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