Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Intellia
Therapeutics, Inc. (NASDAQ:NTLA) today announced an expanded
research collaboration to develop additional in vivo CRISPR-based
gene editing therapies focused on neurological and muscular
diseases. This builds on the success of the companies’ existing
collaboration and continues to combine both companies’ deep biology
and technology expertise. The collaboration will leverage
Regeneron’s proprietary antibody-targeted adeno-associated virus
(AAV) vectors and delivery systems and Intellia’s proprietary Nme2
CRISPR/Cas9 (Nme2Cas9) systems adapted for viral vector delivery
and designed to precisely modify a target gene.
“To date, the widespread use of genetic medicines has generally
been limited by the inability to deliver a genetic payload to cells
of interest in the body beyond the liver. This expansion of our
longstanding and productive collaboration with Intellia is taking
advantage of new technology and innovations to unlock these
opportunities,” said Aris Baras, M.D., Senior Vice President and
Co-Head of Regeneron Genetic Medicines.
“Regeneron has invented and preclinically validated a
proprietary antibody-directed AAV approach that builds on our
decades of experience in antibodies and newly developed AAV capsid
engineering technologies to deliver innovative payloads across many
targeted tissue types and disease settings. We’re excited to put
this approach to the test in combination with Intellia’s
industry-leading gene editing systems, in hopes of generating
important new medicines for people with serious neurological and
muscular diseases,” said Christos Kyratsous, Ph.D., Senior Vice
President, Research, and Co-Head of Regeneron Genetic
Medicines.
“We are excited to expand our successful collaboration with
Regeneron to now accelerate the development of CRISPR-based
therapies outside of the liver for the treatment of neurological
and muscular diseases with significant unmet need,” said Intellia
President and Chief Executive Officer John Leonard, M.D. “At
Intellia, we are continuously innovating our editing and delivery
solutions to realize the full potential of CRISPR gene editing as a
new therapeutic modality. This collaboration is representative of
our long-standing belief that the most groundbreaking solutions
will come from selecting the best tools for each individual
application, all of which are enabled by our industry-leading
genome editing toolbox.”
Under the terms of the expanded agreement, the companies will
initially research two in vivo non-liver targets. Intellia will
lead the design of the editing methodology and Regeneron will lead
the design of the targeted viral vector delivery approach. Each
company will have the opportunity to lead potential development and
commercialization of product candidates for one target, and the
company that is not leading development and commercialization will
have the option to enter into a co-development and
co-commercialization agreement for the target.
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 35 years by physician-scientists, Regeneron’s
unique ability to repeatedly and consistently translate science
into medicine has led to numerous FDA-approved treatments and
product candidates in development, almost all of which were
homegrown in Regeneron's laboratories. Regeneron's medicines and
pipeline are designed to help patients with eye diseases, allergic
and inflammatory diseases, cancer, cardiovascular and metabolic
diseases, 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 additional information about Regeneron, please visit
www.regeneron.com or follow Regeneron on LinkedIn.
About Intellia TherapeuticsIntellia
Therapeutics, a leading clinical-stage genome editing company, is
developing novel, potentially curative therapeutics leveraging
CRISPR-based technologies. To fully realize the transformative
potential of CRISPR-based technologies, Intellia is pursuing two
primary approaches. The company’s in vivo programs use
intravenously administered CRISPR as the therapy, in which
proprietary delivery technology enables highly precise editing of
disease-causing genes directly within specific target tissues.
Intellia’s ex vivo programs use CRISPR to create the
therapy by using engineered human cells to treat cancer and
autoimmune diseases. Intellia’s deep scientific, technical and
clinical development experience, along with its robust intellectual
property portfolio, have enabled the company to take a leadership
role in harnessing the full potential of genome editing to create
new classes of genetic medicine. Learn more at intelliatx.com.
Follow us on X (formerly known as Twitter) @intelliatx.
