On March 2, 2022 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 the first patient was dosed in the Acclaim-1 clinical trial, 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 (Press release, Genprex, MAR 2, 2022, View Source [SID1234609364]). In 2020, Genprex received U.S. Food and Drug Adminstration’s (FDA) Fast Track Designation for treatment of the Acclaim-1 patient population.

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"This is an exciting milestone for Genprex that we believe brings us one step closer to achieving our goal to validate the potential benefits of REQORSA in NSCLC patients who have life-limiting disease and few treatment options," stated Mark S. Berger, M.D., Chief Medical Officer of Genprex. "Based on both the preclinical data and previous clinical data, REQORSA has the potential to improve the response to current targeted therapies, such as Tagrisso, for this study patient population. We look forward to continuing to advance this important trial."

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.

Genprex recently added four new clinical trial sites for the Acclaim-1 trial in order to accelerate enrollment, bringing the current number of sites to five. The Company expects to add additional sites for the Phase 2 portion of the trial.

Genprex previously announced the Centralized Institutional Review Board (IRB) approval for the Acclaim-1 clinical trial in NSCLC. Additional information about the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

"Despite recent advances in immuno-oncology and other targeted treatments, NSCLC remains a significant unmet medical need as resistance to Tagrisso and other targeted therapies is a common clinical problem," said Dr. Berger. "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."

Preclinical Data at AACR (Free AACR Whitepaper) 2021

Supportive preclinical data on the combination of REQORSA and Tagrisso (osimertinib) were presented by Genprex collaborators at the 2021 American Association of Clinical Research (AACR) (Free AACR Whitepaper) annual meeting. The data showed that REQORSA and Tagrisso had a synergistic antitumor effect in EGFR mutant Tagrisso resistant NSCLC tumor xenograft models. In the preclinical study, researchers developed an osimertinib-resistant H1975-OsiR isogenic cell line through continuous exposure to osimertinib. Xenograft tumors from both H1975-parental and H1975-OsiR cells were grown in NSG mice and were treated with osimertinib. The combination of REQORSA and osimertinib showed a robust antitumor effect compared with single agent treatment groups against H1975-OsiR tumors.

Tagrisso is a registered trademark of AstraZeneca plc and its largest selling drug with 2021 sales of over $5 billion.

About REQORSA

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 can specifically target cancer cells, which generally have a negative electrical charge. 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. REQORSA has also been shown to block mechanisms that create drug resistance.