Genprex, Inc. Announces CDMO Deal to Scale Diabetes Gene Therapy

What Happened
On August 18, 2026, Genprex, Inc. announced it entered a development and manufacturing agreement with a leading U.S.-based clinical and commercial CDMO to begin manufacturing scale-up of its AAV-based diabetes gene therapy program. The CDMO will produce drug product in a cGMP-compliant facility to support IND-enabling preclinical studies and future clinical trials. Genprex said the therapy delivers the Pdx1 and MafA genes to the pancreas via the pancreatic duct; a newly optimized plasmid has been cloned, purified and is currently being used to manufacture AAV.

Key Details

• Agreement announced: August 18, 2026; CDMO will manufacture drug product for IND-enabling preclinical studies and future clinical trials.
• cGMP production focus: process optimization, scale-up with capacity bioreactors, analytical qualification (potency assay), and GMP compliance for regulatory readiness.
• Product & R&D notes: therapy uses AAV to deliver Pdx1 and MafA; new plasmid backbone optimized for stability is in use. Genprex is also researching non-viral lipid nanoparticle delivery (potential for re-dosing) and alternative AAV/non-viral constructs.
• Preclinical results cited: in vivo mouse T1D models restored normal blood glucose for extended periods; T1D non-human primate studies showed reduced insulin needs, increased c-peptide and improved glucose tolerance; T2D mouse and NHP models showed replenishment/rejuvenation of beta cells.

Why It Matters
For investors, the deal addresses a key practical step — transitioning from research-grade to clinical/commercial manufacturing — which is essential before IND submission and human trials can proceed. Partnering with an established CDMO can speed scale-up, provide cGMP infrastructure and technical expertise, and reduce the need for Genprex to build internal manufacturing. The filing also includes forward-looking risk language; timelines, regulatory approvals and successful clinical development remain uncertain and depend on many factors disclosed in Genprex’s SEC filings (see Item 1A — Risk Factors in the 2025 10‑K).