Recommends Advancing Acclaim-1 to Increased Dose in Second Cohort of Phase 1 Portion of Trial
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 that the Safety Review Committee (SRC) has approved continuation of the Acclaim-1 Phase 1/2 clinical trial of REQORSA™ in combination with Tagrisso® (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.
Acclaim-1 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® (osimertinib) in patients with late-stage non-small cell lung cancer (NSCLC) whose disease progressed after treatment with Tagrisso.
"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."
The Accaim-1 trial includes up to three sequential dose escalation cohorts that will be treated with REQORSA intravenously on Day 1 in addition to osimertinib 80 mg fixed dose oral daily tablet during 21-day treatment cycles until disease progression or unacceptable toxicity. The first group received REQORSA IV infusion at 0.06 mg/kg, the second group will receive 0.09 mg/kg and the third will receive 0.12 mg/kg (if approved by the SRC) in order to identify the recommended Phase 2 dose.
"REQORSA is a pan-kinase inhibitor shown to inhibit both the EGFR and AKT oncogenic kinase pathways. We believe that REQORSA's multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops," added Dr. Berger. "Confirmation of the safety in this first cohort of Acclaim-1 patients is particularly important as these relapsed patients represent a very sick and compromised population."
The SRC is comprised of three physicians who are principal investigators in the trial. The SRC may recommend that the trial continues at the same dose or at a lower dose, that it escalates to a higher dose, or it can recommend terminating the study altogether due to safety concerns.
The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company's lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor ("EGFR") mutations 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.
REQORSA™ Immunogene Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC) uses Genprex's unique, proprietary ONCOPREX® Nanoparticle Delivery System, which is the first systemic gene therapy delivery platform used for cancer in human clinical trials. The active ingredient in REQORSA is the TUSC2 gene, a tumor suppressor gene. REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a net positive electrical charge. REQORSA is injected intravenously and is preferentially taken up by cancer cells. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed, and the TUSC2 protein is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.
Tagrisso® is a registered trademark of AstraZeneca plc and its largest selling drug with 2021 sales of over $5 billion.
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 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. 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® (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® (pembrolizumab) for patients whose disease progressed after treatment with Keytruda.
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