On August 16, 2022 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 the United States Patent and Trademark Office (USPTO) has granted Genprex U.S. Patent No: 11,278,592 B2 (Press release, Genprex, AUG 16, 2022, View Source [SID1234618426]). The patent covers methods of using REQORSATM Immunogene Therapy in conjunction with immune checkpoint inhibitors, through 2038.
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"This new patent provides critical protection for our REQORSA gene therapy in combination with a checkpoint inhibitor, for example an anti-PD1 antibody, to treat cancer. This is important as our ongoing Acclaim-2 Phase 1/2 clinical trial combines REQORSA with Keytruda, an anti-PD1 antibody, to treat non-small cell lung cancer," noted Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "We continue to strengthen our intellectual property portfolio and continue to build protection around our technology as it safeguards our gene therapy with target-specific combination therapy, is a deterrent to would-be competitors and creates value around our core competencies."
Acclaim-2 is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA Immunogene Therapy, in combination with Keytruda (pembrolizumab) in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda. More information on Acclaim-2 can be found at www.clinicaltrials.gov Identifier NCT05062980.
In 2021, Genprex received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-2 patient population.
Keytruda is a registered trademark of Merck & Co. and is its largest selling drug with 2021 sales of more than $17 billion.
About Acclaim-2
The Acclaim-2 trial is a Phase 1/2 open-label, dose-escalation and clinical response study of REQORSA in combination with Keytruda in patients with advanced, metastatic non-small-cell lung cancer who have progressed after treatment with Keytruda. The Company anticipates enrolling patients at approximately 15 clinical sites and estimates that the Phase 1 portion of the Acclaim-2 trial will enroll up to 30 patients and the Phase 2 portion will enroll approximately 126 patients. Patients enrolled in the Phase 2 portion of the study will be randomized 2:1 to either REQORSA and Keytruda combination therapy or to chemotherapy (docetaxel with or without ramucirumab). Patients will be treated until disease progression or unacceptable toxicity is experienced. Patients must have histologically confirmed unresectable stage III or IV NSCLC (any histology) with radiological progression on Keytruda and an ECOG performance status of 0 to 1. Genprex expects to complete the Phase 1 portion of Acclaim-2 by mid-2023.
About REQORSA
REQORSA Immunogene Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC) uses Genprex’s unique, proprietary ONCOPREX Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials. The active ingredient in REQORSA is the TUSC2 gene, a tumor suppressor gene. REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a net positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.
Tagrisso is a registered trademark of AstraZeneca plc and its largest selling drug with 2021 sales of over $5 billion.