BioNTech loses skin in the neoantigen game

After several delays, hopes had dimmed for BioNTech’s Roche-partnered personalised neoantigen project autogene cevumeran in first-line melanoma, and on Monday the groups finally admitted defeat. BioNTech quietly disclosed in its fourth-quarter earnings presentation that the Imcode-001 trial, testing a Keytruda combo versus Keytruda alone, had failed to hit its PFS primary endpoint. BioNTech added that there was a “numerical OS benefit” with the combo, but is saving details for a medical meeting. Recently, the companies have been shifting their neoantigen focus towards adjuvant settings where, BioNTech told ApexOnco, “the tumour burden is typically low, and immune resistance mechanisms are not fully established”. The next notable readout will be in adjuvant colorectal cancer, with a study versus watchful waiting set to yield data late this year or early 2026. Meanwhile, for advanced, high-volume tumours BioNTech is looking to immuno-oncology combinations with its PD-L1 x VEGF bispecific BNT327; the German company is already forging ahead with ADC combos. BioNTech’s main neoantigen rival, Moderna, is also initially focused on adjuvant indications with its Merck-partnered mRNA-4157, although the groups’ hopes of getting accelerated approval in adjuvant melanoma were dashed last year.

Key trials of BioNTech/Roche’s autogene cevumeran

Note: DFS=disease-free survival; MIUC=muscle-invasive urothelial carcinoma; PDAC=pancreatic ductal adenocarcinoma; PFS=progression-free survival. Source: OncologyPipeline, clinicaltrials.gov & company presentation.