On November 6, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported 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 (Press release, Ziopharm, NOV 6, 2017, View Source [SID1234521591]).
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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.