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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About Genprex Inc.
Genprex is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (“NSCLC”). GPX-001 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. GPX-001 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 GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso(R)) for patients with EFGR (“EFGR”) mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the company’s website at www.Genprex.com
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