� ICON-2 program targets Tissue Factor (TF)
with potential broad impact in oncology �
� Exelixis will make upfront payment and
contribute research funding for option to in-license at
Investigational New Drug (IND) filing �
Exelixis, Inc. (Nasdaq: EXEL) today announced that it has
entered into an exclusive option and license agreement with Iconic
Therapeutics, Inc. (Iconic), a private biopharmaceutical company
focused on cancer and retinal disease, to advance an innovative
next-generation antibody-drug conjugate (ADC) program for cancer.
This collaboration reflects Exelixis’ ongoing strategy to build a
pipeline beyond its lead product, CABOMETYX, through both internal
drug discovery and external business development. This agreement
with Iconic is Exelixis’ second strategic collaboration focused on
novel biologics, following the company’s collaboration with
Invenra, Inc. announced in May 2018. This exclusive agreement is
Iconic’s first strategic collaboration in oncology and leverages
the company’s innovative Tissue Factor antibody expertise.
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Under the terms of the agreement, Exelixis will gain an
exclusive option to license ICON-2, Iconic’s lead oncology ADC
program, in exchange for an upfront option payment to Iconic of
$7.5 million and a commitment of preclinical development funding.
Exelixis would exercise its option at the time of a potential IND
application, and upon doing so would make an option exercise
payment to Iconic and assume responsibilities for all subsequent
clinical development and commercialization activities. Should
Exelixis elect to exercise its option, Iconic will become eligible
for future development, regulatory and commercialization milestone
payments, as well as royalties on potential sales.
“Iconic Therapeutics is pursuing an innovative approach to
targeting Tissue Factor, a promising target with early clinical
validation and potential applicability across a wide variety of
cancers,” said Peter Lamb, Ph.D., Executive Vice President and
Chief Scientific Officer of Exelixis. “This agreement provides
Exelixis with an attractive entry into the antibody-drug conjugate
space, and reflects our preference for success-based terms that
reward our partners for long-term shared success. We’re looking
forward to working with the Iconic team to advance this exciting
program, which is complementary to Exelixis’ small molecule and
emerging biologics capabilities.”
ICON-2 represents a potential best-in-class program targeting TF
in solid tumors. TF is highly expressed on tumor cells and in the
tumor microenvironment. TF overexpression, while not oncogenic
itself, facilitates angiogenesis, metastasis and other processes
important to tumor development and progression. ICON-2 is a
rationally designed second-generation ADC with potential for an
improved therapeutic index and safety profile.
“We believe this partnership with a premier oncology company
provides further validation of our novel approach,” said William L.
Greene, M.D., Chief Executive Officer of Iconic Therapeutics.
“Exelixis’ clinical development and commercialization expertise,
evidenced by the growing success of the cabozantinib franchise,
make it the ideal partner as we advance this promising program
towards the clinic. Iconic Therapeutics’ deep expertise in Tissue
Factor biology and antibody-drug conjugate design sets the ICON-2
program apart from other approaches to this historically
challenging target,” Dr. Greene added.
About Iconic Therapeutics
Iconic Therapeutics, Inc. is a venture-backed biopharmaceutical
company dedicated to translating an understanding of the role of
Tissue Factor biology to new therapeutics for retinal disease and
cancer. The company has developed a portfolio of proprietary
molecules, which bind to and antagonize TF expressed in disease,
both in retina and in solid tumors. Please visit
www.iconictherapeutics.com for additional information.
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a
commercially successful, oncology-focused biotechnology company
that strives to accelerate the discovery, development and
commercialization of new medicines for difficult-to-treat cancers.
Following early work in model genetic systems, we established a
broad drug discovery and development platform that has served as
the foundation for our continued efforts to bring new cancer
therapies to patients in need. Our discovery efforts have resulted
in four commercially available products,
CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib),
COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we
have entered into partnerships with leading pharmaceutical
companies to bring these important medicines to patients worldwide.
Supported by revenues from our marketed products and
collaborations, we are committed to prudently reinvesting in our
business to maximize the potential of our pipeline. We are
supplementing our existing therapeutic assets with targeted
business development activities and internal drug discovery — all
to deliver the next generation of Exelixis medicines and
help patients recover stronger and live
longer. Exelixis is a member of the Standard & Poor’s
(S&P) MidCap 400 index, which measures the performance of
profitable mid-sized companies. For more information
about Exelixis, please visit www.exelixis.com, follow
@ExelixisInc on Twitter or like Exelixis,
Inc. on Facebook.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
strategy to build a pipeline beyond its lead product, CABOMETYX,
through both internal drug discovery and external business
development; Exelixis’ immediate and potential future financial and
other obligations under the option and license agreement with
Iconic; the potential applicability of targeting TF across a wide
variety of cancers; the potential for ICON-2 to be complimentary to
Exelixis’ small molecule and emerging biologics capabilities; the
potential for ICON-2 to represent a best-in-class program targeting
TF and a second-generation ADC with an improved therapeutic index
and safety profile; and the potential of the Exelixis-Iconic
partnership to advance the ICON-2 program towards the
clinic. Any statements that refer to expectations, projections
or other characterizations of future events or circumstances are
forward-looking statements and are based upon Exelixis’ current
plans, assumptions, beliefs, expectations, estimates and
projections. Forward-looking statements involve risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in the forward-looking statements
as a result of these risks and uncertainties, which include,
without limitation: the level of costs associated with Exelixis’
commercialization, research and development, in-licensing or
acquisition of product candidates, and other activities;
uncertainties inherent in the drug discovery and product
development process; Exelixis’ dependence on its relationship with
Iconic, including Iconic’s adherence to its obligations under the
option and license agreement and the level of Iconic’s assistance
to Exelixis in completing clinical trials, pursuing regulatory
approvals or successfully commercializing partnered compounds in
the territories where they may be approved; risks and uncertainties
related to regulatory review and approval processes and Exelixis’
compliance with applicable legal and regulatory requirements;
Exelixis’ and Iconic’s ability to protect their respective
intellectual property rights; market competition; changes in
economic and business conditions; and other factors discussed under
the caption “Risk Factors” in Exelixis’ Quarterly Report on Form
10-Q filed with the Securities and Exchange
Commission (SEC) on May 1, 2019, and in Exelixis’ future
filings with the SEC. All forward-looking statements in this
press release are based on information available
to Exelixis as of the date of this press
release, and Exelixis undertakes no obligation to update
or revise any forward-looking statements contained herein.
Exelixis, the Exelixis logo,
CABOMETYX, COMETRIQ and COTELLIC are registered U.S.
trademarks.
MINNEBRO is a registered Japanese
trademark.
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Exelixis Investors Contact:Susan HubbardEVP, Public
Affairs andInvestor RelationsExelixis,
Inc.650-837-8194shubbard@exelixis.com
Exelixis Media Contact:Hal
Mackins415-994-0040hal@torchcommunications.com
Iconic Investors/Media Contact:Shari
Annes650-888-0902sannes@annesassociates.com
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