Business
Genprex Receives U.S. FDA Fast Track Designation for REQORSA® Immunogene Therapy in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer
Third FDA Fast Track Designation Further Validates the Potential of REQORSA AUSTIN, Texas, June 28, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the
About this update from Genprex, Inc.
[{"type":"text","content":"Third FDA Fast Track Designation Further Validates the Potential of REQORSA\nAUSTIN, Texas, June 28, 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company's lead drug candidate, REQORSA® Immunogene Therapy, in combination with Genentech, Inc.'s Tecentriq® in patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.\n\n \n \n \n \n \n \n\n \nIn the third quarter of 2023, Genprex expects to enroll the first patient in its Acclaim-3 clinical trial, which is a Phase 1/2 dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq for this patient population. The Company has previously received two other FTDs for REQORSA, for REQORSA in combination with AstraZeneca PLC's Tagrisso® in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso, and for REQORSA in combination with Merck & Co's Keytruda® in patients with late-stage NSCLC whose disease progressed after treatment with Keytruda.\n\"We are very pleased to receive a third Fast Track Designation from the FDA for REQORSA, this time for patients with ES-SCLC in combination with the checkpoint inhibitor Tecentriq,\" said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. \"This is another exciting achievement in our REQORSA development program, which further validates REQORSA's potential not only in NSCLC but also in SCLC. We look forward to accelerating the clinical development of REQORSA, and potentially providing a new treatment option for patients with SCLC.\"\nTumor suppressor genes are deleted or inactivated early in the process of cancer development. REQORSA contains a plasmid that expresses a tumor suppressor gene named TUSC2. Virtually 100% of small cell lung cancers express decreased amounts of TUSC2 tumor suppressor protein, and 41% completely lack TUSC2 protein expression. ES-SCLC has a very poor prognosis, with a median progression free survival (PFS...