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BioNTech to Study mRNA Cancer Vaccine as Adjuvant Pancreatic Cancer Treatment in Phase II Trial

NEW YORK – BioNTech on Thursday began a Phase II trial of its mRNA-based neoantigen-specific immunotherapy candidate autogene cevumeran in combination with an anti-PD-L1 immune checkpoint inhibitor and chemotherapy as an adjuvant treatment for resected pancreatic cancer.

Researchers will enroll 260 patients with resected pancreatic ductal adenocarcinoma who have not received prior systemic treatment and have showed no evidence of disease after surgery. The Phase II trial is to evaluate autogene cevumeran plus Genentech's Tecentriq (atezolizumab) and chemo against standard-of-care adjuvant chemo alone.

Autogene cevumeran is an individualized cancer vaccine that encodes up to 20 patient-specific cancer mutations to induce a neoantigen-directed immune response against the tumor. BioNTech is jointly developing the candidate with Genentech.

The companies began this Phase II trial after results from an investigator-initiated Phase I study showed this combination of autogene cevumeran, immunotherapy, and chemo led to longer recurrence-free survival among patients who had a de novo immune response to the vaccine. In that study, at 15 months of follow-up, a median recurrence-free survival among vaccine responders had not been reached, while it was 13.7 months for vaccine non-responders.

"The recent Phase I study has shown that individualized neoantigen vaccination is feasible for this tumor type with low mutational burden and an immunosuppressive microenvironment," BioNTech Chief Medical Officer Özlem Türeci said in a statement. "The Phase II study will provide additional data [on] whether our approach with autogene cevumeran has the potential to provide a benefit for patients in this high unmet medical need setting. Our aim is to prevent relapses and thus ensure that the disease is managed at the earliest possible stage."

BioNTech and Genentech are also studying autogene cevumeran as an adjuvant treatment for colorectal cancer, as a first-line treatment for melanoma, and in locally advanced, recurrent, or metastatic solid tumors.