- Clinical Trials
Our lead product candidate, REQORSA™ immunogene therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary ONCOPREX® nanoparticle delivery system 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 REQORSA in combination with AstraZeneca’s Tagrisso for the treatment of NSCLC.
The active ingredient in our lead product candidate, REQORSA, is the TUSC2 gene, a tumor suppressor gene.
REQORSA consists of the TUSC2 gene encapsulated in a positively charged nanoparticle made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA 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. REQORSA 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. REQORSA has also been shown to block mechanisms that create drug resistance.
REQORSA 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 REQORSA’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.
Tagrisso® is a registered trademark of AstraZeneca.