Collaboration will enable the development of investigational
next-generation bispecific immunotherapies using CytomX's
Probody® and Regeneron's Veloci-Bi®
platforms
CytomX to receive $30 million
upfront payment with the potential for up to $2 billion in research, development, regulatory
and sales-based milestones
TARRYTOWN, N.Y. and SOUTH SAN FRANCISCO, Calif.,
Nov. 17,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and CytomX Therapeutics, Inc. (NASDAQ: CTMX)
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 Regeneron
Regeneron 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.
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.
Regeneron Forward-Looking Statements and Use of
Digital Media
This 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 Forward-Looking Statements
This 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
Contacts:
|
|
|
|
Media
Relations
Daren
Kwok
Tel: +1
914-847-1328
daren.kwok@regeneron.com
|
Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443 Vesna.Tosic@regeneron.com
|
|
|
CytomX
Contacts:
|
|
|
|
Company
Contact
Chris
Ogden
Senior Vice
President
Head of Finance and
Investor Relations
cogden@cytomx.com
(317)
767-4764
|
Investor and Media
Relations Stephanie
Ascher
Stern Investor
Relations
stephanie.ascher@sternir.com
(212) 362-1200
|
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content:https://www.prnewswire.com/news-releases/regeneron-and-cytomx-announce-strategic-research-collaboration-in-the-field-of-conditional-bispecific-therapeutics-for-the-treatment-of-cancer-301681127.html
SOURCE Regeneron Pharmaceuticals, Inc.