Genprex Secures Key Japanese and European Patents for REQORSA Gene Therapy Combined with Immunotherapies in Cancer Treatment

Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company specializing in cancer and diabetes treatments, announced on February 23, 2026, that it has received a favorable Appeal Decision from the Japanese Patent Office granting a patent for the use of its REQORSA® Gene Therapy in combination with PD-L1 antibodies to treat cancer. Concurrently, the European Patent Office issued a Decision to Grant a patent covering the combination of REQORSA with PD-1 antibodies for cancer treatment. Genprex holds exclusive licenses to these patents, which significantly enhance its intellectual property portfolio in key global markets.

Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex, emphasized the importance of these developments: "The recent decisions by the Japanese Patent Office and European Patent Office to grant patents for our REQORSA gene therapy in combination with immunotherapies represent further validation for our innovative approach to cancer treatment. These patents will strengthen our global intellectual property portfolio, providing protection for therapeutic combinations, including our ongoing Acclaim-3 clinical trial."

These newly granted patents build upon Genprex’s existing IP framework. The company already holds granted patents for REQORSA combined with PD-L1 antibodies in the United States and Korea, with a patent pending in Australia. Additionally, Genprex possesses granted patents for the combination of REQORSA and PD-1 antibodies across multiple jurisdictions, including the U.S., Japan, Mexico, Russia, Australia, Chile, China, Singapore, and Europe. The recent Japanese and European grants further solidify the global patent landscape surrounding Genprex’s lead oncology drug candidate.

The Acclaim-3 clinical trial is a Phase 1/2 study evaluating the combination of REQORSA and Genentech’s Tecentriq® (atezolizumab) as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC). Eligible patients have completed initial treatment with Tecentriq and chemotherapy and are candidates for maintenance therapy. Participants receive REQORSA and Tecentriq until disease progression or unacceptable toxicity occurs.

The Phase 2 expansion follows a successful Phase 1 dose escalation that demonstrated REQORSA’s general tolerability with no dose-limiting toxicities. The Phase 2 portion plans to enroll approximately 50 patients, with the primary endpoint being the 18-week progression-free survival rate from the start of maintenance therapy. Survival will also be monitored. An interim analysis is scheduled after 25 patients have completed 18 weeks of follow-up, with enrollment completion and analysis expected in the first and second halves of 2026, respectively.

The Acclaim-3 trial benefits from FDA Fast Track Designation and Orphan Drug Designation, underscoring the potential significance of REQORSA in treating ES-SCLC.

Genprex’s oncology platform leverages its proprietary Oncoprex® Delivery System, a systemic, non-viral lipid nanoparticle technology that delivers gene-expressing plasmids intravenously. This approach enables tumor cells to express tumor suppressor proteins that are deficient in cancerous tissue. REQORSA (quaratusugene ozeplasmid) is the company’s lead gene therapy candidate and is currently under clinical evaluation for both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

Beyond oncology, Genprex is developing gene therapies for diabetes, including GPX-002, which uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. This therapy aims to transform pancreatic alpha cells into insulin-producing beta-like cells in Type 1 diabetes and rejuvenate beta cells in Type 2 diabetes.

Investors and stakeholders are encouraged to follow Genprex’s updates via its website and social media channels.

This announcement contains forward-looking statements subject to risks and uncertainties as detailed in Genprex’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2024. Actual results may differ materially from those expressed or implied herein.