UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of February 2021
Commission
File Number 001-15170
GlaxoSmithKline plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 17 February 2021, London UK; San Francisco US - LSE
announcement
GSK and Vir Biotechnology expand coronavirus collaboration to
advance new therapeutics for influenza and other respiratory
viruses
●
Companies
applying their combined expertise in immunology and infectious
diseases to accelerate the development of promising monoclonal
antibody candidates for influenza
●
Functional
genomics collaboration expanded to include respiratory viruses,
Vir's unique technology, and access to GSK's small molecule
compounds
●
Additional
exploration of up to three other antibodies for pathogens beyond
influenza and coronaviruses
●
GSK
is increasing its equity investment by $120 million and making an
upfront payment of $225 million
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced they have signed a binding agreement
to expand their existing collaboration to include the research and
development of new therapies for influenza and other respiratory
viruses.
The expanded collaboration, which builds on the agreement signed in
2020 to research and develop therapies for coronaviruses,
provides GSK exclusive rights to collaborate with Vir on the
development
of potential best-in-class monoclonal antibodies (mAbs) for the
prevention or treatment of influenza. These include VIR-2482,
an
intramuscularly administered investigational mAb designed as a
universal prophylactic for influenza A that has completed a Phase 1
trial, as well as next
generation antibodies for the prevention or treatment of influenza
during a three-year research period. GSK will have the
exclusive option to co-develop VIR-2482 after Vir completes and
reports Phase 2 trial outcomes, and will share development costs on
the development of all other influenza mAbs.
Influenza causes up to 500,000 hospitalisations and 34,000 deaths
each year in the United States alone,[1] approximately
75% of which are caused by influenza A.2 The
protection provided by current vaccines varies from season to
season, based on the virus strains circulating. People over 65
years of age with at least one comorbidity, such as cardiovascular
disease, diabetes or who are immunocompromised, are at
significantly increased risk of flu and flu-related hospitalisation
and mortality. This is also a population where the currently
available vaccines have historically had lower
efficacy.
As part of the new collaboration agreement, the companies will also
engage in two additional research programmes. The first is an
expansion of their current functional genomics collaboration to
develop potential pan-coronavirus therapeutics to now include other
respiratory virus targets. Under the second programme, the
companies will collaborate to develop up to three neutralising
monoclonal antibodies identified using Vir's antibody technology
platform to target non-influenza pathogens during a three-year
research period.
Dr. Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: "We believe, now
more than ever, that it is very important to develop new therapies
to treat and ideally prevent infectious diseases. I am delighted
that we are expanding our collaboration with Vir whose focus on
novel antibodies, expertise in functional genomics, unique
technology and talented scientists will further strengthen
GSK's position as a world leader in infectious
diseases."
George Scangos, Ph.D., CEO, Vir Biotechnology, said: "GSK has been a valuable
strategic partner and scientific collaborator in the fight against
COVID-19. As part of our functional genomics collaboration directed
at COVID-19, we have turned up multiple targets that have the
potential to treat influenza and other respiratory viruses, and it
makes sense to extend the scope of our collaboration to include
these new targets. This expanded
collaboration supports the rapid advancement of multiple promising
investigational compounds in our pipeline, increasing the
likelihood that these potential life-saving treatments will reach
patients sooner, and will advance our shared goal of developing
single drugs that can address multiple 'bugs.'"
Under the terms of the agreement, GSK will make an upfront payment
of $225 million, and a further equity investment in Vir of $120
million. Initially, Vir will continue to fund the development of
VIR-2482 through completion of Phase 2 trials, after which time, if
GSK exercises its option to co-develop VIR-2482, it will pay an
option fee of $300 million. Following option exercise for VIR-2482,
and for each other program in the expanded collaboration, the
companies will share the development costs and related profits
associated with this agreement. GSK will also pay Vir up to $200
million based on the successful delivery of pre-defined regulatory
milestones. The equity investment and collaboration agreement are
conditional upon customary conditions including regulatory review
by the appropriate regulatory agencies under the Hart-Scott-Rodino
Act.
GSK and Vir entered into an initial strategic collaboration in
April 2020 to research and develop solutions for coronaviruses,
including SARS-CoV-2, the virus that causes COVID-19. The focus of
the collaboration to date has been the development of specific
antibody candidates identified by Vir's monoclonal antibody
platform, VIR-7831 and VIR-7832, that have demonstrated the
potential to both block viral entry into healthy cells and clear
infected cells, and to provide a high barrier to resistance.
VIR-7831 is currently in two global Phase 3 studies as monotherapy
and one Phase 2 study as combination therapy, with initial results
from the first of the Phase 3 studies expected in the first quarter
of 2021. VIR-7832 has been accepted into the NHS-supported AGILE
Phase 1b/2a study with a planned start in February
2021.
