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enGene (ENGN) investor relations material
enGene Oppenheimer 36th Annual Healthcare Life Sciences Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Strategic focus and market outlook
Emphasis on non-viral genetic medicines, with detalimogene voraplasmid as the lead product targeting non-muscle invasive bladder cancer (NMIBC).
NMIBC market expected to grow significantly, with projections from $1 billion to over $20 billion as new agents are adopted and sequencing becomes standard.
Majority of NMIBC patients are treated in community settings, driving demand for therapies that are easy to administer and integrate into existing practices.
Detalimogene is positioned as a convenient, well-tolerated, and efficacious option, fitting the needs of both patients and community urologists.
Anticipated data update in the second half of 2024, BLA filing by year-end, and potential product launch in 2027.
Clinical development and efficacy data
Pivotal trial for detalimogene is fully enrolled with 125 patients, exceeding the initial target.
Six-month complete response (CR) rate of 62% and anytime CR rate of 63% in a high-risk, heavily pretreated population.
Early nine-month data show all evaluable patients remained responders, indicating durable efficacy.
Post-protocol amendment patients demonstrated improved CR rates compared to pre-amendment cohorts.
Competitive efficacy profile compared to other approved and investigational agents in NMIBC.
Safety, tolerability, and administration advantages
Most adverse events are mild (Grade 1 or 2), primarily related to catheterization.
Dose interruptions and discontinuations are very low, supporting strong tolerability.
Detalimogene can be administered quickly, with minimal chair time and no special handling or decontamination required.
Product is stable in standard freezers and refrigerators, simplifying logistics for practices.
Best-in-class convenience and ease of use for both patients and healthcare providers.
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