ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company
focused on new cancer immunotherapies, today announced that the
Company is presenting initial results from an ongoing Phase 1
dose-escalation study of Ad-RTS-hIL-12 + orally administered
veledimex in recurrent or progressive glioblastoma or grade III
malignant glioma. The presentation, titled "Intratumoral Regulated
Expression of IL-12 as a Gene Therapy Approach to Treatment of
Glioma," will be delivered at 5:15 pm CT, Saturday, November 21,
2015 at the 20th Annual Society for Neuro-Oncology (SNO) Annual
Scientific Meeting in San Antonio, Texas. Ad-RTS-hIL-12 + the oral
activator veledimex is a novel viral gene therapy candidate for the
controlled expression of IL-12, a critical protein for stimulating
an anti-cancer T-cell immune response.
"Immunotherapy is an attractive approach for the treatment of
glioma, an aggressive cancer with few treatment options," said Nino
Chiocca, MD, PhD, Harvey W. Cushing Professor of Neurosurgery,
Department of Surgery, Harvard Medical School, Surgical Director,
Center for Neuro-oncology, Dana-Farber Cancer Institute, Chairman,
Neurosurgery, Brigham And Women's Hospital and Co-Director,
Institute for the Neurosciences, Brigham And Women's Hospital.
"IL-12 is among the most potent anti-cancer immune cytokines, yet
carries equally significant potential for immune-mediated
toxicities. The ability to turn IL-12 expression on and off using
an orally activated gene switch, particularly in the brain's immune
privileged environment, is a tremendous advancement in the
potential of this therapeutic approach. We look forward to
enrolling additional patients and follow up from this study to
evaluate Ad-RTS-IL-12's potential in this challenging, rapidly
advancing and lethal disease."
The ongoing multi-center Phase 1 trial of Ad-RTS-hIL-12 +
veledimex examines a gene therapy strategy for recurrent high grade
gliomas, with the goal of generating a localized anti-tumor immune
response. The primary objective of the study is to determine the
safety and tolerability of a single intra-tumoral Ad-RTS-hIL-12
injection activated upon dosing with oral veledimex. Secondary
objectives are to determine the Ad-RTS-hIL-12 + veledimex maximum
tolerated dose, the immune responses elicited by Ad-RTS-hIL-12 +
veledimex, and assessment of biologic response. The study is
expected to enroll up to 72 subjects.
Preclinically, the effects of Ad-RTS-mIL-12 + veledimex were
studied in orthotopic glioma animal models, demonstrating veledimex
crossed the blood-brain-barrier. In a standard orthotopic glioma
mouse model that evaluated dexamethasone, bevacizumab, temozolamide
and a PD-1 inhibitor, Ad-RTS-mIL-12 + veledimex demonstrated a
dramatic dose-related increase in survival, without significant
adverse events, that was superior to all other treatments.
In the current, on-going Phase 1 study, five patients are
available for initial assessment, two with recurrent grade III
malignant glioma and three with grade IV. Results show IL-12 was
detectable in peripheral blood along with downstream IFNg,
indicating that veledimex crossed the blood brain barrier
activating IL-12 expression from intra-tumorally administered
Ad-RTS-hIL-12. Ad-RTS-hIL-12 + veledimex was well tolerated with
minimal neurologic toxicity. The most common adverse events were
headache, fever, hyponatremia and nausea/vomiting. Related serious
adverse events were aseptic meningitis, neutropenia,
thrombocytopenia, leukopenia, with all toxicity to date consistent
with the "on-target" effects of immunotherapy.
"Observing that veledimex can cross the blood brain barrier and
that IL-12 expression can be regulated in the brain, demonstrates a
clear translation of results from the laboratory to the clinic,"
said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of
ZIOPHARM. "We look forward to follow-up of the current recipients
and to further enrollment in this multi-center gene therapy
study."
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology
company employing novel gene expression, control and cell
technologies to deliver safe, effective and scalable cell-based
therapies for the treatment of cancer. The Company's synthetic
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® 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, timing and results of preclinical and
clinical trials involving the Company's drug candidates, and the
progress 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: whether chimeric antigen receptor T cell
(CAR T) approaches, Ad-RTS-IL-12, TCR and NK cell-based therapies,
or any of our other therapeutic candidates will advance further in
the pre-clinical or clinical trials 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-IL-12, TCR and NK cell-based therapies,
and our other therapeutic products will be successfully marketed if
approved; the strength and enforceability of our intellectual
property rights; competition from other pharmaceutical and
biotechnology companies; and the other risk factors contained in
our periodic and interim SEC reports filed from time to time with
the Securities and Exchange Commission, including but not limited
to, our Annual Report on Form 10-K for the fiscal year ended
December 31, 2014, and our Quarterly Reports on Form 10Q for the
quarters ended March 31, 2015, June 30, 2015 and September 30,
2015. Readers are cautioned not to place undue reliance on these
forward-looking statements that speak only as of the date hereof,
and we do 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® (RTS®) technology is a registered
trademark of Intrexon Corporation.
CONTACT: Lori Ann Occhiogrosso
ZIOPHARM Oncology, Inc.
617-259-1987
locchiogrosso@ziopharm.com
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
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