Genprex (NASDAQ: GNPX) is a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes. The company today announced that the Safety Review Committee (“SRC”) has approved continuation of the Acclaim-1 phase 1/2 clinical trial of REQORSA(TM) in combination with Tagrisso(R) (osimertinib) to treat late-stage non-small cell lung cancer (“NSCLC”) following a review of the first cohort of patients in the phase 1 portion of the trial. In 2020, Genprex received U.S. Food and Drug Administration’s (“FDA”) Fast Track Designation for treatment of the Acclaim-1 patient population. “The SRC approval to advance Acclaim-1 to the higher dose in the second cohort of patients is an important milestone that further supports REQORSA’s safety profile and brings us one step closer to bringing this potentially ground-breaking gene therapy approach to treating NSCLC to the patients who need it most,” said Mark Berger, M.D., chief medical officer of Genprex. “Enrollment in Acclaim-1 remains on track to complete the phase 1 portion of the study by year end.”
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About Genprex Inc.
Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX(R) Nanoparticle Delivery System, which the company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. The company’s lead product candidate, REQORSA(TM) (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (“NSCLC”). REQORSA 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. In 2020, the U.S. Food and Drug Administration (“FDA”) granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso(R) (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Merck & Co’s Keytruda(R) (pembrolizumab) for patients whose disease progressed after treatment with Keytruda. For more information, visit the company’s web site at www.Genprex.com.
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