Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that
new and updated data from its hematology pipeline will be shared in
19 abstracts at the American Society of Hematology (ASH) Annual
Meeting from December 9 to 12 in San Diego, CA. These include
research across six investigational medicines that span eight
difficult-to-treat blood cancers and disorders. Together, these
presentations showcase the diversity of approaches Regeneron is
advancing through its hematology pipeline and its dedication to
leading-edge research.
“We are fusing our legacy of innovation with our deep scientific
expertise in hematology to advance research across multiple
modalities as we aim to ultimately make a meaningful impact in
patients’ lives. Our data at ASH are a testament to our progress
towards this ambition,” said L. Andres Sirulnik, M.D., Ph.D.,
Senior Vice President, Translational and Clinical Sciences,
Hematology at Regeneron. “In addition to new results from our
pivotal trials evaluating odronextamab and linvoseltamab, we are
presenting findings on our growing blood disorders pipeline.
Further, our presentations span emerging measures of disease that
contribute to a deeper understanding of these advanced conditions,
which in the future could form the basis of response-directed
treatment paradigms.”
At ASH, 10 abstracts will feature updated data and analyses for
Regeneron’s most advanced investigational blood cancer medicine,
odronextamab (CD20xCD3 bispecific antibody), in relapsed/refractory
(R/R) follicular lymphoma (FL) and R/R diffuse large B-cell
lymphoma (DLBCL). Among them are three oral presentations from its
pivotal trial (ELM-2), including: the final analysis in R/R DLBCL
patients; a comprehensive analysis of minimal residual disease
status and circulating tumor DNA profiling in R/R FL and DLBCL
patients; and updated analyses and long-term follow-up of efficacy,
safety and patient reported outcomes in R/R FL. Furthermore, the
company will share long-term survival outcomes and a responder
analysis for odronextamab from a Phase 1 trial (ELM-1) in R/R DLBCL
patients who have progressed after CAR-T therapy, a patient
population who have a particularly dismal prognosis and limited
effective treatment options. Odronextamab is currently under
regulatory review for the treatment of R/R FL and R/R DLBCL by the
U.S. Food and Drug Administration, with a target action date of
March 31, 2024, as well as by the European Medicines Agency.
Five presentations will highlight data supporting linvoseltamab
(BCMAxCD3 bispecific antibody), including the first presentation of
primary endpoint results with longer follow-up from the pivotal
Phase 2 trial (LINKER-MM1) in heavily pre-treated patients with
multiple myeloma. Additionally, two presentations will review the
latest results from three Phase 2 studies evaluating pozelimab (C5
antibody) in combination with Alnylam Pharmaceuticals, Inc.’s
cemdisiran (siRNA C5 inhibitor) in patients with paroxysmal
nocturnal hemoglobinuria, a rare blood disorder.
Regeneron presentations at ASH:
Abstract title |
Abstract |
Presenting/Lead Author |
Presentationdate/time(PT) |
Odronextamab |
Circulating Tumor DNA Analysis Associates with Progression-Free
Survival (PFS) with Odronextamab Monotherapy in Relapsed/Refractory
(R/R) Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma
(DLBCL): Identification of Minimal Residual Disease Status and
High-Risk Subgroups from the Phase 2 ELM-2 Study |
#427 Oral Presentation |
Jon E. Arnason |
Sunday,December 10,9:30 AM |
|
|
|
|
Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients
with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma
(DLBCL) |
#436 Oral Presentation |
Sabarish Ram Ayyappan |
Sunday,December 10,10:15 AM |
|
|
|
|
Maintenance of Moderate to High Levels of Functioning and Quality
of Life with Odronextamab Monotherapy in Patients with Relapsed or
Refractory Follicular Lymphoma |
#669 Oral Presentation |
Benoît Tessoulin |
Sunday,December 10,5:00 PM |
|
|
|
|
Odronextamab Monotherapy for the Treatment of Relapsed/Refractory
(R/R) Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma
(DLBCL): Focus on Clinical Pharmacology and Pharmacometrics in the
ELM-1 and ELM-2 Studies |
#1436 Poster Presentation |
Min Zhu |
Saturday,December 9,5:30-7:30 PM |
|
|
|
|
Results of a Second, Prespecified Analysis of the Phase 2 Study
ELM-2 Confirm High Rates of Durable Complete Response with
Odronextamab in Patients with Relapsed/Refractory (R/R) Follicular
Lymphoma (FL) with Extended Follow-Up |
#3041 Poster Presentation |
Jose (J.C.) C. Villasboas Bisneto |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
Trial in Progress: Phase 1 Trial Evaluating the Safety and
Tolerability of Odronextamab in Combination with Cemiplimab in
Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma |
#3100 Poster Presentation |
Cecilia Carpio |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
Odronextamab Demonstrates Durable Complete Responses in Patients
with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing After CAR-T
Therapy: Outcomes from the ELM-1 Study |
#4461 Poster Presentation |
Jennifer L. Crombie |
Monday,December 11,6:00-8:00 PM |
|
|
|
|
Health-Related Quality of Life and Symptoms in Patients with
Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated with
Odronextamab Monotherapy in the Phase 2 ELM-2 Study |
#4504 Poster Presentation |
Elżbieta Iskierka-Jażdżewska |
Monday,December 11,6:00-8:00 PM |
|
|
|
|
Key prognostic factors in patients with relapsed/refractory
