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Data from Genprex's Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer
Prnewswire· 2025-11-24 12:00
Core Viewpoint - Genprex, Inc. announced the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy in combination with Tagrisso for advanced non-small cell lung cancer, highlighting promising safety and early efficacy results [1][2][3]. Group 1: Clinical Trial Details - The Acclaim-1 trial is an open-label, multi-center Phase 1/2 study evaluating Reqorsa in combination with osimertinib in patients with late-stage NSCLC who have progressed after osimertinib treatment [2][3]. - The trial's dose escalation portion primarily assessed safety, establishing a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg with no Dose Limiting Toxicities (DLTs) reported [3][8]. Group 2: Patient Outcomes - Among the 12 patients treated, three experienced prolonged time to progression, including one with a continuing partial response after 47 cycles over 32 months [4][5]. - Specific patient outcomes included one patient achieving partial remission after extensive prior treatments and continuing treatment for over three years [5][6]. Group 3: Safety Profile - Reqorsa administration was generally well tolerated, with no DLTs and manageable infusion-related reactions similar to those seen with antibody treatments [8][10]. - Symptoms from infusion-related reactions were effectively managed with prophylactic medications [8]. Group 4: Company Overview - Genprex, Inc. focuses on developing gene therapies for cancer and diabetes, utilizing a non-viral Oncoprex Delivery System to administer disease-fighting genes [9][10]. - The company's lead product, Reqorsa, is under evaluation for NSCLC and small cell lung cancer (SCLC), with both programs receiving Fast Track Designation from the FDA [10].