mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Patients with Resected Pancreatic Cancer

 BioNTech SE today announced three-year follow-up data from a Phase 1 trial with the mRNA-based individualized neoantigen-specific immunotherapy ("iNeST") candidate autogene cevumeran (BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma ("PDAC").

The data show that in 8 out of 16 patients, autogene cevumeran elicited an immune response up to three years post-administration measured by activated T cells.

The persistence of T cells was associated with a longer median recurrence-free survival in cancer vaccine responders.

"These new data are an early signal for the potential of our individualized mRNA cancer vaccine approach in this indication with an unmet medical need. The results indicate that our uridine mRNA-LPX technology can promote activation of cytotoxic T cells that may help to eliminate residual tumor foci at early stages of the disease to delay or prevent recurrence," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech, in a press release on April 7, 2024.

"Our ongoing Phase 2 trial with Genentech aims to confirm these findings on the benefits for patients with PDAC compared with the current standard of care treatment in the post-surgical, adjuvant setting in a larger patient population."

"We remain committed to our vision of personalized cancer medicine and aim to help advance the standard of care for many patients."

The study results were featured in an oral presentation at the American Association for Cancer Research Annual Meeting 2024. Data from the 1.5-year median follow-up were published in Nature in May 2023.