- Companies will partner to develop novel antibody-drug
conjugates using Catalent’s SMARTag bioconjugation platform and
monoclonal antibodies from Exelixis’ growing preclinical
pipeline
- Agreement includes exclusive options on multiple targets
over three-year term, with potential to extend time and scope of
the collaboration
- Deal is the fifth pipeline-enhancing agreement signed by
Exelixis since 2018
Exelixis, Inc. (Nasdaq: EXEL) and Catalent today announced a
partnership under which Catalent’s Redwood Bioscience subsidiary
will develop multiple antibody-drug conjugates (ADCs) for Exelixis
using Catalent’s proprietary SMARTag® site-specific bioconjugation
technology.
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the full release here:
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Under the terms of the agreement, Catalent will use its SMARTag®
bioconjugation platform to build ADCs using monoclonal antibodies
(mAbs) from Exelixis’ growing preclinical pipeline. In exchange for
an upfront payment to Catalent of $10 million, Exelixis received an
exclusive option to nominate up to a fixed number of targets using
the SMARTag® ADC platform over a three-year period. The companies
plan to advance the ADCs into preclinical development, and, prior
to filing an Investigational New Drug application, Exelixis may
exercise its exclusive option to a worldwide license of the related
ADC program and continue clinical development and
commercialization. Exelixis will provide research & development
funding, and Catalent will be eligible for development and
commercial milestones and royalties on net sales of any product
commercialized as part of the collaboration.
Developed by Catalent’s Redwood Bioscience subsidiary, the
SMARTag® technology platform provides optimized site-specific
protein-modification and linker technologies for ADCs and other
bioconjugates. The SMARTag® platform overcomes the limitations
associated with traditional protein chemistries that produce
heterogeneous products with variable conjugate potency, toxicity,
and stability and enables the development of ADCs with a wider
therapeutic window and improved manufacturability.
“With our lead product CABOMETYX now a global oncology
franchise, over the past several years Exelixis has moved beyond
our small molecule medicinal chemistry roots to build out a
pipeline that encompasses a variety of promising therapeutic
modalities,” said Peter Lamb, Ph.D., Executive Vice President,
Scientific Strategy and Chief Scientific Officer of Exelixis. “Our
collaboration with Catalent – the fifth pipeline-enhancing
agreement we’ve signed since 2018 – provides an attractive
framework for identifying and advancing differentiated ADC product
candidates with the potential to improve upon current ADC
therapies. We are looking forward to working with Catalent as we
rapidly advance our mission to help cancer patients recover
stronger and live longer.”
“The SMARTag® platform has recently demonstrated promising
results in the clinic, highlighting the potential to create ADCs
with significantly expanded therapeutic indices,” commented Mike
Riley, Region President, Catalent Biologics, North America. “We are
excited to partner with Exelixis, a leading oncology biotechnology
company, and leverage our experienced team, unique SMARTag®
technology platform, and deep analytical expertise to develop ADCs
targeting various oncology indications.”
About Catalent Biologics
Catalent Biologics is a global leader in development,
manufacturing and analytical services for new biological entities,
cell and gene therapies, biosimilars, sterile injectables, and
antibody-drug conjugates. With over 20 years of proven expertise,
Catalent Biologics has worked with 600+ mAbs and 80+ proteins,
produced 13 biopharmaceutical drugs using GPEx® cell line
development technology, and manufactured 35+ commercially approved
products. Catalent Cell & Gene Therapy, a unit of Catalent
Biologics, is a full-service partner for adeno-associated virus
(AAV) vectors and CAR-T immunotherapies, with deep experience in
viral vector scale-up and production. Catalent recently acquired
MaSTherCell, adding expertise in autologous and allogeneic cell
therapy development and manufacturing. Catalent Cell & Gene
Therapy has produced 100+ cGMP batches across 70+ clinical and
commercial programs. For more information, visit
biologics.catalent.com.
About Catalent
Catalent is the leading global provider of advanced delivery
technologies, development, and manufacturing solutions for drugs,
biologics, cell and gene therapies, and consumer health products.
With over 85 years serving the industry, Catalent has proven
expertise in bringing more customer products to market faster,
enhancing product performance and ensuring reliable global clinical
and commercial product supply. Catalent employs over 13,900 people,
including approximately 2,400 scientists and technicians, at more
than 45 facilities, and in fiscal year 2020 generated over $3
billion in annual revenue. Catalent is headquartered in Somerset,
New Jersey. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
About Exelixis
Founded in 1994, Exelixis, Inc. 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. 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’
immediate and potential future financial and other obligations
under the collaboration, option and exclusive license agreement
with Catalent; the potential for the collaboration with Catalent to
result in the advancement of differentiated ADC product candidates
with the potential to improve upon current ADC therapies and
advance Exelixis’ mission to help cancer patients recover stronger
and live longer; 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
Catalent, including Catalent’s adherence to its obligations under
the collaboration, option and exclusive license agreement and the
level of Catalent’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 and commercial activities; risks
and uncertainties related to regulatory review and approval
processes and Exelixis’ compliance with applicable legal and
regulatory requirements; Exelixis’ and Catalent’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 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
Japanese trademark.
Catalent and SMARTag are registered trademarks
of Catalent Pharma Solutions, Inc. or its affiliates or
subsidiaries in the United States and other countries.
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version on businesswire.com: https://www.businesswire.com/news/home/20200908005557/en/
Exelixis Investors Contact: 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
Catalent Media Contact: Chris Halling +44 (0)7580 041073
chris.halling@catalent.com
Richard Kerns +44 (0) 161 728 5880 richard@nepr.agency
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