Phase 1 Study in Non-Small Cell Lung Cancer Combined Reqorsa® Gene Therapy with Tagrisso®
AUSTIN, Texas, Nov. 24, 2025 /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 the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with Tagrisso® (osimertinib) in patients with advanced non-small cell lung cancer (NSCLC) in the peer-reviewed journal Clinical Lung Cancer.
"We believe REQORSA is an innovative gene therapy that may benefit many lung cancer patients, and we are pleased to see these data for REQORSA published and shared with the scientific community," said Ryan Confer, President and Chief Executive Officer at Genprex. "Genprex is thankful to the patients who participated in this study, along with the investigators who made the completion of the study possible. We believe this new mechanism and novel approach targeting lung cancer, which comes with a strong safety profile and early signs of efficacy, is paving new ground in the fight against lung cancer."
The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with osimertinib in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with osimertinib (osimertinib monotherapy or osimertinib combination therapy).
The Phase 1 dose escalation portion of the trial was designed primarily to assess safety, however, the Company believes promising efficacy results were also observed. The reported results showed no Dose Limiting Toxicities (DLTs), established a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg (the highest dose level administered in the trial) and provided data showing early efficacy of REQORSA in combination with osimertinib.
Of the 12 patients treated with escalating doses of REQORSA and standard doses of osimertinib, all of whom had progressed on osimertinib containing regimens, three patients had experienced prolonged time to progression, including one with continuing partial response.
Specifically, one patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed and osimertinib, had a partial remission by investigator evaluation, and as of the data from April 2025 used in the published manuscript had continued to receive study treatment for 47 cycles over 32 months. The patient continues to receive REQORSA and osimertinib treatment in the trial more than three years after enrolling.
A second patient at the 0.12 mg/kg dose level who was previously treated with cisplatin, pemetrexed, carboplatin and osimertinib had stable disease and received REQORSA for 32 cycles, or approximately 24 months, until disease progression occurred.
A third patient who was at the 0.09 mg/kg dose level, previously treated with osimertinib, had stable disease and received 14 cycles over approximately 10 months before disease progression occurred.
The extended Progression Free Survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early-stage clinical trials of REQORSA and is not expected with treatment with osimertinib alone after progression on osimertinib.
REQORSA administration was generally well tolerated and there were no DLTs. The administration was associated with a delayed infusion-related reaction of muscle aches, fever and chills in some patients, which we believe is similar to reactions seen with the administration of antibodies routinely used in oncology treatment. This was managed with prophylactic steroids, acetaminophen and diphenhydramine, and symptoms decreased with repeat cycles.
To read the article published in Clinical Lung Cancer, click here.
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.
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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; the timing and success of Genprex's clinical trials, its intended regulatory submissions and any resulting regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; including as a potential treatment for patients with late-stage NSCLC with activating EGFR mutations whose disease progressed after treatment with osimertinib; 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.
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