Genprex Receives Conditional FDA Acceptance of Proprietary Name REQORSA™ for Lead Drug Candidate for Treatment of Non-Small Cell Lung Cancer
Genprex, Inc. (NASDAQ: GNPX) announced that the FDA has conditionally accepted the proprietary name REQORSA™ for its lead drug candidate targeting non-small cell lung cancer, previously known as GPX-001. This name approval is a critical step towards marketing the therapy and enhances the brand identity of Genprex. The REQORSA drug utilizes the ONCOPREX® nanoparticle delivery system and previously received Fast Track Designation from the FDA. Final approval of the name is contingent upon successful clinical trials and FDA product candidate approval.
- FDA's conditional acceptance of the proprietary name REQORSA for GNPX's lead drug candidate.
- REQORSA uses the proprietary ONCOPREX® nanoparticle system, enhancing its therapeutic potential.
- The approval supports Genprex's branding strategy.
- Final approval of the REQORSA name is contingent upon successful clinical trials.
- The product candidate must still complete further regulatory hurdles for market entry.
AUSTIN, Texas--(BUSINESS WIRE)--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.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of REQORSA™, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of REQORSA and our other potential product candidates including whether we receive or benefit from fast track or similar regulatory designations; costs associated with developing our product candidates, whether we identify and succeed in acquiring other technologies and whether patents will ever be issued under patent applications that are the subject of our license agreements or otherwise. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
