Ziopharm Oncology Announces Clearance of Taiwan’s First IND of Non-viral CAR-T for the Treatment of Relapsed CD19+ Leukemias and Lymphomas

– Advances Eden BioCell’s clinical program to validate Rapid Personalized Manufacturing (RPM) –

– Clinical trial to study autologous CD19-specific CAR-T using RPM technology designed to reduce cost and simplify production for infusion the day after gene transfer –

BOSTON, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (“Ziopharm” or “the Company”) (Nasdaq: ZIOP), today announced that the Taiwan Food and Drug Administration has cleared an investigational new drug application (IND) from Eden BioCell, a joint venture between Ziopharm and cell therapy company TriArm Therapeutics, for its phase 1 clinical trial to evaluate patient-derived CD19-specific CAR-T, using Ziopharm’s Rapid Personalized Manufacturing (RPM) technology. This is an investigational treatment for patients with relapsed CD19⁺ leukemias and lymphomas and the first clinical study of autologous non-viral CD19-specific CAR-T in Taiwan.

This trial will utilize Ziopharm’s non-viral Sleeping Beauty cell engineering technology to infuse autologous CAR-T the day after T cells have been genetically modified. Ziopharm’s RPM CD19-specific CAR-T therapy results from the stable, non-viral insertion of DNA into the genome of resting T cells to co-express the chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) and a safety switch. The trial is being conducted at National Taiwan University Hospital.

“This study is a testament to the relationship Ziopharm has quickly established with Eden BioCell and TriArm and the progress using patients’ T cells under RPM to target malignancies,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. “The results will help us understand the benefit of engineering T cells with membrane bound IL-15 which could benefit not only CAR-T, but also the engineering of T cells to express T-cell receptors.”

Jay Zhang, Co-Founder and Chief Executive Officer of TriArm, added, “We are very excited to receive clearance of our IND in Taiwan. The learnings from this study will build upon the encouraging early data we are seeing with patients treated with RPM CAR-T targeting CD19 malignancies under compassionate use. We believe our approach has the potential to transform CAR-T therapy by dramatically decreasing the amount of time needed for manufacturing engineered T cells, thereby increasing efficacy and decreasing cost.”