– Phase 1 clinical trial planned for
early 2021, pending the FDA’s acceptance of Exelixis’ planned IND
filing –
– Under the terms of the companies’
agreement, Exelixis has made an option exercise payment of $20
million to Iconic Therapeutics –
– Preclinical data underscore best-in-class
potential for XB002 (formerly ICON-2) in treatment of solid tumors
–
Exelixis, Inc. (Nasdaq: EXEL), Iconic Therapeutics, Inc.
(Iconic) and Zymeworks Inc. (NYSE:ZYME) today announced that
Exelixis has exercised its exclusive option for Iconic’s lead
oncology antibody-drug conjugate (ADC) program under the companies’
May 2019 agreement. As a result, Exelixis now has responsibility
for the future clinical development, commercialization, and
manufacturing of the Tissue Factor (TF)-targeting ADC now known as
XB002 (formerly ICON-2). A rationally designed next-generation ADC,
XB002 comprises a Tissue Factor-targeting antibody with Zymeworks’
proprietary ZymeLink™ linker-payload, creating the potential for an
improved therapeutic index and favorable safety profile as compared
to earlier-generation, TF-targeting ADCs. Exelixis plans to file an
Investigational New Drug application (IND) with the U.S. Food and
Drug Administration (FDA) for XB002 in the near-term and, pending
the FDA’s acceptance of the IND, initiate a phase 1 clinical trial
of XB002 in early 2021.
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“XB002 is an important addition to the Exelixis pipeline given
its potential differentiation from other Tissue Factor-targeting
antibody-drug conjugates and its status as the first program in our
growing biologics portfolio to reach IND filing stage,” said Peter
Lamb, Ph.D., Executive Vice President and Chief Scientific Officer
of Exelixis. “Iconic designed a highly promising molecule and
advanced it through a rigorous preclinical evaluation, setting the
stage for Exelixis to complete our planned IND filing in the coming
weeks. We are grateful for Iconic’s partnership over the past 18
months and look forward to fully evaluating the potential of XB002
to help patients with cancer.”
Under the terms of the May 2019 agreement between Exelixis and
Iconic, Exelixis gained an exclusive option to license XB002 (then
ICON-2) in exchange for an upfront payment to Iconic of $7.5
million and a commitment of preclinical development funding. In
exercising its exclusive option, Exelixis has made an additional
option exercise payment of $20 million to Iconic. Iconic is now
also eligible for future development, regulatory and
commercialization milestone payments, as well as royalties on
potential sales. The ZymeLink ADC technology in XB002 was
originally licensed to Iconic from Zymeworks. Under the terms of
their 2019 agreement, Zymeworks will receive a share of the $20
million option fee and is eligible to receive a share of all future
revenue received by Iconic, as well as tiered royalties on
worldwide sales.
“Exelixis’ decision to in-license our lead oncology program
provides important validation of Iconic’s discovery and development
capabilities, our platform of proprietary anti-Tissue Factor
molecules designed to efficiently but safely bind Tissue Factor,
and the potential of Tissue Factor as an oncology antibody-drug
conjugate target,” said William L. Greene, M.D., Chief Executive
Officer of Iconic Therapeutics. “Preclinical data presented earlier
this year demonstrate that XB002 binds Tissue Factor without
affecting the coagulation cascade, which has hindered prior
development of Tissue Factor-targeting molecules, has activity in
multiple solid tumor cancer models and has improved tolerability
compared to other Tissue Factor-targeting ADCs. We are excited to
see XB002 make further progress as part of Exelixis’
highly-regarded clinical development organization.”
“We are excited to see this promising molecule take an important
step towards clinical trials backed by the experienced clinical
team at Exelixis,” said Tony Polverino, Ph.D., Executive Vice
President, Early Development and Chief Scientific Officer of
Zymeworks. “This would mark the second ZymeLink-based therapeutic
to enter the clinic in addition to our bispecific HER2
antibody-drug conjugate, ZW49, further highlighting the
differentiative potential of our novel antibody-drug conjugate
platform.”
Pending the completion of Exelixis’ planned IND and the FDA’s
acceptance of the filing, Exelixis intends to initiate a phase 1
dose escalation and expansion study of XB002 in subjects with
inoperable locally advanced or metastatic solid tumors early in
2021.
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 system genetics, 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. In November 2020, the company was named to Fortune’s 100
Fastest-Growing Companies list for the first time, ranking 17th
overall and the third-highest biopharmaceutical company. For more
information about Exelixis, please visit www.exelixis.com, follow
@ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
About Iconic Therapeutics
Iconic Therapeutics, Inc. is a biopharmaceutical company
dedicated to leveraging its deep insight into tissue factor biology
and TF’s role in inflammation, tumor growth, and angiogenesis to
develop new therapeutics for serious diseases including retinal
disease and cancer. The Company has developed a portfolio of
proprietary molecules which bind to and antagonize TF expressed in
several disease states. In May, 2019, Iconic Therapeutics entered
into a licensing agreement with Zymeworks that granted to Iconic
non-exclusive rights to Zymeworks’ proprietary ZymeLink™
antibody-drug conjugate (ADC) platform. Please visit
www.iconictherapeutics.com for additional information.
