enGene Therapeutics, a Boston and Montreal-based clinical-stage biotechnology company, has named Michael Heffernan as Chairman of its Board of Directors, succeeding Dr. Richard Glickman, who is stepping down after more than 14 years in the role. The leadership transition is timed to support enGene’s planned regulatory and commercial milestones for detalimogene voraplasmid, its lead investigational therapy for high-risk non-muscle invasive bladder cancer (NMIBC).
Heffernan brings more than 30 years of biopharmaceutical experience, most notably as founder and former President, CEO, and Chairman of Collegium Pharmaceutical. He has previously held leadership roles at Onset Dermatologics, Clinical Studies Ltd., and Eli Lilly, and currently serves on the boards of NMD Pharma, Avalo Therapeutics, AAVantgarde Bio, Biohaven, Trevi Therapeutics, and K36 Therapeutics. He is a registered pharmacist and holds a Bachelor of Science in Pharmacy from the University of Connecticut.
Dr. Glickman, who guided enGene from a seed-stage research organization through its evolution into a publicly listed, late-clinical-stage company, was instrumental in developing the company’s Dually Derivatized Oligochitosan (DDX) platform — a proprietary non-viral gene delivery technology — and in supporting its capital markets and financing activities.
Detalimogene is a non-viral gene therapy designed to be instilled directly into the bladder to trigger a localized anti-tumor immune response in patients with BCG-unresponsive NMIBC with carcinoma in situ — a form of bladder cancer that does not adequately respond to standard BCG immunotherapy and typically leaves patients facing either cystectomy or continued disease progression. The therapy was developed using the DDX platform, which enables delivery of genetic material to mucosal tissues without the manufacturing complexity, cold chain requirements, or immunogenicity risks associated with viral-based gene therapies.
Detalimogene holds both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, and has been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program. It is being evaluated in the ongoing Phase 2 LEGEND trial, whose pivotal cohort of 125 BCG-unresponsive NMIBC patients with carcinoma in situ is designed to support a Biologics License Application filing. enGene plans to hold a pre-BLA meeting with the FDA in the second half of 2026, initiate the BLA submission in the second half of 2026, and targets potential FDA approval in 2027.
KEY QUOTES:
“We are pleased that Michael Heffernan will assume the role of Chairman. With a strong track record of guiding companies through development and commercialization, Mike is well positioned to lead our Board as we plan for the potential approval and launch of detalimogene. It has been a pleasure to work alongside Dr. Glickman. As a longtime member of the Board, he has played an essential role in guiding enGene’s evolution from a research organization to a late clinical-stage company.”
Ron Cooper, President and Chief Executive Officer, enGene
“With a clinical-stage asset approaching both a key pivotal readout and planned BLA filing in the second half of this year, a potential approval in 2027 and in a strong capital position, enGene is well positioned for a period of meaningful growth. I’m excited to step into the role of Chairman and work closely with the Board and management team to advance detalimogene in NMIBC.”
Michael Heffernan, Chairman, enGene
