Genprex Receives Approval to Advance Clinical Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer

Genprex, a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced 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. 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.

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 a Genprex 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) 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.