidly shifting standard-of-care landscape.
The partners said at the time that they had chosen to reallocate their resources to pancreatic and colorectal cancers instead. The latest trial to be terminated was evaluating autogene cevumeran as an add-on treatment in certain patients with high-risk stage II or stage III colorectal cancer.
The troubles didn't stop there. During its latest review, an independent data safety monitoring board recommended stopping the trial early after noticing that more patients survived in one treatment group than the other. Based on this disparity, the board concluded that continuing the trial was futile and probably wouldn't show any further benefit.
The trial had crossed a futility boundary in October, indicating it had reached a point where the chance of finding a positive or statistically significant outcome was too low to justify continuing. However, the board determined at that time that the data weren't mature enough to support conclusions regarding efficacy.
BioNTech co-founder and chief medical officer Özlem Türeci said the results were disappointing, but the findings offer valuable insight into why difficult-to-treat, immune-suppressive tumors resist immunotherapy.
The findings "will help inform the further development of mRNA-based treatments," Türeci added, describing mRNA as "a key pillar" in the company's oncology strategy.
Although trials for two potential indications have met their end, a third is examining the vaccine in patients with pancreatic cancer. Autogene cevumeran is being tested as part of a multi-drug regimen for pancreatic ductal adenocarcinoma, the most aggressive form of the disease.
The update stands in contrast to last week's optimism around Moderna and Merck after their mRNA cancer vaccine candidate, intismeran autogene, succeeded in a late-stage trial. The positive readout sent biotech stocks soaring, with Moderna nearly tripling and BioNTech recording its best trading session in six years.
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