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Genprex Announces the Opening for Enrollment of its Phase 1/2 Acclaim-2 Clinical Trial of REQORSA™ Immunogene Therapy in Combination With Keytruda® to Treat Non-Small Cell Lung Cancer
Company Has FDA Fast Track Designation for Combination of REQORSA and Keytruda AUSTIN, Texas--(BUSINESS WIRE)-- Genprex, Inc. (“Genprex” or the “Company”)
About this update from Genprex, Inc.
[{"type":"text","content":"\nCompany Has FDA Fast Track Designation for Combination of REQORSA and Keytruda\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nGenprex, 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, today announced the opening for patient enrollment of its Acclaim-2 clinical trial. 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. In 2021, Genprex received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.\n\n“We are pleased to have opened Acclaim-2 for patient enrollment and expect to promptly begin screening patients for their eligibility to participate in the trial,” stated Mark S. Berger, M.D., Chief Medical Officer of Genprex. “This marks an important milestone in our clinical development program for REQORSA as we continue to engage with prestigious clinical trial sites to build patient enrollment and provide hope to lung cancer patients who suffer from this devastating disease and who are in desperate need of new treatment options. We look forward to completing the Phase 1 portion of Acclaim-2 by the end of the first quarter of 2023 and to generating data to show the synergistic effects REQORSA combined with immunotherapies can have in patients.”\n\nPreviously presented preclinical data have shown synergy between REQORSA and Keytruda. Those data showed that REQORSA combined with the checkpoint inhibitor Keytruda was more effective than Keytruda alone in increasing the survival of mice with a humanized immune system that had metastatic lung cancer. Those studies in mice with a humanized immune system also documented multiple effects of REQORSA on the immune system, such as an increase in Natural Killer cells and a decrease in myeloid derived suppressor cells in the tumor, that are likely to contribute to the synergy seen with Keytruda.\n\nThe Company expects the Phase 1 portion of the Acclaim-2 trial to enroll up to 30 patients in a dose escalation study to determine the maximum tolerated dose of the combinat...