Genprex Selects Andelyn Biosciences to Scale Manufacturing for Diabetes Gene Therapy Program

Editor’s Take: The candidate works differently in treating type 1 and type 2 diabetes, but carries broad potential in both.

Genprex, a clinical-stage company, has chosen the CDMO Andelyn Biosciences to support scale-up manufacturing for its diabetes gene therapy program.

The program is being developed to potentially treat both type 1 and type 2 diabetes. It delivers genes Pdx1 and MafA directly to the pancreas, via the pancreatic duct, using an adeno-associated virus (AAV) vector.

Andelyn to Use CGT Platform

Drawing on its Curator cell and gene therapy platform, Andelyn will transition Genprex’s candidate in numerous ways supporting clinical trials. These services include process optimization, scale-up, and Investigational New Drug (IND)-enabling and clinical-stage manufacturing. Also among Andelyn’s capabilities: analytical quantification and potency assay development, all within a current good manufacturing practice (cGMP)-compliant facility.

Genprex President and CEO Ryan Confer focused on IND-enabling studies and future clinical evaluation in his comments on the partnership.

“Selecting Andelyn marks an important step in preparing our diabetes gene therapy program,” Confer said. “Andelyn’s experience in AAV development and cGMP manufacturing will help us advance the manufacturing process toward the clinic.”

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

How Genprex Candidate is Designed

In type 1 diabetes, Genprex’s gene therapy program transforms pancreatic alpha cells into functional, beta-like cells that can produce insulin.

The candidate works differently in type 2 diabetes, where autoimmunity is not a primary driver of disease. Here, Genprex is weighing if its approach might help replenish or rejuvenate exhausted insulin-producing beta cells.

Mouse and nonhuman primate models have reported preclinical findings so far.