Genprex Announces Groundbreaking Data from Non-Human Primate Study Evaluating Novel Gene Therapy to Treat Type 1 Diabetes at 16th Annual International Conference on Advanced Technologies & Treatment for Diabetes 2023

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Feb 23, 2023, 07:00 ET

Results show statistically significant decreases in insulin requirements, increases in c-peptide levels and improvements in glucose tolerance compared to baseline

Disruptive gene therapy approach developed by University of Pittsburgh researchers may be a promising treatment for Type 1 and Type 2 diabetes

AUSTIN, Texas, Feb. 23, 2023 /PRNewswire/ -- 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, today announced that data highlighting the potential of Genprex's gene therapy for Type 1 diabetes is being presented by its research collaborators at the University of Pittsburgh (Pitt) at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) taking place February 22-25, 2023 in Berlin, Germany.

The abstract data were released, and the presentation will be delivered on February 25th at 2:25 pm CET by Ranjeet S. Kalsi, DO, a member of the laboratory of George Gittes, MD, from Pitt's Division of Pediatric Surgery, Pittsburgh, Pennsylvania. The complete presentation will be available on the Company's website here following the close of Dr. Kalsi's presentation.

The presentation titled, "Pancreatic Intraductal Infusion of Adeno-Associated Virus (AAV) to Treat Non-Human Primates in a Toxin-Induced Diabetes Model," will report results from eight non-human primates (NHPs) with toxin-induced diabetes after streptozocin administration. They received a novel infusion process that used an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas.

"These results are compelling as they demonstrate the potential for this gene therapy to create newly formed beta-like cells that can produce insulin. They also validate earlier studies of this approach in diabetic mouse models that showed restoration of normal blood glucose levels for several months," stated Mark Berger, MD, Chief Medical Officer of Genprex. "We are eager to continue working to advance this gene therapy into human clinical trials in order to replicate these outcomes in people and potentially provide long-term replacement of beta-cells."

The statistically significant study results show that post-infusion of the AAV engineered construct, the eight NHPs had "decreased insulin requirements (p<0.001); increased c-peptide levels (p<0.05); and improved glucose tolerance compared to baseline (p<0.05) with one demonstrating reestablished normoglycemia. Immunohistochemistry revealed insulin and glucagon staining, which suggest the formation of insulin-producing cells."

The diabetes technologies licensed from Pitt by Genprex were developed in 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. "We are delighted with the statistically significant outcomes from this NHP study in Type-1 diabetes as it further supports our thesis on the potential of our gene therapy approach in diabetes. Importantly, it shows a positive data progression from our earlier mouse model data to these NHP data," noted Dr. Gittes.

"These promising data are very encouraging and further support our belief that this gene therapy approach to treating diabetes has the potential to change the course of the disease in both Type 1 and Type 2 diabetes," said Rodney Varner, President and Chief Executive Officer of Genprex. "Based on data from a number of preclinical in vivo studies, we are encouraged that our novel gene therapy approach could provide long-term efficacy in humans potentially making exogenous insulin unnecessary, which would be a gamechanger for the 537 million people around the world living with diabetes."

About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body. The Company's lead product candidate, REQORSA® (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Both NSCLC clinical programs received a Fast Track Designation from the Food and Drug Administration. Genprex's diabetes gene therapy approach 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. 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. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.

For more information, please visit the Company's web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements
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. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2021.

Because forward-looking 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 timing and success of Genprex's pre-clinical development programs, clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status; Genprex's commercial and strategic partnerships, including those with its third party manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

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