Genprex Secures Canadian Patent Allowance for REQORSA Gene Therapy Combined with PD-1/PD-L1 Antibodies in Lung Cancer Treatment

Genprex, Inc., a clinical-stage gene therapy company based in Austin, Texas, has received a Notice of Allowance from the Canadian Intellectual Property Office (CIPO) for a patent covering the use of its REQORSA® Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 or PD-L1 antibodies for treating both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex, emphasized that securing this patent strengthens the company’s intellectual property portfolio. He noted that it provides crucial protection for the therapeutic combinations currently being evaluated in the Acclaim-3 clinical trial, reinforcing Genprex’s competitive advantage and supporting its strategy to deliver innovative cancer treatments globally.

This Canadian patent allowance expands upon previously granted patents for REQORSA combined with PD-1 and PD-L1 antibodies in jurisdictions including the United States, Japan, Mexico, Russia, Chile, China, Singapore, Europe, South Korea, Australia, and Israel.

REQORSA is being developed initially in combination with approved cancer drugs to treat lung cancer. Preclinical studies have demonstrated that REQORSA complements targeted drugs and immunotherapies. Genprex believes REQORSA’s unique properties position it to potentially improve current therapies for lung cancer patients and possibly other cancer types.

Lung and bronchus cancer is the most commonly diagnosed cancer in Canada, excluding non-melanoma skin cancers, and is the leading cause of cancer death among both men and women. The Canadian Cancer Society estimates that 32,900 Canadians will be diagnosed with lung and bronchus cancer in 2026, representing 13% of all new cancer cases. It also projects 19,300 deaths from these cancers in 2026, accounting for 22% of all cancer fatalities in the country.

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.

In the trial, patients receive REQORSA and Tecentriq until disease progression or unacceptable toxicity occurs. The Phase 2 expansion follows a successful Phase 1 dose escalation that showed REQORSA was generally well tolerated. Approximately 50 patients are expected to enroll in Phase 2, with the primary endpoint being the 18-week progression-free survival rate from the start of maintenance therapy. Survival follow-up is also planned.

Genprex intends to conduct an interim analysis after the 25th patient enrolled reaches 18 weeks of follow-up. The Acclaim-3 trial benefits from U.S. Food and Drug Administration (FDA) Fast Track Designation and Orphan Drug Designation.

Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Delivery System, which encapsulates gene-expressing plasmids in lipid-based nanoparticles (lipoplexes). Administered intravenously, the therapy targets tumor cells to express tumor suppressor proteins deficient in the cancer.

REQORSA is the company’s lead product candidate and is currently being evaluated in two clinical trials for NSCLC and SCLC. Both lung cancer programs have received FDA Fast Track Designations, and the SCLC program holds an FDA Orphan Drug Designation.

Beyond oncology, Genprex is developing gene therapy approaches for diabetes using an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In Type 1 diabetes models, GPX-002 converts pancreatic alpha cells into functional beta-like cells capable of insulin production, potentially evading immune system attack. For Type 2 diabetes, GPX-002 aims to rejuvenate and replenish exhausted beta cells.

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Genprex cautions that forward-looking statements in its communications are subject to risks and uncertainties, including clinical development timelines, regulatory approvals, and market conditions. Actual results may differ materially from those expressed or implied. The company disclaims any obligation to update forward-looking statements except as required by law.