Genprex, Inc. 8-K

What Happened
Genprex, Inc. filed an 8-K on January 6, 2026 announcing positive preliminary preclinical data for its diabetes gene therapy candidate GPX-002. Research collaborators reported in vivo proof-of-concept in Type 2 diabetes (T2D) non-human primates (NHPs) and mice after delivery of an adeno-associated virus (AAV) vector carrying the Pdx1 and MafA genes (with an insulin promoter). Genprex said one T2D NHP treated by intraductal AAV infusion achieved normal glucose tolerance at seven months and required less insulin; a second NHP treated by direct pancreatic injection showed significant improvement at three months but did not normalize. In T2D mice, intraductal GPX-002 produced statistically significant improvements in glucose tolerance and restored normal glucose levels by four weeks.

Key Details

• Filing date: January 6, 2026 (Form 8-K) announcing preliminary preclinical results.
• GPX-002 construct: AAV vector with Pdx1 and MafA genes and an insulin promoter; delivery via pancreatic duct infusion or direct pancreatic injection.
• NHP results: Intraductal infusion → improved glucose tolerance over several months and normal tolerance at 7 months; direct injection → improvement at 3 months but not full normalization.
• Mouse results: No immunosuppression required; increased glucose‑stimulated insulin secretion, reversal of hyperglycemia and normal glucose levels at 4 weeks.
• Development plans: Ongoing NHP studies (including evaluations after six months of immunosuppression), planning formal toxicology studies and an Investigational New Drug (IND) submission.

Why It Matters
These preliminary preclinical results suggest GPX-002 could potentially rejuvenate exhausted beta cells in T2D and extend Genprex’s diabetes program beyond Type 1 diabetes; T2D represents roughly 90–95% of diabetes patients. For investors, the filing signals scientific progress toward an IND-enabling path (toxicology and IND planning) but remains early-stage: results are preclinical, limited in sample size, and the company cautions that preclinical data may not predict clinical outcomes. Genprex also noted immunosuppression timing considerations in NHPs (AAV protein expression observed up to ~6 months), which could affect clinical design and safety monitoring.