NetworkNewsBreaks – Genprex Inc. (NASDAQ: GNPX)
Post# of 231
Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, announced that it has achieved a significant milestone for its REQORSA(TM) Immunogene Therapy. The company has met all specifications and passed all final release tests for its initial scaled-up, clinical-grade manufacturing run of REQORSA(TM) immunogene therapy. This achievement comes in advance of GNPX’s upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (“NSCLC”). This announcement also follows the company’s successful completion of the technology transfer of the 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”). In addition, Genprex noted that it has also completed the manufacturing scale-up for the clinical-grade production of REQORSA, subject to final testing that is already underway. According to the company, clinical-grade REQORSA has been shipped and delivered to a cold storage depot, the first step to the product being delivered to the clinical trial sites; the company is now waiting for FDA clearance to start those trials. “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 Genprex president and CEO Rodney Varner in the press release. “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.”
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