Clinical Report: BioNTech claims mRNA cancer vaccine success

Partners BioNTech SE (NASDAQ:BNTX) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) are claiming a Phase II victory for mRNA cancer vaccine BNT111 in a melanoma study, but unanswered questions about the study design and magnitude of benefit make it difficult to predict where it might fit in the therapeutic landscape.

The company reported that BNT111 plus Regeneron’s PD-1 inhibitor Libtayo cemiplimab met the primary endpoint in the Phase II study with a statistically significant increase in objective response rate (ORR) over a historical control arm. The study included patients with Stage IIB-III melanoma who relapsed or were refractory to prior anti-PD-(L)1 therapy...