– Data to Be Presented at the 21st Society for
Neuro-Oncology Annual Meeting –
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company
focused on new immunotherapies, today announced the presentation of
both clinical and nonclinical data for Ad-RTS-hIL-12 +
orally-administered veledimex for recurrent brain cancer at the
21st Annual Scientific Meeting of the Society for Neuro-Oncology
(SNO) held November 17-20, 2016 in Scottsdale, Arizona.
Ad-RTS-hIL-12 + veledimex is a novel viral gene therapy candidate
utilizing the proprietary RheoSwitch Therapeutic System® (RTS®)
technology for the controlled expression of interleukin 12 (IL-12),
a critical protein for stimulating a vigorous immune response
against cancers.
In a poster presentation titled “Phase 1 study
of intra-tumoral viral delivery of Ad-RTS-hIL-12 + oral veledimex
is well tolerated and suggests survival benefit in recurrent
high-grade glioma,” the Company will report interim results from
patients with recurrent high-grade gliomas enrolled in three
veledimex dosing cohorts (20mg, n=7; 30mg, n=6; and 40mg, n=6).
Subjects with relapsed high-grade gliomas, either glioblastoma
(GBM) or anaplastic astrocytoma (AA), undergoing re-resection were
intra-tumorally injected once with Ad-RTS-hIL-12 along with oral
doses of veledimex to activate and control production of IL-12.
As of October 14, 2016, the date of data
collection for the SNO presentation, median overall survival (mOS)
was 12.8 months, with 11 of 17 subjects alive. Survival rates at 6,
9, and 12 months for patients with multiple recurrences prior to
administration of Ad-RTS-hIL-12 are described in the table:
Treatment |
N |
Relapsed Brain Tumor |
Medium
#Recurrences |
mOS (months) |
Survival Rate (%) |
6 months |
9 months |
12 months |
Ad + V (Overall) |
17 |
16 GBM, 1 AA |
3 |
12.8 |
87 |
65 |
54 |
Ad + V (20 mg) |
7 |
6 GBM, 1 AA |
3 |
12.8 |
100 |
86 |
71 |
GBM is an aggressive brain tumor affecting
approximately 74,000 people worldwide each year.i,ii For patients
who have experienced recurrences the prognosis is particularly
poor, with a mOS of 6-7 months, while mOS in patients that have
failed temozolomide and bevacizumab, or equivalent salvage
chemotherapy, is approximately 3-5 months.iii, iv
In the study, IL-12 leading to the production of
interferon-gamma in the bloodstream was measured and found to be
proportional to the three doses of veledimex, demonstrating that
this orally-delivered activator crossed the blood brain barrier to
engage the RTS® gene switch and express IL-12 in a dose-dependent
manner. Toxicities in all three dose cohorts were consistent with
those previously reported, with a higher incidence of grade 3 or
greater adverse events in the 40 mg dose group. Importantly, all
related side effects were reversed upon cessation of veledimex.
Based on the tolerability and survival benefit seen, the 20 mg dose
of veledimex has been selected for an ongoing expansion cohort.
“These translational data confirm the activity
of Ad-RTS-hIL-12 + veledimex in the clinic, demonstrating that
veledimex crosses the blood brain barrier to activate the
RheoSwitch® gene switch and produce IL-12, resulting in an immune
response to the tumor and now, impressively, overall survival
outcomes,” said Francois Lebel, M.D., Executive Vice President,
Research and Development, Chief Medical Officer at ZIOPHARM. “With
median overall survival beyond 12 months in these patients who have
experienced multiple recurrences, the therapeutic potential of
Ad-RTS-hIL-12 + veledimex is very promising. We look forward to
enrolling additional patients in the expanded 20 mg dose cohort and
to discussing the results of the Phase I multi-center study with
the FDA, with the goal of determining a registration pathway for
this therapeutic in a disease with far too few treatment
options.”
The Company will also present results from a
pre-clinical study of Ad-RTS-mIL-12 + veledimex as an
investigational therapy for pediatric glioma in a poster titled
“Local regulated IL-12 expression as an immunotherapy for the
treatment of pontine glioma”. Glioma in the pontine region of the
brain accounts for approximately 15% of all cases of pediatric
brain tumors, with a median survival time of less than one year. In
an orthotopic pons model, veledimex was shown to cross the blood
brain barrier to control mouse IL-12 production from the tumor,
which stimulated the immune system and resulted in a profound
increase in overall survival. Based on these results, the Company
plans to initiate a Phase 1 clinical trial in pediatric brain
tumors, including diffuse intrinsic pontine glioma (DIPG) in
2017.
“DIPG is an aggressive disease, and because of
its location in the brain, it is virtually untreatable,” added
Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM.
“Ad-RTS-hIL-12 + veledimex has unique potential in this indication
especially given our ability to not only turn IL-12 on and off, but
also to titrate IL-12 levels thanks to the RTS® technology. Our
Ad-RTS-IL-12 + veledimex program continues to gain momentum, with
the potential for a registration pathway in recurrent high-grade
glioma in adults and expected study initiations as monotherapy in
pediatric patients, as well as, in combination with checkpoint
inhibitors in adult patients with brain cancer.”
All poster presentations will be available
online at www.ziopharm.com.
Conference Call and Slide
Webcast
ZIOPHARM will host a conference call and webcast
slide presentation today, Thursday, November 17, 2016, at 8:00 am
ET to discuss updated data from the Company’s Phase 1 study of
Ad-RTS-hIL-12 + veledimex in high-grade glioma. The call can be
accessed by dialing (844) 309-0618 (U.S. and Canada) or (661)
378-9465 (international). The passcode for the conference call is
11110235. To access the slides and live audio webcast, or the
subsequent archived recording, visit the "Investors & Media"
section of the ZIOPHARM website at www.ziopharm.com. The webcast
will be recorded and available for replay on the Company's website
for two (2) weeks.
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
September 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® are
registered trademarks of Intrexon Corporation.
i. Mrugala MM. Advances and challenges in the
treatment of glioblastoma: a clinician's perspective. Discov Med.
2013;15:221-230.
http://www.discoverymedicine.com/Maciej-M-Mrugala/2013/04/25/advances-and-challenges-in-the-treatment-of-glioblastoma-a-clinicians-perspective/.
Accessed March 24, 2015. ii. McCubrey JA, LaHair MM, Franklin RA.
OSU—0312 in the treatment of glioblastoma. Mol Pharmacol.
2006;70:437-439. iii. Omuro, A. Glioblastoma and Other
Malignant Gliomas. A Clinical Review JAMA. 2013 Nov
6;310(17):1842-50. iv. Iwamoto et al. Patterns or relapse and
prognosis after bevacizumab failure in recurrent glioblastoma.
Neurology 2009; 73(15):1200-1206
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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