Genprex, Inc. announced a plan to accelerate the opening of clinical trial sites for the Acclaim-1 clinical trial which combines the Company's lead product candidate, REQORSA™ (quaratusugene ozeplasmid) Immunogene Therapy with AstraZeneca's Tagrisso®, as a potential innovative treatment for non-small cell lung cancer (NSCLC). Under a collaboration agreement with a large network of integrated, community-based oncology practices, the opening of four clinical trial sites to enroll patients in the Phase 1 portion of Genprex's Acclaim-1 clinical trial is underway, with an expectation of opening additional sites in the Phase 2 portion of the study. The Acclaim-1 clinical trial 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 in patients with late-stage NSCLC 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.