National Institutes of Health (NIH) Awards Research Grant of $2.59 Million to University of Pittsburgh for Diabetes Gene Therapy Technology Licensed by Genprex
July 21, 2020
Grant to fund ongoing preclinical research for important proof-of-principle non-human studies in preparation for human gene therapy clinical trials
AUSTIN, Texas — (July 21, 2020) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that Dr. George K. Gittes, MD of the University of Pittsburgh, the lead researcher that developed the Company’s potentially curative diabetes gene therapy, was awarded a grant of $2.59 million from the National Institutes of Health (“NIH”) National Institute of Diabetes and Digestive and Kidney Diseases. The grant will assist Dr. Gittes’s development for his research project titled, “Alpha Cell Conversion to Beta Cells in Non-human Primates” and will build upon his accumulating groundbreaking gene therapy work toward finding a cure for diabetes. In this project, Dr. Gittes’ research team will conduct important proof-of-principle studies in non-human primates as the last steps in preparation for human gene therapy clinical trials. This technology is the subject of an exclusive license agreement entered into between Genprex and the University of Pittsburgh in February of 2020.
“We are excited to receive this funding to support our research in diabetic primates as we move toward human clinical trials,” said Dr. George Gittes, Co-Scientific Director and Professor of Surgery at the UPMC (University of Pittsburgh Medical Center) Children’s Hospital of Pittsburgh and the lead researcher behind the diabetes gene therapy. “We saw encouraging data in our preclinical mice studies, where the gene therapy reprogrammed pancreatic cells to restore normal blood glucose levels in diabetic mice for approximately four months, which could translate to decades in humans. More recently, preliminary results in non-human primates (monkeys) has also been very promising.”
Dr. Gittes’ gene therapy for diabetes, which Genprex refers to as “GPX-002,” uses a novel infusion process comprised of an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The genes express proteins that transform 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.
Diabetes affects approximately 10 percent of the U.S. population, or more than 34 million people. The diabetes gene therapy could not only become a new treatment option for millions of diabetes patients who need insulin replacement therapy, but it holds the potential to provide long-term effectiveness, or may even be a cure, for diabetic patients.
Dr. Gittes is the inventor of the gene therapy for diabetes, and he is eligible to receive royalties on this technology in the future.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.
The project described in this press release is being supported by the National Institute of Diabetes and Digestive And Kidney Diseases of the National Institutes of Health under Award Number R01DK120377. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of GPX-001, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates and whether patents will ever be issued under patent applications that are the subject of our license agreements. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.