CytomX Therapeutics, Inc. (NASDAQ: CTMX) and Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a
collaboration and licensing agreement to create
conditionally-activated investigational bispecific cancer therapies
utilizing CytomX’s Probody® therapeutic platform and Regeneron’s
Veloci-Bi® bispecific antibody development platform.
The collaboration is strategically focused on
applying CytomX’s biologic masking strategies to develop
investigational Regeneron bispecifics that remain inactive until
activated by proteases in the tumor microenvironment. This
technology has the potential to widen the therapeutic window and
help minimize off-target effects for these next-generation T-cell
engaging therapies, potentially addressing tumor types that have
historically been unresponsive to immunotherapy.
“At Regeneron, we’re focused on developing a
paradigm-changing portfolio of oncology medicines for patients, by
combining a deep understanding of cancer biology with cutting-edge
technologies,” said John Lin, M.D., Ph.D., Senior Vice President,
Immuno-oncology and Head of Bispecifics, at Regeneron. “This
collaboration will enable Regeneron and CytomX to combine our
collective oncology expertise with two premier platforms – Probody
and Veloci-Bi – to develop novel immunotherapies and research their
potential to transform patient lives.”
“CytomX has pioneered the field of
conditionally-activated therapeutics through high quality and
differentiated science, leading to broad experience in biologic
masking strategies and a deep understanding of the protease tumor
microenvironment,” said Sean McCarthy, D. Phil, CEO and Chairman of
CytomX. “We are thrilled that our scientific expertise has
attracted Regeneron as our newest collaborator, and we look forward
to working closely together to further optimize T-cell engager
strategies and push the boundaries of cancer immunotherapy to new
levels.”
Under the agreement, Regeneron and CytomX will
collaborate on the discovery activities to identify and validate
conditionally active bispecific antibodies. Regeneron will be
responsible for funding preclinical and clinical development and
commercialization activities. CytomX will receive an upfront
payment of $30 million and will be eligible to receive future
target nomination payments and preclinical, clinical, and
commercial milestones of up to $2 billion. CytomX is also eligible
to receive tiered global net sales royalties.
About CytomX Therapeutics,
Inc. CytomX is a clinical-stage, oncology-focused
biopharmaceutical company dedicated to destroying cancer
differently. By pioneering a novel class of conditionally activated
biologics, powered by its Probody® technology platform, CytomX’s
goal is to transcend the limits of current cancer treatments.
CytomX’s robust and differentiated pipeline comprises seven
therapeutic candidates across multiple treatment modalities
including antibody-drug conjugates (“ADCs”), T-cell engaging
bispecific antibodies (“TCBs”), and immune modulators such as
cytokines and checkpoint inhibitors (“CPIs”). CX-2029 is an
investigational conditionally activated antibody-drug conjugate
(ADC) directed toward CD71, which has demonstrated encouraging
antitumor activity in patients with squamous non-small cell lung
cancer and is being developed in collaboration with AbbVie.
CytomX’s clinical pipeline also includes cancer immunotherapeutic
candidates against validated targets such as the CTLA-4-targeting
Probody therapeutics, BMS-986249 and BMS-986288, partnered with
Bristol Myers Squibb, as well as CX-904, a conditionally activated
T-cell-engaging bispecific antibody targeting the epidermal growth
factor receptor (EGFR) on tumor cells and the CD3 receptor on T
cells, which is partnered with Amgen. In addition, CytomX has a
diverse preclinical portfolio of wholly-owned assets including
CX-801, an interferon alpha-2b Probody cytokine that has broad
potential applicability in traditionally immuno-oncology sensitive
as well as insensitive (cold) tumors and CX-2051, a conditionally
activated ADC directed toward EpCAM, with potential applicability
across multiple EpCAM-expressing epithelial cancers. Praluzatamab
ravtansine is an investigational conditionally activated ADC
directed toward CD166 that demonstrated single agent clinical
activity in a Phase 2 study for patients with advanced
HR+/HER2-non-amplified breast cancer. Following the Phase 2
results, CytomX decided not to further progress praluzatamab
ravtansine alone and is seeking a partner to further develop the
molecule. CytomX has also established strategic collaborations with
multiple leaders in oncology, including AbbVie, Amgen, Astellas,
Bristol Myers Squibb and Regeneron. For more information about
CytomX and how it is working to make conditionally activated
treatments the new standard-of-care in the fight against cancer,
visit www.cytomx.com and follow us on LinkedIn and Twitter.
