Genprex Receives Fast Track Designation for Lung Cancer Gene Therapy

Genprex received fast track designation from the FDA for its lung cancer therapy Oncoprex (TUSC2) in combination with AstraZeneca’s Tagrisso (osimertinib) for the treatment of non-small cell lung cancer patients with EFGR mutations that progressed after treatment with osimertinib alone.

The drugmaker is preparing to launch a phase 1/2 clinical trial to evaluate Oncoprex in combination with osimertinib, as well as a new phase 1 trial evaluating the treatment with a checkpoint inhibitor.

Oncoprex includes the company’s Tumor Suppressor Candidate 2 (TUSC2) gene combined with a lipid nanoparticle.