Andelyn Biosciences to Lead Manufacturing Scale-up for Genprex's Diabetes Gene Therapy

Andelyn Biosciences has been selected by Genprex, Inc. to scale up manufacturing for the biotech's gene therapy candidate targeting both Type 1 and Type 2 diabetes, the companies announced on September 1, 2026.

The Columbus-headquartered contract development and manufacturing organisation (CDMO) will take on process optimisation, scale-up, technology transfer, analytical development and cGMP-compliant drug product manufacturing to support Genprex's move toward IND-enabling preclinical studies and, eventually, clinical trials.

What the therapy is designed to do

Genprex's candidate uses an adeno-associated virus (AAV) vector to deliver two genes, Pdx1 and MafA, directly into the pancreas via the pancreatic duct. The mechanism differs depending on the type of diabetes being treated.

In Type 1 diabetes, the approach is designed to reprogram pancreatic alpha cells into functional beta-like cells that can produce insulin. Genprex has reported preclinical data in Type 1 diabetes mouse models showing extended restoration of normal blood glucose levels, along with nonhuman primate data pointing to lower insulin requirements, higher C-peptide levels and improved glucose tolerance.

Type 2 diabetes doesn't involve the same autoimmune destruction of beta cells, so the strategy there is different: rather than replacing lost cells, Genprex is investigating whether the gene therapy can revive beta cells that have become exhausted but are still present. The company says it has generated supporting preclinical activity in both mouse and nonhuman primate models for this indication too.

Why the manufacturing step is important

Gene therapies live or die on manufacturing as much as on biology. A vector that performs well at research scale in a university lab doesn't automatically translate into a process that can produce consistent, high-quality material at the volumes and purity a regulator will accept for human trials. That handover, from academic-grade production to a validated cGMP process, is where a lot of promising cell and gene therapy programmes stall.

That's the gap Andelyn has been brought in to close. The company will apply its Curator® Cell and Gene Therapy Platform, along with its AAV process development and analytical expertise, to build out potency assays, qualify analytical methods and manufacture drug product at cGMP standard.

"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."

Ryan Confer, President and CEO of Genprex, framed the deal in similar terms: "Selecting Andelyn marks an important step in preparing our diabetes gene therapy program for IND-enabling studies and future clinical evaluation. 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 bigger picture

Diabetes remains one of the largest areas of unmet medical need worldwide, and most existing treatments, insulin included, manage the disease rather than address its underlying biology. A therapy that could restore or rejuvenate the body's own insulin-producing cells would represent a genuinely different approach, not an incremental improvement on current care.

It's worth being clear-eyed about where this programme actually stands, though. The data so far are preclinical, drawn from mouse and nonhuman primate models rather than people, and there's no IND filing yet. A manufacturing partnership is a necessary condition for reaching the clinic, not a guarantee of what will happen once the therapy gets there. Plenty of gene therapies with encouraging animal data have run into difficulty when tested in humans.

Still, the choice of partner is a reasonable signal of intent. Andelyn has built a track record in AAV-based cell and gene therapy manufacturing, and bringing in that kind of specialist expertise at this stage suggests Genprex is treating the diabetes programme as a serious clinical candidate rather than a research curiosity. For a company hoping to move an AAV-based diabetes gene therapy toward human trials, getting the manufacturing foundation right now is the less glamorous but more decisive part of the work.