Engene Holdings Inc. has announced the appointment of Joan Connolly as Chief Technology Officer (CTO) and member of the corporate leadership team. Ms. Connolly brings over 30 years of experience in CMC development for large and small molecules, manufacturing management, regulatory filings, and product commercialization, as well as supply chain, logistics, and sourcing, and procurement. She has extensive experience filing submissions for regulatory approval and product launches.
In her most recent role, Ms. Connolly served as Chief Technology Officer of Albireo Pharma, Inc., where she oversaw drug substance and product development, clinical supply distribution, commercial supply chain, and quality. Prior to Albireo, she held senior roles at Stemline Therapeutics, Inc., Imclone Systems Inc., and Bristol-Myers Squibb.
Engene's co-founder and former CTO, Anthony Cheung, Ph.D., will transition to the role of Chief Scientific Officer, succeeding James Sullivan, MSc, Ph.D. Dr. Cheung has been central to the discovery and development of the company's novel and proprietary Dually Derivatized Oligochitosan (DDX) platform and in the creation of detalimogene.
Engene CEO Ron Cooper stated that Ms. Connolly's experience in managing the technical operations required to drive a late-stage clinical asset through to commercialization will be critical as the company completes the pivotal portion of the Legend study of detalimogene and anticipates filing the BLA in mid-2026.
Engene's lead program, detalimogene voraplasmid, is being evaluated in the ongoing multi-cohort Legend phase 2 study, which includes a pivotal cohort studying detalimogene in Bacillus Calmette Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS). Detalimogene was developed using Engene's proprietary DDX platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.
These appointments mark a significant change in Engene's leadership team, with the company emphasizing the importance of experience and expertise in driving the development and commercialization of its investigational product. As a result of these announcements, the company's shares have moved 1.2% on the market, and are now trading at a price of $9.12. If you want to know more, read the company's complete 8-K report here.
