Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company utilizing a unique, nonviral 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(TM) immunogene therapy in combination with EGFR inhibitor osimertinib (AstraZeneca’s Tagrisso(R)). Tagrisso(R), with worldwide sales of $1.86 billion in 2018 and $2.31 billion in the first 9 months of 2019, 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. Genprex has treated more than 50 lung cancer patients with Oncoprex, comprised of the TUSC2 (Tumor Suppressor Candidate 2) gene complexed with a lipid nanoparticle, in Phase I and II clinical trials. “Genprex is excited to receive this important FDA designation,” Genprex Chairman and Chief Executive Officer Rodney Varner said in the news release. “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.”
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About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for cancer patients based upon a unique proprietary technology platform. Genprex’s platform technologies are designed to administer cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. The company’s lead product candidate, Oncoprex(TM) immunogene therapy for non-small cell lung cancer (“NSCLC”), has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis, or programmed cell death, in cancer cells, and modulates the immune response against cancer cells. Oncoprex has also been shown to block mechanisms that create drug resistance. For more information, please visit the company’s web site at www.Genprex.com.
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