June 22 2026 —
Genprex announced that the Canadian Intellectual Property Office has issued a Notice of Allowance for a patent covering the use of REQORSA® Gene Therapy, also known as quaratusugene ozeplasmid, in combination with PD-1 or PD-L1 antibodies for the treatment of both non-small cell lung cancer, or NSCLC, and small cell lung cancer, or SCLC.
The newly allowed Canadian patent expands Genprex’s intellectual property portfolio for REQORSA-based immunotherapy combinations. Similar patents have previously been granted in multiple regions, including the United States, Europe, Japan, China, Korea, Australia, Israel, Singapore, Mexico, Russia, and Chile.
REQORSA is Genprex’s lead oncology gene therapy candidate. It uses a plasmid containing the TUSC2 gene encapsulated in positively charged, non-viral lipid nanoparticles through the company’s Oncoprex® Delivery System. Administered intravenously, REQORSA is designed to specifically target and deliver a functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue.
The TUSC2 gene is a tumor suppressor gene that is often deficient or inactive in cancer cells. By delivering a functional copy of TUSC2, REQORSA is designed to restore tumor suppressor activity and support anti-cancer effects. In vitro studies at MD Anderson showed 10- to 33-fold greater TUSC2 uptake in tumor cells compared with normal cells after REQORSA treatment.
The Canadian patent is relevant to Genprex’s Acclaim-3 clinical trial, which is evaluating REQORSA in combination with Tecentriq®, also known as atezolizumab, Genentech’s PD-L1 antibody. Acclaim-3 is a Phase 1/2 study assessing the combination as maintenance therapy in patients with extensive-stage small cell lung cancer, or ES-SCLC, who are candidates for maintenance treatment after receiving Tecentriq and chemotherapy as standard-of-care initial therapy.
The Phase 1 dose-escalation portion of Acclaim-3 has been completed and showed that REQORSA was generally well tolerated. The Phase 2 expansion portion is expected to enroll approximately 50 patients. Its primary endpoint is the 18-week progression-free survival rate from the start of maintenance therapy with REQORSA and Tecentriq. Patients will also be followed for overall survival, and Genprex plans to conduct an interim analysis after the 25th enrolled and treated patient reaches 18 weeks of follow-up.
The Acclaim-3 program is supported by FDA Fast Track Designation and Orphan Drug Designation for the SCLC indication. Genprex is also evaluating REQORSA in clinical development for NSCLC, and the company believes the therapy may complement approved targeted therapies and immunotherapies based on preclinical findings.
Lung cancer remains a major unmet medical need globally and in Canada. According to the Canadian Cancer Society, lung and bronchus cancer is expected to be the most commonly diagnosed cancer in Canada in 2026, excluding non-melanoma skin cancers, and the leading cause of cancer death for both men and women.
Beyond oncology, Genprex is also developing a diabetes gene therapy program using an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. The approach is designed to reprogram pancreatic cells to restore insulin-producing function in models of Type 1 and Type 2 diabetes.
The Canadian patent allowance strengthens Genprex’s intellectual property position as it advances REQORSA-based combination strategies in lung cancer and continues building a broader gene therapy pipeline across oncology and metabolic disease.
