
Core Insights - Genprex, Inc. has initiated the Phase 2 expansion of the Acclaim-3 clinical study for Reqorsa® Gene Therapy in combination with Tecentriq® for extensive stage small cell lung cancer (ES-SCLC) patients [1][2] - The study aims to determine the 18-week progression-free survival (PFS) rate, with a median PFS of 5.2 months for ES-SCLC and 2.6 months for those receiving Tecentriq as maintenance therapy [2] - The FDA has granted Fast Track and Orphan Drug Designations for Reqorsa, indicating its potential significance in treating SCLC [3] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a novel cancer treatment platform that re-expresses tumor suppressor genes [4][7] - The lead product candidate, Reqorsa, is being evaluated in clinical trials for both non-small cell lung cancer (NSCLC) and SCLC, with Fast Track Designation from the FDA for both programs [8] Clinical Study Details - The Acclaim-3 trial is an open-label, multi-center Phase 1/2 study evaluating Reqorsa in combination with Tecentriq as maintenance therapy for ES-SCLC patients who did not progress after initial treatment [6] - The Phase 2 expansion will enroll 50 patients across 10 to 15 U.S. sites, with an interim analysis planned after the first 25 patients complete 18 weeks of follow-up [2][5] Research Findings - Data from studies presented at the October 2023 AACR-NCI-EORTC conference indicate that the combination of Reqorsa and Tecentriq shows significantly better tumor control compared to either agent alone [5]