enGene Announces FDA Approval of IND Application for EG-70, an Intravesical Dual Immune Modulator for the Treatment of Muscular Non-invasive Bladder Cancer
Start of phase 1/2 clinical study scheduled for early 2021
EG-70 is enGene’s first clinical-stage product candidate
BOSTON and MONTREAL, November 2, 2020 / PRNewswire / – enGene Inc., a biotechnology company developing non-viral gene therapies for local delivery into mucosal tissue through its proprietary DDX platform, today announced that the Food and Drug Administration (FDA) of US has cleared its investigational new drug (IND) application for EG-70, a first-class non-viral gene therapy for the expression of innate and adaptive immune system activators circumscribed to the bladder. As part of this IND, enGene intends to initiate its multicenter phase 1/2 study in patients with non-invasive muscular bladder cancer (NMIBC) insensitive to Bacille Calmette-Guérin (BCG ) in early 2021.
“The FDA clearance of our IND for EG-70 is an important moment in the field of gene therapy, and above all, an important step for patients, as we are now one step closer to a treatment that is if necessary “, said Jason hanson, President and CEO of enGene. “This milestone is remarkably exciting 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 world. “
“Our preclinical data suggests that EG-70 has the potential to produce significant and lasting responses in cancer patients,” said Jose lora, scientific director of enGene. “EG-70 brings our technology to NMIBC patients unresponsive to BCG, a population with very limited treatment options. We believe the EG-70 can change that. “
“The entry of EG-70 into the clinic is the culmination of a number of technological enhancements to our platform and our ability to manufacture our proprietary DDX gene therapies at scale and quality ready for use. clinic ”, commented Anthony cheung, co-founder and CTO at enGene. “Our formulation work resulted in a stability profile that allows EG-70 to be stored and used in the same way community urologists treat NMIBC patients today – a significant advantage over other modalities. gene therapy. “
The study design consists of an open label dose escalation phase 1 study to assess the safety and tolerability of EG-70 and to determine the recommended phase 2 dose, followed by a portion of phase 2 to assess efficacy and safety.
Jose lora added, “Based on our findings to date, we hope to achieve a crucial therapeutic benefit: locally harnessing the potency of IL-12 and RIG-I activation without paying the price for systemic toxicity. Establishing this paradigm would provide a basis for EG-70 to be examined on multiple tumor types with high unmet medical need. “
About enGene Inc.
enGene Inc. is a biotechnology company developing a proprietary non-viral gene therapy platform for the localized delivery of nucleic acid payloads to mucosal tissues. The Double Derived Chitosan (DDX) platform has a high degree of payload flexibility, including DNA and various forms of RNA with wide tissue and pathological applications. In addition to developing EG-70 for non-BCG-responsive NMIBC, enGene is developing unique genetic drugs for respiratory indications and the company is advancing its technology to enable applications in multiple mucosal tissues with areas where medical needs are not needed. satisfied are important. http://www.engene.com
Note regarding forward-looking statements
This press release contains certain “forward-looking statements” which reflect the beliefs and assumptions of the Company on the basis of data and information currently available. These forward-looking statements fall within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as: “target”, “believe”, “s'” expect, “” will “,” be able “,” anticipate “,” estimate “,” would “,” position “,” future “and other similar expressions which predict or indicate future events or trends or which do not are not statements of historical matters. Forward-looking statements are neither historical facts nor guarantees of future performance. Instead, they are based solely on engene’s current beliefs, expectations and assumptions which by definition involve risks, uncertainties, which are difficult to predict, and are subject to factors beyond the control of management and that could cause actual results to differ materially from statements made, including but not limited to: risks associated with the success of preclinical studies, clinical trials, research and development programs, as well as regulatory approval processes. Actual results may differ materially from those shown in forward-looking statements. enGene currently has no approved drugs available for sale and may never have an approved drug. You are cautioned not to rely on enGene’s forward-looking statements, which are made only as of the date hereof. The Company has no obligation to update these statements.
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