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

Ziopharm Oncology (NASDAQ:ZIOP) has announced that its investigational new drug (IND) application which was submitted by the National Cancer Institute (NIC) received clearance from the US Food and Drug Administration (FDA) for a clinical trial in solid tumors to test T-cell receptor (TCR) T-cell therapy using the company’s Sleeping Beauty platform.

As quoted in the press release:

“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.

Click here to read the full press release.