enGene Appoints James C. Sullivan, PhD as Chief Scientific Officer

BOSTON and MONTRÉAL, March 17, 2022enGene Inc., a clinical-stage biotechnology company pioneering novel non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, today announced the appointment of James C. Sullivan, PhD, as its Chief Scientific Officer (CSO). In his role as CSO, Dr. Sullivan will lead research and development efforts that focus on new ways to expand the use of the company’s gene therapy platform and assets.

Dr. Sullivan’s experience includes end-to-end drug development across multiple therapeutic modalities and IND and s/NDA filings. He has co-authored over 30 peer-reviewed publications.

“I have been very impressed with the entire enGene team and its platform technology,” stated Dr. Sullivan. “I believe that I am joining the organization at an incredibly momentous time in its history. By leveraging our unique platform, we are capable of creating so many opportunities for meaningful gene therapies that will benefit patients’ lives around the globe. The tremendous potential of our pipeline and technology, combined with the compelling clinical results of enGene’s NMIBC trial, has firmly positioned us to develop first-and best-in-class therapies.”

Dr. Sullivan joins enGene from Translate Bio, a Sanofi company, following its $3.2 billion acquisition in 2021, as Senior Vice President, Head of Pulmonary Discovery where he assisted in the development and advancement of mRNA therapeutics across rare and common diseases. Dr. Sullivan was also an Executive Director focused on cell and gene therapy at Sana Biotehnology, responsible for building the translational science function and build-out for clinical trial design and PK/PD biomarker development for gene therapy programs. At Vertex Pharmaceuticals, he was an s/NDA team member for several innovative products, including, Kalydeco®, Orkambi®, Symdeko®, Incivek®, as well the first-ever CRISPR-based gene editing therapeutic product for the treatment of certain hemoglobinopathies. Dr. Sullivan obtained his PhD in Biology at Boston University.

“We are remarkably excited to welcome James to the enGene team,” said Jason Hanson, Chief Executive Officer at enGene. “James is joining enGene at a pivotal time as we continue to see strong results emerge from our Phase 1/2 registrational study for Non-Muscle Invasive Bladder Cancer (NMIBC). He brings an extensive range of expertise that spans basic research and clinical development, along with a robust track record of developing and executing innovative strategies that have realised significant impacts on patients’ lives. We look forward to his scientific expertise as we grow our portfolio of genetic medicines for mucosal tissues and expand the clinical development repertoire of EG-70 for difficult-to-treat cancers.”

Editor’s Notes About enGene’s DDX platform – EG-70
Based on enGene’s DDX platform, EG-70 is a novel non-viral gene therapy encoding two RIG-I agonists to stimulate the innate immune system, and IL-12 to stimulate the adaptive immune system. By stimulating both arms of the immune system, intravesically administered EG-70 yields remarkable tumor regression in preclinical models of bladder cancer, with induction of effective immunological memory and minimal signs of toxicity.

About the LEGEND study
The LEGEND study, both first-in-human and first-in-class, is an open-label, monotherapy, multi-center, dose-escalation trial evaluating safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of EG-70 administered by intravesical instillation. To learn more about the first-in-human clinical trial of EG-70 in BCG-unresponsive NMIBC, please visit ClinicalTrials.gov. For additional information about the LEGEND study, please visit thelegendstudy.com.

About enGene Inc.
enGene Inc. is a clinical-stage biotechnology company developing non-viral gene therapies based on 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 preclinical models, enGene’s DDX technology has been demonstrated to effectively induce expression of therapeutic genes following delivery to the lung, gastrointestinal tract and urinary bladder. Engene has developed scalable GMP-compliant manufacturing of DDX products.

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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