On January 5, 2023 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it has entered into an exclusive license agreement (the Agreement) with the University of Pittsburgh (Pitt), granting Genprex a worldwide, exclusive license to a patent application and related technology and a worldwide, non-exclusive license to use certain related know-how, all related to gene therapy for Type 2 diabetes using the genes of the Pdx1 and MafA transcription factors (Press release, Genprex, JAN 5, 2023, View Source [SID1234625896]). The preclinical technology, GPX-003, is believed to work by rejuvenating diminished beta cells to increase insulin expression by introducing transcription factors controlled by an insulin promoter.

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"This marks the Company’s third technology license this year supporting our diabetes program, demonstrating the continued strengthening of our intellectual property portfolio, our diabetes program, and our position as a lead innovator in emerging diabetes gene therapies," said Rodney Varner, President and Chief Executive Officer of Genprex. "We are thrilled to have secured multiple cutting edge technologies from Pitt that expand our diabetes gene therapy program and specifically target Type 1 and Type 2 diabetes."

"With this license agreement, Genprex now has a drug product candidate for Type 1 diabetes, GPX-002, that uses a glucagon promoter specifically optimized for use in alpha cells and another drug product candidate, GPX-003 for Type 2 diabetes, that uses an insulin promoter optimized for beta cells," said Mark Berger, MD, Chief Medical Officer of Genprex. "Both product candidates are based on the same general gene therapy approach under Genprex’s original license that is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas. Each of these technologies may have the potential to provide long-term efficacy and to change the course of this disease for the millions of patients around the world with diabetes."

All of the diabetes technologies licensed from Pitt by Genprex are out of the laboratory of George Gittes, MD, Professor of Surgery and Pediatrics and Chief of the Division of Pediatric Surgery at the University of Pittsburgh School of Medicine.

Genprex recently announced a license agreement with the University of Pittsburgh for a preclinical technology that transforms macrophages enabling them to reduce autoimmune activity in Type 1 diabetes, a technology that could be complementary to the Company’s GPX-002 diabetes technology.

In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

Earlier studies in diabetic mouse models showed that an earlier version of GPX-002 restored normal blood glucose levels for an extended period of time, typically around four months. It is believed that the duration of restored blood glucose levels in mice could translate to decades in humans. Preliminary data from a more recent study in a non-human primate model of Type 1 diabetes also have been promising and are expected to be presented at a scientific meeting during the first quarter of 2023.

More than 537 million people around the world have diabetes, and in the U.S. alone, there are 37.3 million people with diabetes. In 2021, diabetes took the lives of more than 6.7 million people.