On November 2, 2020 enGene Inc., a biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EG-70, a first-in-class non-viral gene therapy for the expression of innate and adaptive immune system activators circumscribed to the bladder (Press release, enGene, NOV 2, 2020, View Source [SID1234569728]). Under this IND, enGene intends to initiate its Phase 1/2, multi-center study in patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) in early 2021.
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"The FDA’s clearance of our IND for EG-70 is a significant moment in the field of gene therapy, and importantly, a major milestone for patients, as we are now one step closer to a treatment that is so critically needed," said Jason Hanson, President and Chief Executive Officer of enGene. "This milestone is a remarkably exciting one for us as we embark on our next chapter as a clinical stage company, harnessing the power of our non-viral gene therapy platform to impact the lives of patients around the globe."
"Our preclinical data suggest that EG-70 has the potential to produce meaningful and durable responses in patients with cancer," said Jose Lora, enGene’s Chief Scientific Officer. "EG-70 brings our technology to BCG-unresponsive NMIBC patients, a population with very limited therapeutic options. We believe EG-70 can change that."
"EG-70 entering the clinic is the culmination of a number of technological refinements to our platform and our ability to manufacture our proprietary DDX gene therapies at clinic-ready scale and quality," commented Anthony Cheung, Co-founder and Chief Technology Officer at enGene. "Our formulation work has resulted in a stability profile that enables storage and use of EG-70 in the same way that community urologists care for NMIBC patients today – a significant advantage over other gene therapy modalities."
The study design consists of an open label dose escalation Phase 1 study to evaluate the safety and tolerability of EG-70 and to determine the recommended Phase 2 dose, followed by a Phase 2 portion to evaluate efficacy and safety.
Jose Lora added "Based on our findings to date, we expect to achieve a crucial therapeutic advantage: locally harnessing the power of IL-12 and RIG-I activation without paying the price of systemic toxicity. Establishing this paradigm would provide a foundation for EG-70 to be examined across multiple tumor types with high unmet medical need."