Genprex approved to advance to highest dose in Phase 1 lung cancer trial

Genprex has completed the 0.09 mg/kg dose group of the Phase 1 dose escalation portion of the Acclaim-3 clinical trial of Reqorsa Gene Therapy in combination with Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer. In addition, the Safety Review Committee has approved escalation to the highest dose group of 0.12 mg/kg. The combination of REQORSA and atezolizumab previously received FDA Fast Track Designation for the treatment of the Acclaim-3 patient population and the FDA has also granted Orphan Drug Designation to Reqorsa for the treatment of SCLC. There were no dose limiting toxicities in this dose group and the SRC recommended moving up to the highest dose group planned in the trial. The first patient treated in the Phase 1 dose escalation portion of the Acclaim-3 trial had a partial remission from prior to the start of maintenance therapy to the time of the CT scan performed after two cycles of maintenance therapy. The company believes this suggests that Reqorsa may be providing clinical benefit. The primary endpoint of the Phase 1 escalation portion is to determine the maximum tolerated dose or recommended Phase 2 dose. After the Phase 1 portion is complete, the Phase 2 expansion portion will enroll 50 patients at 10 to 15 U.S sites.