Genprex, Inc. 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 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. 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.