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enGene Holdings (ENGN) investor relations material
enGene Holdings Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key product and technology highlights
Lead asset detalimogene voraplasmid is a non-viral gene therapy for non-muscle invasive bladder cancer (NMIBC).
Demonstrates strong efficacy, tolerability, and ease of use, targeting community urologists.
Non-viral approach allows for larger genetic payload, redosing, and lower manufacturing costs.
Product consists of two RIG-I agonists and IL-12, stimulating both innate and adaptive immunity.
Manufacturing is scalable, cost-effective, and does not require special handling or storage.
Market and patient landscape
NMIBC affects about 730,000 people in the US, with 65,000 new cases annually.
NMIBC is the sixth most common cancer in the US, with high treatment costs.
Current standard BCG therapy faces chronic shortages and challenging administration.
Community urologists manage most NMIBC cases, with unique logistical and economic pressures.
Buy-and-bill is a growing revenue model for urologists, expected to reach 15-20% of revenue by 2025.
Clinical development and data
Pivotal LEGEND trial fully enrolled 125 BCG-unresponsive NMIBC patients, largest cohort in this indication.
Recent data update: six-month complete response (CR) rate of 62%, with strong tolerability (mostly grade 1/2 AEs).
Protocol amendments improved efficacy from 41% to 62% at six months.
Dose interruptions and discontinuations are low (1.6% and 0.8%, respectively).
Efficacy and tolerability compare favorably to approved and in-development agents.
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