Ziopharm Oncology Presents Pre-Clinical Data Validating “Rapid Personalized Manufacture” (RPM) with TCR at the 2019 American Society for Hematology Annual Meeting

– Membrane bound IL-15 (mbIL15) improves anti-tumor effect of TCR-modified T cells –

– T cells expressing T-cell receptor (TCR) and mbIL15 can be infused day after gene transfer –

BOSTON, Dec. 08, 2019 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq:ZIOP), today announced the presentation of pre-clinical data of Rapid Personalized Manufacture (RPM), in the “Adoptive Immunotherapy: Mechanisms and New Approaches” session at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando.

“These pre-clinical data demonstrate that T cells genetically modified using DNA plasmids from the Sleeping Beauty system to express TCR with membrane bound IL-15 (mbIL15) exhibit anti-tumor effects,” said Drew Deniger, Ph.D., leader of Ziopharm’s TCR program. “These data build on our approach to reduce the cost and complexity of T-cell therapies. We have previously demonstrated that mbIL15 can be combined with a CD19-specific chimeric antigen receptor (CAR) to shorten the time to generate clinical-grade T cells and an IND is cleared to evaluate this RPM technology.”
                  
Data were presented today in the poster presentation “Rapid Personalized Manufacture (RPM) of Sleeping Beauty System-generated NY-ESO-1-specific TCR-T Cells Co-Expressing Membrane-bound IL-15 Yields Antitumor Responses” and demonstrated:

• T cells can be genetically modified with the Sleeping Beauty system to express TCR and mbIL15;
• T cells expressing TCR and mbIL15 exhibited superior anti-tumor effects compared with TCR-modified T cells without mbIL15;
• T cells expressing TCR and mbIL15 are infused the day after gene transfer per RPM;
• Low-dose of T cells genetically modified per RPM to express TCR and mbIL15 exhibit anti-tumor effects;
• T cells expressing TCR and mbIL15 persist in mouse model.

This proof-of-concept study, reported today at ASH, targets a well-understood antigen (NY-ESO-1) which supports using DNA plasmids from the Sleeping Beauty platform to express TCRs with mbIL15 to improve the manufacture of T cells with specificity for neoantigens. The Company announced in October 2019 a new research and development agreement with MD Anderson Cancer Center relating to Ziopharm’s Sleeping Beauty immunotherapy program to use non-viral gene transfer to stably express and clinically evaluate neoantigen-specific TCRs in T cells. This agreement, along with the license of TCRs targeting neoantigens in three hotspots from the National Cancer Institute in May 2019, provide the Company with a platform to launch clinical trials utilizing TCRs from the library specific for hotspot mutations and personalized TCRs targeting patient-specific neoantigens.