ZIOPHARM Presents Data Demonstrating Activation of Anti-Tumor Immune Response Using Ad-RTS-hIL-12 in Patients with Advanced B...
October 10 2016 - 07:00AM
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced the presentation of
preliminary data from the Company’s Phase 1b/2 study of
Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the
treatment of patients with locally advanced or metastatic breast
cancer. The poster presentation, titled “Phase 1b/2 study of
intratumoral Ad-RTS-hIL-12+veledimex in patients with
chemotherapy-responsive locally advanced or metastatic breast
cancer,” was presented at the European Society for Medical Oncology
(ESMO) 2016 Congress today in Copenhagen, Denmark.
The study, which is being conducted at the
Memorial Sloan Kettering Cancer Center in New York, is designed to
examine the safety, tolerability and efficacy of Ad-RTS-hIL-12
immunotherapy in up to 40 women with locally advanced or metastatic
breast cancer of all subtypes. Ad-RTS-hIL-12 + veledimex is a novel
gene therapy which controls local expression of IL-12. The ability
to regulate the production of IL-12 by modulating veledimex dosing
is designed to improve its therapeutic index with standard of
care.
Following entry into the trial, patients go on a
chemotherapy holiday and enter an immunotherapy phase of treatment.
A single cycle of Ad-RTS-hIL-12, along with the oral activator
ligand veledimex, is given during the immunotherapy phase, with the
goal of maintaining or improving pre-study response.
As of August 30, 2016, a total of nine patients
were available for initial assessment. Results show that
Ad-RTS-hIL-12 + 7 days of veledimex consistently elicited
production of IL-12 which in turn produced IFNγ. It was notable
that the intratumoral influx of CD8+ T cells and IFNγ were present
six weeks after completion of veledimex consistent with the ability
of Ad-RTS-hIL-12 to favorably impact the tumor environment over the
long term. In two patients, Ad-RTS-hIL-12 + veledimex provided a
meaningful drug holiday, with durable responses for 18 and 35
weeks. In all patients, disease control rate (DCR) was 44% at Week
6 and 22% at Week 12. Overall response rate (ORR), defined as
achieving a partial response (PR) or better, was 11% at Week 12.
Most toxicities promptly reversed upon discontinuation of
veledimex, including cytokine release syndrome (grade 1-2 CRS),
observed in six of nine patients. The higher than expected
incidence of CRS was likely related to CYP-3A4 drug interactions
with veledimex (80 mg) which resulted in enhanced peak cytokine
expression.
“These data provide additional evidence that
IL-12 expression and corresponding downstream signaling is
activated using Ad-RTS-hIL-12 + veledimex, consistent with results
observed in other studies and tumor types,” said Francois Lebel,
M.D., Executive Vice President, Research and Development, Chief
Medical Officer at ZIOPHARM. “Early results from this study are
promising, providing further support and validation for our ongoing
study of Ad-RTS-hIL-12 in glioblastoma, a program we anticipate
moving into a pivotal trial.”
ESMO Presentation Details
Title: Phase 1b/2 study of
intratumoral Ad-RTS-hIL-12+veledimex in patients with
chemotherapy-responsive locally advanced or metastatic breast
cancer Abstract Number: 280PDate and
Time: October 10, 2016, 1:00-2:00p CET
Location: Hall E
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- 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® 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 Company's plans and
expectations regarding its securities offerings, fundraising
activities and financial strategy, 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: our ability to
finance our 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 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-hIL-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, 2015, and our Quarterly Report for the quarter ended
June 30, 2016. 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® and RTS® technology are registered trademarks
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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