Gene therapy company Genprex Inc (NASDAQ:GNPX) reported on Tuesday the receipt of US Food and Drug Administration (FDA) Fast Track Designation for its Oncoprex immunogene therapy in combination with osimertinib for non-small cell lung cancer (NSCLC).

The Oncoprex immunogene therapy in combination with AstraZeneca's EGFR inhibitor osimertinib is being studied for the treatment of non-small cell lung cancer (NSCLC) patients with EFGR mutations that progressed after treatment with osimertinib alone.

Oncoprex is comprised of the TUSC2 (Tumor Suppressor Candidate 2) gene complexed with a lipid nanoparticle. TUSC2 is the active agent in Oncoprex, added the company.

In conjunction, the company said it has treated more than 50 lung cancer patients with Oncoprex in Phase I and II clinical trials. The data from these trials are encouraging as to both safety and efficacy. The initial disease indication for Oncoprex is NSCLC.

According to the company, it is preparing to initiate a Phase I/II clinical trial evaluating Oncoprex in combination with osimertinib, as well as a new Phase I clinical trial evaluating Oncoprex in combination with a checkpoint inhibitor.