Company Achieves Clinical Development Milestones in 2025, Advances Program for Future Scale Up and Studies
AUSTIN, Texas, Jan. 7, 2026 /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 a clinical program update on its diabetes gene therapy program for GPX-002, the Company's diabetes gene therapy drug candidate, detailing recent achievements and future advancements. This update follows the recent announcement of positive preliminary preclinical data from studies of GPX-002 in both mouse and non-human primate (NHP) models, specifically addressing Type 2 diabetes (T2D).
"This past year was instrumental for Genprex as we expanded our preclinical research beyond Type 1 diabetes and into Type 2 diabetes, marking the achievement of a significant milestone in our diabetes gene therapy program, including the successful initiation of preclinical research in Type 2 diabetic animal models," said Ryan Confer, President and Chief Executive Officer. "Furthermore, we have successfully executed our strategic plan to transfer production of GPX-002 to an experienced Contract Development and Manufacturing Organization (CDMO) and to submit a request to the FDA for a meeting regarding our Investigational New Drug (IND)-enabling studies, marking a pivotal step toward human clinical trials."
The Company has achieved important milestones within its diabetes program in 2025, marking progress in its clinical drug development. These include:
- Expansion of Research: Genprex commenced preclinical studies in T2D animal models, broadening the scope of its investigational studies beyond T1D. This step allows for an augmented, comprehensive evaluation of GPX-002's effects in relevant disease models. Moreover, preliminary preclinical data demonstrated in vivo proof-of-concept for the novel diabetes gene therapy in T2D animal studies, where GPX-002 rejuvenated exhausted beta cells and normalized glucose levels.
- Regulatory Engagement: Genprex has executed its strategy to submit a meeting request to the U.S. Food and Drug Administration (FDA) by the end of 2025. This meeting, which is scheduled to occur in the first quarter of 2026, is intended to discuss the necessary IND-enabling preclinical studies, a critical step before potentially initiating clinical trials in humans.
- Technology Transfer: Genprex has successfully transferred the manufacturing process for the production of GPX-002 from its academic collaborators where it was previously manufactured, to an experienced, integrated network of CDMOs and other vendors.
These advancements underscore the progression of Genprex's diabetes gene therapy program, moving its lead candidate through the stages of preclinical evaluation and regulatory planning. Looking ahead, the Company is preparing for necessary next steps to advance GPX-002, including:
- Manufacturing Scale Up: The Company plans to begin the clinical scale production of GPX-002 in a current Good Manufacturing Practices (cGMP) compliant facility, allowing Genprex to accelerate its manufacturing processes necessary for IND-enabling preclinical studies and clinical trials.
- Product Optimization: Genprex is continuing work with CDMOs and research partners to optimize constructs and evaluate an alternative second-generation approach for GPX-002 using a non-viral lipid nanoparticle delivery system.
- Toxicology Studies: Following the FDA interaction, Genprex will finalize the design and initiate toxicology studies. Subsequent data from the toxicology studies are expected to enable IND filing. Toxicology studies are a required step of drug development, ensuring that new treatments are safe and effective for human use while identifying potential risks, determining safe dosages and monitoring for side effects.
GPX-002 is under development as a potential treatment for both T1D and T2D. In T1D, GPX-002 is designed to work by transforming alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In vivo, preclinical studies show that GPX-002 restored normal blood glucose levels for an extended period of time in T1D mouse models. In T1D NHP in vivo models, GPX-002 demonstrated the ability to decrease insulin requirements, increase c-peptide levels and improve glucose tolerance.
In a similar approach for T2D, where autoimmunity is not at play, GPX-002 demonstrated the ability to replenish and rejuvenate exhausted beta cells that make insulin in both mouse and NHP models.
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 systemic, non-viral Oncoprex® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an 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 may be distinct enough from beta cells to evade the body's immune system. In a similar approach for Type 2 diabetes, where autoimmunity is not at play, GPX-002 is believed to rejuvenate and replenish exhausted beta cells.
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website, registering for Email Alerts and by following 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, 2024.
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: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications, including anticipated manufacturing scale-up and technology transfer of GPX-002; the timing and success of Genprex's clinical trials, its intended regulatory submissions and any resulting regulatory approvals, including the outcome of an upcoming meeting with the FDA and potential future toxicology studies as well as the Company's beliefs about the anticipated effects of GPX-002 and its potential as a therapeutic approach; 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, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; Genprex's intellectual property and licenses; and Genprex's current expectations, estimates, forecasts and projections about the industry and markets in which it operates.
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.
Genprex, Inc.
(877) 774-GNPX (4679)
GNPX Investor Relations
investors@genprex.com
GNPX Media Contact
Kalyn Dabbs
media@genprex.com
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SOURCE Genprex, Inc.
