BioNTech and Roche Publish Personalized Vaccine Data

Data from a Phase I clinical trial of BioNTech and Roche’s personalized cancer vaccine candidate, adjuvant autogene cevumeran, was published in Nature on May 10, 2023. The study evaluated the vaccine’s ability to fight pancreatic ductal adenocarcinoma (PDAC), an aggressive form of pancreatic cancer that the study noted is the third leading cause of death from cancer in the United States and lethal in approximately 88% of patients.

The treatment is an individualized neoantigen vaccine based on uridine messenger RNA (mRNA)–lipoplex nanoparticles, which was developed using mRNA neoantigen vaccines in real time from surgically resected PDAC tumors. When treated with adjuvant autogene cevumeran, in combination with atezolizumab and mFOLFIRINOX, eight of the 16 patients developed T cells that could potentially fight PDAC. Vaccine-expanded T cells were durable, persisting up to two years after injection.

“High-magnitude vaccine-induced T-cell responses, the focus of our immune response analysis that included a new method to track vaccine-expanded clones, correlated with delayed PDAC recurrence,” reads the study. “Despite the limited sample size, these early results warrant larger studies of individualized mRNA neoantigen vaccines in PDAC.”