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Genprex Plans Launch of Diabetes-Focused Gene Therapy Company

NEW YORK – Genprex said Wednesday that it is launching a new company to focus on its diabetes program, including its diabetes gene therapy candidate GPX-002.

Gene therapy developer Genprex will transfer its diabetes program and assets into a new, wholly owned subsidiary to develop GPX-002 for type 1 and type 2 diabetes. GPX-002, which Genprex licensed from the University of Pittsburgh last year, is an adeno-associated virus vector-based gene therapy containing the Pdx1 and MafA genes and is administered to the pancreatic duct through an endoscopy procedure.

GPX-002 is designed to transform alpha cells in the pancreas into beta-like cells that can produce insulin but may differ enough from typical beta cells to avoid the immune system response that occurs in type 1 diabetes. In preclinical studies, the company says GPX-002 was able to restore normal blood glucose levels. In type 2 diabetes, GPX-002 is thought to work by supplementing the insulin-making beta cells.

Austin, Texas-based Genprex, meanwhile, will concentrate on its oncology clinical development program.

By creating two distinct businesses, Genprex said the diabetes-focused company would be better positioned for direct investments and strategic collaborations. "With the potential to address the entire diabetes market, we believe our gene therapy approach would position [the new company] as an innovator in emerging diabetes therapies," Genprex President and CEO Ryan Confer said in a statement.

The move to separate its diabetes and oncology programs also comes after Genprex announced it would prioritize the regulatory submission of its lead drug candidate Reqorsa (quaratusugene ozeplasmid), an immunogene therapy for lung cancer.

Earlier this year, Genprex began treating EGFR-mutant non-small cell lung cancer patients with Reqorsa and AstraZeneca's EGFR inhibitor Tagrisso (osimertinib) in an expansion cohort of the Phase IIa Acclaim-1 trial. Initial trial results are expected in 2025.