TARRYTOWN, N.Y., Nov. 6, 2019 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it
will share new and updated data for two investigational medicines
for blood cancers and a third for a rare blood disease at the 2019
American Society of Hematology (ASH) Annual Meeting from
December 7-10 in Orlando, FL.
Among the accepted abstracts are the first clinical data for
REGN5458 (BCMAxCD3) in relapsed/refractory (R/R) multiple myeloma,
as well as updated data for REGN1979 (CD20xCD3) in R/R B-cell
non-Hodgkin lymphoma (B-NHL). Beyond oncology, the company will
share data on pozelimab, a monoclonal antibody designed to block
complement factor C5 and prevent the destruction of red blood cells
(hemolysis) that cause the symptoms of paroxysmal nocturnal
hemoglobinuria (PNH).
"The ASH presentations highlight Regeneron's growing portfolio
in blood cancer and rare diseases, including data from two of our
six bispecific antibodies currently in clinical development," said
David Weinreich, M.D., Senior Vice
President, Head of Global Clinical Development and Co-Head of
Global Development at Regeneron. "We will also present data on
pozelimab, which we are studying in a Phase 2 program in paroxysmal
nocturnal hemoglobinuria."
"We continue to make important progress with REGN1979 and are
currently enrolling a potentially registrational Phase 2 trial. At
ASH, we plan to share new data with additional patients and longer
duration of follow-up, with about 20 patients at effective dose
levels for each cohort of follicular lymphoma and diffuse large
B-cell lymphoma," said Israel Lowy,
M.D., PhD, Senior Vice President and Head of Clinical and
Translational Sciences for Oncology at Regeneron. "As part of our
expanding bispecific portfolio, we will also present encouraging,
early single-agent data on REGN5458, our BCMAxCD3 bispecific for
multiple myeloma. Additional investigational bispecific antibodies
are expected to enter clinical trials in the coming year."
The abstracts published today reflect older data; presentations
with updated data will be shared at ASH as follows:
REGN1979
- Oral presentation: Clinical Activity of REGN1979, a
Bispecific Human, Anti-CD20xAnti-CD3 Antibody, in Patients with
Relapsed/Refractory (R/R) B-cell Non-Hodgkin Lymphoma
(B-NHL) (Abstract 762; Rajat
Bannerji, M.D., Ph.D.: Monday,
December 9, 2:45-4:15 PM
ET)
- Poster presentation: A Phase 2 Study of REGN1979, an
Anti-CD20xAnti-CD3 Bispecific Antibody (Ab), in Patients with
Relapsed/Refractory (R/R) B-Cell Non-Hodgkin Lymphoma
(B-NHL) (Abstract 4007, Max S.
Topp, M.D.: Monday, December
9, 6:00-8:00 PM ET)
REGN5458
- Poster presentation: Safety and Preliminary Clinical
Activity of REGN5458, an Anti-BCMAxAnti-CD3 Bispecific Antibody, in
Patients with Relapsed/Refractory (R/R) Multiple
Myeloma (Abstract 3176; Dennis
Cooper, M.D.: Sunday, December
8, 6:00-8:00 PM ET)
Pozelimab/PNH
- Oral presentation: A Novel Patient Reported Outcome Instrument
Assessing the Symptoms of Paroxysmal Nocturnal Hemoglobinuria
(Abstract 385; R Paola Daly: Sunday,
December 8, 7:30-9:00 AM
ET)
- Poster presentation: Pozelimab, a Human Antibody Against
Complement Factor C5, Demonstrates Robust Inhibition of Alternative
Complement Activity Both in Normal Human Serum and in Phase I
Normal Healthy Volunteers (Abstract 2278; Kishor
Devalaraja-Narashimha, Ph.D., DVM: Sunday,
December 8, 6:00-8:00 PM
ET)
- Poster presentation: Epidemiology of PNH and Real-World
Treatment Patterns Following Incident PNH Diagnosis in the
U.S. (Abstract 3407; Jessica J Jalbert, Ph.D.: Sunday, December 8, 6:00-8:00 PM ET)
About the Regeneron Bispecific Antibody Platform
All
of Regeneron's bispecific antibodies are designed to closely
resemble natural human antibodies. They are derived from a
next-generation version of Regeneron's proprietary
VelocImmune® technology and created using the
company's VelociBi™ platform.
