On May 27, 2021 enGene Inc., a clinical-stage biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, reported the dosing of the first patient in the LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, enGene, MAY 27, 2021, View Source [SID1234583245]).
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Based on enGene’s DDX platform, EG-70 is a non-viral gene therapy encoding two RIG-I agonists to stimulate the innate immune system, and IL-12 to stimulate the adaptive immune system. By stimulating both arms of the immune system, intravesically administered EG-70 yields remarkable tumor regression in preclinical models of bladder cancer, with induction of effective immunological memory and minimal signs of toxicity.
"Initiating our first clinical study of EG-70 is an important milestone for enGene, validating the potential of our platform to develop novel therapeutics towards clinically meaningful outcomes," said Jason Hanson, Chief Executive Officer at enGene. "This is the first time a non-viral gene therapy directly activating both innate and adaptive immunity is being evaluated as an anti-tumor agent in humans, and we are excited about the outcome of this trial towards positively impacting the lives of patients battling difficult-to-treat cancers."
"Patients with BCG-unresponsive high risk NMIBC have limited treatment options other than radical cystectomy which is associated with significant morbidity and quality of life alterations. Based on our understanding of high grade bladder cancer, the mechanism of BCG resistance/relapse, and the EG-70 mechanism of action, I strongly believe that this novel intravesical therapy has the potential, with few side effects, to make a meaningful difference for patients," said Dr. Gary Steinberg, Professor and Director at the Perlmutter Cancer Center Goldstein Urology Bladder Cancer Program of NYU Langone Health, and lead Principal Investigator for the EG-70 Phase 1/2 study.
The LEGEND study, both first-in-human and first-in-class, is an open-label, monotherapy, multi-center, dose-escalation trial evaluating safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of EG-70 administered by intravesical instillation. To learn more about the first-in-human clinical trial of EG-70 in BCG-unresponsive NMIBC, please visit ClinicalTrials.gov.