BOSTON and MONTRÉAL, Dec. 3, 2020 – enGene Inc., a biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to enGene for EG-70, the company’s lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
The Fast Track program is intended to facilitate the development and expedite the review of therapies that treat serious conditions and fill an unmet medical need. Therapeutic programs that receive Fast Track Designation can benefit from more frequent communication with the FDA, eligibility for Priority Review and Accelerated Approval, and potentially for Rolling Review of the marketing application.
“Fast Track Designation underscores the urgent need for new and effective treatments for BCG-unresponsive NMIBC patients,” said Jason Hanson, Chief Executive Officer at enGene. “We are pleased with the FDA’s recognition of our EG-70 program with this designation and we look forward to working closely with the FDA throughout the clinical development process to bring this innovative treatment to patients as quickly as possible.”
About enGene Inc.
enGene Inc. is a biotechnology company developing a proprietary non-viral gene therapy platform for localized delivery of nucleic acid payloads to mucosal tissues. The dually derived chitosan (DDX) platform has a high-degree of payload flexibility including DNA and various forms of RNA with broad tissue and disease applications. In addition to developing EG-70 for BCG-unresponsive NMIBC, enGene is developing unique genetic medicines for respiratory indications and the company is evolving its technology to enable applications in multiple mucosal tissues with areas of high unmet medical need. http://www.engene.com
Note regarding forward-looking statements
This press release contains certain “forward-looking statements” that reflect the Company’s beliefs and assumptions based on currently available data and information. These forward-looking statements fall within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on enGene’s current beliefs, expectations, and assumptions that by definition involve risks, uncertainties, that are difficult to predict and are subject to factors outside of management’s control and that could cause actual results to differ substantially 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 and outcomes may differ materially from those indicated in the forward-looking statements. enGene has no approved drugs available for sale marketing at this time and may never have an approved drug. You are cautioned not to rely on enGene’s forward looking statements, which are only made as of the date hereof. The Company is under no obligation to update these statements.
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