On July 3, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or "the Company") (Nasdaq:ZIOP), reported Drew Deniger, Ph.D., will join Ziopharm from the National Cancer Institute (NCI) to lead the company’s program to genetically modify T cells to express neoantigen-specific T-cell receptors (TCRs), effective July 29, 2019 (Press release, Ziopharm, JUL 3, 2019, View Source [SID1234537377]).

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Since 2013, Dr. Deniger has worked at the NCI under Dr. Steven Rosenberg where he has served as Lead Investigator for the group’s efforts in three initiatives: Identifying "hotspot" neoantigens for T-cell therapy; targeting neoantigens in metastatic endometrial and ovarian cancers; and non-viral gene therapy using the Sleeping Beauty platform to generate TCR-modified T cells targeting neoantigens.

"At the foundation of our TCR-T program is the partnership we have developed with Dr. Rosenberg and his team at the NCI. As an integral part of that group, Dr. Deniger has helped harness our Sleeping Beauty technology to express neoantigen-specific T-cell receptors and prepare for the start of the upcoming clinical trial in patients with solid tumors," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "As a recognized leader in the identification of neoantigens in hotspots, advancing innovative immunotherapy approaches into the clinic, and with years of expertise with the Sleeping Beauty system, we’re delighted to welcome Drew to Ziopharm."

Author of multiple peer-reviewed manuscripts describing detection of neoantigen-reactive T cells for personalized cancer immunotherapy and T-cell responses to hotspot mutations, Dr. Deniger has also written validating publications related to the non-viral Sleeping Beauty transposon-transposase system. Dr. Deniger is the named inventor on patents related to TCRs recognizing mutated p53 and methods of isolating T cells having antigenic specificity for a p53 cancer specific-mutation, and has been the recipient of numerous awards in cancer immunotherapy.

"Evaluating and validating the Sleeping Beauty platform has been one of my research priorities during my time at NCI," said Drew Deniger, Ph.D. "Utilizing Sleeping Beauty to genetically modify T cells is an extremely compelling path to treating solid tumors and I am excited to be able to join Laurence and the Ziopharm team as we advance TCR-T into the clinic. We look forward to building out a broad library of TCRs reactive to neoantigens including within KRAS, p53 and EGFR hotspots for use with the Sleeping Beauty platform in the future."

Prior to his tenure at the NCI, Dr. Deniger earned B.S. degrees in Chemistry and Biochemistry from the University of Texas at Austin, a M.S. in Cancer Biology and a Ph.D. in Immunology from the University of Texas MD Anderson Cancer Center. His post-doctoral instruction was in the laboratory of Dr. Rosenberg, where he was trained in clinical translation of cancer immunotherapy, including tumor infiltrating lymphocytes (TIL), neoantigen-specific T cells and TCR-T therapy.

Ziopharm and the NCI are partnered through January 2022 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, neoantigen-specific TCRs, which Ziopharm believes will be foundational technology to successfully targeting and treating metastatic solid tumors.

Last month, Ziopharm announced that the investigational new drug (IND) application submitted by the NCI had received clearance from the U.S. Food and Drug Administration (FDA) for a clinical trial in solid tumors to evaluate TCR-T utilizing Ziopharm’s Sleeping Beauty platform.