enGene Therapeutics Inc.

enGene Therapeutics Inc. is a clinical-stage biotechnology company dedicated to advancing gene therapy through the non-viral delivery of therapeutics to mucosal tissues and other organs. Headquartered in Saint-Laurent, Quebec, Canada, with an additional office in Boston, MA, United States, the company's mission is to develop innovative, non-viral medicines aimed at improving the quality of life for individuals suffering from urological cancers, initially focusing on non-muscle invasive bladder cancer (NMIBC).

The company's primary product candidate is detalimogene voraplasmid, also known as detalimogene or EG-70. This novel, non-viral gene therapy is being developed for patients with Non-Muscle Invasive Bladder Cancer (NMIBC), a disease characterized by high clinical burden. Detalimogene is engineered using enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform, which facilitates the localized delivery of genetic medicines directly to mucosal tissues.

Effective April 8, 2026, the company officially changed its name from enGene Holdings Inc. to enGene Therapeutics Inc., signaling its progression towards becoming a commercial organization. Detalimogene is currently undergoing evaluation in the multi-cohort LEGEND Phase 2 clinical trial, including a pivotal cohort for high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC. The U.S. Food and Drug Administration (FDA) has granted detalimogene Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, recognizing its potential to address significant unmet medical needs. A Biologics License Application (BLA) submission for detalimogene is anticipated in the second half of 2026, with potential approval projected for 2027. Ron Cooper serves as the President and Chief Executive Officer, while Anthony T. Cheung is the Co-Founder and Chief Scientific Officer.