Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion recommending conditional marketing authorization of
odronextamab to treat adults with relapsed/refractory (R/R)
follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma
(DLBCL), after two or more lines of systemic therapy.
The European Commission is expected to announce a final
decision in the coming months.
FL and DLBCL are the two most common subtypes of B-cell
non-Hodgkin lymphoma (B-NHL). While FL is a slow-growing subtype,
it is an incurable disease, and most patients will relapse after
initial treatment. DLBCL is an aggressive subtype, with up to 50%
of high-risk patients experiencing progression after first-line
treatment (e.g., relapsing or refractory to treatment). It is
estimated that approximately 120,000 FL cases and 163,000 DLBCL
cases are diagnosed annually worldwide. In Europe, it is estimated
that approximately 15,000 FL cases and 31,000 DLBCL cases are
diagnosed each year.
The positive CHMP opinion is supported by results from the Phase
1 ELM-1 and pivotal Phase 2 ELM-2 trials, which demonstrated
robust, durable response rates and an acceptable safety profile of
odronextamab in adults with R/R FL or R/R DLBCL. In a pooled safety
population, the most common serious adverse reactions were cytokine
release syndrome, pneumonia, COVID-19 and pyrexia.
The EMA previously granted odronextamab Orphan Designation for
both FL and DLBCL. Odronextamab is currently under clinical
development and has not been approved by any regulatory
authority.
Regeneron continues to evaluate the use of odronextamab as a
monotherapy and in combination across earlier lines of therapy in
challenging-to-treat lymphomas. This includes the registrational
ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program,
which is one of the largest clinical programs in lymphoma
evaluating odronextamab in earlier lines of therapy and additional
B-NHLs, as well as early-stage trials with chemotherapy-free
combinations.
About the Odronextamab Clinical Trial Program
Odronextamab is an investigational CD20xCD3 bispecific antibody
designed to bridge CD20 on cancer cells with CD3-expressing T cells
to facilitate local T-cell activation and cancer-cell killing.
ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to
investigate the safety and tolerability of odronextamab in patients
with CD20+ B-cell malignancies previously treated with
CD20-directed antibody therapy, including a cohort of patients who
had progressed after CAR-T therapy.
ELM-2 is an ongoing, open-label, multicenter Phase 2 trial
investigating odronextamab across five independent disease-specific
cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone
lymphoma and other subtypes of B-NHL. The primary endpoint is
objective response rate according to the Lugano Classification as
assessed by independent review committee, and secondary endpoints
include complete response, progression-free survival, overall
survival and duration of response.
In addition to the Phase 3 OLYMPIA development program,
Regeneron is investigating odronextamab in combination with a
costimulatory bispecific antibody, REGN5837 (CD22xCD28), and
Regeneron’s PD-1 inhibitor cemiplimab for R/R aggressive B-NHL
through the ATHENA-1 and CLIO-1 studies, respectively. For more
information, visit the Regeneron clinical trials website, or
contact clinicaltrials@regeneron.com or +1
844-734-6643.
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
combination with each other 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 (NASDAQ: REGN) is
a leading biotechnology company that
invents, develops and commercializes life-transforming
medicines for people with serious diseases. Founded and led by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to
numerous approved treatments and product candidates in development,
most 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, neurological diseases, hematologic conditions,
infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery
and accelerates drug development using our
proprietary technologies, such as VelociSuite®, which produces
optimized fully human antibodies and new classes of bispecific
antibodies. We are shaping the next frontier of medicine with
data-powered insights from the Regeneron Genetics
Center® and pioneering genetic medicine platforms, enabling us
to identify innovative targets and complementary approaches to
potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow
Regeneron on LinkedIn, Instagram, Facebook or X.
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 odronextamab; the impact of the opinion adopted
by the European Medicines Agency's Committee for Medicinal Products
for Human Use discussed in this press release on the potential
conditional marketing authorization by the European Commission of
odronextamab to treat adults with relapsed/refractory (“R/R”)
follicular lymphoma (“FL”) or R/R diffuse large B-cell lymphoma
(“DLBCL”) after two or more lines of systemic therapy; 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 odronextamab for the
treatment of R/R FL or R/R DLBCL as discussed in this press release
as well as odronextamab in combination with REGN5837 (CD22xCD28
costimulatory bispecific antibody) or cemiplimab (PD-1 inhibitor)
as 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; 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 odronextamab) 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
(including the pending civil proceedings initiated or joined by the
U.S. Department of Justice and the U.S. Attorney's Office for the
District of Massachusetts), 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 and its Form 10-Q for the quarterly
period ended March 31, 2024. 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: |
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|
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Media
Relations Aditi
BhandariTel: +1
914-374-1841aditi.bhandari@regeneron.com |
Investor
RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
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