Genprex to Launch Company Focused on Gene Therapy for Diabetes

Genprex, Inc., a clinical-stage gene therapy company based in Austin, Texas, revealed plans to create a new subsidiary, NewCo, to focus on its diabetes clinical development program. This move will allow Genprex to concentrate on its oncology clinical development program. The new entity will primarily develop and commercialize GPX-002, a gene therapy candidate for treating both Type 1 and Type 2 diabetes.

Ryan Confer, President and CEO of Genprex, mentioned that the diabetes program has attracted considerable interest from potential investors and collaborators. He believes that separating the diabetes program from the oncology projects could expedite clinical development and increase its value. NewCo would emerge as a biopharmaceutical company exclusively concentrated on diabetes, while Genprex would remain focused on oncology. This separation aims to attract direct investments and strategic partnerships to advance the diabetes program, addressing the global diabetes epidemic with potentially groundbreaking treatments.

The intended spin-off would enable both Genprex and NewCo to focus better on their respective fields. If everything goes as planned, NewCo will solely develop GPX-002, and Genprex will retain its oncology programs. This decision underscores Genprex's commitment to streamlining its strategies and research priorities. The formation and transfer of the diabetes program to NewCo is expected to be completed by the end of 2024, contingent on sufficient financing and necessary approvals.

This strategic move follows Genprex's recent decision to refocus its oncology clinical development program, particularly for the expedited regulatory submission of its lead oncology candidate, Reqorsa® Gene Therapy. The company is continuously exploring ways to optimize its clinical, research, and operational strategies and is considering various options to enhance shareholder value.

GPX-002, licensed exclusively from the University of Pittsburgh, employs an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly into the pancreatic duct. This novel approach aims to transform alpha cells into functional insulin-producing beta-like cells in Type 1 diabetes and rejuvenate exhausted beta cells in Type 2 diabetes. Preclinical studies show promising results in restoring normal blood glucose levels and improving glucose tolerance.

Research from the University of Pittsburgh presented in February 2023 at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) in Berlin highlighted GPX-002's therapeutic potential. The study showed reduced insulin requirements, increased c-peptide levels, and improved glucose tolerance in treated animals.

Confer emphasized the potential of this gene therapy to revolutionize diabetes treatment, which has not seen a significant advancement since the introduction of insulin over 100 years ago. By potentially eliminating the need for daily blood glucose monitoring and insulin replacement therapy, GPX-002 could disrupt the diabetes market significantly.

As of 2024, the U.S. Centers for Disease Control reports that 38.4 million Americans, or 11.6% of the population, have diabetes, with more than 97 million adults having prediabetes. Globally, in 2021, 537 million adults were living with diabetes, a number expected to rise to 643 million by 2030 and 783 million by 2045. The global diabetes epidemic resulted in over 6.7 million deaths in 2021 and approximately $966 billion in health expenditures, a 316% increase over the previous fifteen years.

Genprex's initiative to separate its diabetes program underscores its dedication to developing innovative treatments for significant health challenges. By creating distinct entities focused on oncology and diabetes, Genprex aims to accelerate advancements and improve outcomes for patients in both fields.

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