enGene Therapeutics Appoints Erik Goluboff as Chief Medical Officer and Jason Duncan as Chief Legal and Administrative Officer
enGene Therapeutics Inc., a clinical-stage biotechnology company focused on developing non-viral genetic medicines, has announced the appointments of Erik T. Goluboff, MD, MBA, as Chief Medical Officer and Jason Duncan as Chief Legal and Administrative Officer. Both appointments became effective on November 9, 2026.
The leadership changes come as enGene advances its lead investigational candidate, detalimogene voraplasmid (detalimogene), through clinical development. The candidate is being evaluated in the ongoing, multi-cohort LEGEND Phase 2 clinical trial, which includes a pivotal cohort investigating its use in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (CIS), with or without concomitant papillary disease.
The appointments are intended to strengthen the company’s leadership team during an important period of clinical and regulatory development. Dr. Goluboff brings extensive experience in urologic oncology, clinical medicine and global biopharmaceutical development, including leadership positions at AstraZeneca, Genentech/Roche and Tyra Biosciences. Mr. Duncan contributes more than 20 years of experience in legal affairs, corporate governance, compliance, program management and biotechnology company operations, including experience supporting drug approvals and commercialization.
With a planned Biologics License Application (BLA) submission for detalimogene later in the fourth quarter of 2026 and preparations for a potential approval in 2027, enGene expects the new executives to play important roles in supporting its transition toward the next stage of development.
Leadership Appointments Support enGene’s Next Development Phase
Ron Cooper, Chief Executive Officer of enGene, said Dr. Goluboff’s clinical background and experience in global drug development make him well suited to lead the company’s medical and clinical development activities as it prepares for the planned regulatory submission.
“As a former urologic oncologist and global clinical development leader, Dr. Goluboff’s industry experience and clinical perspective are uniquely suited to support our detalimogene BLA filing and commercialization plans,” Cooper said.
He also highlighted Mr. Duncan’s combination of legal, governance and operational expertise, noting that his background includes helping biotechnology companies advance through late-stage development, regulatory approvals and commercialization.
“At the same time, Jason Duncan brings to us a rare combination of legal, governance and operational experience helping scale biotechnology companies through late-stage development, regulatory approvals, and commercialization,” Cooper added.
Cooper also acknowledged the contributions of Dr. Bill Grossman, a member of enGene’s Board of Directors, who had served as interim Chief Medical Officer since June 2026.
“We would like to thank Dr. Bill Grossman, a member of our Board of Directors, for his contributions and support while serving as interim Chief Medical Officer since June of this year,” Cooper said.
The appointments reflect enGene’s focus on building the clinical, regulatory and corporate capabilities required to support a potential transition from clinical development to commercialization. As the company approaches a planned BLA submission, experienced leadership across medical development and corporate operations is expected to be increasingly important.
Dr. Erik Goluboff to Lead Medical and Clinical Development
Dr. Erik T. Goluboff joins enGene as Chief Medical Officer with more than 30 years of experience across biotechnology, global biopharmaceutical development, academic medicine and direct patient care. His background includes nearly three decades in academic urologic oncology, followed by senior clinical development positions within major pharmaceutical and biotechnology companies.
His experience in urologic oncology is particularly relevant to enGene’s clinical program because detalimogene is being investigated in patients with high-risk, BCG-unresponsive bladder cancer. His combination of clinical and industry experience is expected to support the company’s clinical strategy, regulatory preparation and potential commercialization planning.
Before joining enGene, Dr. Goluboff served as Senior Vice President of Clinical Development, Oncology, at Tyra Biosciences. In that position, he was involved in oncology clinical development activities, building on his previous experience leading medical and research programs in the pharmaceutical industry.
Earlier, Dr. Goluboff joined Genentech/Roche, where he served as Principal Medical Lead for urologic cancers. His responsibilities included work related to the development of treatments for cancers affecting the urinary system.
