FDA Places Clinical Hold On Ziopharm's Cancer Trial; Stock Down

(RTTNews) - Ziopharm Oncology Inc. (ZIOP) said that the U.S. Food and Drug Administration placed on clinical hold a Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care and requested additional information in support of the investigational new drug or IND application for the trial.

Ziopharm, Precigen, Inc., a wholly-owned subsidiary of Intrexon Corp. (XON) and The University of Texas MD Anderson Cancer Center, the IND sponsor, are seeking to conduct a clinical trial to evaluate CAR+ T cells manufactured with Sleeping Beauty technology as an investigational treatment for patients with relapsed or refractory, CD19+ leukemias and lymphomas.

CAR+ T cells very-rapidly manufactured with the Sleeping Beauty platform for this third-generation trial are designed to co-express CD19-specific chimeric antigen receptor, or CAR, membrane-bound interleukin 15 and a safety switch.

The FDA has requested additional information relative to Chemistry, Manufacturing and Controls. Ziopharm and its partners will address the FDA's requests, and the initiation of this trial may be delayed.

Ziopharm said it believes this feedback from the FDA does not affect timelines for the Company's planned trial at the National Cancer Institute using the Sleeping Beauty platform to target solid tumors infusing TCR-modified T cells. The second-generation clinical trial evaluating Sleeping Beauty-manufactured CD19-specific CAR-T cells continues enrolling and infusing patients at MD Anderson.

In the Monday's pre-market trade, ZIOP is trading at $4.00, down $0.30 or 6.98%.