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

- June 11th, 2019

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 … Continued

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.

The newest developments in genetics investing

 
Find out what to watch for in the world of genetics

Leave a Reply

Your email address will not be published. Required fields are marked *