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Ziopharm Oncology Announces First Patient Infused in CD19 RPM CAR-T Phase I Clinical Trial Being Conducted by Joint Venture Partner Eden BioCell

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Ziopharm Oncology, Inc. has initiated its CD19-Specific Rapid Personalized Manufacturing CAR-T Phase I Trial, with the first patient infused at National Taiwan University Hospital. This trial, conducted by Eden BioCell in collaboration with TriArm Therapeutics, aims to evaluate the safety of genetically engineered T cells produced via the Sleeping Beauty transposon system. Up to 24 patients suffering from relapsed CD19+ leukemias and lymphomas will be enrolled. The primary goal is to assess the tolerability of the RPM process.

Positive
  • Initiation of CD19-Specific RPM CAR-T Phase I Trial with first patient infused.
  • Trial aims to evaluate safety and tolerability of the CAR-T treatment.
  • Collaboration with Eden BioCell and TriArm Therapeutics bolsters development efforts.
Negative
  • None.

BOSTON and HOUSTON and TAIPEI, Taiwan, April 19, 2021 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (“Ziopharm” or the “Company”) (Nasdaq: ZIOP), announced today that in March, the first patient was infused in the CD19-Specific Rapid Personalized Manufacturing (“RPM”) CAR-T Phase I Trial, being conducted by Eden BioCell, its joint venture with TriArm Therapeutics.

The patient was treated at National Taiwan University Hospital under the direction of lead investigator, Dr. Shang-Ju Wu.

The patient’s T cells, collected from the patient via apheresis, were genetically engineered utilizing the Company’s non-viral Sleeping Beauty transposon transposase system and infused two days after gene transfer.

“We are excited to be conducting this important trial for this experimental treatment,” said Dr. Jay Zhang, Chief Executive Officer of TriArm Therapeutics.

The Company and Eden BioCell will provide updates regarding the experimental treatment and other patient data in the second half of the year at appropriate venue(s), including scientific conferences, publications and / or bespoke events that the Company may convene.

About the Trial “Infusion of CD19-Specific Chimeric Antigen Receptor T-cells Produced by Rapid Personalized Manufacture for Patients with Advanced Lymphoid Malignancies”
This is a single center phase I, open-label dose-escalation trial, for patients with relapsed CD19+ leukemias and lymphomas. Up to 24 patients will be enrolled in this trial. The primary endpoint of the trial is to evaluate the safety and tolerability of autologous CD19-specific T cells manufactured using the RPM process.

About Ziopharm Oncology, Inc.
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 rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program, and a precisely controlled IL-12 gene therapy. The Company has clinical and strategic collaborations with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Regeneron Pharmaceuticals. For more information, please visit www.ziopharm.com.

About Eden BioCell
In December 2018, Ziopharm and TriArm Therapeutics announced the launch of Eden BioCell to lead clinical development and commercialization of Ziopharm’s RPM Sleeping Beauty-generated CAR-T therapies in Greater China and Korea.

About TriArm Therapeutics
TriArm Therapeutics is a cell therapy company with R&D operations in Germany, United States and Asia. The company is dedicated to the treatment of cancer and autoimmune diseases.

Investor Relations Contact:
Adam D. Levy, Ph.D., MBA
EVP, Investor Relations and Corporate Communications
T: 508.552.9255
E: alevy@ziopharm.com

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 number of patients to be enrolled, and the timing of updates for, Eden BioCell’s CAR-T Phase I 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; the strength and enforceability of Ziopharm’s intellectual property rights; competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharm’s Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. 


FAQ

What is the purpose of the CD19-Specific RPM CAR-T Phase I Trial by ZIOP?

The trial aims to evaluate the safety and tolerability of genetically engineered T cells for patients with relapsed CD19+ leukemias and lymphomas.

When was the first patient infused in the ZIOP trial?

The first patient was infused in March 2021.

How many patients will be enrolled in the ZIOP CAR-T trial?

Up to 24 patients will be enrolled in the trial.

What technology is being used in ZIOP's CAR-T trial?

The trial utilizes the non-viral Sleeping Beauty transposon transposase system for T cell engineering.

What are the next steps for ZIOP after the trial initiation?

Ziopharm plans to provide updates regarding the experimental treatment and patient data in the second half of the year.

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