Biotechnology company enGene Holdings Inc (Nasdaq: ENGN) declared on Wednesday that it has reached its target enrollment of 100 patients for the pivotal cohort of the Phase 2 LEGEND trial evaluating detalimogene voraplasmid in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS).

An update from the pivotal cohort is expected in the fourth quarter of 2025, with a Biologics License Application submission now planned for the second half of 2026.

Detalimogene, developed with enGene's Dually Derivatized Oligochitosan (DDX) platform, is a non-viral gene therapy designed to trigger a localised anti-tumour immune response. The therapy has received Regenerative Medicine Advanced Therapy and Fast Track designations from the U.S. Food and Drug Administration.

The multi-cohort LEGEND trial is also enrolling patients across the USA, Canada, Europe and the Asia-Pacific region in additional cohorts, including BCG-naïve and BCG-exposed NMIBC patients with CIS, as well as those with papillary-only disease.