September 3, 2025 — Leads & Copy — enGene Holdings Inc. has reached its target enrollment of 100 patients for the pivotal cohort of its Phase 2 LEGEND trial of detalimogene voraplasmid in patients with high-risk, non-muscle invasive bladder cancer (NMIBC).
The company anticipates over-enrollment, which may adjust the guidance for a Biologics License Application (BLA) submission to the second half of 2026. The LEGEND trial is evaluating detalimogene in patients with high-risk NMIBC with carcinoma in-situ (CIS) with or without concomitant papillary disease. Patients in screening remain eligible for enrollment.
Detalimogene is a novel, investigational, non-viral gene therapy designed to elicit a localized anti-tumor immune response. It has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA.
Ron Cooper, CEO of enGene, expressed gratitude to study participants, investigators, and the clinical organization for their contributions.
About enGene:
enGene is a clinical-stage biotechnology company focused on gene therapy for mucosal tissues and other organs. Its lead program, detalimogene voraplasmid, targets Non-Muscle Invasive Bladder Cancer (NMIBC).
Source: enGene
