TARRYTOWN, N.Y., June 11, 2020 /PRNewswire/ --
Clinical program consists of four separate study populations:
two for treatment and two for prevention
First studies evaluate safety and efficacy in hospitalized
and non-hospitalized patients with COVID-19
Two-antibody 'cocktail' is designed to help protect against
viral escape
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced initiation of the first clinical trial of REGN-COV2, its
investigational dual antibody cocktail for the prevention and
treatment of COVID-19. The REGN-COV2 clinical program will consist
of four separate study populations: hospitalized COVID-19 patients,
non-hospitalized symptomatic COVID-19 patients, uninfected people
in groups that are at high-risk of exposure (such as healthcare
workers or first responders) and uninfected people with close
exposure to a COVID-19 patient (such as the patient's housemate).
The placebo-controlled trials will be conducted at multiple
sites.
"We have created a unique anti-viral antibody cocktail with the
potential both to prevent and treat infection, and also to preempt
viral 'escape,' a critical precaution in the midst of an ongoing
global pandemic," said George D.
Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief
Scientific Officer of Regeneron. "REGN-COV2 could have a major
impact on public health by slowing spread of the virus and
providing a needed treatment for those already sick – and could be
available much sooner than a vaccine. The antibody cocktail
approach may also have long-term utility for elderly and
immuno-compromised patients, who often do not respond well to
vaccines. Ultimately, the world needs multiple solutions for
COVID-19, and the innovative biopharma industry is collectively
working hard to help as many people as possible with a variety of
complementary approaches."
Regeneron scientists evaluated thousands of fully-human
antibodies produced by the company's proprietary
VelocImmune® mice, which have been
genetically-modified to have a human immune system, as well as
antibodies isolated from humans who have recovered from COVID-19.
They selected the two most potent, non-competing and
virus-neutralizing antibodies and have scaled them up for clinical
use with the company's in-house VelociMab® and
manufacturing capabilities. The two antibodies bind
non-competitively to the critical receptor binding domain (RBD) of
the virus's spike protein, which diminishes the ability of mutant
viruses to escape treatment, as demonstrated in upcoming
Science publications of preclinical research.
Regeneron used the same 'rapid response' capabilities and
cocktail approach to develop REGN-EB3, a novel triple antibody
treatment for Ebola that is now under regulatory review by the U.S.
Food and Drug Administration (FDA). 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.
The first two adaptive Phase 1/2/3 studies are evaluating
REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and
non-hospitalized patients with COVID-19. The Phase 1 portion will
focus on virologic and safety endpoints, and the Phase 2 portion
will focus on virologic and clinical endpoints. Data from the Phase
1 and Phase 2 studies will be used to refine the endpoints and
determine size for the Phase 3 studies.
"We are particularly excited to begin studies of REGN-COV2,
which is a novel antibody cocktail targeted specifically against
SARS-CoV-2," said trial investigator Dr. Suraj Saggar, Chief of Infectious Disease at
Holy Name Medical Center in Teaneck, New
Jersey. "Over the last long months, we have learned that
repurposing existing medicines unfortunately does not offer a
broadly effective solution for COVID-19. For this reason, we need
to investigate custom-designed approaches like REGN-COV2. The first
studies will evaluate if REGN-COV2 can improve disease outcomes in
both hospitalized and non-hospitalized patients with COVID-19."
About Regeneron's Anti-Viral Antibodies
When faced
with a harmful pathogen, such as a virus or bacteria, the human
immune system typically produces antibodies to fight the invader.
Specifically, the immune system produces 'anti-viral' antibodies
that recognize, bind, and kill or neutralize the virus. Vaccination
involves injecting a dead or weakened virus, or a critical small
piece of a virus, to induce this protective immune response,
resulting in the same antibodies the immune system would typically
make in a person who actually had the infectious disease.
Regeneron's core technologies allow for rapid and efficient
generation of these protective anti-viral antibodies outside of the
body, derived from either genetically-humanized mice or
convalescent humans. The resulting antibodies correspond to the
most potent of anti-viral antibodies that could be elicited by a
vaccine or through exposure to a pathogen. These antibodies can be
delivered to people via injection, providing "passive immunity" and
protection from the disease immediately, though they must be
re-administered to remain effective over time. These antibodies can
also treat an existing infection, unlike vaccines which can only be
used preventatively.
The concept that drug cocktails can prevent viral escape has
previously been demonstrated for traditional antiviral drugs used
to treat HIV and other viruses. In the upcoming Science
publications, Regeneron scientists report the fundamental
realization that this can also be true for antibody-based
therapies. Regeneron's preclinical studies demonstrate that,
in the setting of a single therapeutic antibody that blocks the
ability of a virus to infect healthy cells, spontaneously arising
mutant forms of the virus are able to 'escape' or evade the
antibody's blocking action. These mutants are then 'selected'
(i.e., are able to survive and proliferate despite the single
antibody treatment) and may ultimately become the dominant strain
of the virus. Regeneron therefore pursues a multi-antibody cocktail
approach designed to decrease the potential for the virus to
escape.
Regeneron has developed additional technologies that allow for
the large-scale manufacturing and purification of these anti-viral
antibodies, potentially allowing many people to be granted immunity
before vaccines become widely available.
About Regeneron
Regeneron (NASDAQ:
REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for over 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, pain, 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 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.