- Genprex has entered a development and manufacturing agreement with a U.S.-based CDMO to scale manufacturing of its AAV-based diabetes gene therapy program.
- The partnership will support cGMP production for IND-enabling studies, future clinical trials, and the transition to clinical and commercial-ready manufacturing.
Genprex, Inc. has signed a development and manufacturing agreement with a U.S.-based clinical and commercial contract development and manufacturing organization (CDMO) to scale the manufacturing of its diabetes gene therapy program. The collaboration will transition the company’s AAV-based therapeutic candidate from research-grade production to clinical and commercial-ready manufacturing in a cGMP-compliant facility.
Under the agreement, the CDMO will manufacture and supply drug product for Genprex’s IND-enabling preclinical studies and future clinical trials. The company said the partnership provides the manufacturing infrastructure needed to support the advancement of its diabetes gene therapy program toward clinical evaluation.
The manufacturing program includes process optimization using AAV production technologies, scale-up through higher-capacity bioreactors, analytical qualification and potency assay development, and adherence to current Good Manufacturing Practices to support future regulatory submissions. Genprex said these activities are intended to improve production efficiency, increase dose availability for multicenter trials, and ensure product potency, stability, and purity.
Genprex’s diabetes gene therapy candidate delivers the Pdx1 and MafA genes to the pancreas via an AAV vector. The therapy is being developed as a potential treatment for both Type 1 and Type 2 diabetes, with preclinical studies evaluating its ability to restore insulin production and improve glucose regulation.
“This strategic partnership represents a significant advancement for our diabetes gene therapy clinical program. Through this collaboration, Genprex aims to advance its diabetes gene therapy program toward clinical evaluation, focusing on the safety and efficacy required for upcoming toxicology studies.”
Ryan Confer, President and Chief Executive Officer of Genprex.
