Fri. 1 Oct 2021, 9:14am ETBenzinga
In: Biotech, News, Health Care, Movers, Trading Ideas, General
  • BioNTech SE (NASDAQ: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 (OTC: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.