About RegeneronRegeneron is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for nearly 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune®, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center®, which
is conducting one of the largest genetics sequencing efforts in the
world.
For more information, please visit
www.Regeneron.com or follow @Regeneron on Twitter.
CytomX Forward-Looking
StatementsThis press release includes forward-looking
statements. Such forward-looking statements involve known and
unknown risks, uncertainties and other important factors that are
difficult to predict, may be beyond our control, and may cause the
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied in such statements, including those related to
the future potential of partnerships or collaboration agreements.
Accordingly, you should not rely on any of these forward-looking
statements, including those relating to the potential benefits,
safety and efficacy or progress of CytomX’s or any of its
collaborative partners’ product candidates, including CX-2029,
BMS-986249, BMS-986288, pacmilimab, CX-904, CX-801,CX-2051, and
praluzatamab ravtansine, the potential benefits or applications of
CytomX’s Probody platform technology, CytomX’s ability to develop
and advance product candidates into and successfully complete
clinical trials, including the ongoing and planned clinical trials
of CX-2029, BMS-986249, BMS-986288, pacmilimab, CX-904, and
praluzatamab ravtansine, and the timing of the commencement of
clinical trials, initial and ongoing data availability,
investigational new drug applications and other development
milestones. Risks and uncertainties that contribute to the
uncertain nature of the forward-looking statements include: the
unproven nature of CytomX’s novel Probody Platform technology;
CytomX’s clinical trial product candidates are in the initial
stages of clinical development and its other product candidates are
currently in preclinical development, and the process by which
preclinical and clinical development could potentially lead to an
approved product is long and subject to significant risks and
uncertainties, including the risk that the COVID-19 worldwide
pandemic may continue to negatively impact the business, research
and clinical operations of CytomX or its partners, including the
development of preclinical drug candidates due to delays in and
disruption of research activities and the development of clinical
drug candidates due to delays in or disruption of clinical trials,
including impacts on the enrollment of patients in clinical trials
or other clinical trial disruptions; the possibility that the
results of preclinical research and early clinical trials may not
be predictive of future results; the possibility that CytomX’s
clinical trials will not be successful; the possibility that
current preclinical research may not result in additional product
candidates; CytomX’s dependence on the success of CX-2029,
BMS-986249, BMS-986288, pacmilimab, CX-904, CX-801, and CX-2051;
CytomX’s reliance on third parties for the manufacture of the
Company’s product candidates; and possible regulatory developments
in the United States and foreign countries. Additional
applicable risks and uncertainties include those relating to our
preclinical research and development, clinical development, and
other risks identified under the heading "Risk Factors" included in
CytomX’s Quarterly Report on Form 10-Q filed with
the SEC on August 4, 2022. The forward-looking
statements contained in this press release are based on information
currently available to CytomX and speak only as of the date on
which they are made. CytomX does not undertake and specifically
disclaims any obligation to update any forward-looking statements,
whether as a result of any new information, future events, changed
circumstances or otherwise.
Probody is a U.S. registered trademark of CytomX
Therapeutics, Inc.
