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Genprex Announces First Patient Dosed in Phase 1/2 Acclaim-1 Clinical Trial of REQORSA™ Immunogene Therapy in Combination with Tagrisso® to Treat Non-Small Cell Lung Cancer
Company has FDA Fast Track Designation for combination of REQORSA and Tagrisso Preclinical Data Presented at American Association of Clinical Research (AACR)
About this update from Genprex, Inc.
[{"type":"text","content":"\nCompany has FDA Fast Track Designation for combination of REQORSA and Tagrisso\n\nPreclinical Data Presented at American Association of Clinical Research (AACR) 2021 Showed That REQORSA Can Overcome Resistance to Tagrisso\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 that the first patient was dosed in the Acclaim-1 clinical trial, an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combination with Tagrisso® (osimertinib) in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso. In 2020, Genprex received U.S. Food and Drug Adminstration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.\n\n“This is an exciting milestone for Genprex that we believe brings us one step closer to achieving our goal to validate the potential benefits of REQORSA in NSCLC patients who have life-limiting disease and few treatment options,” stated Mark S. Berger, M.D., Chief Medical Officer of Genprex. “Based on both the preclinical data and previous clinical data, REQORSA has the potential to improve the response to current targeted therapies, such as Tagrisso, for this study patient population. We look forward to continuing to advance this important trial.\"\n\nThe Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor (“EGFR”) mutations whose disease progressed after treatment with Tagrisso. Genprex expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients in a dose escalation study to determine the maximum tolerated dose of the combination. The Phase 2 portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or Tagrisso monotherapy. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An inte...