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Genprex Announces Safety Review Committee Approves Dose Escalation in Acclaim-1 Phase 1/2 Trial of REQORSA™ in Combination with Tagrisso® in Non-Small Cell Lung Cancer
Recommends Advancing Acclaim-1 to Increased Dose in Second Cohort of Phase 1 Portion of Trial AUSTIN, Texas, Aug. 15, 2022 /PRNewswire/ -- Genprex, Inc.
About this update from Genprex, Inc.
[{"type":"text","content":"Recommends Advancing Acclaim-1 to Increased Dose in Second Cohort of Phase 1 Portion of Trial\nAUSTIN, Texas, Aug. 15, 2022 /PRNewswire/ -- 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, today announced that the Safety Review Committee (SRC) has approved continuation of the Acclaim-1 Phase 1/2 clinical trial of REQORSA™ in combination with Tagrisso® (osimertinib) to treat late-stage non-small cell lung cancer (NSCLC) following a review of the first cohort of patients in the Phase 1 portion of the trial. In 2020, Genprex received U.S. Food and Drug Administration's (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.\n\n \n \n \n \n \n \n\n \nAcclaim-1 is 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. \n\"The SRC approval to advance Acclaim-1 to the higher dose in the second cohort of patients is an important milestone that further supports REQORSA's safety profile and brings us one step closer to bringing this potentially ground-breaking gene therapy approach to treating NSCLC to the patients who need it most,\" said Mark Berger, M.D., Chief Medical Officer of Genprex. \"Enrollment in Acclaim-1 remains on track to complete the Phase 1 portion of the study by year end.\" \nThe Accaim-1 trial includes up to three sequential dose escalation cohorts that will be treated with REQORSA intravenously on Day 1 in addition to osimertinib 80 mg fixed dose oral daily tablet during 21-day treatment cycles until disease progression or unacceptable toxicity. The first group received REQORSA IV infusion at 0.06 mg/kg, the second group will receive 0.09 mg/kg and the third will receive 0.12 mg/kg (if approved by the SRC) in order to identify the recommended Phase 2 dose. \n\"REQORSA is a pan-kinase inhibitor shown to inhibit both the EGFR and AKT oncogenic kinase pathways. We believe that REQORSA's multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops,\" added Dr. Berger. \"Confirmation...