FDA clears Ziopharm Oncology IND for T-cell receptor therapy


The FDA has cleared Ziopharm Oncology’s (NASDAQ:ZIOP) IND for its T-cell receptor therapy (TCR-T) for the treatment of solid tumors.

Ziopharm’s TCR-T consists of T-cells that have been genetically modified to express multiple, tumor-specific TCRs, to target and treat metastatic solid tumors. TCR-T is based on Ziopharm’s “Sleeping Beauty” platform, which uses non-viral T-cell modification.

“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,” Laurence Cooper, Ziopharm’s CEO, said in a statement.

The IND was submitted by the NCI, Ziopharm’s research and development partner.

“In collaboration with the NCI, we are now in position to be the first company to bring non-viral TCR-T into the clinic,” he added.

Michelle Carr