On May 30, 2023 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, reported that it has completed the Phase 1 portion 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), and the Safety Review Committee (SRC) has approved continuation to the Phase 2 expansion portion of the trial (Press release, Genprex, MAY 30, 2023, View Source [SID1234632214]). The combination of REQORSA and osimertinib received U.S. Food and Drug Administration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.

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Based on full safety data which showed no dose limiting toxicities, the SRC determined that the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg. This was the highest dose level delivered in the Phase 1 portion and is twice the highest dose level delivered in Genprex’s prior clinical trial combining REQORSA with Tarceva for the treatment of late-stage lung cancer. The SRC also recommended the trial advance to the Phase 2 expansion portion of the study, which the Company expects to begin in the third quarter of 2023.

"We are proud of the notable progress we made during the Phase 1 portion of the Acclaim-1 clinical trial, and the SRC recommendation to move into the Phase 2 expansion portion of the trial is another validation for our REQORSA development program," said Rodney Varner, Chairman, President and Chief Executive Officer of Genprex. "As we move into the Phase 2 expansion portion of the trial, we remain steadfast in our efforts to bring new therapies to lung cancer patients with unmet medical need."

Genprex recently announced positive preliminary clinical data from the Phase 1 dose escalation portion of its Acclaim-1 clinical trial in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results showed that REQORSA was generally well tolerated, and there were no dose limiting toxicities. Genprex also reported that encouraging evidence of efficacy was observed in the Phase 1 portion of the study. The full abstract can be accessed here.

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 that the study be terminated altogether due to safety concerns.

The Phase 2 expansion portion of the study is expected to enroll approximately 66 patients; half will be patients who received only prior Tagrisso treatment and the other half will be patients who received prior Tagrisso treatment and chemotherapy, in order to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort.

About Acclaim-1

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.

The enrollment of the dose escalation Phase 1 portion of the Acclaim-1 trial has been completed. The Phase 2 expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment and the other half will have received Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. The Phase 2 randomized 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 platinum-based chemotherapy. 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 28 events.

About REQORSA Immunogene Therapy

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 agent in REQORSA is a plasmid that expresses the TUSC2 tumor suppressor gene. REQORSA consists of the TUSC2 gene expressing plasmid encapsulated in non-viral lipid nanoparticles made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and specifically targets 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 is its top-selling drug with 2022 sales of more than $5 billion.