Ziopharm Oncology (NASDAQ:ZIOP) completed enrollment of 36 subjects in its Phase 2 trial evaluating controlled IL-12, in combination with PD-1 inhibitor cemiplimab, for the treatment of recurrent or progressive glioblastoma (rGBM).
Ziopharm’s controlled IL-12 is a gene therapy designed to induce and control production of IL-12, which plays a major role in immune system regulation.
The trial will assess the safety and efficacy of controlled IL-12 in combination with cemiplimab in patients with rGBM scheduled for resection, who have not been treated previously with immune checkpoint inhibitors.
Controlled IL-12 will be administered intratumorally at the time of surgical resection and patients will receive 20 mg of veledimex, an oral activator of controlled IL-12, daily for 14 days. Patients will also receive 350 mg IV cemiplimab every three weeks until documented progression or withdrawal from the study.
“We look forward to the results of this ongoing Phase 2 trial that will inform whether controlled IL-12 in combination with cemiplimab could represent a potential treatment option for patients with rGBM, a devastating brain cancer for which there is a significant unmet need for new effective therapies,” Dr. Rimas Lukas, the Phase 2 study investigator, said in a statement.
