On January 4, 2022 Genprex reported that FDA has granted a fast track designation to a combination comprised of the immunogene therapy quaratusugene ozeplasmia (REQORSA) and pembrolizumab (Keytruda) for use in patients with histologically confirmed, unresectable, stage III or IV non–small cell lung cancer (NSCLC) who experienced disease progression following treatment with pembrolizumab (Press release, Genprex, JAN 4, 2022, View Source [SID1234607477]).1

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The product utilizes Genprex, Inc.’s proprietary ONCOPREX Nanoparticle Delivery System, which is believed to be the first systemic gene delivery platform leveraged for cancer in humans, according to the clinical-stage gene therapy company.2

Quaratusugene ozeplasmia is comprised of the tumor suppressor gene, TUSC2, which is encapsulated in a nanoparticle composed from lipid molecules with a positive electrical charge. The product is intravenously administered, and was designed to target cancer cells, which are known to generally have a negative charge. Once the product is taken into the cancer cell, the gene is expressed into a protein that can restore select defective functions that arise in the cancer cell.

The gene therapy has a multimodal mechanism of action in that it can disrupt cell-signaling pathways that are responsible for the replication and proliferation of cancer cells; it can also re-establish pathways for apoptosis and modulate the immune system so that it responds against cancer cells.

Additionally, the pan-kinase inhibitor simultaneously inhibits the EGFR and AKT pathways both in vitro and in vivo. When a cancer cell takes up the TUSC2-containing nanoparticle, it is reprogrammed to die. It is known that resistance to existing targeted agents and checkpoint inhibitors can develop when alternate bypass pathways are activated. The multimodality activity of the gene therapy allows it to block emerging bypass pathways and reduce the probability of drug resistance.

"We are thrilled to receive a second fast track designation from the FDA for REQORSA in patients with late-stage NSCLC, this time in combination with the checkpoint inhibitor pembrolizumab," Rodney Varner, president and chief executive officer at Genprex, stated in a press release. "This fast track designation is an important step in our efforts to accelerate clinical development of REQORSA and another validation of the potential of REQORSA to treat the unmet medical need of patients with late-stage NSCLC."

In the first quarter of 2022, the company expects to launch the open-label, multicenter, phase 1/2 Acclaim-2 trial (NCT05062980), which will evaluate the safety and efficacy of the gene therapy in combination with pembrolizumab in patients with previously treated NSCLC.3