Ziopharm Oncology Announces Immuno-oncology Clinical Supply Agreement with Regeneron

Ziopharm Oncology, Inc.,today announced a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate Ziopharm’s Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo® (cemiplimab-rwlc) to treat patients with recurrent glioblastoma (rGBM).

Ad-RTS-hIL-12 plus veledimex is an investigational gene therapy designed to induce and control the production of human interleukin 12 (hIL-12) that activates the immune system and recruits cancer-fighting T cells into tumors. Libtayo has been approved in the United States for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

"Our PD-1 inhibitor Libtayo has been developed as the backbone of Regeneron’s immuno-oncology pipeline and to facilitate innovative combination immunotherapies," said Israel Lowy, M.D., Ph.D., Head of Clinical and Translational Sciences, Oncology at Regeneron. "With Ziopharm, we are excited to learn more about the benefit of combining Libtayo with local production of the IL-12 cytokine to potentially augment the cancer-fighting capability of the immune system."

Under the terms of the agreement, Ziopharm and Regeneron will initiate a Phase 2 study in the first half of 2019 in patients with rGBM to measure preliminary safety and efficacy of Ad-RTS-hIL-12 plus veledimex in combination with Libtayo. Ziopharm will be responsible for the conduct and costs of the clinical trial, and Regeneron will supply Libtayo for the study. The companies potentially may explore the Ad-RTS-hIL-12 plus veledimex in combination with Libtayo in additional indications. Regeneron, in collaboration with Sanofi, is developing Libtayo both alone and in combination with other therapies for the treatment of various cancers.

"We are excited to collaborate with the oncology team at Regeneron, a world-class, science-driven company with robust oncology expertise," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "With IL-12 expression under the control of the RheoSwitch Therapeutic System®, we have seen anti-tumor activity as a monotherapy and there is potential to improve upon that response in combination with Libtayo to provide much-needed therapeutic options for patients with rGBM."

GBM is the most aggressive malignant primary brain tumor with an estimated incidence rate of 3.3 per 100,000 persons in the United States and an estimated 3.5 new cases per 100,000 people per year worldwide. With GBM’s potential for rapid tumor growth and aggressive local spread, the survival rate for adults after five years is approximately 3 percent to 5 percent. Prognosis for adult patients is poor as nearly all cases of GBM recur despite treatment combining multiple approaches such as surgery, radiation and chemotherapy.Globally, about 189,000 people each year die because of brain cancer with GBM being the most common form of the disease.