Benzinga | Jan 3, 2022 08:03AM EST

Genprex Receives FDA Fast Track Designation For REQORSA Immunogene Therapy In Combination With Keytruda For Treatment Of Non-Small Cell Lung Cancer

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(tm) Immunogene Therapy, in combination with Merck & Co's Keytruda(r) in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda. In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, which is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Keytruda, for this patient population. The Company previously received its first FTD for REQORSA in combination with AstraZeneca PLC's Tagrisso(r) in patients with histologically confirmed unresectable stage III or IV NSCLC, with EGFR mutations that progressed after treatment with Tagrisso.