Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Portion of Acclaim-3 Clinical Trial of Reqorsa® Gene Therapy in Combination with Tecentriq® in Extensive Stage Small Cell Lung Cancer

Core Insights - Genprex has completed the Phase 1 dose escalation portion of the Acclaim-3 clinical trial for Reqorsa® Gene Therapy in combination with Tecentriq® for treating extensive stage small cell lung cancer (ES-SCLC) [1][9] - The Safety Review Committee (SRC) has approved the transition to the Phase 2 expansion portion of the trial, which is now open for enrollment [1][3] Company Developments - The combination of Reqorsa and Tecentriq has received FDA Fast Track Designation and Orphan Drug Designation for SCLC treatment [2] - The Recommended Phase 2 Dose (RP2D) of Reqorsa is set at 0.12 mg/kg, the highest dose level from Phase 1, with no dose limiting toxicities reported [3][6] - The Phase 2 expansion will enroll approximately 50 patients across 10 to 15 U.S. sites, focusing on the 18-week progression-free survival rate as the primary endpoint [7] Clinical Trial Insights - The Phase 1 trial demonstrated a partial remission in the first patient treated, with a 30% decrease in tumor size after four cycles of maintenance therapy [4] - Data from humanized mouse models indicate that the combination of Reqorsa and Tecentriq significantly improves tumor control compared to either agent alone [8] - The Acclaim-3 trial is designed to evaluate Reqorsa as maintenance therapy for patients who did not experience tumor progression after initial treatment [9] Future Outlook - The company anticipates promising enrollment rates for the Phase 2 portion of the trial and plans to present Phase 1 results at a clinical meeting in 2025 [4] - Genprex is focused on developing innovative therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System for gene therapy applications [10]