Genprex, Inc. announced 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) Annual Meeting, taking place June 2-6, 2023 in Chicago, IL and online. Details of the abtract are below: 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.

The abstract reports preliminary results from eight patients in Genprex's Phase 1 portion of its AccAcclaim-1 clinical trial evaluatingREQORSA Immunogene Therapy (quaratusugene ozeplASid) 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. 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.