Thursday, June 29, 2023
Genprex, Inc. a clinical-stage gene therapy company, has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its lead drug candidate, REQORSA® Immunogene Therapy. The FTD is granted for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients who have not experienced tumor progression after receiving Tecentriq® and chemotherapy as initial standard treatment.
Genprex plans to initiate the Acclaim-3 clinical trial in the third quarter of 2023. The trial will evaluate REQORSA in combination with Tecentriq as a maintenance therapy for ES-SCLC patients. REQORSA has previously received FTD for its use in combination with other medications for the treatment of late-stage non-small cell lung cancer (NSCLC).
Rodney Varner, President, Chairman, and CEO of Genprex, expressed satisfaction with the FDA's FTD, emphasizing the potential of REQORSA in treating both NSCLC and SCLC. The company aims to accelerate the clinical development of REQORSA and provide a new treatment option for SCLC patients.
REQORSA contains a plasmid that expresses the tumor suppressor gene TUSC2, which is often reduced or absent in small cell lung cancers. ES-SCLC has a poor prognosis, and there is a need for improvement in maintenance therapy. The Acclaim-3 trial will focus on evaluating the efficacy of REQORSA and Tecentriq as maintenance therapy, targeting ES-SCLC patients who have shown a response or stable disease after initial treatment with carboplatin, etoposide, and Tecentriq.
The Acclaim-3 trial consists of a Phase 1 dose escalation portion and a Phase 2 portion. The Phase 1 portion aims to determine the Maximum Tolerated Dose (MTD) of REQORSA and Tecentriq, while the Phase 2 portion will evaluate the 18-week progression-free survival rate as the primary endpoint.
Fast Track Designation by the FDA is granted to expedite the development and review process of drugs that address unmet medical needs for serious or life-threatening conditions. Genprex's REQORSA has shown promise in clinical trials, and the FTD designation will facilitate its potential approval and availability for ES-SCLC patients.