Genprex, Inc. announced that the Korean Patent Office has issued a Notice of Patent Grant for a broad patent that covers the use of Genprex's lead drug candidate, Reqorsa Immunogene Therapy, in combination with anti-PD-1 and PD-L1 antibodies through 2037. This patent will expand on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibitors, e.g., PD-1 and PD-L 1 inhibitors. These patents are applicable to Genprex's Acclaim-2 and Acclaim-3 clinical trials.

The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions - a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.'s Keytruda in patients with late-stage non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with Keytruda. Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study in the second half of 2024.

Genprex was granted FDA Fast Track Designation for the Acclaim-2 patient population. The Acclaim-3 study has two portions - a Phase 1 dose expansion portion and a Phase 2 expansion portion. In November 2022Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of RE QORSA and Genprex's Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

Patients will be treated with REQORSA and Tecentriq until disease progression or acceptable toxicity is experienced. The Phase 1 portion of the Acclaim-3 study is open for enrollment, and Genprex expects to complete the Phase 1 portion of the study by the second half of 2024. Genprex was granted FDA Fast track Designation and Orphan Drug Designation for the Acc Acclaim-3 patient population.