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
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
'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
'CAR-T therapy has proved an effective therapy for B-cell cancers,' noted Dr.
Up to 24 patients with relapsed CD19+ leukemias and lymphomas will be enrolled in this phase 1 trial, with the goal of infusing 16 subjects (Taiwan FDA #1096030182). The primary endpoint of the study is to evaluate the safety and tolerability of autologous CD19-specific T cells manufactured using the RPM process.
About Eden BioCell
In
About TriArm Therapeutics
TriArm Therapeutics is a cell therapy company formed by Panacea Venture with R&D operations in
About
Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the body's immune system to treat the millions of people globally diagnosed with cancer each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology. Ziopharm's pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic collaborations with the
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as 'may,' 'will,' 'could,' 'expects,' 'plans,' 'anticipates,' and 'believes.' These statements include, but are not limited to, statements regarding the potential benefits of the Company's CAR-T therapy and the Company's expectations regarding the number of patients expected in this phase 1 clinical trial. Although Ziopharm's management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in Eden BioCell's operating plans that may impact its cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharm's product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the
Contact:
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Email: alevy@ziopharm.com
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