Genprex Receives USAN Approval of Non-Proprietary Name for Lead Drug Candidate
June 25, 2020
Company executes on corporate communication strategy and advances drug branding initiatives
Lead drug candidate for NSCLC now referred to as quaratusugene ozeplasmid or GPX-001
Company rebrands use of Oncoprex™ name for Nanoparticle Delivery Platform
AUSTIN, Texas — (June 25, 2020) — Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that the United States Adopted Names (USAN) Council has approved the non-proprietary name quaratusugene ozeplasmid for GPX-001, formerly called Oncoprex™ immunogene therapy, the Company’s lead drug candidate for non-small cell lung cancer (NSCLC).
The USAN Council is responsible for selecting simple, informative, and unique non-proprietary (generic) drug names. As a part of Genprex’s corporate communication strategy and drug nomenclature branding, the Company is also pursuing formal proprietary brand name approval for its lead drug candidate, GPX-001 (quaratusugene ozeplasmid). Obtaining regulatory approval of these adopted drug names is a necessary step in securing marketing approval.
In conjunction with the adoption of quaratusugene ozeplasmid as the Company’s non-proprietary name for GPX-001, Genprex has rebranded the naming of its unique, proprietary, non-viral nanoparticle delivery system, now referred to as its Oncoprex™ Nanoparticle Delivery Platform, which is the vehicle used to deliver its oncology platform technologies.
“The USAN’s adoption of our non-proprietary name is another step toward advancing our lead drug candidate, GPX-001 for non-small cell lung cancer, toward commercialization,” said Rodney Varner, Chairman and Chief Executive Officer of Genprex. “We look forward to the adoption and rollout of a brand name for this drug as we continue to move along the development pathway. In the meantime, we’ve focused our branding efforts on our proprietary, non-viral nanoparticle delivery system with our recognized Oncoprex™ name. We believe this delivery system is a significant differentiator for GPX-001, as well as an important platform delivery system that could be used for additional drug candidates.”
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, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 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. GPX-001 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 GPX-001 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.
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 GPX-001, 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 GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates and whether patents will ever be issued under patent applications that are the subject of our license agreements. 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.