RJ Kirk, CEO and Chairman of Intrexon, to Join ZIOPHARM Board of
NEW YORK & GERMANTOWN, Md.--(BUSINESS WIRE)--
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:
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;
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 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;
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.
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
Conference Call and Webcast January 6, 2011 at 5:00pm ET
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.
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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ZIOPHARM Oncology, Inc.
David Pitts, 212-600-1902
Robert Beech, 301-556-9812
Source: ZIOPHARM Oncology, Inc.
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