Genprex Inc (NASDAQ: GNPX), a clinical-stage gene therapy company, announced on Tuesday that it has finished the Phase 1 portion of its Acclaim-1 clinical trial, which combines REQORSA with Tagrisso to treat advanced non-small cell lung cancer (NSCLC).

The Safety Review Committee (SRC) has approved the trial's progression to the Phase 2 expansion. Based on safety data, the recommended Phase 2 dose of REQORSA will be 0.12 mg/kg, the highest dose delivered in the Phase 1 portion. The SRC is composed of three physicians who act as principal investigators in the trial.

Genprex plans to begin the Phase 2 expansion in Q3 2023.

The company reported positive preliminary clinical data from the Phase 1 portion, demonstrating a favorable safety profile for REQORSA in solid tumour cancer. The Phase 2 expansion will enroll around 66 patients to evaluate toxicity profiles and efficacy. An interim analysis will be conducted after treating 19 patients in each cohort. REQORSA Immunogene Therapy uses Genprex's ONCOPREX Nanoparticle Delivery System to administer the TUSC2 tumour suppressor gene to cancer cells. REQORSA disrupts cancer cell signaling pathways, promotes programmed cell death and modulates the immune response against cancer cells.