On January 13, 2021 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, reported 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) (Press release, Genprex, JAN 13, 2021, View Source [SID1234573953]).
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"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.