About Zymeworks
Zymeworks is a clinical-stage biopharmaceutical company
dedicated to the development of next-generation multifunctional
biotherapeutics. Zymeworks’ suite of therapeutic platforms and its
fully integrated drug development engine enable precise engineering
of highly differentiated product candidates. Zymeworks’ lead
clinical candidate, zanidatamab (ZW25), is a novel Azymetric™
bispecific antibody which has been granted Breakthrough Therapy
designation by the FDA and is currently enrolling in a
registration-enabling clinical trial for refractory HER2+ biliary
tract cancer as well as several Phase 2 clinical trials for HER2+
gastroesophageal and breast cancers. Zymeworks’ second clinical
candidate, ZW49, is a bispecific antibody-drug conjugate currently
in Phase 1 clinical development and combines the unique design and
antibody framework of zanidatamab with Zymeworks’ proprietary
ZymeLink™ linker-cytotoxin. Zymeworks is also advancing a deep
preclinical pipeline in oncology (including immuno-oncology agents)
and other therapeutic areas. In addition, its therapeutic platforms
are being leveraged through strategic partnerships with nine
biopharmaceutical companies. For additional information about
Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on
Twitter.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
plans to file an IND with the FDA for XB002 in the near-term and,
pending the FDA’s acceptance of the IND, initiate a phase 1
clinical trial of XB002 in early 2021; the therapeutic potential of
XB002 for cancer patients and favorable safety profile of the
molecule as compared to earlier-generation, TF-targeting ADCs;
Exelixis’ potential future financial and other obligations under
the exclusive option and license agreement with Iconic; and
Exelixis’ plans to reinvest in its business to maximize the
potential of the company’s pipeline, including through targeted
business development activities and internal drug discovery. 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
exclusive 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; the
continuing COVID-19 pandemic and its impact on Exelixis’ research
and development operations; complexities and the unpredictability
of the regulatory review and approval processes in the U.S. and
elsewhere; Exelixis’ and Iconic’s continuing compliance with
applicable legal and regulatory requirements; Exelixis’, Iconic’s
and Zymeworks’ ability to protect their respective intellectual
property rights; market competition; changes in economic and
business conditions; and other factors affecting Exelixis and its
product pipeline discussed under the caption “Risk Factors” in
Exelixis’ Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission (SEC) on November 5, 2020, 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, except as required by law.
Zymeworks Forward-Looking Statement
This press release includes “forward-looking statements” within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and “forward-looking information” within the meaning of
Canadian securities laws, or collectively, forward-looking
statements. Forward-looking statements in this press release
include, but are not limited to, statements that relate to the
payment to Zymeworks of a share of the $20 million option fee
received by Iconic, Zymeworks’ eligibility to receive a share of
future revenue received by Iconic as well as tiered royalties on
worldwide sales, Zymeworks’ clinical and preclinical development of
its product candidates, and other information that is not
historical information. When used herein, words such as “will”,
“plan”, “intend”, and similar expressions are intended to identify
forward-looking statements. In addition, any statements or
information that refer to expectations, beliefs, plans,
projections, objectives, performance or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking. All forward-looking statements
are based upon Zymeworks’ current expectations and various
assumptions. Zymeworks believes there is a reasonable basis for its
expectations and beliefs, but they are inherently uncertain.
Zymeworks may not realize its expectations, and its beliefs may not
prove correct. Actual results could differ materially from those
described or implied by such forward-looking statements as a result
of various factors, including, without limitation, market
conditions and the factors described under “Risk Factors” in
Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended
September 30, 2020 (a copy of which may be obtained at www.sec.gov
and www.sedar.com). Consequently, forward-looking statements should
be regarded solely as Zymeworks’ current plans, estimates and
beliefs. Investors should not place undue reliance on
forward-looking statements. Zymeworks cannot guarantee future
results, events, levels of activity, performance, or achievements.
Zymeworks does not undertake and specifically declines any
obligation to update, republish, or revise any forward-looking
statements to reflect new information, future events or
circumstances or to reflect the occurrences of unanticipated
events, except as may be required by law.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a
registered Japanese trademark.
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EXELIXIS CONTACTS:
Investor Inquiries: Susan Hubbard Executive Vice
President, Public Affairs & Investor Relations (650) 837-8194
shubbard@exelixis.com
Media Contact: Hal Mackins for Exelixis, Inc. (415)
994-0040 hal@torchcommunications.com
ICONIC CONTACTS:
Media and Investor Inquiries: Shari Annes (650) 888-0902
sannes@annesassociates.com
ZYMEWORKS CONTACTS:
Investor Inquiries: Ryan Dercho, Ph.D. (604)
678-1388 ir@zymeworks.com Tiffany Tolmie (604) 678-1388
ir@zymeworks.com Media Inquiries: Mary Klem (604)
678-1388 media@zymeworks.com
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