- Detalimogene voraplasmid is a novel, investigational, pivotal-stage, non-viral genetic medicine designed to mitigate systemic risks and deliver durable efficacy for patients with high-risk NMIBC, including Bacillus Calmette-Guérin (BCG)-unresponsive disease
- Ongoing, pivotal, registrational LEGEND study is actively enrolling patients with sites participating in the USA, Canada, Europe and the Asia-Pacific region
- enGene’s Dually Derivatized Oligochitosan® (DDX) platform is designed to potentially overcome the limitations of viral gene therapies and increase patient and clinician access to therapies
“Patients with NMIBC often face a debilitating, multi-year journey with limited treatment options and significant negative impacts to daily life. These patients are most commonly treated by community urologists who face unique challenges accessing and providing optimal care, including global treatment shortages and complex usage and handling,” said Ron Cooper, Chief Executive Officer of enGene. “We are determined to develop genetic therapies for underserved conditions like NMIBC and ultimately provide a long overdue treatment innovation designed to advance care and ease the treatment burden.”There are an estimated 730,000 patients in the U.S. living with bladder cancer, and approximately 75% to 80% of all bladder cancer diagnoses are NMIBC. Among patients diagnosed with high-risk NMIBC, more than half (50-70%) will become BCG-unresponsive and experience recurrence and/or progression after treatment.
“The current treatment options for patients with high-risk NMIBC are sadly sub-optimal, often resulting in disease progression, recurrence or removal of the bladder as a life-altering measure of last resort,” said Anthony Cheung, Chief Scientific Officer and Co-Founder of enGene. “If approved, we believe detalimogene voraplasmid will be uniquely compelling to both patients and physicians by combining a streamlined administration process designed to ease the treatment experience with durable efficacy and a favorable safety and tolerability profile.”Presentation details are outlined below:
Preliminary Results from LEGEND: A Phase 2 Study of Detalimogene Voraplasmid (EG-70), a Novel, Non-Viral Intravesical Gene Therapy for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in Situ (CIS)
Abstract #: 802
Poster #: F29
Clinical Trial Registration Number: NCT04752722
Session Title: Poster Session B: Urothelial Carcinoma
Presentation Date/Time: Friday, February 14 from 11:30am-12:45pm PT
Location: Level 1, West Hall
Presenting Author: John Taylor III, MD, MS, Professor of Urology & Cancer Biology, University of Kansas Cancer Center
Mechanism of Action and Translation to the Clinic of Detalimogene Voraplasmid (EG-70): A Novel, Investigational, Non-Viral Immunotherapy for Non-Muscle-Invasive Bladder Cancer (NMIBC)
Abstract #: 826
Poster #: G22
Clinical Trial Registration Number: NCT04752722
Session Title: Poster Session B: Urothelial Carcinoma
Presentation Date/Time: Friday, February 14 from 11:30am-12:45pm PT
Location: Level 1, West Hall
Presenting Author: Vikram Narayan, MD, Assistant Professor in the Department of Urology at Emory University School of Medicine
A Phase 1/2 Study of Detalimogene Voraplasmid (EG-70) Intravesical Monotherapy for Patients with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)
Abstract #: TPS886
Poster #: J14
Clinical Trial Registration Number: NCT04752722
Session Title: Trials In Progress Poster Session B: Urothelial Carcinoma
Presentation Date/Time: Friday, February 14 from 11:30am-12:45pm PT
Location: Level 1, West Hall
Presenter: Shreyas Joshi, MD, MPH, Assistant Professor in the Department of Urology at Emory University School of Medicine
Source: enGene Holdings. enGene to Present Three Posters at the 2025 ASCO Genitourinary Cancers Symposium (ASCO GU) Highlighting the Ongoing Clinical Development of Detalimogene Voraplasmid for the Treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) [Press Release]. 2025. https://engene.com/engene-to-present-three-posters-at-the-2025-asco-genitourinary-cancers-symposium-asco-gu-highlighting-the-ongoing-clinical-development-of-detalimogene-voraplasmid-for-the-treatment-of-non-muscle-inv/