On May 25, 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 positive data from the Phase 1 portion of its Acclaim-1 clinical trial evaluating REQORSA Immunogene Therapy in combination with Tagrisso in late-stage non-small cell lung cancer (NSCLC) were published in an abstract at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2023 in Chicago, IL and online (Press release, Genprex, MAY 25, 2023, View Source [SID1234632059]).

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"We are thrilled to have our abstract, which reports positive results from the Phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO (Free ASCO Whitepaper) Annual meeting," said Mark Berger, MD, Chief Medical Officer at Genprex. "We are encouraged by the favorable safety profile of REQORSA, as well as the preliminary efficacy data we have observed, and we believe this data will support our advancement to the Phase 2 portion of the clinical trial."

Details of the abtract are below:

Abstract Number: e15081

Title: ACCLAIM-1 dose escalation: Determination of quaratusugene ozeplasmid and osimertinib recommended phase 2 dose (RP2D)

Session Title: Publication Only: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Track: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

The abstract reports preliminary results from eight patients in Genprex’s Phase 1 portion of its Acclaim-1 clinical trial evaluating REQORSA Immunogene Therapy (quaratusugene ozeplasmid) with Tagrisso (osimertinib) in patients with advanced, EGFR mutant NSCLC whose disease progressed after Tagrisso. REQORSA was generally well tolerated, as there were no dose limiting toxicities. Full safety and efficacy data on the Phase 1 portion of the study will be presented at an upcoming medical meeting.

While the Phase 1 portion of the clinical trial is designed primarily to assess safety, promising efficacy results were also observed. One patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed, and osimertinib, had a partial remission (PR) by investigator evaluation and treatment is ongoing after 16 cycles, which is approximately 10.5 months. Another patient at the 0.09 mg/kg dose level, previously treated with osimertinib, has stable disease and treatment is ongoing after 14 cycles, or approximately 9 months. The extended and ongoing progression free survival (PFS) of each of these patients is significantly greater than the median PFS observed from treatment with osimertinib alone in this treatment setting in several prior clinical trials1 and is consistent with long-term PFS seen in prior clinical trials of REQORSA. PFS is the primary endpoint of both the Phase 2 expansion portion and the Phase 2 randomized portion of the Acclaim-1 trial.

"Demonstrating a favorable safety profile substantially de-risks the REQORSA development program and is a major accomplishment for Genprex," said Rodney Varner, Chairman, President and Chief Executve Officer of Genprex. "It is encouraging that several patients who were progressing on their previous therapy are now having long periods of response and stable disease in the Phase 1 portion of the study. We wish to thank the patients and investigators participating in our clinical trials and our investors who make it possible to move our drug candidates forward toward availability for patients in need."

1. CHRYSALIS-2 NSCLC clinical trial data reported at ASCO (Free ASCO Whitepaper) 2022

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 25 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.