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Genprex Receives Safety Review Committee Approval to Proceed to Final Cohort in Acclaim-1 Phase 1 Dose Escalation Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer
Recommendation to Advance to Increased Dose in Third and Final Cohort of Phase 1 Portion of Trial Indicates Favorable Safety Profile of Novel Gene Therapy in
About this update from Genprex, Inc.
[{"type":"text","content":"Recommendation to Advance to Increased Dose in Third and Final Cohort of Phase 1 Portion of Trial Indicates Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer\nAUSTIN, Texas, Dec. 14, 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 to the third and final cohort in the dose escalation Phase 1 portion 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). In 2020, the combination of REQORSA and osimertinib 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.\nThe SRC is comprised of three physicians who are principal investigators in the trial. The SRC may recommend that the trial continues at the same dose or at a lower dose, that it escalates to a higher dose, or that the study be terminated altogether due to safety concerns.\n\"The SRC's recommendation to increase the dosing of REQORSA is further confirmation of its favorable safety profile and it enables us to advance Acclaim-1 into the final cohort of the Phase 1 dose escalation portion of the study,\" said Mark Berger, M.D., Chief Medical Officer of Genprex. \"We look forward to completing enrollment of this final cohort in the first quarter of 2023.\"\nThe Accaim-1 trial includes up to three sequential dose escalation cohorts that will treat study participants 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 received 0.09 mg/kg, and the third group will receive 0.12 mg/kg. \nFollowing successful completion of the Phase 1 dose ...