Approval of new name marks important branding milestone and aligns with the program’s overall progress
REQORSA immunogene therapy uses the company’s unique, proprietary ONCOPREX™ nanoparticle delivery system to deliver cancer-fighting genes
FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® for the treatment of non-small cell lung cancer earlier this year
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 conditionally accepted the proprietary name REQORSA™ for its lead drug candidate in development for the treatment of non-small cell lung cancer, known previously by the laboratory designation GPX-001.
The name REQORSA (pronounced “re-KORE-suh”), was developed in accordance with FDA’s guidance for the submission and evaluation of proprietary names. The Company selected the name based on comprehensive and disciplined review of name candidates, including a research study of healthcare practitioners across the U.S. to ensure accurate prescription and safety interpretation of the name.
“We are very pleased to receive FDA’s conditional acceptance of our proprietary name, REQORSA, which is a necessary step toward being able to market our lead drug candidate for non-small cell lung cancer,” said Rodney Varner, President and Chief Executive Officer of Genprex. “This name approval also marks an important milestone in our overall branding strategy, giving us a unique, easily understood name people can associate with the Genprex brand and mission.”
Genprex will resubmit its proprietary name for FDA final review upon completion of all required clinical trials and prior to the submission of a Biologics License Application. Final approval of the REQORSA brand name is conditional on FDA approval of the product candidate.
REQORSA uses the company’s unique, proprietary ONCOPREX® nanoparticle delivery system, which delivers cancer-fighting genes by encapsulating them into nanoparticles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. In January 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® for the treatment of non-small cell lung cancer.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, REQORSA™ immunogene therapy drug (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.
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