Company passes final release tests of scaled-up clinical grade production to supply drug product for upcoming Acclaim-1 and Acclaim-2 clinical trials in lung cancer
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 met all specifications and passed all of the final release tests for its first scaled-up clinical-grade manufacturing run of REQORSA™ immunogene therapy, in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (NSCLC).
“The successful completion of this final step in our scaled-up clinical grade manufacturing of REQORSA marks a key manufacturing milestone for Genprex, and is credited to the hard work and commitment of both our internal manufacturing group and our manufacturing partners,” said Rodney Varner, President and Chief Executive Officer of Genprex. “This production provides supply of REQORSA for our two upcoming Acclaim clinical trials and advances our mission to develop innovative new treatments for non-small cell lung cancer patients greatly in need of effective therapy options.”
Genprex recently announced the successful completion of the technology transfer of its manufacturing process for the production of REQORSA from the major research institution where it was previously manufactured to experienced commercial Contract Development and Manufacturing Organizations (CDMOs). The Company also reported the completion of the manufacturing scale-up for the clinical-grade production of REQORSA, subject to final testing that was underway. Passing all lot release specifications marks the successful completion of Genprex’ manufacture of REQORSA 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.
Clinical-grade REQORSA has been shipped and delivered to its first cold storage depot. From there, REQORSA supply will be delivered to the clinical trial sites pending FDA clearance to commence the clinical trials. This production run 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.
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.
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