Andelyn Biosciences to scale manufacturing for Genprex’s Diabetes Gene Therapy Program

Andelyn Biosciences, a contract development and manufacturing organisation, announced that Genprex 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 optimisation, 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 optimisation, 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.” The post Andelyn Biosciences to scale manufacturing for Genprex’s Diabetes Gene Therapy Program appeared first on Express Pharma.