Ziopharm Oncology Completes Enrollment of Phase 2 Trial Evaluating Controlled IL-12 in Combination with Libtayo in Patients with Glioblastoma

BOSTON, June 22, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (“Ziopharm” or “the Company”) (Nasdaq:ZIOP) today announced that 36 subjects have been enrolled in the phase 2 clinical trial evaluating Ad-RTS-hIL-12 with veledimex (Controlled IL-12) in combination with the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the treatment of recurrent or progressive glioblastoma (rGBM) in adults. Subjects in this multi-center trial were enrolled from seven hospitals specializing in the treatment of brain cancers across the United States.

“Achieving this milestone reinforces the critical need for new treatments for rGBM and highlights the optimism from the clinical community for the potential of Controlled IL-12,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. “I want to thank the clinicians and healthcare workers for their dedication and commitment to oncology patient care which has allowed us to continue advancing the development of our Controlled IL-12 program during these challenging times.”

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 a monotherapy and in combination with PD-1 inhibitors. Clinical data supporting the combination of Controlled IL-12 and a PD-1 inhibitor were initially published in Science Translational Medicine (Chiocca et al., 2019). Data from serial biopsies in patients with rGBM revealed that Controlled IL-12 results in the sustained influx of activated T cells and upregulation of PD-1 expression, providing a compelling rationale for this combination. Recently, additional data from a phase 1 trial were presented at the American Society of Clinical Oncology (ASCO) 2020 virtual meeting showing Controlled IL-12 in combination with a PD-1 inhibitor had a favorable safety profile and preliminary signs of anti-tumor efficacy.

Rimas Lukas, M.D., Associate Chief of the Neuro-Oncology Division, Northwestern University Feinberg School of Medicine and the Lou and Jean Malnati Brain Tumor Institute, and investigator in the phase 2 study, added, “The data presented at ASCO earlier this year demonstrated encouraging anti-tumor effects of combining Controlled IL-12 with a PD-1 inhibitor. 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 recurrent glioblastoma, a devastating brain cancer for which there is a significant unmet need for new effective therapies.”