Multiple clinical trial sites to be opened under oncology research network collaboration
Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced a plan to accelerate the opening of clinical trial sites for the Acclaim-1 clinical trial which combines the Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid) Immunogene Therapy with AstraZeneca’s Tagrisso®, as a potential innovative treatment for non-small cell lung cancer (NSCLC). Under a collaboration agreement with a large network of integrated, community-based oncology practices, the opening of four clinical trial sites to enroll patients in the Phase 1 portion of Genprex’s Acclaim-1 clinical trial is underway, with an expectation of opening additional sites in the Phase 2 portion of the study.
“We are pleased to target community based oncology practices for the conduct of our Acclaim-1 clinical trial,” said Mark S. Berger, MD, Genprex’s Chief Medical Officer. “Not only does this approach provide cancer patients with access to innovative oncology treatments at the office of their primary oncologist, it also allows Genprex to more readily access patients for the clinical trial and move it forward in a more efficient and expeditious manner. Our Acclaim-1 trial offers a unique opportunity to transform cancer care for patients with advanced lung cancer who have EGFR mutations that are no longer responsive to standard targeted therapies.”
The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA™ Immunogene Therapy, in combination with Tagrisso in patients with late-stage NSCLC whose disease progressed after treatment with Tagrisso. Genprex expects the Phase 1 portion of the Acclaim-1 trial to enroll up to 18 patients in a dose escalation study to determine the maximum tolerated dose of the combination. The Phase 2 portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or Tagrisso monotherapy. The primary endpoint of the Phase 2 portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 25 events.
In January 2020, Genprex received FDA Fast Track Designation for the Acclaim-1 patient population. Additional information about the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.
About Genprex, Inc.
Genprex, Inc. 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® 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™ (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 January 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (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® (pembrolizumab) for late-stage patients whose disease progressed after treatment with Keytruda.
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