Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing treatments for patients with cancer and diabetes, today announced that the first patient was dosed in the Acclaim-1 clinical trial. The open-label, multi-center phase 1/2 clinical trial will evaluate the company’s lead drug candidate, REQORSA(TM) Immunogene Therapy, in combination with Tagrisso(R) (osimertinib) in patients with late-stage non-small cell lung cancer (“NSCLC”) whose disease progressed after treatment with Tagrisso. Genprex received U.S. Food and Drug Adminstration’s (“FDA”) Fast Track Designation for treatment of the Acclaim-1 patient population in 2020. “This is an exciting milestone for Genprex that we believe brings us one step closer to achieving our goal to validate the potential benefits of REQORSA in NSCLC patients who have life-limiting disease and few treatment options,” stated Genprex Chief Medical Officer Mark S. Berger, M.D. “Based on both the preclinical data and previous clinical data, REQORSA has the potential to improve the response to current targeted therapies, such as Tagrisso, for this study patient population. We look forward to continuing to advance this important trial.”
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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 then 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. REQORSA has also been shown to block mechanisms that create drug resistance. 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 EGFR 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 late-stage 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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