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Oral presentation highlights rational design of EG-70 to address challenges faced by other intravesical treatment options, including preparation, handling, and safety considerations
BOSTON and MONTREAL, May 2, 2024 /CNW/ - enGene Holdings Inc. (NASDAQ:ENGN) or ("enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead program EG-70 is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), today announced an oral presentation at the American Urology Association (AUA) 2024 Annual Meeting being held May 3-6, 2024 in San Antonio, Texas.
The presentation, "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)," will be given by Dr. Gordon Brown, Director of the Center for Advanced Therapeutics and Urologic Oncology, Summit Health-South, at 10:30 a.m. CT on Friday, May 3rd during the Paradigm-shifting, Practice-changing Clinical Trials in Urology Plenary Session. The complete dataset from the 12-month follow-up of all patients in the Phase 1 portion of LEGEND will be reported at a future meeting or within a peer-reviewed publication.
"I am pleased to present a detailed overview of EG-70 and the pivotal Phase 1/2 LEGEND study. EG-70 is designed to be a practice-changing product that does not require a change in practice for urologists, offering attributes that render it practical for use in community-based and high-volume clinics." said Dr. Brown.
Dr. Richard Bryce, enGene's Chief Medical Officer, added: "The promising initial efficacy and safety data from LEGEND's Phase 1 cohort in high-risk, BCG-unresponsive NMIBC patients with CIS, combined with its ease of handling, simplicity of administration, minimal storage requirements, and lack of post-procedural patient restrictions, demonstrate EG-70's potential to unlock the power of genetic medicine for any and all urologists."
"EG-70 was rationally designed to be easy to use and meet the needs of patients and urologists alike. As a non-viral, non-infectious, locally delivered genetic medicine, EG-70 is designed to synergistically activate both the innate and adaptive immune responses, be easily reconstituted in water, and require only a short procedural time," said Jason Hanson, Chief Executive Officer of enGene. "Within the subgroup of patients in LEGEND's Phase 1 who received our optimized Phase 2 dose, we saw complete response rates of 70% and 60% at three months and six months, respectively, which speak to EG-70's potential to drive durable remissions. The encouraging safety data from the Phase 1 study also suggest that this efficacy was achieved without significant impairment to the patients' quality of life. We look forward to providing additional updates on the broader EG-70 program as we look to expand its potential use across bladder cancer."
Posted In: ENGN
