AUSTIN, Texas, August 18, 2026
Genprex, Inc. has entered into a development and manufacturing agreement with a leading U.S.-based clinical and commercial Contract Development and Manufacturing Organization (CDMO) to begin the manufacturing scale-up of its diabetes gene therapy program, marking an important step in moving the candidate from research-grade production toward clinical and commercial-ready manufacturing. The collaboration is focused on establishing a reliable manufacturing infrastructure for Genprex’s AAV-based diabetes gene therapy in a current Good Manufacturing Practices (cGMP)-compliant facility, with the CDMO expected to manufacture and supply drug product for upcoming IND-enabling preclinical studies and future clinical trials. By transferring manufacturing activities from an academic setting into a specialized commercial CDMO environment, Genprex is creating a more structured pathway for process development, quality control, production scale-up and regulatory readiness. The manufacturing transition is particularly important for gene therapy programs because reproducible production, product quality and analytical characterization become increasingly critical as candidates progress toward human studies.
CDMO Partnership Targets GMP Manufacturing Readiness
The new collaboration gives Genprex access to specialized CDMO capabilities for complex biologic manufacturing, with the immediate objective of optimizing the production process and establishing sufficient manufacturing capacity for the next stages of development. Key manufacturing priorities include process optimization, production scale-up, analytical qualification, potency assay development and cGMP compliance. Genprex plans to apply advanced AAV production technologies to improve manufacturing efficiency while increasing available drug product through larger-capacity bioreactors. The company is also working to establish rigorous analytical methods capable of assessing AAV potency, purity and stability, providing critical quality information needed to support future regulatory submissions. The manufacturing program is designed to create a more scalable production process rather than relying on research-scale manufacturing, an important distinction as the diabetes program moves toward toxicology studies and eventual clinical evaluation. For cGxP.wire readers across biopharma manufacturing, CDMO operations, gene therapy development and CMC, the development highlights the growing importance of specialized manufacturing infrastructure in translating early-stage gene therapy research into clinically usable drug products.
AAV Process Development Supports Diabetes Program
Genprex’s diabetes gene therapy candidate uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas through the pancreatic duct. From a manufacturing perspective, the company has incorporated advanced technologies into the development process to optimize the plasmid construct, improve expression stability and align the plasmid backbone with other constructs used in AAV production. The company has completed cloning and purification of the updated plasmid, which is now being used in the manufacture of the AAV product. Genprex is continuing collaboration with CDMOs and research partners to optimize its constructs and evaluate alternative approaches, including different AAV systems and non-viral delivery technologies. The company is also researching a lipid nanoparticle-based non-viral delivery approach, which could potentially provide opportunities for repeat dosing. These activities demonstrate that the manufacturing strategy is being developed alongside the broader product-development program, with attention to vector production, construct optimization, analytical testing and scalable manufacturing processes. The broader objective is to establish manufacturing options that can support the candidate as it advances through preclinical development and, if successful, into clinical-stage production.
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Manufacturing Scale-Up Supports Future Clinical Development
The manufacturing agreement comes as Genprex continues developing its diabetes gene therapy for potential application in Type 1 diabetes (T1D) and Type 2 diabetes (T2D). In preclinical studies, the candidate has demonstrated activity in animal models, including restoration of blood glucose levels in T1D mouse models and reductions in insulin requirements, increases in C-peptide levels and improved glucose tolerance in T1D non-human primate studies. In T2D models, the approach has been investigated for its potential to replenish and rejuvenate exhausted insulin-producing beta cells. However, these findings remain preclinical and do not establish clinical efficacy in humans. The more immediate development priority is therefore manufacturing and IND-enabling work, including production of consistent cGMP drug material and preparation for toxicology studies. The selection of a clinical and commercial CDMO provides Genprex with infrastructure intended to support this transition and potentially future multi-center clinical development. The move illustrates how scalable cGMP manufacturing, process control and analytical readiness can become decisive development milestones for emerging gene therapy programs before they enter human trials.
Source: Genprex press relese