follicular lymphoma: An evidence based systematic literature and
medical review |
#7261 Online publication |
Ana Jimenéz-Ubieto |
N/A |
|
|
|
|
Key prognostic factors in patients with relapsed/refractory diffuse
large B-cell lymphoma: An evidence based systematic literature and
medical review |
#7258 Online Publication |
Bastien von Tresckow |
N/A |
|
|
|
|
Linvoseltamab |
Incidence of Second Primary Malignancies in Medicare-Insured
Patients in the US with Triple-Class Exposed Relapsed/Refractory
Multiple Myeloma |
#912 Oral Presentation |
Sikander Ailawadhi |
Monday,December 11,4:00 PM |
|
|
|
|
Health-Related Quality of Life (HRQoL) Among Patients with
Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM)
Treated with Linvoseltamab in LINKER-MM1: Interim Assessment Up to
36 Weeks of Treatment |
#3359 Poster Presentation |
James E. Hoffman |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
Trial In Progress: A Phase 2 Study of Linvoseltamab for the
Treatment of High-Risk Smoldering Multiple Myeloma
(LINKER-SMM1) |
#3393 Poster Presentation |
Paula Rodriguez-Otero |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
Real-World Study of Patients with Triple-Class Exposed
Relapsed/Refractory Multiple Myeloma: Analysis Across a Spectrum of
Advanced Disease Stage Medicare Patients in the United States |
#3773 Poster Presentation |
Qiufei Ma |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
Patterns of Response to 200 mg Linvoseltamab in Patients with
Relapsed/Refractory Multiple Myeloma: Longer Follow-up of the
LINKER-MM1 study |
#4746 Poster Presentation |
Sundar Jagannath |
Monday,December 11,6:00-8:00 PM |
|
|
|
|
Pozelimab + Cemdisiran* |
Psychometric Evaluation of the PNH Symptom Questionnaire (PNH-SQ)
Among Patients With Paroxysmal Nocturnal Hemoglobinuria from Three
Phase 2 Clinical Trials With Pozelimab Monotherapy or in
Combination With Cemdisiran |
#3752 Poster Presentation |
Christopher Hartford |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
52-Week Open-Label Extension Data from A Phase 2 Study Evaluating
the Safety and Efficacy of Pozelimab and Cemdisiran Combination
Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria Who
Switched from Eculizumab |
#2716 Poster Presentation |
Richard J. Kelly |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
REGN7999 (TMPRSS6 inhibitor) |
Single Ascending Doses of REGN7999, A Monoclonal Antibody Inhibitor
of TMPRSS6, Increase Serum Hepcidin And Cause Deep, Sustained
Reductions in Serum Iron in Healthy Human Volunteers |
#3841 Poster Presentation |
Nikhil Singh |
Monday,December 11,6:00-8:00 PM |
|
|
|
|
REGN7257 (IL2RG antibody) |
Blockade of Common Gamma Chain Cytokine Signaling with REGN7257, an
Interleukin 2 Receptor Gamma (IL2RG) Monoclonal Antibody, in
Combination with Costimulatory Blockers Delayed Skin Graft
Rejection in Mice |
#2550 Poster Presentation |
Audrey Le Floc’h |
Sunday,December 10,6:00-8:00 PM |
|
|
|
|
REGV131-LNP1265 (in vivo CRISPR/Cas9-based Factor 9 gene insertion
therapy)** |
Novel Approaches for Gene-Based Therapies: Targeted Gene Insertion
of Factor 9 as a Durable Treatment for Hemophilia B |
Invited Talk |
Leah Sabin |
Saturday,December 9,9:30-10:45 AM |
|
|
|
|
|
|
|
|
*In collaboration with Alnylam Pharmaceuticals, Inc.**In
collaboration with Intellia Therapeutics, Inc.
The potential uses of odronextamab, linvoseltamab, pozelimab,
cemdisiran, REGN7999, REGN7257, and REGV131-LNP1265 described above
are investigational, and their safety and efficacy have not been
fully evaluated by any regulatory authority.
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.
If you are interested in learning more about our clinical
trials, please contact us (clinicaltrials@regeneron.com or
844-734-6643) or visit our clinical trials website.
About Regeneron Regeneron (NASDAQ: REGN) 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, 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. 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 its
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.
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
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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 (CD20xCD3 bispecific antibody), linvoseltamab
(BCMAxCD3 bispecific antibody), pozelimab (C5 antibody) in
combination with Alnylam Pharmaceuticals, Inc.’s cemdisiran (siRNA
C5 inhibitor), and other of Regeneron’s Product Candidates
discussed or referenced 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, including odronextamab for the treatment of
relapsed/refractory (“R/R”) diffuse large B-cell lymphoma and R/R
follicular lymphoma, linvoseltamab for the treatment of multiple
myeloma, and pozelimab in combination with cemdisiran for the
treatment of paroxysmal nocturnal hemoglobinuria; 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 odronextamab,
linvoseltamab, and pozelimab in combination with cemdisiran); 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, linvoseltamab, and
pozelimab in combination with cemdisiran) 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) as well
as Regeneron’s agreement with Alnylam Pharmaceuticals, Inc. as
referenced in this press release, 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 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 September 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
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Contacts: Media
RelationsTammy Allen Tel: +1
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