enGene to Present Phase 1/2 LEGEND Study of EG-70 in BCG-Unresponsive Bladder Cancer at AUA 2024

enGene Holdings Inc., a clinical-stage genetic medicines company, recently shared a significant oral presentation at the American Urology Association (AUA) 2024 Annual Meeting in San Antonio, Texas. The presentation, titled "LEGEND: a Phase 1/2 study of EG-70 (detalimogene voraplasmid), a novel, non-viral intravesical gene therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS)," was delivered by Dr. Gordon Brown, Director of the Center for Advanced Therapeutics and Urologic Oncology, Summit Health-South.

EG-70 is enGene’s lead program, aiming to treat non-muscle invasive bladder cancer (NMIBC) in patients who do not respond to Bacillus Calmette-Guérin (BCG) therapy. The therapy is designed to be practical for community-based and high-volume clinics, addressing key challenges like preparation, handling, and safety.

Dr. Richard Bryce, Chief Medical Officer of enGene, emphasized the promising initial efficacy and safety data from EG-70's Phase 1 cohort. These initial results highlighted the gene therapy's ease of use, simplicity of administration, minimal storage requirements, and lack of post-procedural patient restrictions. Dr. Bryce pointed out that these attributes could make EG-70 a powerful tool for urologists, enabling them to harness the potential of genetic medicine.

Jason Hanson, Chief Executive Officer of enGene, provided further insights into EG-70's design and performance. He explained that EG-70 is engineered to activate both innate and adaptive immune responses synergistically. The gene therapy is easily reconstituted in water and requires only a short procedural time, making it user-friendly for medical practitioners. Hanson also noted impressive complete response rates of 70% and 60% at three and six months, respectively, among patients who received the optimized Phase 2 dose during the Phase 1 trial. These results suggest that EG-70 may offer durable remissions without significantly affecting patients' quality of life.

The promising safety profile from the Phase 1 study further supports the potential of EG-70 as an effective treatment. enGene looks forward to expanding its use in bladder cancer and possibly other medical conditions.

enGene is committed to advancing genetic medicines for diseases with high clinical needs, utilizing its proprietary Dually Derivatized Oligochitosan (DDX) platform. This technology enables the delivery of various therapeutic agents, including DNA and RNA, to mucosal tissues and other organs. The ongoing Phase 2 pivotal study of EG-70 continues to build on the encouraging results observed so far.

In summary, enGene’s innovative approach with EG-70 could significantly impact the treatment landscape for NMIBC, particularly for patients unresponsive to current BCG therapy. The company remains optimistic about the future developments and broader applications of EG-70.