ZIOPHARM
Oncology and Intrexon Announce Worldwide Partnership for Synthetic Biology
DNA-based Oncology Therapeutics
RJ
Kirk, CEO and Chairman of Intrexon, to Join ZIOPHARM Board of
Directors
NEW YORK, NY and GERMANTOWN, MD
(January 6, 2011) – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a small
molecule late-stage oncology drug development company, and Intrexon Corporation,
a next generation synthetic biology company, announced today a global exclusive
channel partnership in oncology where ZIOPHARM will develop and commercialize
DNA-based therapeutics using Intrexon’s UltraVector® Technology. Under the
partnership, ZIOPHARM will utilize Intrexon’s advanced transgene engineering
platform for the controlled and precise cellular production of anti-cancer
effectors. ZIOPHARM will have rights to Intrexon’s entire human in vivo effector platform
within the field of oncology which includes two lead clinical-stage product
candidates, one which is in an advanced Phase I study and another which will be
the subject of an Investigational New Drug (“IND”) filing during the first half
of 2011. ZIOPHARM and Intrexon will host a conference call and audio webcast
today, Thursday, January 6th at 5:00
p.m. ET to discuss the global exclusive channel partnership.
Intrexon
employs its modular genetic engineering platform in the areas of therapeutics,
protein production, industrial, and agriculture products. The exclusive channel
partnership between Intrexon and ZIOPHARM has been established specifically for
the field of human oncologic therapeutics. Under the partnership, Intrexon
remains responsible for technology discovery efforts and managing the patent
estate as well as for certain aspects of manufacturing. ZIOPHARM will be
responsible for conducting preclinical and clinical development of candidates,
as well as for other aspects of manufacturing and the commercialization of the
candidates.
Intrexon’s
core synthetic biology technology is designed to create Better DNA™ at
industrial scale, enabling unprecedented control over the function and output of
living cells by providing external control over in vivo activation and
regulation of potent effectors. This platform, called UltraVector®, provides
speed, flexibility, consistency and precision to the design, production and
testing of rationally designed complex transgenes and their encoded genetic
circuits. These qualities allow an iterative and rational approach to
transgene design, which can be continually engineered until their performance is
optimized. Through
this process, Intrexon is able to overcome the challenges inherent in current
therapeutic strategies, including recombinant protein therapies and constitutive
gene therapies, thereby enhancing capabilities, improving safety and lowering
cost for human therapeutics. The lead oncology product candidate developed using
Intrexon’s technologies is currently in Phase Ib clinical study for metastatic
melanoma. ZIOPHARM expects to submit an Investigational New Drug (IND)
application with U.S. Food and Drug Administration for a second oncology product
candidate in the first half of this year.
“Controllable,
scalable synthetic biology, the tightly regulated delivery of therapeutic
proteins from within the body, is an aspirational and disruptive technology
which Intrexon has brought from scientific theory to medical application,” said
Jonathan Lewis, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer
of ZIOPHARM. “As the sole channel partner for in vivo therapeutic
candidates for human oncology, ZIOPHARM plans to leverage this technology for
next-generation products targeting key pathways used by cancers to grow and
metastasize. Intrexon has developed a technology that is uniquely
flexible, scalable and controllable, adding significantly to our small molecule
drug development capabilities and our ability to translate science to the
patient using our world-class global team.”
“We are
very pleased to collaborate with ZIOPHARM, which, under the leadership of
Jonathan Lewis, is building an industry leading oncology company with a
strategic vision regarding cancer medicine. ZIOPHARM’s oncology expertise,
development capabilities, as well as its excellent reputation within the
oncology community make ZIOPHARM an exceptional investment for Intrexon and
ideal partner to rapidly achieve the full therapeutic benefit and commercial
potential of Intrexon’s disruptive technologies,” stated RJ Kirk, Intrexon’s
Chairman and CEO. “This collaboration leverages the capabilities and strengths
of each partner and has the potential to create significant value for
shareholders.”
Under
terms of the agreement:
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Intrexon
will purchase 2,422,542 shares of ZIOPHARM ‘s common stock (representing
5% of ZIOPHARM’s currently outstanding shares) in a private placement for
a total purchase price of $11,628,202, or $4.80 per share, which is the
trailing 10-day volume-weighted average price per share of ZIOPHARM’s
common stock;
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ZIOPHARM
will simultaneously issue to Intrexon for no additional consideration an
additional 3,631,391 shares of its common stock, representing
7.495% of ZIOPHARM’s currently outstanding shares; ZIOPHARM has agreed to
issue to Intrexon additional shares of its common stock for no additional
consideration, representing an additional 7.495% under certain conditions
upon dosing of the first patient in a ZIOPHARM-conducted U.S. Phase II
clinical trial of a product candidate created, produced or developed by
ZIOPHARM using Intrexon technology;
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Intrexon
has agreed to purchase up to $50 million in conjunction with securities
offerings that may be conducted by ZIOPHARM in the future, subject to
certain conditions and limitations;
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Subject
to certain expense allocations, ZIOPHARM will pay Intrexon 50% of the
cumulative net quarterly profits derived from the sale of products
developed from the channel
partnership.
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Pursuant
to the agreement, Mr. Kirk has agreed to join the ZIOPHARM Board of Directors.
