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Genprex Receives U.S. FDA Fast Track Designation for Gene Therapy that Targets Lung Cancer
Lung cancer is the world’s leading cause of cancer deaths AUSTIN, Texas & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genprex, Inc. (“Genprex” or the “Company”)
About this update from Genprex, Inc.
[{"type":"text","content":"\nLung cancer is the world’s leading cause of cancer deaths\n\n AUSTIN, Texas & CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nGenprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company utilizing a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells, today announced that the U.S Food and Drug Administration (FDA) has granted Fast Track Designation for Genprex’s Oncoprex™ immunogene therapy in combination with EGFR inhibitor osimertinib (AstraZeneca’s Tagrisso®, which had worldwide sales in 2018 of $1.86 billion, $2.31 billion in the first 9 months of 2019 and is currently AstraZeneca’s highest grossing product) for the treatment of non-small cell lung cancer (NSCLC) patients with EFGR mutations that progressed after treatment with osimertinib alone. Oncoprex is comprised of the TUSC2 (Tumor Suppressor Candidate 2) gene complexed with a lipid nanoparticle. TUSC2 is the active agent in Oncoprex.\n\n\nGenprex has treated more than 50 lung cancer patients with Oncoprex in Phase I and II clinical trials. The company believes the data from these trials are encouraging as to both safety and efficacy.\n\n\n“Genprex is excited to receive this important FDA designation,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immunogene therapy in combination with EGFR inhibitors for the treatment of lung cancer. We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment.”\n\n\nFDA may award Fast Track Designation if it determines that a drug demonstrates the potential to address unmet medical needs for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.\n\n\nFast Track drug candidates must show advantages over available therapies, such as superior effectiveness, avoiding serious side effects, improving diagnosis and outcome, decreasing significant toxicity, and th...