Ziopharm to Host Conference Call at 8 a.m.
Ziopharm Oncology, Inc. (Nasdaq: ZIOP) and Precigen, Inc., a
wholly-owned subsidiary of Intrexon Corporation (Nasdaq: XON),
today announced a new definitive license agreement to replace all
existing agreements between the companies that will provide
Ziopharm with certain exclusive and non-exclusive rights to
technology controlled by Precigen, Inc.
Through the new agreement, Ziopharm will
primarily focus its resources on developing its Controlled IL-12
and Sleeping Beauty (SB) T-cell receptor (TCR) platform
technologies which have the capability to treat solid tumors, while
Intrexon further establishes Precigen as a therapeutics company
concentrating on immuno-oncology, autoimmune and infectious disease
therapies. Both companies will be better positioned to
independently focus on their respective platforms and markets with
full developmental and financial controls.
With this exclusive license, Ziopharm now has
full developmental control and exclusivity utilizing SB for TCRs
targeted towards neoantigens and public antigens. The existing
Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute related to SB-generated T cells
expressing TCRs to target neoantigens buried within solid tumors
will be transferred to Ziopharm, and Ziopharm will maintain this
exclusive relationship with the NCI for this program. Ziopharm will
build on its IL-12 platform utilizing Precigen’s RheoSwitch® gene
switch with both the existing human adenovirus program and now with
rights to pursue next-generation viral technologies. Using the SB
system, Ziopharm will continue to advance its CD19-specific
chimeric antigen receptor (CAR) program, while retaining rights to
a second, unnamed CAR target. Precigen gains exclusive rights for
all other CAR-T therapies, including CD33-specific CAR-T therapies,
subject to the agreement with Merck KGaA.
“This is a new day for Ziopharm, as we have the
power and flexibility to advance IL-12 and Sleeping
Beauty-generated TCRs,” said Ziopharm Chief Executive Officer
Laurence Cooper, M.D., Ph.D. “We now have focused the company on
the two platforms to drive the most shareholder value and
transitioned a significant portion of our CAR-T program to
Precigen. The ability of both Ziopharm and Precigen to autonomously
execute their respective operating plans on their independent
platforms, while sharing in future economics, enables both parties
to undertake more efficient ‘divide and conquer’ drug-development
plans to the benefit of all constituents.”
In partial consideration for the termination of
the former agreements, in addition to the grant of the revised
limited exclusive license, the companies agree that Ziopharm will
retire all outstanding shares of its Series 1 Preferred Stock held
by Intrexon, including any accrued dividends, valued at
approximately $156.9 million, as of Sept. 30, 2018. Additionally,
the companies have terminated Intrexon’s contractual right to a
seat on Ziopharm’s board. Randal J. Kirk, Chairman and Chief
Executive Officer of Intrexon, who has served as a director on the
board of Ziopharm since 2011, has stepped down from that position,
effective immediately, and Ziopharm plans to fill all vacant seats
in the near term.
“In 2011 with Ziopharm, we entered into our
first exclusive collaboration and therewith granted a field that
was far broader than any other. Today's announcement is about
seeing Ziopharm's tighter focus and about our desire to invest in
Precigen. We believe that Ziopharm will succeed under the license
to develop and bring to market important new cancer therapeutics,
and we look forward to enjoying benefits from these while we
continue our investments in Precigen,” commented Mr. Kirk.
Ziopharm will receive a low single digit, capped
royalty on Precigen products in the field of point-of-care (P-O-C)
CAR T-cell therapies. Precigen will receive milestone payments on
late-stage regulatory events as well as commercial royalties in the
low to high single-digit range for certain CAR and IL-12 targets
that Ziopharm develops. Precigen will receive capped commercial
royalties in low- to mid-single digits for the TCR products that
Ziopharm develops. Further details on the terms of the transaction
will be available within SEC filings respectively filed by Intrexon
and Ziopharm.
Ziopharm Clinical Programs
UpdateZiopharm today updated guidance on the timing of its
response to the request for more information from the U.S. Food and
Drug Administration (FDA) regarding the clinical hold placed on the
investigational new drug (IND) application for its third-generation
Phase 1 trial to evaluate CD19-specific CAR-T therapies under P-O-C
technology. Ziopharm expects to respond to the FDA’s request for
information in the second half of 2019.
Ziopharm also affirmed its guidance on the
planned Phase 1 trial to evaluate SB-modified TCRs to treat solid
tumors. As disclosed in Ziopharm’s second quarter business update,
the IND application for this Phase 1 trial, which is being led by
and conducted at the National Cancer Institute, remains on track to
be submitted in the fourth quarter of 2018 followed by enrollment
of patients beginning in 2019, pending regulatory clearance.