There are six Regeneron investigational bispecific antibodies
currently in ongoing clinical trials for multiple blood cancers and
solid tumors. These bispecifics fall into three categories:
- CD3 bispecifics are designed to bridge T-cells and tumor
cells. At the tumor site, they activate T-cells via their CD3
receptors and promote T-cell killing of the cancer cells.
Investigational candidates include:
-
- CD20xCD3 (REGN1979) for non-Hodgkin B-cell lymphomas;
- Two distinct BCMAxCD3s (REGN5458 and REGN5459) for multiple
myeloma;
- MUC16xCD3 (REGN4018) for ovarian cancer.
- CD28 costimulatory bispecifics are also designed to
bridge T-cells and tumor cells. At the tumor site, they costimulate
T-cells via their CD28 receptors and may synergize with PD-1
inhibitors and/or CD3 bispecifics. Investigational candidates
include:
-
- PSMAxCD28 (REGN5678) in combination with Libtayo®
(cemiplimab) for prostate cancer.
- Tumor-targeted bispecifics are designed
to target proteins only on the cancer cell. In this way, they
may affect various signaling pathways to hamper the cancer cells'
ability to survive and proliferate. Investigational candidates
include:
-
- METxMET (REGN5093) for non-small cell lung cancer that is
driven by MET mutations and/or amplifications. REGN5093 targets two
different parts of the MET receptor on cancer cells to degrade the
receptor and block its ability to trigger cell proliferation.
Regulatory Status of Programs
REGN1979, REGN5458,
REGN5459, REGN4018, REGN5678, REGN5093, pozelimab and Libtayo are
currently under clinical development for the diseases noted in this
press release, and their safety and efficacy have not been
evaluated by any regulatory authority for these diseases. As part
of a global collaboration agreement, Regeneron and Sanofi are
jointly developing Libtayo, as well as Regeneron's BCMAxCD3 and
MUC16xCD3 bispecific programs.
Libtayo is approved in the U.S. for the treatment of patients
with metastatic cutaneous squamous cell carcinoma (CSCC) or locally
advanced CSCC who are not candidates for curative surgery or
curative radiation, and in other countries for similar indications.
In the U.S., the generic name for Libtayo is cemiplimab-rwlc, with
rwlc as the suffix designated in accordance with Nonproprietary
Naming of Biological Products Guidance for Industry issued by the
U.S. Food and Drug Administration.
About Regeneron Pharmaceuticals,
Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology
company that invents life-transforming medicines for people with
serious diseases. Founded and led for 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, 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, infectious diseases, pain
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses a unique
genetically-humanized mouse 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 the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron Forward-Looking Statements and Use of Digital
Media
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 Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation REGN1979 in
patients with relapsed or refractory B-cell non-Hodgkin lymphoma
and other potential indications, as well as REGN5458 (BCMAxCD3
bispecific antibody being investigated in multiple myeloma) and
pozelimab (C5 antibody), and Regeneron's earlier-stage product
candidates (such as Regeneron's other bispecific antibodies and
costimulatory bispecific antibody discussed in this press release
(as a monotherapy or in combination with Libtayo®
(cemiplimab), as applicable)); unforeseen
safety issues resulting from the administration of products and
product candidates in patients, including serious complications or
side effects in connection with the use of Regeneron's product
candidates (such as REGN1979, REGN5458, and pozelimab) in clinical
trials; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in other studies and lead to therapeutic
applications; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates and new indications for marketed products;
ongoing regulatory obligations and oversight impacting Regeneron's
marketed products, research and clinical programs, and business,
including those relating to patient privacy; 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 product candidates;
competing drugs and product candidates that may be superior to
Regeneron's products and product candidates; uncertainty of market
acceptance and commercial success of Regeneron's products and
product candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's products and product candidates;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's products and product candidates; the availability and
extent of reimbursement of the Company'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; 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 or
collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their
respective affiliated companies, as applicable), to be cancelled or
terminated without any further product success; 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
Dupixent® (dupilumab) and
Praluent® (alirocumab)), 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
fiscal year ended December 31, 2018
and its Form 10-Q for the quarterly period ended September 30, 2019. 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 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 (http://newsroom.regeneron.com)
and its Twitter feed (http://twitter.com/regeneron).
Contacts:
Media Relations
Daren
Kwok
Tel: +1 (914) 847-1328
Daren.Kwok@regeneron.com
Investor Relations
Justin Holko
Tel: +1 (914) 847-7786
Justin.Holko@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.