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, announced today that it has completed the manufacturing scale-up of REQORSA™ immunogene therapy. The clinical-grade production is intended to supply the Company’s upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer, subject to passing final testing that is currently underway. The Company recently announced the successful manufacturing technology transfer to commercial Contract Development and Manufacturing Organizations (CDMOs) and the successful engineering run of REQORSA, that passed all testing specifications.
For the first time, REQORSA was manufactured in a scaled-up clinical production in accordance with the current Good Manufacturing Practices (cGMP) required by the U.S. Food and Drug Administration (FDA) in advance of commercial approval of a drug product. This product will supply the Company’s upcoming Acclaim-1 and Acclaim-2 clinical trials that combine REQORSA with Tagrisso® (marketed by AstraZeneca) and with Keytruda® (marketed by Merck & Co., Inc.), respectively, both of which are on track to be initiated in the first-half of 2021. This production includes process improvements that resulted in significantly higher yields and lower costs than prior manufacturing campaigns. Previously, REQORSA was manufactured at the major cancer research institution where it was invented.
“The scaled-up production of clinical-grade REQORSA is yet another significant manufacturing milestone for the Company,” said Michael Redman, Executive Vice President and Chief Operating Officer of Genprex. “Utilizing advanced processes, we were able to successfully improve our production yield multi-fold with significantly improved economies of scale. This production is intended to provide REQORSA for our upcoming Acclaim clinical trials. Furthermore, this achievement positions Genprex with the manufacturing capability for potential future commercialization in the rapidly growing lung cancer therapeutics market, which is projected to grow to $26.3 billion by 2023.”
Upon completion of testing and lot release, REQORSA will be transported to cold storage depots. These depots will facilitate shipments to the clinical trial sites following FDA clearance to commence the upcoming clinical trials. Unlike some biologicals that require shipment and storage at -80°C temperatures, REQORSA requires storage at only 2-8°C.
REQORSA is comprised of TUSC2 plasmid DNA (the active agent in REQORSA) encapsulated in non-viral nanoparticles that are administered intravenously and designed to target tumor cells.
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™ (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.
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™ immunogene therapy drug, 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 any FDA approvals 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.
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