Genprex Inc (NASDAQ:GNPX) announced Wednesday that it has met the necessary specifications and passed the final release tests for its first manufacturing run of REQORSA immunogene therapy in advance of non-small cell lung cancer (NSCLC) clinical trials.
The trials, Acclaim-1 and Acclaim-2, will evaluate REQORSA in combination with AstraZeneca’s drug Tagrisso and Merck & Co’s Keytruda, and both are on track to be initiated in the first half of the year.
“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 CEO Rodney Varner said in a statement.
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“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,” Varner said.
In January 2020, the FDA granted Fast Track Designation to REQORSA for NSCLC in combination therapy with Tagrisso for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso alone.
Now, passing all lot release specifications marks the successful completion of REQORSA manufacturing in accordance with the current Good Manufacturing Practices (cGMP) required by the US Food and Drug Administration (FDA) for commercial approval
Clinical-grade REQORSA has been shipped and delivered to its first cold storage depot, the company said, and from there it will be sent to the clinical trial sites pending FDA clearance.
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