Ziopharm is developing our Sleeping Beauty platform in collaboration with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Eden BioCell. The Company also has a clinical collaboration agreement with Regeneron Pharmaceuticals for our Controlled IL-12 platform.
We are advancing our Sleeping Beauty platform for our novel T-cell receptor (TCR) therapies and chimeric antigen receptor T-cell (CAR-T) therapies in collaboration with The University of Texas MD Anderson Cancer Center. We have research facilities on the campus of MD Anderson in Houston, and we expect to initiate a clinical trial for our third-generation Sleeping Beauty CD19-specific CAR-T program there. Our novel TCR therapies, CAR-T therapies, non-viral gene transfer systems, genetic modification and/or propagation approaches arose from the laboratory of Laurence Cooper, M.D., Ph.D., who was a tenured professor of pediatrics at MD Anderson. In 2015, Dr. Cooper became Ziopharm’s Chief Executive Officer after Ziopharm licensed this foundational technology from MD Anderson.
In 2017, Ziopharm entered into a Cooperative Research and Development Agreement with the National Cancer Institute (NCI) bringing together the clinical development expertise and resources of the NCI with Ziopharm’s Sleeping Beauty platform. The NCI under the leadership of Steven Rosenberg, M.D. will conduct a Phase 1 trial to evaluate adoptive cell transfer immunotherapies using the Sleeping Beauty transposon/transposase system to express TCRs for the treatment of solid tumors. These genetically modified TCRs are designed to recognize and attack specific neoantigens expressed within a patient’s cancer.
In 2018, Ziopharm entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo® (cemiplimab-rwlc) to treat patients with recurrent glioblastoma (rGBM) in a Phase 2 study. 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. 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.