TARRYTOWN, N.Y., June 11, 2020 /PRNewswire/ --
Regeneron utilized 'rapid response' VelociSuite®
technologies to identify pairs of potent and complementary
antibodies that could be combined into antibody 'cocktails' for
COVID-19
Cocktail approach protects against viral mutants by requiring
simultaneous mutation at multiple genetic positions for viral
escape
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that Science has accepted for publication two
papers describing the creation of its novel two-antibody
cocktail, REGN-COV2, and its potential to diminish risk of viral
escape by effectively binding to the virus's critical spike protein
in two separate, non-overlapping locations. The publications will
be available online on Monday. Regeneron also announced today that
REGN-COV2 has entered human clinical trials.
"Our work inventing novel antibodies has shown that individual
antibodies, no matter how good, are likely not enough against the
devastating virus that causes COVID-19 and the ways it seeks to
'escape' being neutralized," said George D.
Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief
Scientific Officer at Regeneron. "The concept that drug cocktails
can prevent viral escape has previously been demonstrated for
traditional antiviral drugs used to treat HIV and other viruses. We
now report the fundamental realization that this can also be true
for antibody-based therapies, supporting our hope that our
REGN-COV2 cocktail can be a potent weapon against COVID-19 while
preventing the emergence of viral drug-resistance."
The first paper entitled "High-Throughput Effort Using
Both Humanized Mice and Convalescent Humans Yields SARS-CoV-2
Antibody Cocktail" describes Regeneron's parallel efforts
using both humanized VelocImmune® mice and blood
samples from recovered COVID-19 patients to generate a large and
diverse collection of antibodies targeting multiple different
regions of the critical receptor-binding domain (RBD) of the
SARS-CoV-2 spike protein. The spike protein on the virus cell
surface binds to the host cell and is required for infectivity. By
blocking its interaction with the host cell, antibodies are able to
neutralize the virus and block infection. Regeneron scientists
selected pairs of highly potent individual antibodies that
simultaneously and non-competitively bind to the RBD. Regeneron
pursues a multi-antibody cocktail approach for infectious diseases
in order to decrease the potential for the virus to escape.
Viral escape is when, under pressure from an anti-viral
therapeutic, spontaneously arising mutant forms of the virus are
able to 'escape' or evade the therapeutic's blocking action. These
mutants are then 'selected' (i.e., are able to survive and
proliferate despite the single therapeutic treatment) and may
ultimately become the dominant strain of the virus.
The concept that drug cocktails can prevent viral
escape has previously been demonstrated for traditional
antiviral drugs used to treat HIV and other viruses. Regeneron now
reports the fundamental realization that this can also be true for
antibody-based therapies as reported in the second paper,
entitled "Antibody Cocktail to SARS-Cov-2 Spike Protein
Prevents Rapid Mutational Escape Seen with Individual
Antibodies," which further defines the protective value of
the multiple-antibody approach against SARS-CoV-2 specifically.
This research for the first time demonstrates that, under pressure
from individual antibodies, mutant viruses were rapidly selected
that evaded the blocking function of all individual antibodies
tested, including antibodies that potently bind to highly-conserved
regions on the spike protein. However, escape mutants could not be
efficiently generated following exposure to the REGN-COV2 cocktail
since it utilizes two antibodies that can simultaneously bind to
distinct regions of the RBD.
"Our manuscripts describe the results of a cross-functional,
comprehensive study, aiming to generate, isolate, select and
functionally characterize human antibodies against
SARS-CoV-2. We previously used the same technologies and
cocktail approach to develop REGN-EB3, a novel triple antibody
treatment for Ebola that demonstrated safety and efficacy versus
the standard of care in a clinical trial in the Democratic Republic of Congo,"
said Christos Kyratsous, Ph.D., Vice President of Research,
Infectious Diseases and Viral Vector Technologies at Regeneron. "We
hope to see similar success with this program and help improve
outcomes against this terrible disease."
REGN-COV2's preclinical development and preclinical/clinical
manufacturing has been funded in part with federal funds from the
Biomedical Advanced Research and Development Authority (BARDA),
part of the office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services,
under OT number: HHSO100201700020C.
About Regeneron
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 impact of SARS-CoV-2
(the virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, suppliers, and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs (including those discussed in this press release),
Regeneron's ability to manage its supply chain, net product sales
of products marketed by Regeneron and/or its collaborators
(collectively, "Regeneron's Products"), and the global economy; the
nature, timing, and possible success and therapeutic applications
of Regeneron's Products and product candidates and research and
clinical programs now underway or planned, including without
limitation REGN-COV2 (Regeneron's investigational dual
antibody cocktail for the prevention and treatment of COVID-19) and
REGN-EB3 (Regeneron's novel triple antibody treatment for
Ebola); the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's product
candidates (such as REGN-COV2 and REGN-EB3) and new indications for
Regeneron's Products; unforeseen safety issues resulting from the
administration of Regeneron's Products and product candidates (such
as REGN-COV2 and REGN-EB3) in patients, including serious
complications or side effects in connection with the use of
Regeneron's Products and 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
product candidates, including without limitation REGN-COV2 and
REGN-EB3; ongoing regulatory obligations and oversight impacting
Regeneron's Products, research and clinical programs, and business,
including those relating to patient privacy; 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 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 Regeneron's Products and product
candidates; 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 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, labelling, distribution, and other steps
related to Regeneron's Products and product candidates;
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 year ended December 31, 2019 and its Form
10-Q for the quarterly period ended March
31, 2020. 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).
Regeneron Contacts:
Media Relations
Alexandra
Bowie
Tel: +1 (914) 847-3407
Alexandra.Bowie@regeneron.com
Investor Relations
Vesna
Tosic
Tel: +1 (914) 847-5443
Vesna.Tosic@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.