The company recently announced a dose escalation in the ACCLAIM-1 study.
The US Patent and Trademark Office (USPTO) has granted a patent to Genprex for quaratusugene ozeplasmid (REQORSA) the company’s Immunogene therapy being evaluated for the treatment of late-stage non-small cell lung cancer (NSCLC).1
"This new patent provides critical protection for our REQORSA gene therapy in combination with a checkpoint inhibitor, for example an anti-PD1 antibody, to treat cancer. This is important as our ongoing Acclaim-2 Phase 1/2 clinical trial combines REQORSA™ with Keytruda®, an anti-PD1 antibody, to treat non-small cell lung cancer," Thomas Gallagher, Esq., Senior Vice President, Intellectual Property and Licensing, Genprex, said in a statement.1 "We continue to strengthen our intellectual property portfolio and continue to build protection around our technology as it safeguards our gene therapy with target-specific combination therapy, is a deterrent to would-be competitors and creates value around our core competencies."
The patent, which covers Genprex’s methods of using REQORSA in combination with immune checkpoint inhibitors, lasts through 2038. REQORSA is currently being evaluated in the open-label, multi-center, phase 1/2 ACCLAIM-1 (NCT04486833) and ACCLAIM-2 (NCT05062980) trials in NSCLC. ACCLAIM-1 is evaluating REQORSA in combination with osimertinib (Tagrisso) and ACCLAIM-2 is evaluating the therapy in combination with pembrolizumab (Keytruda). The FDA has granted fast track designation to both programs.
REQORSA uses Genprex’s ONCOPREX nanoparticle delivery system to deliver the TUSC2 tumor suppressor gene to cancer cells. The therapy is designed to interrupt cell signaling pathways, reestablish pathways for apoptosis, and to modulate the body’s immune response against cancer cells.
Genprex recently announced that a safety review committee, comprised of 3 principal investigator physicians, has approved a dose escalation in the ACCLAIM-1 trialafter reviewing data from the first cohort of patients.2 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.
"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 an earlier statement.2 "Enrollment in Acclaim-1 remains on track to complete the Phase 1 portion of the study by year end."
The ACCLAIM-1 trial plans to enroll up to 18 patients in the phase 1 portion 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 approved. The phase 2 portion, primarily evaluating progression free survival, will enroll around 74 patients to be randomized to the combination therapy or Tagrisso monotherapy.
The ACCLAIM-2 trial plans to enroll up to 30 patients in the phase 1 portion to determine a maximum tolerated dose in a 3+3 dose escalation scheme in addition to 200 mg of pembrolizumab.1 The study will evaluate 0.06, 0.09 and 0.12 mg/kg of REQORSA. Genprex expects phase 1 enrollment to complete by mid-2023. The phase 2 portion will enroll up to 126 patients to be randomized to the REQORSA combination therapy or to docetaxel ± ramucirumab treatment.