Genprex Inc (NASDAQ:GNPX) announced that the Safety Review Committee (SRC) has approved a continuation of the Acclaim-1 Phase 1/2 clinical trial of the company's lead drug candidate REQORSA in combination with Tagrisso (osimertinib) to treat late-stage non-small cell lung cancer (NSCLC).
The approval follows a review of the first cohort of patients in Phase 1 by the SRC, which comprised of three physicians who are principal investigators in the trial, the clinical-stage gene therapy company said.
"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," Genprex chief medical officer (CMO) Dr Mark Berger said in a statement.
READ: Genprex CEO shares key progress for non-small cell lung cancer treatment REQORSA in shareholder letter
"Enrollment in Acclaim-1 remains on track to complete the Phase 1 portion of the study by year-end," he added.
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 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 milligram (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.
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 in a combination therapy or Tagrisso in monotherapy, the company said.
"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," CMO Berger noted. "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," he added.
The REQORSA Immunogene Therapy 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.
In 2020, the US 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.
Genprex is focused on developing life-changing therapies for patients with cancer and diabetes. Its 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.
Contact the author at jon.hopkins@proactiveinvestors.com