On February 10, 2026 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, reported that IP Australia, the Australian government agency responsible for administering Australia’s intellectual property rights system, has issued a Notice of Acceptance, on February 5, 2026, of the Genprex patent application claiming the use of Reqorsa Gene Therapy in combination with PD-L1 antibodies for the treatment of cancers. The subject claims have been successfully granted in other countries. Should the patent grant, it will strengthen Genprex’s intellectual property portfolio, providing crucial protection for the therapeutic combination currently being evaluated in the Acclaim-3 clinical trial.
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"The intent to grant a new patent by IP Australia for Reqorsa Gene Therapy in combination with PD-L1 antibodies is a pivotal development for Genprex, further bolstering the intellectual property surrounding our innovative therapeutic approach," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. "This patent specifically provides additional protection for the therapeutic combination currently being evaluated in our Acclaim-3 clinical trial, underscoring our commitment to advancing cancer treatment."
A granted patent will secure exclusivity for this drug combination in Australia, preventing potential competitors from manufacturing, using or selling it. Such exclusivity is vital for protecting the significant investments made in research and development, ensuring that Genprex can continue to pursue and commercialize its novel therapeutic approaches without immediate competitive infringement in this specific combination.
The grant of a patent will build upon Genprex’s existing intellectual property foundation, which includes granted patents for the use of REQORSA in combination with PD-L1 antibodies in the U.S. and Korea. Genprex is actively pursuing additional patent applications in key international markets, including Europe, Canada, Brazil, China and Israel. This comprehensive patent strategy is designed to safeguard the company’s innovations and maximize the potential of its pipeline assets.
In addition, the Company has also recently opened an additional clinical trial site for the Acclaim-3 clinical trial to include the University of Kentucky. The Company expects to add and open additional clinical trial sites for its Acclaim clinical trials in an effort to expand its reach to additional patients and expedite enrollment. These developments further underscore Genprex’s commitment to protecting and expeditiously advancing its clinical trials in lung cancer.
About Acclaim-3
Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of REQORSA and Genentech’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as standard of care initial treatment. In this study, patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.
The Phase 2 expansion study follows the successful completion of the Phase 1 dose escalation portion of the study, which showed REQORSA was generally well tolerated. There were no dose limiting toxicities, and in Acclaim-3, the Phase 2 patients are receiving the same dose of REQORSA as patients in the Phase 2 portion of Acclaim-1.
The Phase 2 expansion portion is expected to enroll approximately 50 patients. The primary endpoint of the Phase 2 portion is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. Genprex’s team plans to conduct an interim analysis after the 25th patient enrolled and treated reaches 18 weeks of follow up. The Company expects to complete enrollment of the first 25 patients for interim analysis in the Phase 2 expansion portion of the study in the first half of 2026 and expects the interim analysis in the second half of 2026. The Acclaim-3 clinical trial is supported by FDA Fast Track Designation and Orphan Drug Designation.
(Press release, Genprex, FEB 10, 2026, View Source [SID1234662564])