Genprex to Evaluate Higher Dose of REQORSA in NSCLC
A safety review committee approved the dose-escalation after reviewing the first cohort of patients.
Genprex is set to escalate doses in the ACCLAIM-1 phase 1/2 trial (NCT04486833) of quaratusugene ozeplasmid (REQORSA) in combination with osimertinib (Tagrisso) for the potential treatment of late-stage non-small cell lung cancer (NSCLC).
"The SRC approval to advance Acclaim-1 to the higher dose in the second cohort of patients is an important milestone that further supports REQORSA's safety profile and brings us one step closer to bringing this potentially ground-breaking gene therapy approach to treating NSCLC to the patients who need it most," Mark Berger, MD, chief medical officer, Genprex, said in a statement. "Enrollment in Acclaim-1 remains on track to complete the Phase 1 portion of the study by year end."
The dose-escalation has been permitted to continue after the Safety Review Committee (SRC) reviewed the first cohort of patients and gave a positive recommendation. The SRC is comprised of 3 physicians who are principal investigators in the trial and the committee had the choice of recommending to continue the study at the same dose or at a lower dose, to escalate doses, or to terminate the study.
REQORSA, an immunogene therapy, has received fast track designation from the FDA. The therapy is developed using Genprex’s ONCOPREX nanoparticle delivery system to deliver the TUSC2 tumor suppressor gene to cancer cells. REQORSA is designed to interrupt cell signaling pathways, reestablish pathways for apoptosis, and to modulate the body’s immune response against cancer cells.
READ MORE: Acclaim-2 Begins Enrollment to Asses Ozeplasmid Plus Pembrolizumab in Late-Stage NSC Lung Cancer
ACCLAIM-1 is an open-label, multi-center trial evaluating the REQORSA-osimertinib combination in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease has progressed after treatment with osimertinib. The phase 1 portion plans to enroll up to 18 patients to determine a maximum tolerated dose with 3 sequential dose escalation cohorts in addition to 80 mg of osimertinib. The dose escalation has started at 0.06 mg/kg; the second group will receive 0.09 mg/kg, and the third will receive 0.12 mg/kg if escalation is approved again.
The phase 2 portion will enroll around 74 patients to be randomized tothe combination therapy or Tagrisso monotherapy. The phase 2 portion of the study is primarily evaluating progression free survival and an analysis will be performed at 25 events.
"REQORSA is a pan-kinase inhibitor shown to inhibit both the EGFR and AKT oncogenic kinase pathways. We believe that REQORSA's multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops," Berger added. "Confirmation of the safety in this first cohort of Acclaim-1 patients is particularly important as these relapsed patients represent a very sick and compromised population."
