Positive Phase I trial data indicates that Reqorsa (quaratusugene ozeplasmid) has shown early efficacy for the treatment of non-small cell lung cancer (NSCLC).
The data will be presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.
Developed by gene therapy company Genprex, Reqorsa is a non-viral gene therapy that leads to expression of the TUSC2 tumour suppressor gene in cancers.
“The encouraging Phase I results in the Acclaim-1 trial document Reqorsa’s favourable safety profile thus far and show early efficacy in patients with NSCLC whose disease has progressed on Tagrisso,” said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex.
“In addition, the preclinical data presented by our research collaborators is very encouraging, as we know that despite the broader success of immunotherapies, such as checkpoint inhibitors, they have limited efficacy in the treatment of SCLC. We look forward to evaluating Reqorsa in combination with a checkpoint inhibitor to treat SCLC in our upcoming Acclaim-3 clinical trial, where we have both FDA Fast Track and Orphan Drug Designations for this patient population.”
No Dose Limiting Toxicities
Data from the Phase I dose escalation portion of the Acclaim-1 clinical trial of Reqorsa in combination with Tagrisso (osimertinib) showed no Dose Limiting Toxicities. Of the 12 patients treated with escalating doses of Reqorsa and standard doses of Tagrisso, all of whom had progressed on Tagrisso containing regimens, two patients experienced prolonged time to progression, including one with continuing partial response.
The study’s Safety Review Committee recommended moving to the Phase II expansion portion of the study.
Genprex’s Oncoprex Nanoparticle Delivery System is a novel non-viral approach utilising lipid nanoparticles to deliver tumour suppressor genes that have been deleted during the course of cancer development. The platform allows a therapeutic affect without the risk of toxicity often associated with viral delivery systems.