Genprex, Inc. (NASDAQ: GNPX) today announced receiving Fast Track Designation from the U.S. Food and Drug Administration (FDA) for Genprex’s Oncoprex™ immunogene therapy in combination with EGFR inhibitor osimertinib for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations that progressed after treatment with osimertinib alone.
Oncoprex is comprised of the TUSC2 (Tumor Suppressor Candidate 2) gene, which is the active agent in Oncropex, complexed with a lipid nanoparticle.
“Genprex is excited to receive this important FDA designation,” said Rodney Varner, Chairman and CEO of Genprex.
Genprex is a clinical gene therapy company that uses a unique, non-viral proprietary platform designed to deliver tumor suppressor genes to cancer cells. The Company’s main focus is to fight the world’s leading cause of cancer deaths: lung cancer.
The Chief Executive Officer added: “In addition to potentially facilitating and expediting our pathway to approval, we believe that this FDA designation validates our plan to commercialize Oncoprex immunogene therapy in combination with EGFR inhibitors for the treatment of lung cancer. We hope that Fast Track Designation helps us bring our gene therapy to patients more rapidly and that our unique gene therapy platform is more widely recognized for its potential in cancer treatment.”
Genprex is convinced that the data from the Phase I and II clinical trials, where more than 50 lung cancer patients were treated with Oncoprex, are encouraging signs for the safety and efficacy of the product.
The FDA Fast Track is a process with the purpose to get important new drugs to the patient earlier. Awarded to drugs that demonstrate the potential to unmet medical needs, the Fast Track Designation is designed to facilitate the development and expedite the review of drugs.
Candidates of the Fast Track must show advantages over already available therapies, avoiding serious side effects, decreasing significant toxicity, being able to address public health needs and improving diagnosis and outcome.