Andelyn Biosciences, a Columbus, Ohio-based contract development and manufacturing organization (CDMO), will support scale-up manufacturing for Genprex Inc.’s diabetes gene therapy program.

Genprex’s candidate uses an adeno-associated virus (AAV) vector to deliver the Pdx1 and MafA genes directly to the pancreas through the pancreatic duct. The program is being developed as a potential treatment for Type 1 and Type 2 diabetes.

Under the agreement, Andelyn will support process optimization, scale-up, and manufacturing for IND-enabling studies and clinical trials. Planned activities include analytical qualification, potency assay development and drug product manufacturing in a current Good Manufacturing Practices (cGMP)-compliant facility.

The collaboration will use Andelyn’s Curator cell and gene therapy platform and capabilities in AAV process development, technology transfer, analytical development, and cGMP manufacturing. The work is intended to transition Genprex’s candidate toward a scalable manufacturing process for preclinical and clinical development.

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 extended restoration of normal blood glucose levels, 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. The company has reported preclinical activity in mouse and nonhuman primate models.

The manufacturing collaboration follows Andelyn’s April partnership with South Korea-based CDMO ENCell to establish a U.S.-Asia-Pacific manufacturing network for gene therapy production. The companies said the network is intended to support regional clinical supply, technology transfer, and localized manufacturing as gene therapy programs advance.