FDA Grants Fast Track Designation to Quaratusugene Ozeplasmid Immunogene Therapy Plus Pembrolizumab for NSCLC

The combination of quaratusugene ozeplasmid immunogene therapy plus pembrolizumab was granted fast track designation by the US FDA for the treatment of patients with unresectable stage III or IV non–small cell lung cancer who previously progressed on pembrolizumab.

The FDA granted fast track designation to quaratusugene ozeplasmid (Reqorsa), an immunogene therapy, in combination with pembrolizumab (Keytruda) as a potential treatment for patients with histologically confirmed, unresectable stage III or IV non–small cell lung cancer (NSCLC) who progressed after treatment with pembrolizumab, according to a press release from developer, Genprex, Inc.1

Data that were previously presented have shown a strong synergy between quaratusugene ozeplasmid and pembrolizumab in patients with NSCLC compared with pembrolizumab alone. The data highlighted a survival benefit, as well as an increase in natural killer cells and a decrease in PD-L1 expression on tumor cells following treatment with the immunogene therapy in a population of mice with a humanized immune system and metastatic lung cancers.

“We are thrilled to receive a second fast track designation from the FDA for Reqora in patients with late-stage NSCLC, this time in combination with the checkpoint inhibitor Keytruda,” Rodney Varner, president and chief executive officer at Genprex, said in a press release. “This fast track designation is an important step in our efforts to accelerate clinical development of Reqorsa and another validation of the potential of Reqorsa to treat the unmet medical need of patients with late-stage NSCLC.”

The company has made plans to launch the open-label, multi-center phase 1/2 Acclaim-2 clinical trial (NCT05062980) in order to investigate the immunogene therapy combination within this cohort of patients. Genprex expects to recruit approximately 150 patients across 15 facilities for the clinical study.2

Previously, quaratusugene ozeplasmid received fast track designation from the FDA in combination with osimertinib (Tagrisso) in a population of patients with histologically confirmed, unresectable stage III or IV NSCLC whose EGFR mutations have progressed following previous osimertinib treatment.

The therapy utilizes a multimodal mechanism of action that appears to interfere with cell signaling pathways responsible for cancer cell replication and proliferation. Additionally, quaratusugene ozeplasmid re-establishes signaling pathways for apoptosis and modulates immune response against cancer cells in addition to blocking certain mechanisms of drug resistance. The immunogene therapy is given intravenously and consists of a tumor suppressor gene, TUSC2, which is encapsulated in a nanoparticle made from lipid molecules that have a positive electrical charge.3

“This [fast track designation] provision is intended to facilitate development and expedite review of such drugs so that a product, if approved, can reach the market expeditiously,” Mark Berger, MD, Chief Medical Officer of Genprex, said in a press release. “Advanced NSCLC represents a large patient population that is in desperate need of new therapies.”


  1. Genprex receives U.S. FDA fast track designation for REQORSA™ immunogene therapy in combination with Keytruda® for the treatment of non­­–small cell lung cancer. News release. Genprex, Inc. January 3, 2022. Accessed January 4, 2022. https://tinyurl.com/2p8ky8mb
  2. Genprex initiates site recruitment for Acclaim-2 clinical trial for the treatment of non–small cell lung cancer. News release. Genprex, Inc. May 4, 2021. Accessed January 4, 2022. https://tinyurl.com/2p8ttuma
  3. Genprex. The first systemically delivered gene therapy used for cancer in humans. Accessed January 4, 2021. https://bit.ly/3nimhL9