BOSTON and MONTREAL, Sept. 7, 2023 – enGene, Inc., a clinical-stage biotechnology company mainstreaming gene therapy through its novel platform for the delivery of therapeutics to mucosal tissues and other organs, today announced the appointment of Richard Bryce, MBChB, MRCGP, MFPM as its Chief Medical Officer, effective September 19, 2023. Dr. Bryce will oversee the clinical development of EG-70, enGene's lead product candidate for non-muscle invasive bladder cancer (NMIBC), as well as the development strategy for enGene's therapeutic pipeline of tissue-targeted non-viral gene therapies.
“We are thrilled to have Dr. Bryce join enGene during a pivotal period in our growth as we advance our Phase 1/2 registrational LEGEND study for EG-70 in NMIBC,” said Jason Hanson, CEO of enGene. “We believe that the potential efficacy and ease of administration of EG-70 could transform how NMIBC is managed, and Dr. Bryce's extensive track record advancing oncology therapeutics through late-stage trials and approval makes him well positioned to lead this program, while also leveraging our Dually Derivatized Oligochitosan (DDX)® platform to expand our pipeline.”
Before joining enGene, Dr. Bryce was most recently Chief Medical Officer at Rain Oncology, a late-stage company developing precision oncology therapeutics, where he built a clinical development team and oversaw multiple clinical studies, including a global Phase 3 registrational study in dedifferentiated liposarcoma. Prior to that, he was Chief Medical & Scientific Officer at Puma Biotechnology, where he led the development strategy for neratinib. His leadership of this program resulted in FDA, EMA and multiple other global approvals, a diverse clinical development program, and an active translational program with several hundred scientific and clinical publications during his tenure. Earlier in his career, Dr. Bryce was Senior Director of Clinical Science for Onyx Pharmaceuticals, where he oversaw the Phase 3 registrational studies for carfilzomib.
“I am excited to join the enGene team and share in its relentless focus on patient needs and dedication to the translation of innovative science into practical non-viral genetic medicines,” said Dr. Bryce. “I believe EG-70 has the potential to change the treatment paradigm for NMIBC patients and clinicians, and I look forward to advancing the pivotal LEGEND study and expanding our pipeline of non-viral genetic medicines.”
Dr. Bryce obtained his Bachelor of Medicine and Bachelor of Surgery (MBChB) Degrees from the University of Edinburgh and is certified in the EU in primary care/general practice and pharmaceutical medicine. He holds numerous postgraduate specialist clinical qualifications including those from the Royal College of Obstetricians & Gynaecologists (RCOG) and the Royal College of Physicians (RCP). He also served as a Surgeon Lieutenant Commander in the Royal Navy.
enGene Inc. is a clinical-stage biotechnology company mainstreaming gene therapy through its novel platform for delivery of therapeutics to mucosal tissues and other organs, potentially creating new ways to address diseases with high unmet clinical needs. Our proprietary Dually Derivatized Oligochitosan (DDX)® platform is designed to enable a carrier to penetrate mucosal tissue and deliver a wide range of sizes and types of cargo, including DNA and various forms of RNA, by turning mucosal cells into therapeutic production “factories” that generate proteins and RNAs for a desired local effect. This platform will enable localized treatment specifically to the target site without the immunogenicity and systemic effects typical of viral vector-based genetic medicines, potentially expanding gene therapy to multiple clinical settings.
enGene's lead product candidate, EG-70, is a non-viral immunotherapy comprised of three gene cargos delivered via our proprietary DDX platform; it is being evaluated as a monotherapy in a registrational study to treat NMIBC patients with carcinoma-in-situ (Cis) who are unresponsive to treatment with Bacillus Calmette-Guérin (BCG). It is also being studied as a monotherapy to treat NMIBC patients with Cis who are naïve to BCG. EG-70 is applied by intravesical administration and encodes two RIG-I agonists intended to stimulate the innate immune system and IL-12 to stimulate the adaptive immune system. With cargoes selected to stimulate both arms of the immune system, EG-70 is designed to generate a strong local immune reaction in proximity to tumors, enabling the immune system to reduce or clear the tumor and develop memory to resist recurrence without significant systemic toxicities.
The LEGEND study, both first-in-human and first-in-class, is a Phase 1/2 open-label, monotherapy, multi-center, dose-escalation trial evaluating the 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.
This press release contains certain “forward-looking statements” that reflect enGene's beliefs and assumptions based on currently available data and information. These 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 in this press release may include, for example, statements regarding: enGene's research and development programs, regulatory and business strategy, future development plans, and management; enGene's ability to advance product candidates and the timing or likelihood of regulatory filings and approvals. 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 and 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. enGene is under no obligation to update these statements.
The information provided herein may be relevant to the proposed business combination between enGene and Forbion European Acquisition Corp. (“FEAC”) (Nasdaq: FRBN), In connection with the business combination agreement and the proposed transaction, enGene Holdings Inc. (“Newco”), which will be the surviving public company of the business combination, has filed with the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which includes a preliminary proxy statement/prospectus, and this communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Newco or FEAC has filed or may file with the SEC in connection with the proposed business combination. After the registration statement on Form S-4 has been declared effective, the definitive proxy statement/prospectus will be mailed to shareholders of FEAC as of a record date to be established for voting on the proposed business combination and the other proposals regarding the proposed business combination set forth in the proxy statement/prospectus. Before making any voting or investment decision, investors and shareholders of FEAC are urged to carefully read the entire proxy statement/prospectus, when available, as well as any amendments or supplements thereto, because they will contain important information about the proposed business combination. FEAC investors and shareholders will also be able to obtain copies of the preliminary and definitive proxy statements/prospectuses, without charge, once available, at the SEC's website at www.sec.gov, or by directing a request to: Forbion European Acquisition Corp., Gooimeer 2-35, 1411 DC Naarden, The Netherlands, Attention: Cyril Lesser.
FEAC, enGene, Newco and their respective directors, managers, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from FEAC's shareholders with respect to the proposed business combination under the rules of the SEC. FEAC's investors and security holders may obtain more detailed information regarding the names and interests in the proposed business combination of FEAC's directors and officers, without charge, in FEAC's filings with the SEC, including the preliminary proxy statement/prospectus and the amendments thereto, the definitive proxy statement/prospectus, and other documents filed with the SEC. Such information with respect to enGene's and Newco's directors and executive officers will also be included in the proxy statement/prospectus.
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and will not constitute an offer to sell or exchange, or a solicitation of an offer to buy or exchange, any securities (including securities of enGene, FEAC, Newco or the combined company), nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
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