Ziopharm Oncology Announces FDA Clearance of IND for Sleeping Beauty TCR-T Cell Therapy Trial at NCI

– Positions Ziopharm to be first company to bring non-viral TCR-T into the clinic –

BOSTON, MA, USA I June 11, 2019 I Ziopharm Oncology, Inc. (“Ziopharm” or “the Company”) (Nasdaq:ZIOP) announced that the investigational new drug (IND) application submitted by the National Cancer Institute (NCI) has received clearance from the U.S. Food and Drug Administration (FDA) for a clinical trial in solid tumors to evaluate T-cell receptor (TCR) T-cell therapy utilizing Ziopharm’s Sleeping Beauty platform.

“This study is the result of extensive work by Dr. Steven Rosenberg and his team at the NCI, including Dr. Drew Deniger, to harness our Sleeping Beauty non-viral gene transfer technology to express neoantigen-specific T-cell receptors (TCRs),” said Dr. Laurence Cooper, Chief Executive Officer of Ziopharm. “This important regulatory milestone combined with our recent license from the NCI for a library of TCRs reactive to mutations, or neoantigens, within KRAS, p53 and EGFR hotspots for use with the Sleeping Beauty platform, underscores the broad scope and potential of our TCR-T program. In collaboration with the NCI, we are now in position to be the first company to bring non-viral TCR-T into the clinic.”

Ziopharm and the NCI are partnered in a cooperative research and development agreement (CRADA), under the direction of Dr. Rosenberg, Chief of the Surgery Branch of the NCI, supporting clinical work to evaluate a non-viral approach to manufacturing TCR-T with the Sleeping Beauty platform that target solid tumors. With this approach, T cells can be genetically modified to express multiple, tumor-specific TCRs, which Ziopharm believes will be foundational technology to successfully targeting and treating metastatic solid tumors.

The Company will host an informational webcast and conference call to provide additional context related to its non-viral TCR-T program on Wednesday, June 12, at 8:30 am ET.  The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 3782556. To access the live webcast or the subsequent archived recording, visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company's website for two weeks.

About Ziopharm Oncology, Inc.
Ziopharm Oncology is an immuno-oncology company focused on developing end-to-end cost-effective solutions using its non-viral Sleeping Beauty platform for TCR and CAR T-cell therapies and immune-stimulating gene therapy with Controlled Interleukin 12 (IL-12). The Sleeping Beauty platform genetically modifies T cells with DNA plasmids to express T-cell receptors (TCRs) to target specific antigens in solid tumors and chimeric antigen receptors (CARs) to target CD19 in blood cancers with the Company’s very rapid T-cell manufacturing process. The Sleeping Beauty platform is being advanced in collaboration with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Eden BioCell. The Company also is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, as monotherapy and in combination with immune checkpoint inhibitors to treat brain cancer, including in collaboration with Regeneron Pharmaceuticals.

SOURCE: Ziopharm Oncology

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