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Genprex Completes Manufacturing Scale-Up for Clinical-Grade Production of REQORSA™ Immunogene Therapy for Upcoming Acclaim-1 and Acclaim-2 Clinical Trials For Lung Cancer
Major Manufacturing Milestone Positions the Company for Success In the Lung Cancer Therapeutics Market, expected to grow to $26.3 Billion by 2023 Achievement
About this update from Genprex, Inc.
[{"type":"text","content":"\nMajor Manufacturing Milestone Positions the Company for Success In the Lung Cancer Therapeutics Market, expected to grow to $26.3 Billion by 2023\n\nAchievement Highlighted by Important Process Improvements and Significantly Improved Economies of Scale\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nGenprex, 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.\n\nFor 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.\n\n“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...