Regeneron Forward-Looking Statements and
Use of Digital MediaThis press release includes
forward-looking statements that involve risks and uncertainties
relating to future events and the future performance
of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the
"Company"), and actual events or results may differ materially from
these forward-looking statements. Words such as "anticipate,"
"expect," "intend," "plan," "believe," "seek," "estimate,"
variations of such words, and similar expressions are intended to
identify such forward-looking statements, although not all
forward-looking statements contain these identifying words. These
statements concern, and these risks and uncertainties include,
among others, the impact of SARS-CoV-2 (the virus that has caused
the COVID-19 pandemic) on Regeneron's business and its employees,
collaborators, and suppliers and other third parties on which
Regeneron relies, Regeneron's and its collaborators' ability to
continue to conduct research and clinical programs, Regeneron's
ability to manage its supply chain, net product sales of products
marketed or otherwise commercialized by Regeneron and/or its
collaborators or licensees (collectively, "Regeneron's Products"),
and the global economy; the nature, timing, and possible success
and therapeutic applications of Regeneron's Products and product
candidates being developed by Regeneron and/or its collaborators or
licensees (collectively, "Regeneron's Product Candidates") and
research and clinical programs now underway or planned, including
without limitation any conditionally-activated investigational
bispecific cancer therapies contemplated under the collaboration
discussed in this press release; the extent to which the results
from the research and development programs conducted by Regeneron
and/or its collaborators or licensees (including based on the
collaboration discussed in this press release) may be replicated in
other studies and/or lead to advancement of product candidates to
clinical trials, therapeutic applications, or regulatory approval;
the potential for any license, collaboration, or supply agreement,
including Regeneron's agreements with Sanofi and Bayer (or their
respective affiliated companies, as applicable), as well as
Regeneron's collaboration with CytomX Therapeutics, Inc. discussed
in this press release, to be cancelled or terminated; the potential
of utilizing CytomX’s Probody® therapeutic platform in combination
with Regeneron’s Veloci-Bi® bispecific antibody development
platform as discussed in this press release; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's Product Candidates and new indications for
Regeneron's Products; uncertainty of the utilization, market
acceptance, and commercial success of Regeneron's Products and
Regeneron's Product Candidates and the impact of studies (whether
conducted by Regeneron or others and whether mandated or voluntary)
on any of the foregoing or any potential regulatory approval of
Regeneron's Products and Regeneron's Product Candidates; the
ability of Regeneron's collaborators, licensees, suppliers, or
other third parties (as applicable) to perform manufacturing,
filling, finishing, packaging, labeling, distribution, and other
steps related to Regeneron's Products and Regeneron's Product
Candidates; the ability of Regeneron to manage supply chains for
multiple products and product candidates; safety issues resulting
from the administration of Regeneron's Products and Regeneron's
Product Candidates in patients, including serious complications or
side effects in connection with the use of Regeneron's Products and
Regeneron's Product Candidates in clinical trials; determinations
by regulatory and administrative governmental authorities which may
delay or restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products and Regeneron's Product
Candidates; ongoing regulatory obligations and oversight impacting
Regeneron's Products, research and clinical programs, and business,
including those relating to patient privacy; the availability and
extent of reimbursement of Regeneron's Products from third-party
payers, including private payer healthcare and insurance programs,
health maintenance organizations, pharmacy benefit management
companies, and government programs such as Medicare and Medicaid;
coverage and reimbursement determinations by such payers and new
policies and procedures adopted by such payers; competing drugs and
product candidates that may be superior to, or more cost effective
than, Regeneron's Products and Regeneron's Product Candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
financial projections or guidance and changes to the assumptions
underlying those projections or guidance; and risks associated with
intellectual property of other parties and pending or future
litigation relating thereto (including without limitation the
patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection, Praluent® (alirocumab),
and REGEN-COV® (casirivimab and imdevimab)), other litigation
and other proceedings and government investigations relating to the
Company and/or its operations, the ultimate outcome of any such
proceedings and investigations, and the impact any of the foregoing
may have on Regeneron's business, prospects, operating results, and
financial condition. A more complete description of these and other
material risks can be found in Regeneron's filings with
the U.S. Securities and Exchange Commission, including its
Form 10-K for the year ended December 31, 2021 and its
Form 10-Q for the quarterly period ended September 30, 2022.
Any forward-looking statements are made based on management's
current beliefs and judgment, and the reader is cautioned not to
rely on any forward-looking statements made by Regeneron. Regeneron
does not undertake any obligation to update (publicly or otherwise)
any forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new
information, future events, or otherwise.
Regeneron uses its media and investor relations
website and social media outlets to publish important information
about the Company, including information that may be deemed
material to investors. Financial and other information about
Regeneron is routinely posted and is accessible on Regeneron's
media and investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
CytomX Contacts:Company
ContactChris OgdenSenior Vice
PresidentHead of Finance and Investor Relations
cogden@cytomx.com(317) 767-4764 |
Investor and Media RelationsStephanie
AscherStern Investor
Relationsstephanie.ascher@sternir.com(212) 362-1200 |
Regeneron Contacts:Media
Relations Daren
KwokTel: +1
914-847-1328daren.kwok@regeneron.com |
Investor RelationsVesna TosicTel:
+1 914-847-5443Vesna.Tosic@regeneron.com |
CytomX Therapeutics (NASDAQ:CTMX)
過去 株価チャート
から 6 2024 まで 7 2024
CytomX Therapeutics (NASDAQ:CTMX)
過去 株価チャート
から 7 2023 まで 7 2024