Ziopharm Oncology, Inc. has entered 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 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 U.S. 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.

Ziopharm and Regeneron will initiate a Phase II study in 1H19 in patients with rGBM to measure preliminary safety and efficacy of the combination. 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.

GBM is the most aggressive malignant primary brain tumor with an estimated incidence rate of 3.3 per 100,000 persons in the U.S. and an estimated 3.5 new cases per 100,000 people per year worldwide.