- Clinical Trials
Our lead product candidate, GPX-001 (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary Oncoprex™ nanoparticle delivery platform which delivers cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanoparticles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. In January 2020, the FDA granted Fast Track Designation for GPX-001 in combination with AstraZeneca’s Tagrisso® for the treatment of NSCLC.
The active ingredient in our lead product candidate, GPX-001, is the TUSC2 gene, a tumor suppressor gene.
GPX-001 consists of the TUSC2 gene encapsulated in a positively charged nanoparticle made from lipid molecules with a positive electrical charge. GPX-001 is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once GPX-001 is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. GPX-001 has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance.
GPX-001 is a pan-kinase inhibitor shown to simultaneously inhibit the EGFR and AKT oncogenic kinase pathways in vitro and in vivo. Once the cancer cell takes up the nanovesicle containing TUSC2, it is reprogrammed to die. Resistance to targeted drugs and checkpoint inhibitors develop through activation of alternate bypass pathways. For example, when PD-1 is blocked, the TIM-3 checkpoint is up-regulated. We believe that GPX-001’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.
Tagrisso® is a registered trademark of AstraZeneca.