Andelyn Biosciences to Scale Manufacturing for Genprex's Diabetes Gene Therapy Program

The collaboration will support Genprex's AAV-based diabetes gene therapy candidate for IND-enabling preclinical studies and cGMP clinical manufacturing.

COLUMBUS, Ohio, Sept. 1, 2026 /PRNewswire/ -- Andelyn Biosciences, a leading contract development and manufacturing organization, announced today that Genprex, Inc. has selected Andelyn to support scale-up manufacturing for its diabetes gene therapy program.

Genprex's diabetes gene therapy candidate is designed to deliver the Pdx1 and MafA genes directly to the pancreas via the pancreatic duct using an AAV vector. The program is being developed as a potential treatment for Type 1 and Type 2 diabetes.

Under the agreement, Andelyn will transition Genprex's adeno-associated virus (AAV)-based diabetes gene therapy candidate with process optimization, scale-up, and IND-enabling and clinical-stage manufacturing to support clinical trials.

The collaboration will draw on Andelyn's Curator® Cell and Gene Therapy Platform and experience in AAV process development, technology transfer, analytical development, and cGMP manufacturing. Manufacturing activities are expected to include process optimization, scale-up, analytical qualification, potency assay development, and drug product manufacturing in a cGMP-compliant facility.

In Type 1 diabetes, Genprex's candidate is designed to transform pancreatic alpha cells into functional beta-like cells capable of producing insulin. Genprex has reported preclinical findings in Type 1 diabetes mouse models showing restoration of normal blood glucose levels for an extended period, as well as findings in nonhuman primate models indicating reduced insulin requirements, increased C-peptide levels, and improved glucose tolerance.

For Type 2 diabetes, where autoimmunity is not a primary driver of disease, Genprex is evaluating whether its approach may help replenish and rejuvenate exhausted insulin-producing beta cells. The company has reported preclinical activity in both mouse and nonhuman primate models.

"Andelyn is pleased to support Genprex as it advances this important diabetes gene therapy program," said Matt Niloff, CCO at Andelyn. "The transition from academic or research-grade manufacturing to a scalable cGMP process is a pivotal step in developing an advanced therapy. Our team will provide the technical, operational, and quality expertise needed to establish a robust manufacturing foundation for Genprex's upcoming preclinical and clinical milestones."

"Selecting Andelyn marks an important step in preparing our diabetes gene therapy program for IND-enabling studies and future clinical evaluation," said Ryan Confer, President and Chief Executive Officer of Genprex. "Andelyn's experience in AAV development and cGMP manufacturing will help us advance the manufacturing process as we work to move this program toward the clinic."

About Andelyn Biosciences

Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on developing, characterizing, and producing viral vectors for gene therapy. With more than 20 years of experience, Andelyn's deep scientific expertise has resulted in the production of cGMP material for more than 500 clinical batches and 85 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven Curator® Cell and Gene Therapy Platforms, or by tech transfer within an established client program. Capabilities include cGMP manufacturing for suspension and adherent processes. A rigorous, commercial-grade quality system, phase-appropriate manufacturing, and supply chain vertical integration further help clients bring critical therapies to market.

For more information, please visit andelynbio.com and follow Andelyn Biosciences on LinkedIn.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.

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SOURCE Andelyn Biosciences