Ziopharm Oncology, Inc. (NASDAQ:ZIOP) awakened markets on Tuesday with the announcement of its newest cancer treatment.
The Boston-based company 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.
According to CEO Laurence Cooper, "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 NCI are partnered in a cooperative research and development agreement, 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.
Ziopharm 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 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.
ZIOP shares gained 24 cents, or 5.6%, to $4.44
