Genprex, Inc. is a clinical-stage gene therapy company and has announced the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the drug, Reqorsa Immunogene Therapy (quratusugene ozeplasmid) for the treatment of small cell lung cancer. Earlier in June 202e, FDA granted Fast Track Designation for Reqorsa Immunogene Therapy, in combination with Tecentriq in patients with extensive-stage small cell lung cancer who did not develop tumor progression after receiving Tecentriq and chemotherapy as an initial standard treatment.
REQORSA has a plasmid that expresses a tumor suppressor gene protein and this is called TUSC2. Virtually, all of small cell lung cancers reduced or to no TUSC2 protein expression and 41% lack TUSC2 protein expression. The studies suggested that re-expressing TUSC2 protein may lead to clinical efficacy. The combination of quratusugene ozeplasmid and atezolizumab is being evaluated as a maintenance therapy in patients with ES-SCLC. REQORSA is being evaluated in three clinical trials as a treatment for non-small cell lung cancer and small cell lung cancer.
Genprex president, chairman and CEO Rodney Varner said: “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,” he added.
ODD status is granted by FDA to investigational therapies developed to treat, diagnose or prevent a rare condition affecting less than 200,000 people in the United States. With ODD status, the drug developers receives some benefits like assistance in drug development process, waiver of certain FDA fees, tax credits for qualified trails and potential for seven years of post-approval marketing exclusivity.
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