Andelyn Biosciences, a Contract Development and Manufacturing Organisation (CDMO) specialising in cell and gene therapies, has announced that Genprex has selected the company to support scale-up manufacturing for its diabetes gene therapy programme.

Under the agreement, Andelyn will support the transition of Genprex’s Adeno-Associated Virus (AAV)-based gene therapy candidate from development-stage manufacturing towards a scalable process suitable for IND-enabling studies and clinical development. The programme is being investigated as a potential treatment for both type 1 and type 2 diabetes.

Genprex’s candidate is designed to deliver the Pdx1 and MafA genes directly to the pancreas through the pancreatic duct using an AAV vector. In type 1 diabetes, the approach is intended to transform pancreatic alpha cells into functional beta-like cells capable of producing insulin. For type 2 diabetes, Genprex is evaluating whether the therapy could help replenish and rejuvenate exhausted insulin-producing beta cells.

Andelyn’s scope will include process optimisation, technology transfer, scale-up, analytical development and qualification, potency assay development and drug product manufacturing at a cGMP-compliant facility. The work will leverage the company’s Curator Cell and Gene Therapy Platform and its experience in AAV process development and manufacturing.

Genprex has reported preclinical findings supporting the programme in type 1 diabetes models. In mouse studies, the company reported restoration of normal blood glucose levels for an extended period. Studies in nonhuman primates reportedly showed reduced insulin requirements, increased C-peptide levels and improved glucose tolerance.

The company has also reported preclinical activity for its approach in type 2 diabetes models, including mouse and nonhuman primate studies. The programme remains under development, with further work required to establish its safety and efficacy in clinical trials.

Matt Niloff, Chief Commercial Officer at Andelyn Biosciences, said the transition from research-grade manufacturing to a scalable cGMP process represents an important development milestone for advanced therapies. He added that Andelyn would provide technical, operational and quality expertise to establish a manufacturing foundation for Genprex’s upcoming preclinical and clinical milestones.

Ryan Confer, President and Chief Executive Officer of Genprex, said selecting Andelyn represents an important step in preparing the diabetes gene therapy programme for IND-enabling studies and future clinical evaluation. He highlighted Andelyn’s experience in AAV development and cGMP manufacturing as key capabilities for advancing the programme towards clinical development.

Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on viral-vector development, characterisation and manufacturing. The company has more than 20 years of experience and has produced cGMP material for more than 500 clinical batches and 85 global clinical trials.

Genprex is a clinical-stage gene therapy company developing therapies for cancer and diabetes, with its technologies focused on delivering therapeutic genes to address diseases with significant unmet medical needs.