Conference Call and Slide
WebcastZiopharm will host a webcast and conference call
today, October 9 at 8 a.m. ET. The call can be accessed by dialing
1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international).
The passcode for the conference call is 9789556. To access the
slides and live webcast or the subsequent archived recording, visit
the “Investors Events and 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 weeks.
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. 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 cells. These programs are
being advanced in collaboration with MD Anderson Cancer Center and
the National Cancer Institute.
About Precigen: Advancing Medicine with
Precision™Founded in 2017, Precigen is a dedicated
discovery and clinical stage biopharmaceutical company advancing
the next generation of gene and cellular therapies using precision
technology to target the most urgent and intractable diseases in
oncology, autoimmune disorders, and emerging specialty therapy
areas. Our technologies enable us to find innovative solutions for
affordable biotherapeutics in a controlled manner. Precigen
operates as an innovation engine progressing a preclinical and
clinical pipeline of well-differentiated unique therapies toward
clinical proof-of-confidence and commercialization. Precigen was
founded as a wholly-owned subsidiary of Intrexon Corporation
(Nasdaq: XON) and leverages Intrexon’s proprietary technology
platforms to advance human health. Learn more about Precigen at
www.precigentherapeutics.com.
About Intrexon Corporation
Intrexon Corporation (Nasdaq: XON) is Powering the Bioindustrial
Revolution with Better DNA™ to create biologically-based products
that improve the quality of life and the health of the planet.
Intrexon’s integrated technology suite provides its partners across
diverse markets with industrial-scale design and development of
complex biological systems delivering unprecedented control,
quality, function, and performance of living cells. We call our
synthetic biology approach Better DNA®, and we invite you to
discover more at www.dna.com or follow us on Twitter at @Intrexon,
on Facebook, and LinkedIn.
TrademarksIntrexon, RheoSwitch,
Powering the Bioindustrial Revolution with Better DNA, and Better
DNA are trademarks of Intrexon and/or its affiliates. Other names
may be trademarks of their respective owners.
Forward-Looking Statements
DisclaimerThis press release contains forward-looking
statements as defined in 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 Ziopharm’s and Intrexon’s
goals, expectations, financial or other projections, intentions or
beliefs, including statements regarding Ziopharm’s and Intrexon’s
business and strategic plans; the expected benefits of the
strategic transaction, such as creating shareholder value, growth
potential, market profile, enhanced competitive position and
flexibility; the progress and timing of the development of
Ziopharm’s research and development programs, including the
expected timing for its response to the U.S. FDA and of the filing
of its IND applications; the timing for the initiation and readouts
of Ziopharm’s upcoming clinical trials; expected additions to
Ziopharm’s board of directors; and statements regarding future
performance. Although Ziopharm’s and Intrexon’s management teams
believe that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Ziopharm and Intrexon, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including whether
any of Ziopharm’s and Intrexon’ product candidates will advance
further in the preclinical research or clinical trial process,
including receiving clearance from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies to conduct
clinical trials and whether and when, if at all, they will receive
final approval from the U.S. FDA or equivalent foreign regulatory
agencies and for which indication; the strength and enforceability
of Ziopharm’s and Intrexon’s intellectual property rights;
Ziopharm’s ability to attract qualified board candidates;
competition from other pharmaceutical and biotechnology companies
as well as risk factors discussed or identified in the public
filings with the Securities and Exchange Commission made by
Ziopharm and Intrexon, including those risks and uncertainties
listed in Ziopharm’s and Intrexon’s annual reports on Form 10-K for
the year ended December 31, 2017 and subsequent Quarterly Reports
on Form 10-Q filed by Ziopharm and Intrexon with the Securities and
Exchange Commission. We are providing this information as of
October 9, 2018, and neither Ziopharm nor Intrexon undertake any
obligation to update or revise the information contained in this
press release whether as a result of new information, future events
or any other reason.
For more information contact:
Ziopharm Oncology Contacts:David
ConnollyVice President, Corporate Communications/Investor
RelationsTel: +1 (617) 502-1881Email:
dconnolly@ziopharm.com |
Mike MoyerVice President, Portfolio
StrategyTel : +1 (617) 765-3770Email :
mmoyer@ziopharm.com |
|
|
Intrexon Investor Contact:Steven
HarasymVice President, Investor RelationsTel: +1 (214)
721-0607investors@dna.com |
Intrexon Corporate Contact:Marie
Rossi, Ph.D. Vice President, CommunicationsTel: +1 (301)
556-9850publicrelations@dna.com |
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