The preclinical study reported that tumor-selective Oncoprex suppresses human colon tumor growth in vivo in mouse models. (Cancers, January 12, 2022, Vol. 14(2), e361). Genprex's oncology program uses the non-viral Oncoprex nanoparticle delivery system, which is the first systemic gene therapy delivery platform used to treat cancer in humans, according to the company.

The Oncoprex delivery system delivers tumor suppressor 2, mitochondrial calcium regulator (TUSC2) plasmid DNA in Genprex's Reqorsa immunogene therapy. The U.S. Food and Drug Administration granted a fast track designation for Reqorsa for non-small cell lung cancer (NSCLC) in combination therapy with Tagrisso (osimertinib) for late-stage patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. Reqorsa was also granted a fast track designation for NSCLC in combination therapy with Keytruda (pembrolizumab) for late-stage patients whose disease progressed after treatment with Keytruda.

Genprex has treated more than 50 NSCLC patients in clinical trials with Reqorsa, the company's lead drug candidate that uses the Oncoprex nanoparticle delivery system to deliver the TUSC2 gene. A phase I clinical trial showed that systemic, intravenous therapy using the Oncoprex nanoparticle delivery system was shown to selectively and preferentially target tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing an extended half-life in the circulation, Genprex said.