Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, has reached a significant milestone. The company successfully completed the technology transfer of its manufacturing process for the production of its lead candidate for immunogene therapy, REQORSA(TM). The transfer was made from the major cancer research institution where it had previously been manufactured to experienced, commercial contract development and manufacturing organizations (“CDMOs”). This step marks the first time REQORSA has been manufactured outside of the research institution where it was discovered and at commercial scale in a current Good Manufacturing Practices (“cGMP”)-compliant facility. According to the company, the move will provide production and process improvements that will result in a reliable, scalable, reproducible and stable drug product suitable for storage, shipment and patient use. “The successful completion of our manufacturing technology transfer represents a major milestone for Genprex,” said Genprex president and CEO Rodney Varner in the press release. “We are delighted to collaborate with leading, global CDMOs that have enabled us to complete the successful engineering batch. We are now focused on the completion of commercial scale production of REQORSA, for use in our two upcoming clinical trials. At the same time, our clinical group is engaging with clinical trial sites who will recruit and treat patients related to our clinical trials.”
To view the full press release, visit https://ibn.fm/YSShu
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” 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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