In addition to his responsibilities at Intrexon, Mr. Kirk has served, since
March 1999, as Senior Managing Director and Chief Executive Officer of Third
Security, LLC, an investment management firm founded by Mr. Kirk. Additionally,
Mr. Kirk founded and became Chairman of the Board of New River Pharmaceuticals
Inc. in 1996, and was President and Chief Executive Officer between October 2001
and April 2007. New River was acquired by Shire plc in 2007. Mr. Kirk
also currently serves as a member of the Board of Directors of Halozyme
Therapeutics, Inc. (Nasdaq: HALO), and as Chairman of the Board for Clinical
Data, Inc. (Nasdaq: CLDA). Previously, Mr. Kirk served as a member of the Board
of Directors of Scios, Inc. (acquired by Johnson & Johnson) between February
2000 and May 2002. Mr. Kirk served on the Board of Visitors of Radford
University from July 2003 to June 2009, was Rector of the Board from September
2006 to September 2008, and has served on the Board of Directors of the Radford
University Foundation, Inc. since September 1998. He has served on the Board of
Visitors of the University of Virginia and Affiliated Schools since July 2009,
on the Virginia Advisory Council on Revenue Estimates since July 2006, on the
Governor’s Economic Development and Jobs Creation Commission since April 2010,
and served as a member of the Board of Directors of the Virginia University
Research Partnership from July 2007 to November 2010. Mr. Kirk received a B.A.
in Business from Radford University and a J.D. from the University of
Virginia.
Regarding
Mr. Kirk’s appointment, Dr. Lewis added: “RJ is a visionary and a winner with a
long record of success and value creation in the life sciences. His addition to
the ZIOPHARM Board of Directors will be invaluable, and we look forward to his
many contributions in this role.”
Griffin
Securities, Inc. acted as an advisor to Intrexon on this
transaction.
ZIOPHARM
and Intrexon will host a conference call and live audio webcast on January 6,
2011 at 5:00pm ET to discuss their global exclusive channel partnership. The
call can be accessed by dialing (877) 375-9144 (U.S. and Canada) or (253)
237-1150 (international). The passcode for the conference call is
‘ZIOPHARM.’ To access the live audio webcast, or the subsequent archived
recording, visit the "Investors - Events & Presentations" 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 biopharmaceutical company engaged in the development and
commercialization of a diverse portfolio of cancer drugs. The Company is
currently focused on three clinical programs.
Palifosfamide
(ZymafosTM or
ZIO-201) is a novel DNA cross-linker in class with bendamustine, ifosfamide, and
cyclophosphamide. ZIOPHARM is currently enrolling patients in a randomized,
double-blinded, placebo-controlled Phase III trial with palifosfamide
administered intravenously for the treatment of metastatic soft tissue sarcoma
in the front-line setting. The Company is also currently conducting a
Phase I intravenous study of palifosfamide in combination with standard of care
addressing small cell lung cancer and expects to initiate an additional study
with drug in the oral form treating solid tumors.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being
developed intravenously for the treatment of peripheral T-cell lymphoma with a
pivotal study expected to begin in late 2011. An oral form is in a Phase I trial
in solid tumors.
Indibulin
(ZybulinTM or
ZIO-301) is a novel, oral tubulin binding agent that is expected to have several
potential benefits including oral dosing, application in multi-drug resistant
tumors, no neuropathy and minimal overall toxicity. It is currently being
studied in Phase I/II in metastatic breast cancer.
ZIOPHARM's
operations are located in Boston, MA with an executive office in New York City.
Further information about ZIOPHARM may be found at www.ziopharm.com.
ZIOP-G
About
Intrexon Corporation:
Intrexon
Corporation is a privately held synthetic biology company that employs modular
DNA control systems to enhance capabilities, improve safety and lower cost in
human therapeutics, protein production, industrial products and agricultural
biotechnology. The company’s advanced transgene engineering platform enables
Better DNA™ by combining breakthroughs in DNA control systems with corresponding
advancements in modular transgene design, assembly and optimization. The company
is currently using these advanced capabilities to undertake foremost challenges
across the spectrum for biological applications. More information about the
company is available at www.DNA.com.
Forward-Looking
Safe Harbor Statement:
This
press release contains forward-looking statements for ZIOPHARM Oncology, Inc.
that involve risks and uncertainties that could cause ZIOPHARM Oncology’s actual
results to differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are based on
current expectations, forecasts and assumptions that are subject to risks and
uncertainties, which could cause actual outcomes and results to differ
materially from these statements. Among other things, there can be no assurance
that any of ZIOPHARM Oncology’s development efforts relating to its product
candidates will be successful, or such product candidates will be successfully
commercialized. Other risks that affect forward-looking information contained in
this press release include the possibility of being unable to obtain regulatory
approval of ZIOPHARM Oncology’s product candidates, the risk that the results of
clinical trials may not support ZIOPHARM Oncology’s claims, the risk that
pre-clinical or clinical trials will proceed on schedules that are consistent
with ZIOPHARM Oncology’s current expectations or at all, risks related to
ZIOPHARM Oncology’s ability to protect its intellectual property and its
reliance on third parties to develop its product candidates, risks related to
the sufficiency of existing capital reserves to fund continued operations for a
particular amount of time and uncertainties regarding ZIOPHARM Oncology’s
ability to obtain additional financing to support its operations thereafter, as
well as other risks regarding ZIOPHARM Oncology’s that are discussed under the
heading "Risk Factors" in ZIOPHARM Oncology’s filings with the United States
Securities and Exchange Commission. Forward-looking statements can be identified
by the use of words such as "may," "will," "intend," " should," "could," "can,"
"would," "expect," "believe," "estimate," " predict," "potential," "plan," "is
designed to," "target" and similar expressions. ZIOPHARM Oncology assumes no
obligation to update these forward-looking statements, except as required by
law.
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Contacts:
For
ZIOPHARM:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
Media:
David
Pitts
Argot
Partners
For
Intrexon:
Robert
Beech
Intrexon
Corporation
Phone:
301.556.9812
