- Andelyn Biosciences will support Genprex’s AAV-based diabetes gene therapy program with process optimization, scale-up, and IND-enabling and clinical-stage manufacturing.
- The collaboration will use Andelyn’s Curator® Cell and Gene Therapy Platform and capabilities in AAV process development, analytical development, technology transfer, and cGMP manufacturing.
Andelyn Biosciences, a contract development and manufacturing organization (CDMO), has been selected by Genprex, Inc. to support scale-up manufacturing for Genprex’s diabetes gene therapy program. The candidate is designed to deliver the Pdx1 and MafA genes directly to the pancreas through the pancreatic duct using an adeno-associated virus (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 AAV-based candidate through process optimization, scale-up, and IND-enabling and clinical-stage manufacturing. The work is intended to support clinical trials as the program advances toward the clinic.
Manufacturing activities are expected to include process optimization, scale-up, analytical qualification, potency assay development, and drug product manufacturing in a cGMP-compliant facility. The collaboration will draw on Andelyn’s Curator® Cell and Gene Therapy Platform, along with its experience in AAV process development, technology transfer, analytical development, and contract manufacturing.
For 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 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, Genprex is evaluating whether the approach may help replenish and rejuvenate exhausted insulin-producing beta cells, with the company reporting preclinical activity in mouse and nonhuman primate models.
“Andelyn is pleased to support Genprex as it advances this important diabetes gene therapy program. 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.”
Matt Niloff, CCO at Andelyn
