Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the European Medicines Agency (EMA) has accepted for
review the Marketing Authorization Application (MAA) for
linvoseltamab to treat adult patients with relapsed/refractory
(R/R) multiple myeloma (MM) who have progressed after at least
three prior therapies. Linvoseltamab is an investigational
bispecific antibody designed to bridge B-cell maturation antigen
(BCMA) on multiple myeloma cells with CD3-expressing T cells to
facilitate T-cell activation and cancer-cell killing.
The MAA is supported by data from a Phase 1/2
pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM,
which were last shared in December 2023. A Biologics License
Application (BLA) was also submitted to the FDA in December
2023.
As the second most common blood cancer, there are over 176,000
new cases of MM diagnosed globally every year. It is characterized
by the proliferation of cancerous plasma cells (MM cells) that
crowd out healthy blood cells in the bone marrow, infiltrate other
tissues and cause potentially life-threatening organ injury. MM is
not curable despite treatment advances. While current treatments
are able to slow the progression of the cancer, most patients will
ultimately experience disease progression and require additional
therapies.
The linvoseltamab clinical development program includes a Phase
3 confirmatory trial (LINKER-MM3) that is currently enrolling.
Additional trials in earlier lines of therapy and stages of disease
are planned or underway, including a Phase 1/2 trial in the
first-line setting, a Phase 2 trial in high-risk smoldering MM and
a Phase 2 trial in monoclonal gammopathy of undetermined
significance. A Phase 1 trial of linvoseltamab in combination with
a CD38xCD28 costimulatory bispecific in MM is also planned. For
more information, contact clinicaltrials@regeneron.com or
844-734-6643, or visit the Regeneron clinical
trials website.
Linvoseltamab is currently under clinical development, and its
safety and efficacy have not been fully evaluated by any regulatory
authority.
About the Phase 1/2 TrialThe ongoing,
open-label, multicenter Phase 1/2 dose-escalation and
dose-expansion LINKER-MM1 trial is investigating linvoseltamab in
patients with R/R MM. Among 282 patients enrolled, all received at
least three prior lines of therapy or were triple refractory.
Linvoseltamab was administered with an initial step-up dosing
regimen followed by the full dose. Additionally, a response-adapted
administration schedule enabled patients who achieved a very good
partial response or a complete response to shift from every
two-week to every-four-week dosing after a minimum of 24 weeks of
therapy.
The Phase 1 intravenous dose-escalation portion of the trial,
which is now complete, primarily assessed safety, tolerability and
dose-limiting toxicities across nine dose levels of linvoseltamab
exploring different administration regimens. The Phase 2 dose
expansion portion is assessing the safety and anti-tumor activity
of linvoseltamab, with a primary objective of objective response
rate. Key secondary objectives include duration of response,
progression free survival, rate of minimal residual disease
negative status and overall survival.
About Regeneron in HematologyAt Regeneron,
we’re applying more than three decades of biology expertise with
our proprietary VelociSuite® technologies to develop
medicines for patients with diverse blood cancers and rare blood
disorders.
Our blood cancer research is focused on bispecific antibodies
that are being investigated both as monotherapies and in various
combinations and emerging therapeutic modalities. Together, they
provide us with unique combinatorial flexibility to develop
customized and potentially synergistic cancer treatments.
Our research and collaborations to develop potential treatments
for rare blood disorders include explorations in antibody medicine,
gene editing and gene-knockout technologies, and investigational
RNA-approaches focused on depleting abnormal proteins or blocking
disease-causing cellular signaling.
About RegeneronRegeneron is a leading
biotechnology company that invents, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for over 35 years by physician-scientists, our
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 our laboratories. Our 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 more information about Regeneron, please visit
www.Regeneron.com or follow Regeneron on LinkedIn.
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 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, including without limitation
linvoseltamab; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron’s Product
Candidates and new indications for Regeneron’s Products, such as
linvoseltamab for the treatment of adult patients with
relapsed/refractory multiple myeloma (including based on
the Marketing Authorization Application discussed in this
press release); 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
the studies 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 (such as
linvoseltamab); 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 (such as linvoseltamab) 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; the
extent to which the results from the research and development
programs conducted by Regeneron and/or its collaborators or
licensees may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; 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 potential for any license, collaboration, or supply
agreement, including Regeneron’s agreements with Sanofi and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; 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), 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. 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).
Contacts:Media
Relations Tammy
Allen Tel: +1 914-306-2698tammy.allen@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
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