NEW YORK – Genprex announced on Friday that quaratusugene ozeplasmid (Reqorsa) will be studied in two new trials, in which non-small cell lung cancer patients with specific molecular markers will receive its investigational drug combined with osimertinib (AstraZeneca's Tagrisso) or pembrolizumab (Merck's Keytruda).
The Phase I/II trials, branded Acclaim, will begin in the first half of 2021. In Acclaim-1, late-stage, EGFR-mutated NSCLC patients who have progressed after treatment with the EGFR inhibitor osimertinib will receive quaratusugene ozeplasmid plus osimertinib. According to the company, the US Food and Drug Administration in January granted fast track designation to quaratusugene ozeplasmid for this indication.
In Acclaim-2, NSCLC patients who have PD-L1 expression in 1 percent to 49 percent of tumor cells and are considered to have low expression status will receive quaratusugene ozeplasmid in combination with the checkpoint inhibitor pembrolizumab.
In preclinical studies, quaratusugene ozeplasmid has been able to simultaneously inhibit the EGFR and AKT oncogenic kinase pathways in vitro and in vivo. In earlier studies, the investigational treatment also appeared to block mechanisms implicated in drug resistance.