Prior to his role at Genentech/Roche, he worked at AstraZeneca, where he held the title of Global Clinical Head and contributed to late-stage research and development efforts in bladder cancer. This experience provides him with familiarity with the clinical and development considerations involved in advancing investigational treatments for bladder cancer through later stages of development.
Before entering the biopharmaceutical industry, Dr. Goluboff spent almost three decades in academic urologic oncology. His academic and clinical career included several senior appointments.
He served as Director of Urology at New York-Presbyterian Hospital/The Allen Pavilion and as Professor of Clinical Urology at Columbia University College of Physicians and Surgeons. He also held a professorship in urology at the Icahn School of Medicine at Mount Sinai.
Dr. Goluboff completed his undergraduate education at Columbia University, earning a Bachelor of Arts degree in Biology. He subsequently attended medical school at Johns Hopkins University. His postgraduate training included residency training at Johns Hopkins and Columbia, as well as a fellowship in urologic oncology.
This combination of medical training, academic leadership and industry experience positions Dr. Goluboff to oversee enGene’s medical and clinical development activities as the company prepares for the next regulatory milestone for detalimogene.
Dr. Goluboff Highlights Potential of Detalimogene
Dr. Goluboff expressed enthusiasm about joining enGene and contributing to the development of detalimogene as a potential treatment option for patients with bladder cancer.
“The emerging detalimogene profile may provide busy urology practices with a unique balance of efficacy and tolerability without disruption to standard clinical workflows,” he said.
He also emphasized his interest in supporting the planned BLA submission and the possibility of bringing another bladder-sparing treatment option to patients.
“I am excited about being part of an important BLA submission and the potential to bring a new bladder-sparing treatment option to patients,” Dr. Goluboff added.
His comments reflect the importance of developing treatment approaches that can address the needs of patients with high-risk bladder cancer while considering the practical requirements of clinical care. Treatment administration, tolerability and compatibility with existing healthcare workflows are important factors for physicians and patients evaluating potential therapeutic options.
For enGene, the addition of a Chief Medical Officer with extensive experience in urologic oncology may support the company’s efforts to communicate the clinical value of detalimogene and prepare for the regulatory and medical considerations associated with a potential commercial launch.
Jason Duncan Joins as Chief Legal and Administrative Officer
Jason Duncan joins enGene as Chief Legal and Administrative Officer, bringing more than two decades of experience in legal, compliance, corporate development and operational leadership within the life sciences sector.
His background includes supporting biotechnology companies through different stages of growth, including clinical development, regulatory approvals, organizational expansion and commercialization. These capabilities are particularly relevant as enGene prepares for a planned BLA submission and evaluates the operational requirements associated with a potential product launch.
Most recently, Duncan served as Chief Legal and Administrative Officer at Neumora Therapeutics. He joined Neumora in 2023, following an earlier leadership role at Albireo Pharma.
At Albireo Pharma, he served as Chief Legal Officer, General Counsel, Secretary to the Board of Directors and Head of Program Management. During his tenure, he helped support the company’s development from an early clinical-stage biotechnology business into a fully integrated commercial organization.
Albireo’s progress included obtaining approvals for two drugs and supporting a global commercial launch. The company was subsequently acquired by Ipsen, providing Duncan with experience in corporate development and the organizational considerations associated with a biotechnology company’s evolution and acquisition.
Before joining Albireo Pharma, Duncan served as General Counsel, Americas, at Stallergenes Greer Holdings. He also held the position of Vice President and Head of Compliance and Legal, North America, at Sobi, Inc.
Earlier in his career, he held positions at EMD Serono, Inc., Acushnet Company, Nixon Peabody LLP and Peabody & Arnold LLP. These roles provided experience across legal practice, corporate operations, compliance and business management.
Duncan earned his Juris Doctor degree, magna cum laude, from Suffolk University Law School. He also holds a Bachelor of Arts degree in Political Science from Dickinson College.
His experience in legal strategy, corporate governance, compliance and operational management is expected to support enGene as it prepares for potential regulatory approval and commercialization of detalimogene.
