Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the U.S. Food and Drug Administration (FDA) has accepted for
Priority Review the Biologics License Application (BLA) for
linvoseltamab to treat adult patients with relapsed/refractory
(R/R) multiple myeloma (MM) that has progressed after at
least three prior therapies. The target action date for the FDA
decision is August 22, 2024. Linvoseltamab is an investigational
bispecific antibody designed to bridge B-cell maturation antigen on
multiple myeloma cells with CD3-expressing T cells to facilitate
T-cell activation and cancer-cell killing.
The BLA 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. Earlier this month, the European Medicines
Agency accepted for review the Marketing Authorization Application
for linvoseltamab in the same indication.
As the second most common blood cancer, it’s estimated 35,000
people will be diagnosed with MM in the U.S. every year. MM 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 in patients with R/R MM (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 Regeneron CD38xCD28 costimulatory bispecific in
MM is also planned. For more information, visit the Regeneron
clinical trials website, or contact via
clinicaltrials@regeneron.com or 844-734-6643.
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
282 enrolled patients with R/R MM. Eligibility in the Phase 2
portion required patients to have received at least three prior
lines of therapy or have triple-class refractory MM. Linvoseltamab
was administered with an initial step-up dosing regimen followed by
the full dose. Additionally, in the Phase 2 portion, a
response-adapted regimen enabled patients treated with
linvoseltamab 200 mg 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 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 endpoint of objective response rate.
Key secondary endpoints 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 for the treatment of
relapsed/refractory (“R/R”) multiple myeloma (“MM”); 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 R/R MM (including based on the Biologics License
Application or the Marketing Authorization Application discussed or
referenced 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, including its Form 10-K for the year ended December 31,
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).
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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