enGene is a clinical-stage biotech focused entirely on a single drug candidate, detalimogene voraplasmid, designed to treat non-muscle invasive bladder cancer (NMIBC) in patients whose cancer has not responded to BCG, the standard first-line therapy. For these "BCG-unresponsive" patients, the current standard of care is radical cystectomy — surgical bladder removal — representing a significant unmet need. Detalimogene is administered directly into the bladder and is designed to activate both innate and adaptive immune responses within the tumor microenvironment, triggering the immune system to clear the tumor. The drug is built on enGene's proprietary DDX platform, a non-viral gene delivery system using a modified chitosan polymer to encapsulate plasmid DNA encoding IL-12 and two non-coding RNAs that together stimulate immune pathways. A practical advantage enGene highlights is detalimogene's handling profile — no ultra-cold storage, no special decontamination — making it suitable for community urology clinics where most urologists practice. enGene is pre-revenue and plans to file a Biologics License Application with the FDA in H2 2026, based on its ongoing LEGEND Phase 2 trial. If approved, enGene plans to commercialize detalimogene independently in the U.S. and partner internationally. Longer term, enGene aims to expand detalimogene into broader NMIBC populations and leverage the DDX platform for lung, gastrointestinal, and other mucosal tissue applications.