BioNTech Starts Dosing In Mid-Stage Colorectal Cancer Immunotherapy Trial

BioNTech SE BNTX has dosed the first patient with its individualized mRNA cancer vaccine BNT122 (autogene cevumeran, RO7198457) in Phase 2 clinical trial.
The trial plans to enroll about 200 patients.
The open-label Phase 2 trial is investigating BNT122 in stage 2/3 colorectal cancer patients after surgical resection of their tumor and completion of adjuvant chemotherapy.
The trial will investigate the efficacy of autogene cevumeran as a single agent compared to the standard of care.
The primary endpoint for the study is disease-free survival (DFS). Secondary objectives include relapse-free survival (RFS), overall survival (OS), and safety.
Autogene cevumeran is individualized neoantigen-specific immunotherapy (iNeST) and the lead candidate from BioNTech's mRNA-based cancer vaccine platform.
Since 2016, BioNTech has advanced mRNA-based cancer vaccines targeting neoantigens in collaboration with Genentech, a unit of Roche Holdings AG RHHBY.
BioNTech will sponsor and operationalize the colorectal cancer Phase 2 trial.
Joint development with Genentech of autogene cevumeran in other trials with Genentech will continue.
Price Action: BNTX stock is down 7.01% at $253.85 during the premarket session on the last check Friday.