Duncan Looks Ahead to a Key Company Milestone
Duncan said he was pleased to join enGene at a significant point in the company’s development, particularly as it approaches its planned regulatory submission and prepares for a possible approval.
“With a planned BLA filing later this quarter and preparations for a potential approval of detalimogene next year, I am thrilled to join enGene at this transitional time,” he said.
His appointment is intended to strengthen the company’s ability to manage the legal, administrative and operational requirements associated with late-stage clinical development and a potential commercial transition.
A BLA submission represents an important regulatory milestone for a biologic product in the United States. Preparing for such a submission requires coordination across clinical development, regulatory affairs, manufacturing, quality, legal and corporate functions. If a product receives approval, companies must also prepare for commercialization, including organizational infrastructure and ongoing compliance responsibilities.
Duncan’s previous experience supporting a company through two drug approvals and a global launch provides relevant background as enGene works toward these objectives.
Detalimogene Advances in the LEGEND Phase 2 Trial
enGene’s lead investigational candidate, detalimogene voraplasmid, is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial. The study includes a pivotal cohort investigating detalimogene in patients with high-risk, BCG-unresponsive carcinoma in situ, with or without concomitant papillary disease.
BCG is an established treatment used in bladder cancer, particularly in patients with non-muscle-invasive disease. However, some patients experience persistent or recurrent disease despite receiving BCG treatment. These patients may face limited treatment options and a need for additional bladder-preserving approaches.
Carcinoma in situ is a high-grade, flat form of bladder cancer that can carry a risk of progression. Patients with BCG-unresponsive disease represent an important population for clinical research because their disease has not responded adequately to the standard BCG treatment approach.
Detalimogene is being investigated as a potential treatment option for this patient population. Its development is central to enGene’s clinical strategy, and the LEGEND trial is expected to provide clinical evidence supporting the company’s regulatory plans.
The company’s planned BLA filing later in the fourth quarter of 2026 represents a significant upcoming milestone. enGene is also preparing for the possibility of regulatory approval in 2027, although approval remains subject to the regulatory review process.
Inducement Grants for Newly Appointed Executives
In connection with the appointments of Dr. Goluboff and Duncan, enGene’s Board of Directors approved employment inducement grants consisting of stock options for both executives.
Dr. Goluboff received an inducement grant covering 450,000 stock options, while Duncan received an inducement grant covering 500,000 stock options.
The options are structured to vest over a four-year period. Twenty-five percent of each grant will vest and become exercisable on November 13, 2027. The remaining options will vest and become exercisable in substantially equal monthly installments over the following three years.
The vesting schedule is subject to each executive’s continued employment with enGene on the applicable vesting dates. The stock options are also governed by the terms and conditions outlined in the stock option agreements covering the grants.
The company stated that the stock options are being granted as inducements material to Dr. Goluboff’s and Duncan’s employment with enGene. The grants are being made in accordance with Nasdaq Listing Rule 5635(c)(4), which provides for certain equity awards to be issued as employment inducements outside shareholder-approved equity compensation plans, subject to applicable requirements.
Strengthening Leadership Ahead of Potential Commercialization
The appointments of Dr. Goluboff and Duncan mark an important leadership development for enGene as it advances detalimogene toward a planned BLA submission. Their combined experience spans urologic oncology, global clinical development, regulatory preparation, legal affairs, corporate governance and commercial operations.
Dr. Goluboff’s background in bladder cancer research and development is expected to support the company’s medical strategy and clinical program. Duncan’s experience guiding biotechnology organizations through approvals, commercial launches and corporate transactions is expected to strengthen the company’s legal and operational capabilities.
With detalimogene continuing to be evaluated in the LEGEND Phase 2 trial, enGene is preparing for a major regulatory milestone and the potential transition toward commercialization. The company believes the new appointments will provide important leadership as it works to advance its investigational non-viral genetic medicine for patients with high-risk, BCG-unresponsive bladder cancer.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall.
NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot generally be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.
About Detalimogene Voraplasmid
Detalimogene is a novel, investigational, non-viral gene therapy 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.
Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan® (DDX) 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, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.