Ziopharm Oncology Enrolls First Patient in Phase 1 Trial Evaluating Combination Therapy of Controlled IL-12 and OPDIVO®
June 28 2018 - 4:01PM
Ziopharm Oncology, Inc. (Nasdaq:ZIOP), a biotechnology company
focused on development of next generation immunotherapies utilizing
gene- and cell-based therapies to treat patients with
cancer, today announced that it has enrolled the first patient
in its Phase 1 clinical trial to evaluate Ad-RTS-hIL-12 plus
veledimex in combination with OPDIVO® (nivolumab), an immune
checkpoint, or PD-1, inhibitor, in adult patients with recurrent
glioblastoma (rGBM).
“We are excited about the first-ever dosing of
this combination and its potential to bring a potent and controlled
anti-tumor immune response to glioblastoma,” said Francois Lebel,
M.D., Executive Vice President, Research and Development, Chief
Medical Officer at Ziopharm. “By controlling interleukin 12,
Ad-RTS-hIL-12 plus veledimex already has shown it can recruit
killer T cells into the tumor and increase expression of
checkpoints in this microenvironment. The combination with an
anti-PD-1 has the potential to further improve anti-cancer effects
of IL-12 and provide a much-needed new therapeutic option for
patients with brain cancer.”
The Company expects to enroll up to 18 patients
with recurrent glioblastoma in this single-arm study to evaluate
the safety and tolerability of this combination regimen, establish
optimal dosing of veledimex and nivolumab, and measure overall
patient survival. Patients with rGBM scheduled for resection who
have not been treated previously with inhibitors of
immune-checkpoint pathways will receive Ad-RTS-hIL-12
intratumorally at the time of surgical resection plus an escalating
dose of veledimex (10 and 20mg), an oral activator ligand, daily
for 14 days. Patients will receive nivolumab intravenously (either
1 mg/kg or 3 mg/kg) one week before resection, 15 days
post-resection and approximately every two weeks until documented
progression or withdrawal from the study. This study is enrolling
patients at multiple leading brain cancer centers in the United
States.
About Controlled
IL-12Ad-RTS-hIL-12 plus veledimex, or Controlled IL-12, is
a novel gene therapy candidate designed to express human
interleukin 12 (hIL-12) under the control of an orally administered
activator ligand, veledimex through a proprietary RheoSwitch
Therapeutic System® (RTS®) gene switch. IL-12 is a powerful
cytokine that has demonstrated a targeted, anti-tumor immune
response with the ability to activate and recruit killer T cells to
the tumor site. Biopsy data from a Phase 1 study evaluating
Ad-RTS-hIL-12 plus veledimex as a single agent to treat patients
with rGBM showed consistent, dose-dependent production of IL-12 and
interferon gamma, an influx of CD3+ CD8+ cytotoxic T cells and
evidence of overexpression of PD-1/PD-L1 markers. Data from this
same trial show median overall survival (mOS) of 12.7 months has
been sustained for patients treated with Ad-RTS-hIL-12 plus 20mg of
veledimex (n=15) at a mean follow-up time of 12.9 months as of May
4, 2018. This mOS of 12.7 months compares favorably to the 5 to 8
months survival established in historical controls for patients
with rGBM in a similar patient population. Preclinical data from a
study evaluating Ad-RTS-IL-12 plus veledimex in combination with an
anti-PD-1 are promising, including 100 percent survival in one
dosing cohort. An ongoing Phase 1 trial is evaluating Ad-RTS-hIL-12
plus veledimex as a monotherapy to treat patients with rGBM, and
the Company also is enrolling pediatric patients in its Phase 1
trial of Ad-RTS-hIL-12 with veledimex for the treatment of brain
tumors at multiple U.S. sites. In addition to these trials,
Ziopharm is exploring combination therapies with Controlled IL-12
and checkpoint inhibitors in additional tumor types.
About Ziopharm Oncology,
Inc.Ziopharm Oncology is a Boston-based biotechnology
company focused on the development of next-generation
immunotherapies utilizing gene- and cell-based therapies to treat
patients with cancer. In partnership with Precigen Inc., a
wholly-owned subsidiary of Intrexon Corporation (NYSE:XON),
Ziopharm is focused on the development of two platform technologies
designed to deliver safe, effective and scalable cell- and
viral-based therapies for the treatment of multiple cancer types:
Controlled IL-12 and Sleeping Beauty for genetically
modifying T cells. The Company's lead asset, Ad-RTS-hIL-12 plus
veledimex, has demonstrated in clinical trials the potential to
control interleukin-12, leading to an infiltration of T cells that
fight brain cancer. The Company also is advancing therapies
using Sleeping Beauty, a non-viral approach to genetically
modify chimeric antigen receptor (CAR+) and T-cell receptor (TCR+)
T cells, which target specific antigens in blood cancers and
neoantigens in solid tumors. Sleeping Beauty is designed
using the Company's point-of-care technology, a shortened
manufacturing process which potentially can be developed as a
decentralized manufacturing process based in hospitals. These
programs are being advanced in collaboration with Precigen and with
MD Anderson Cancer Center, the National Cancer Institute and Merck
KGaA, Darmstadt, Germany.
Forward-Looking DisclaimerThis
press release contains certain forward-looking statements within
the meaning of 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 business and
strategic plans, the availability of cash resources, the Company's
ability to establish a commercially-viable manufacturing approach
as well as the progress and timing of the development of the
Company's research and development programs. All 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:
changes in the Company's financial condition and cash needs,
funding or other strategic opportunities that become available to
the Company, 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 Annual Report on Form 10-K for the fiscal year
ended December 31, 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.
Contact: David Connolly Ziopharm Oncology 617-502-1881
dconnolly@ziopharm.com
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