Genprex Inc CEO Rodney Varner said the clinical stage gene therapy company has achieved “many key milestones” already this year in a letter to shareholders.
So far, "We announced our second Fast Track Designation for REQORSA Immunogene Therapy, we commenced patient treatment in our Phase 1/2 Acclaim-1 clinical trial for non-small cell lung cancer (NSCLC), we opened our Phase 1/2 Acclaim-2 clinical trial for NSCLC and commenced patient treatment in that trial, ...and we expanded our clinical development pipeline to include small cell lung cancer (SCLC)” Varner wrote.
“I am enthusiastic about our future as we continue to advance our leading-edge gene therapy programs with the goal of extending hope and life to patients with serious disease and unmet need,” he added.
READ: Genprex announces opening of patient enrollment for its Acclaim-2 clinical trial
The Food and Drug Administration Fast Track Designation for REQORSA Immunogene Therapy covers its use in combination with Merck and Co’s drug Keytruda (pembrolizumab) in NSCLC patients whose disease progressed on Keytruda.
That drug combination and subset of patients are the subject of the Acclaim-2 clinical trial, which saw its first patient treated in April.
The company has previously said it expects the Phase 1 portion of the Acclaim-2 trial to enroll up to 30 patients in a dose-escalation study to determine the maximum tolerated dose of the combination of REQORSA and Keytruda. The Phase 2 portion of the study is expected to enroll approximately 126 patients to be randomized 2:1 to receive either REQORSA and Keytruda combination therapy or docetaxel and/or ramucirumab.
REQORSA consists of the gene TUSC2 inserted into a DNA plasmid and encapsulated in a nonviral delivery system made from lipid nanoparticles, the company said. It is injected intravenously and targets cancer cells, where, once inside, the TUSC2 gene expresses its namesake protein.
That protein has been shown to be capable of restoring certain functions that are often defective in the cancer cell, the company said.
Relatedly, Varner noted, Genprex also recently announced positive preclinical data showing that its ONCOPREX Nanoparticle Delivery System may be used to deliver tumor suppressor genes other than TUSC2 to address multiple types of cancer.
That opens the door for other potential uses for its delivery system using other therapeutic genes, whether alone or in combination with other approved cancer therapies.
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
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