Boston — enGene Therapeutics reported third-quarter 2026 financial results and said it remains on track to begin a Biologics License Application submission for detalimogene during the fourth quarter.
The clinical-stage genetic medicines company also plans to hold a pre-BLA meeting with the U.S. Food and Drug Administration in the fourth quarter to discuss the planned filing for detalimogene in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer.
enGene expects to report updated data from the pivotal cohort of its LEGEND clinical trial later this year, including complete response rates, durability of response and other regulatory endpoints.
“As we move through the second half of 2026, our focus is on maturing regulatory endpoints data from LEGEND’s pivotal cohort and our planned engagement with the FDA regarding a BLA filing for detalimogene,” said Ron Cooper, President and Chief Executive Officer of enGene.
“We believe the clinical profile observed to date, together with detalimogene’s potential best-in-class tolerability and straightforward, office-based administration, supports it becoming an important treatment option for urologists and their patients with BCG-unresponsive NMIBC.”
Detalimogene previously produced an interim complete response rate of 54% at any time in LEGEND’s pivotal Cohort 1, which is evaluating the treatment without surfactant in patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
The company also reported a 3.2% rate of progression to muscle-invasive disease in the cohort.
enGene said it plans to provide updated results during the fourth quarter, including complete response at any time, duration of response of at least 12 months and additional durability data.
The company is separately enrolling patients in another LEGEND cohort evaluating detalimogene with a brief bladder rinse using polidocanol, an FDA-approved surfactant.
enGene said the surfactant safety run-in period has been completed successfully. Preclinical studies conducted by the company found that pretreatment with polidocanol increased mean IL-12 expression about tenfold in mouse models and improved distribution of detalimogene nanoparticles and IL-12 expression in a large-animal model.
“We are pleased to have cleared the surfactant safety run-in period and are encouraged by the progress of the cohort, which is designed to explore whether we can further enhance efficacy and durability while preserving tolerability and the practical attributes that we believe differentiate detalimogene,” Cooper said.
enGene plans to host a webinar on Oct. 15 to discuss the preclinical data supporting use of the surfactant rinse and provide guidance on enrollment in the cohort. David Cahn, M.D., and Suzanne Merrill, M.D., FACS, of Colorado Urology are scheduled to participate.
The company ended the quarter with $266 million in cash, cash equivalents and marketable securities. enGene said the funds are expected to support development of detalimogene through its planned BLA filing and preparations for potential commercialization.