Regeneron Forward-Looking Statements 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 nature, timing, and possible success and therapeutic
applications of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively,
“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, such as the research programs
with Intellia Therapeutics, Inc. to develop in vivo CRISPR-based
gene editing therapies focused on neurological and muscular
diseases discussed in this press release; 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 Intellia discussed in this press release, to be cancelled or
terminated; the extent to which the results from the research and
development programs conducted by Regeneron and/or its
collaborators or licensees (including those conducted as part of
the collaboration with Intellia 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 of utilizing for therapeutic
purposes Regeneron’s novel adeno-associated virus (AAV) vectors and
delivery systems and Intellia’s proprietary Nme2 CRISPR/Cas9
(Nme2Cas9) systems adapted for viral vector delivery 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, including those discussed or
referenced in this press release) 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; the impact of public
health outbreaks, epidemics, or pandemics (such as the COVID-19
pandemic) on Regeneron's business; 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 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,
2022 and its Form 10-Q for the quarterly period ended June 30,
2023. 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 (https://investor.regeneron.com) and its
LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Intellia Forward-Looking Statements This press
release contains "forward-looking statements" of Intellia
Therapeutics, Inc. ("Intellia" or the "Company") within the meaning
of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to, express
or implied statements regarding Intellia's beliefs and expectations
regarding its: research and development of a proprietary Nme2Cas9
system adapted for viral vector delivery and the combination of
that system with Regeneron Pharmaceuticals, Inc.’s (“Regeneron”)
proprietary antibody-targeted adeno-associated virus vectors and
delivery systems to develop product candidates for neurological and
muscular diseases, including development and design of editing
methodologies for such product candidates; ability to accelerate
the development of CRISPR-based therapies outside of the liver for
the treatment of neurological and muscular diseases with
significant unmet need; advancement and expansion of its
CRISPR/Cas9 technology to develop human therapeutic products,
including its ability to continuously innovate its editing and
delivery solutions to realize the full potential of CRISPR gene
editing as a new therapeutic modality and to enable groundbreaking
solutions with its industry-leading genome editing toolbox; ability
to lead the potential development and commercialization of product
candidates for in vivo non-liver targets; ability to maintain and
expand its intellectual property portfolio related to CRISPR/Cas9
technology; and ability to optimize the impact of its
collaborations on its development programs, including but not
limited to its collaboration with Regeneron.
Any forward-looking statements in this press release are based
on management's current expectations and beliefs of future events,
and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those
set forth in or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: risks
related to Intellia's ability to protect and maintain its
intellectual property position; risks related to Intellia's
relationship with third parties, including Regeneron and its other
licensors and licensees; risks related to the ability of its
licensors to protect and maintain their intellectual property
position; uncertainties related to the research, development and
commercialization of product candidates for neurological and
muscular diseases, including product candidates that combine
Intellia's proprietary Nme2Cas9 system with Regeneron’s proprietary
antibody-targeted adeno-associated virus vectors and delivery
systems; the risk that any one or more of Intellia's product
candidates, or product candidates it develops with Regeneron, will
not be successfully developed and commercialized; the risk that the
results of preclinical studies or clinical studies will not be
predictive of future results in connection with future studies; and
the risk that Intellia's collaboration Regeneron will not continue
or will not be successful. For a discussion of these and other
risks and uncertainties, and other important factors, any of which
could cause Intellia's actual results to differ from those
contained in the forward-looking statements, see the section
entitled "Risk Factors" in Intellia's most recent annual report on
Form 10-K or quarterly report of Form 10-Q, as well as discussions
of potential risks, uncertainties, and other important factors in
Intellia's other filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and Intellia undertakes no duty to update this
information unless required by law.
Regeneron Contacts:
Investors:Vesna
Tosic+1-914-847-5443vesna.tosic@regeneron.com
Media:Ella
Campbell+1-914-847-7017ella.campbell@regeneron.com
Intellia Contacts:
Investors:Ian KarpSenior Vice President,
Investor Relations and Corporate
Communications+1-857-449-4175ian.karp@intelliatx.com
Lina LiSenior Director, Investor Relations and Corporate
Communications +1-857-706-1612lina.li@intelliatx.com
Media:Matt CrensonTen Bridge
Communications+1-917-640-7930media@intelliatx.commcrenson@tenbridgecommunications.com
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