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Genprex Granted FDA Orphan Drug Designation (ODD) for REQORSA® Immunogene Therapy for the Treatment of Small Cell Lung Cancer
ODD is in addition to Three FDA Fast Track Designations Genprex expects to dose the first patient in the Acclaim-3 clinical trial in the fourth quarter of
About this update from Genprex, Inc.
[{"type":"text","content":"ODD is in addition to Three FDA Fast Track Designations\nGenprex expects to dose the first patient in the Acclaim-3 clinical trial in the fourth quarter of 2023 \nAUSTIN, Texas, Aug. 10, 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 the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company's lead drug candidate, REQORSA® Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC). \n\n \n \n \n \n \n \n\n \nIn addition to ODD for the treatment of SCLC, in June 2023, the FDA granted Fast Track Designation (FTD) for 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. With ES-SCLC, the cancer has spread from one lung to the other, or to other parts of the body. Extensive-stage is the most common type of SCLC. FDA has also granted Genprex FTD for two other indications of REQORSA Immunogene Therapy, including REQORSA in combination with Tagrisso for non-small cell lung cancer (NSCLC) in patients who have progressed after Tagrisso treatment, and REQORSA in combination with Keytruda for NSCLC in patients who have progressed after Keytruda treatment.\n\"We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC,\" said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. \"This FDA Orphan Drug Designation in combination with our recently received FDA Fast Track designation underscores the great need for better treatment options for patients with SCLC,ES-SCLC and NSCLC. We look forward to initiating the Acclaim-3 clinical trial expected in the fourth quarter of 2023 in order to bring hope of an effective new therapy to patients suffering with this life-limiting cancer.\"\nThe FDA grants ODD status to investigational therapies being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Further, ODD provides benefits to drug developers, includin...