enGene Holdings, a clinical-stage, non-viral genetic medicines company, announced the appointment of Amy Pott as Chief Global Commercialization Officer. In this role, Ms. Pott will serve as the Company’s first dedicated executive for commercialization planning and execution, reporting to enGene’s Chief Executive Officer, Ron Cooper.
This appointment marks a significant milestone, as the Company expects to file a Biologics License Application (BLA) with the FDA in mid-2026 for detalimogene voraplasmid, its lead investigational agent in Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC), following the completion of the pivotal cohort of the LEGEND trial.
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“Amy brings a unique combination of P&L, full commercialization, gene therapy, deep analytics, and global experience to enGene,” said enGene CEO, Ron Cooper. “We are thrilled to welcome Amy as our Chief Global Commercialization Officer and believe her leadership and track record of success will be a tremendous asset in preparing and executing the planned launch of detalimogene.”
Ms. Pott joins enGene from Astellas Pharma, where she most recently served as Senior Vice President (SVP), Strategic Brand Marketing, Ophthalmics and Rare Diseases, and previously as Head of Commercial, Gene Therapies. Prior to Astellas, she was President, North America for Swedish Orphan Biovitrum, and Global Vice President (GVP) U.S. Franchise Head for Internal Medicine and Oncology, as well as GVP, U.S. Commercial Operations at Shire. Before joining Shire, Ms. Pott was Vice President, Strategy, Planning and Analytics at Baxalta, Inc.
Ms. Pott holds a Master of Science in European Studies from the London School of Economics and a Bachelor of Arts in History from the University of Bristol.
“I am excited to join enGene at such a pivotal moment in its journey,” said Ms. Pott. “I look forward to working with this talented team to advance the mission to help transform the treatment landscape for bladder cancer patients with our innovative genetic medicine.”
About Detalimogene
Detalimogene is a novel, investigational, non-viral genetic medicine for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.
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Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, simplify safe handling and cold storage complexities, and streamline both manufacturing processes and administration paradigms.
Detalimogene has received Fast Track designation from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
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Source – PR Newswire
