- ICON-2 is pharmacologically more potent in
vivo and in vitro, with better nonclinical tolerability, compared
with a monomethyl auristatin E (MMAE) anti-TF antibody-drug
conjugate (ADC) -
- Data presented this week at the World ADC
Digital Conference -
Exelixis, Inc. (Nasdaq: EXEL) and Iconic Therapeutics today
announced new preclinical data that support the continued
development of ICON-2, an ADC comprised of an anti-Tissue Factor
(TF) antibody and Zymeworks’ proprietary linker-payload, for the
treatment of diverse solid tumors. Exelixis has an exclusive option
and license agreement for ICON-2 in oncology indications under its
May 2019 agreement with Iconic Therapeutics, which discovered and
is developing this novel ADC. The new data, which demonstrate the
superior tolerability and exposure of ICON-2 compared with an MMAE
anti-TF ADC, are being presented this week in a poster at the World
ADC Digital Conference, which is being held online September
15-18.
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“These data provide additional preclinical validation both of
our platform of proprietary anti-TF molecules designed to
efficiently but safely bind TF, which is overexpressed in a variety
of solid tumors, and specifically for Iconic Therapeutics’ strategy
to advance its next generation ADC targeting TF,” said William L.
Greene, M.D., Chief Executive Officer of Iconic Therapeutics.
“Other anti-TF ADCs that use MMAE as a linker-payload have been
associated with side effects that can reduce tolerability,
including bleeding, neutropenia and skin toxicities. The data
presented today demonstrate ICON-2 effectively kills solid tumor
cells in a variety of preclinical studies with an improved
tolerability profile, and support continued development of ICON-2
as a treatment for solid tumors. We are currently conducting
additional preclinical and nonclinical studies in support of
initiating human clinical trials of this potentially best-in-class
anti-TF ADC.”
TF plays a critical role in the coagulation cascade and its
expression is generally restricted in normal tissue. However, solid
tumors, including gastrointestinal, head and neck, cervical,
ovarian and bladder tumors, frequently express TF at high levels,
which is associated with poor prognosis. Although TF is an
attractive target for ADC therapy, previous approaches have
demonstrated the potential to interfere with the coagulation
cascade and may have additional toxicities that could negatively
impact their risk-benefit profile.
The data presented today include results from several
preclinical studies of ICON-2. Key findings from these studies
are:
- ICON-2 binds to TF on human and non-human primate (NHP) cells
with high affinity but does not affect coagulation as measured by
FXa conversion and thrombin generation assays.
- ICON-2 does not induce neutropenia in NHPs.
- ICON-2 is more potent than an ADC containing MMAE conjugated to
the same anti-TF antibody in mouse xenograft model of human
pancreatic tumor cells.
- ICON-2 is highly active in patient-derived xenograft models
derived from multiple tumor types.
- ICON-2 exhibits superior tolerability and exposure when
compared directly with an MMAE ADC using the same anti-TF antibody
in a NHP study.
“We entered into our exclusive option and license agreement with
Iconic Therapeutics because its expertise in TF biology and access
to proprietary ADC technology provide a robust foundation for
developing potentially best-in-class therapies for solid tumor
indications with significant unmet clinical need,” said Peter Lamb,
Ph.D., Executive Vice President, Scientific Strategy and Chief
Scientific Officer of Exelixis. “The data presented today continue
to support that potential and differentiate ICON-2 from other
anti-TF ADCs. These promising results also underscore Exelixis’
ability to identify promising licensing opportunities as part of
our ongoing pipeline expansion strategy, which includes both
internally developed and in-licensed programs.”
Under the terms of the May 2019 agreement, Exelixis has an
exclusive option to license ICON-2 in exchange for an upfront
option payment to Iconic of $7.5 million and a commitment of
preclinical development funding. Exelixis can exercise its option
at any time up to 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.
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 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 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.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’ and
Iconic Therapeutics’ plans to present preclinical data in support
of the continued development of ICON-2 at the World ADC Digital
Conference; Exelixis’ belief that Iconic Therapeutics’ expertise in
TF biology and access to proprietary ADC technology provide a
robust foundation for developing potentially best-in-class
therapies for solid tumor indications with significant unmet
clinical need; Exelixis’ potential future financial and other
obligations under the exclusive option and license agreement with
Iconic Therapeutics; 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 availability of data at the
referenced times; 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 Therapeutics, including Iconic Therapeutics’ adherence to
its obligations under the collaboration and license option
agreement and the level of Iconic Therapeutics’ 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 Therapeutics’ continuing compliance with applicable
legal and regulatory requirements; Exelixis’ and Iconic
Therapeutics’ 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 August 6, 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.
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 Hubbard Executive Vice
President, Public Affairs & Investor Relations (650) 837-8194
shubbard@exelixis.com
Exelixis Media Contact: Hal Mackins For Exelixis, Inc.
(415) 994-0040 hal@torchcommunications.com
Iconic Therapeutics Media/Investors Contact: Shari Annes
(650) 888-0902 sannes@annesassociates.com
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