Ziopharm Oncology Completes Enrollment of Controlled IL-12 plus Opdivo Phase 1 Combination Trial

Ziopharm Oncology (NASDAQ:ZIOP) has announced it has finished enrolling the third cohort of a Phase 1 clinical trial testing Controlled IL-12 in combination with the PD-1 inhibitor OPDIVO to treat recurring or progressive glioblastoma multiform in adult patients.

Investigators from this multi-center trial, conducted at Northwestern University in Chicago, Brigham and Women’s Hospital in Boston, and The University of Texas MD Anderson Cancer Center in Houston, have indicated interest in expanding the study and the Company now expects to enroll additional patients at the highest dosing level, subject to final agreement by the Data and Safety Monitoring Board.

“We are pleased to complete enrollment of the dose escalation of Ad-RTS-hIL-12 + veledimex and nivolumab and explore the potential to expand this combination trial to further enrich our clinical experience,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. “The enthusiasm for combining PD-1 inhibitors with IL-12 in the current study is evident, and we also look forward to initiating a phase 2 trial with Ad-RTS-hIL-12 plus veledimex and cemiplimab in the coming days.”

Ziopharm’s Controlled IL-12 platform is an investigational gene therapy designed to induce and control the production of human interleukin 12 (hIL-12) a master-regulator of the immune system. In the setting of rGBM, the Company is leveraging the anti-tumor effects for Controlled IL-12 as monotherapy by combining with PD-1 inhibitors. Previously reported data from serial biopsies in patients with rGBM revealed that Controlled IL-12 results in sustained influx of T cells and upregulation of PD-1 expression, providing a compelling rationale for this combination. Initial phase 1 data from this trial were presented at the American Society for Clinical Oncology (ASCO) Annual Meeting on June 2, 2019, showing Controlled IL-12 can be combined with PD-1 inhibitor OPDIVO and the initial data were consistent with immune mediated anti-tumor effects with a favorable safety profile.

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