Genprex, Inc., 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, was developed in accordance with the FDA’s guidance for the submission and evaluation of proprietary names. The Company selected the name based on a 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 tumour 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.