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Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Expansion Portion of Acclaim-1 Clinical Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer
Results from Phase 1 Portion Indicate Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer AUSTIN, Texas, May 30, 2023 /PRNewswire/ --
About this update from Genprex, Inc.
[{"type":"text","content":"Results from Phase 1 Portion Indicate Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer\nAUSTIN, Texas, May 30, 2023 /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 it has completed the 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), and the Safety Review Committee (SRC) has approved continuation to the Phase 2 expansion portion of the trial. 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 \nBased on full safety data which showed no dose limiting toxicities, the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in Genprex's prior clinical trial combining REQORSA with Tarceva® for the treatment of late-stage lung cancer. The SRC also recommended the trial advance to the Phase 2 expansion portion of the study, which the Company expects to begin in the third quarter of 2023.\n\"We are proud of the notable progress we made during the Phase 1 portion of the Acclaim-1 clinical trial, and the SRC recommendation to move into the Phase 2 expansion portion of the trial is another validation for our REQORSA development program,\" said Rodney Varner, Chairman, President and Chief Executive Officer of Genprex. \"As we move into the Phase 2 expansion portion of the trial, we remain steadfast in our efforts to bring new therapies to lung cancer patients with unmet medical need.\"\nGenprex recently announced positive preliminary clinical data from the Phase 1 dose escalation portion of its Acclaim-1 clinical trial in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The results showed that REQORSA was generally well tolerated, and there were no dose limiting toxicities. Genprex also reported that encouraging evidence of efficacy was observed in the Phase 1 portion of the study. The full abstract can be accessed...