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Press Release

ZIOPHARM Announces Four Presentation Abstracts at the 2017 Annual Meeting of the Society for Neuro-Oncology


Posted on: 06 Nov 17

- Update to survival data from Phase 1 Trial of Ad-RTS-hIL-12 to treat recurrent glioblastoma (GBM) to be presented -

- Additional biomarker and biopsy data provides evidence of IL-12 driving immune response to GBM -

BOSTON, Nov. 06, 2017 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, today announced the release of four presentation abstracts highlighting data from the Company’s controlled human interleukin-12 (hIL-12) gene therapy candidate for brain cancer at the 22nd Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), November 16-19, 2017 in San Francisco.

With three oral and one poster presentations, the Company will update data on Ad-RTS-hIL-12 plus veledimex, a gene therapy designed to control the expression of hIL-12, a powerful cytokine that has demonstrated a targeted, anti-tumor immune response for the treatment of recurrent GBM (rGBM).

“In our Phase 1, multi-centric study of Ad-RTS-hIL-12 plus veledimex, we continue to show a marked improvement of survival in patients with recurrent glioblastoma over historical controls. We are excited about the long-lasting T-cell response that is being observed through brain biopsies as well as emerging radiologic and peripheral blood correlative studies,” said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM.

The Company previously presented data from a cohort of 15 patients receiving intra-tumoral Ad-RTS-hIL-12 with 20 mg of orally-administered veledimex following craniotomy with median overall survival (mOS) of 12.5 months at a mean follow up of 9.2 months, which compares favorably to historical controls. Emerging data revealed that an elevated ratio of circulating CD8+/FOXP3+ (effector/suppressor) T cells correlated with mOS which is consistent with IL-12-mediated activation of the immune system. The superior survival rate in the 20 mg cohort that had been observed will be updated in those patients that received low dose steroids.

“We look forward to sharing this important data with the scientific community at SNO,” continued Dr. Lebel.

The Company plans to host a conference call and webcast soon after the presentations of data at SNO. Details of the call and webcast, including timing, will follow at a later date.

Details for the SNO presentations are as follows:

Poster Presentation Title: Phase 1 Study of Ad-RTS-hIL-12 plus Veledimex in Pediatric Brain Tumors
Author: Stuart Goldman, MD
Session: Friday Traditional Posters
Date and Time: Friday, November 17, 2017, 7:30 p.m. PT
Abstract code: 5571

E-Talk Title: A Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in Adult Recurrent Glioblastoma
Presenter: E. Antonio Chiocca, M.D., Ph.D.
Session Title: Adult Therapeutics
Date and Time: Saturday, November 18, 2017, 5:32 – 5:36 p.m. PT
Abstract Code: ATIM-26

Title: Controlled Expression of IL-12 Improves Survival in Glioma by Activating the Immune Response in Mice and Humans
Presenter: John A. Barrett, Ph.D.
Session Title: Immunology – Preclinical and Clinical I
Date and Time: Sunday, November 19, 2017, 9:15-9:20 a.m. PT
Abstract Code: IMMU-34

Title: Controlled Local Expression of IL-12 as Gene Therapy Concomitant with Systemic Chemotherapy Improves Survival in Glioma
Presenter: John A. Barrett, Ph.D.
Session Title: Immunology – Preclinical and Clinical I
Date and Time: Sunday, November 19, 2017, 10:00-10:05 a.m. PT
Abstract Code: IMMU-33

All accepted abstracts will be accessible via SNO’s official journal.

About Ad-RTS-hIL-12 plus Veledimex:

ZIOPHARM is advancing Ad-RTS-hIL-12 plus veledimex as a gene therapy for glioblastoma. Ad-RTS-hIL-12 is an adenoviral vector administered via a single injection into the tumor and engineered to express hIL-12, a powerful cytokine that has demonstrated the potential to stimulate a targeted, anti-tumor immune response. The expression of hIL-12 is controlled and modulated with the RheoSwitch Therapeutic System® (RTS®) by the small molecule veledimex, an activator ligand which has been shown to cross the blood brain barrier. ZIOPHARM anticipates initiation of a pivotal registration trial for Ad-RTS-hIL-12 plus veledimex for the treatment of rGBM by the end of 2017. The Company also has initiated a Phase 1 study to evaluate the stereotactic administration of Ad-RTS-hIL-12 plus veledimex in adult patients with rGBM, as well as a trial to evaluate the gene therapy as a treatment for pediatric brain tumors. In addition, ZIOPHARM plans to initiate enrollment of adult patients with rGBM who will receive a single dose of Ad-RTS-hIL-12 plus veledimex in combination with a checkpoint inhibitor targeting programmed cell death protein 1 (PD-1) by the end of the year.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing innovative gene expression, control and cell technologies to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of cancer and graft-versus-host-disease. The Company's immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE:XON) and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell-based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation's RheoSwitch Therapeutic System® (RTS®) technology, a switch to turn on and off, and precisely modulate, gene expression in order to improve therapeutic index. The Company's pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.

Forward-Looking Safe-Harbor Statement:

This press release contains certain forward-looking information about ZIOPHARM Oncology, Inc. that is intended to be covered by the safe harbor for "forward-looking statements" provided by 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 progress and timing of the development of the Company's research and development programs. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements. These risks and uncertainties include, but are not limited to: the Company's ability to finance its operations and business initiatives and obtain funding for such activities; whether chimeric antigen receptor T cell (CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, or any of other product candidates will advance further in the preclinical research or clinical trial process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether chimeric antigen receptor T cell (CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies, and the Company's other therapeutic products it develops will be successfully marketed if approved; the strength and enforceability of the Company's intellectual property rights; competition from other pharmaceutical and biotechnology companies; as well as other risk factors contained in the Company's periodic and interim reports filed from time to time with the Securities and Exchange Commission, including but not limited to, the risks and uncertainties set forth in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and subsequent reports that the Company may file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Trademarks 

RheoSwitch Therapeutic System® and RTS® are registered trademarks of Intrexon Corporation.

Contact:
David Connolly
ZIOPHARM Oncology
617-502-1881
dconnolly@ziopharm.com

David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

GlobeNewswire
globenewswire.com

Last updated on: 06/11/2017

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