BioNTech-Genentech cancer vax records more deaths than control in scrapped ph. 2 test

Biotech BioNTech-Genentech cancer vax records more deaths than control in scrapped ph. 2 test By Darren Incorvaia Aug 28, 2026 1:50pm BioNTech Genentech cancer vaccine mRNA Following Merck and Moderna’s phase 3 triumph with a Keytruda-paired personalized mRNA cancer vaccine, a similar shot from BioNTech and Genentech has faltered in a reminder of the approach’s struggles as a standalone therapy. BioNTech and Genentech have terminated a phase 2 study of autogene cevumeran (BNT122) in patients with surgically removed stage 2 or 3 colorectal cancer.

The trial was testing whether the vaccine, tweaked to target each patient’s unique cancer mutations, helped prevent recurrence of disease following the surgery. Instead, BioNTech said today that there was “a numerical imbalance in overall survival” between patients given the personalized shot and those under observation. After this was identified by an independent Data Safety Monitoring Board, the board recommended the trial be stopped.

Reached for comment by Fierce, a Genentech spokesperson confirmed in a statement that there were “more deaths in the vaccine arm in this specific patient population.” Another phase 2 trial of BNT122, testing the vaccine in combination with immunotherapy, is still ongoing. “We remain committed to investigating the efficacy and safety of autogene cevumeran in collaboration with our development partner BioNTech,” the Genentech spokesperson said. At the time of publication, BioNTech had not responded to questions from Fierce.

“While this outcome is not what we had envisioned for mRNA as a monotherapy in colorectal cancer, it provides scientific insight into the challenges of treating immunotherapy-insensitive tumor types with immune-suppressive microenvironments and will help inform the further development of investigational mRNA cancer immunotherapies,” Özlem Türeci, M.D., BioNTech’s co-founder and outgoing chief medical officer, said in the company’s release. “We remain committed to mRNA as a key pillar in our oncology strategy and our novel-novel combination approaches.” The scrapped trial is mainly a knock against BNT122’s potential as a monotherapy in so-called “cold” tumors that don’t have an active immune response, analysts from Citi wrote in a note to investors Friday. Presenting personalized antigens to T cells through a vaccine is less likely to be effective if those T cells aren't activated to fight the tumor.

This is why many companies now, including Merck and Moderna, are pursuing cancer vaccines in combination with immunotherapies that rev up the immune system. The termination is “a clear setback” that “raises the bar for BNT122,” the Citi analysts wrote, but they continue to see potential for the vaccine in combination with other approaches. “With several meaningful catalysts ahead, we continue to see attractive risk/reward and remain buyers,” the analysts wrote.

BioNTech’s stock dipped around 7.5% on the news, a stark contrast to Moderna’s rapid ascent following a phase 3 win that has set the mRNA specialist up for an approval push. Moderna’s share price closed up 177% after the topline result was announced. BioNTech Genentech cancer vaccine mRNA colorectal cancer failed trials Clinical Trial Results Biotech