###
About Vir's Antibody Platform
Vir has a robust method for capitalising on unusually successful
immune responses naturally occurring in people who are protected
from, or have recovered from, infectious diseases. The platform is
used to identify rare antibodies from survivors that have the
potential to treat and prevent rapidly evolving and/or previously
untreatable pathogens via direct pathogen neutralization and immune
system stimulation. Vir engineers the fully human antibodies that
it discovers to enhance their therapeutic potential. This platform
has been used to identify and develop antibodies for pathogens
including SARS-CoV-2, hepatitis B virus, influenza A, Ebola
(mAb114, approved for use in the U.S. as EbangaTM and
marketed by Ridgeback Therapeutics LP), malaria, and
others.
About VIR-2482
VIR-2482 is an investigational intramuscularly administered
influenza A-neutralizing monoclonal antibody. In vitro, it has been
shown to cover all major strains of influenza A that have arisen
since the 1918 Spanish flu pandemic. VIR-2482 is designed as
a universal
prophylactic for influenza A. It has the potential to overcome the
limitations of current flu vaccines and lead to meaningfully higher
levels of protection due to its broad strain coverage and because
it does not rely on an individual to create their own
protective antibody response. VIR-2482 has been half-life
engineered so that a single dose has the potential to last the
entire flu season.
About VIR-7831 / GSK4182137
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal
antibody. Preclinical data suggest it has the potential to both
block viral entry into healthy cells and clear infected cells.
The antibody binds to an epitope on SARS-CoV-2 that is shared with
SARS-CoV-1 (the virus that causes SARS), indicating that the
epitope is highly conserved, which may make it more difficult for
resistance to develop. VIR-7831 also has been designed to achieve
high concentration in the lungs to ensure optimal penetration into
airway tissues affected by SARS-CoV-2 and to have an extended
half-life.
About VIR-7832
/ GSK4182136
VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal
antibody. Preclinical data suggest it has the potential to both
block viral entry into healthy cells and an enhanced ability to
clear infected cells. The antibody binds to an epitope on
SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes
SARS), indicating that the epitope is highly conserved, which may
make it more difficult for resistance to develop. VIR-7832 also has
been designed to achieve high concentration in the lungs to ensure
optimal penetration into airway tissues affected by SARS-CoV-2 and
to have an extended half-life. Importantly, VIR-7832 has also been
engineered to potentially enhance virus-specific T cell function,
which could help treat and/or prevent COVID-19
infection.
About the Vir and GSK Collaboration
In April 2020, Vir and GSK entered into a collaboration to research
and develop solutions for coronaviruses, including SARS-CoV-2, the
virus that causes COVID-19. The collaboration uses Vir's
proprietary monoclonal antibody platform technology to accelerate
existing and identify new anti-viral antibodies that could be used
as therapeutic or preventive options to help address the current
COVID-19 pandemic and future outbreaks. The companies are
leveraging GSK's expertise in functional genomics and combine their
capabilities in CRISPR screening and artificial intelligence to
identify anti-coronavirus compounds that target cellular host
genes. They are also applying their combined expertise to research
SARS-CoV-2 and other coronavirus vaccines.
About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on
combining immunologic insights with cutting-edge technologies to
treat and prevent serious infectious diseases. Vir has assembled
four technology platforms that are designed to stimulate and
enhance the immune system by exploiting critical observations of
natural immune processes. Its current development pipeline consists
of product candidates targeting COVID-19, hepatitis B virus,
influenza A and human immunodeficiency virus. For more information,
please visit www.vir.bio.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com/about-us.
GSK enquiries:
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Media
enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Kristen
Neese
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+1 804
217 8147
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(Philadelphia)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Vir Biotechnology:
Cara
Miller
VP,
Corporate Communications
cmiller@vir.bio
+1 415
941 6746
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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Vir Forward-Looking Statements
This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as "may," "will," "plan," "potential," "aim,"
"promising" and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. These
forward-looking statements are based on Vir's expectations and
assumptions as of the date of this press release. Forward-looking
statements contained in this press release include statements
[regarding the potential benefits of the collaboration with GSK,
the completion of a definitive collaboration agreement, the total
potential deal value of the collaboration, the ability to obtain
clearance under the HSR Act and to satisfy the other closing
conditions, the potential benefits of VIR-2482, and Vir's ability
to address influenza, respiratory diseases, coronaviruses,
including the current COVID-19 pandemic, and future outbreaks of
any such diseases.] Many factors may cause differences between
current expectations and actual results, including unexpected
safety or efficacy data observed during preclinical or clinical
studies, challenges in the treatment of hospitalized patients,
difficulties in collaborating with other companies or government
agencies, challenges in accessing manufacturing capacity,
successful development and/or commercialization of alternative
product candidates by our competitors, changes in expected or
existing competition, delays in or disruptions to our business or
clinical trials due to the COVID-19 pandemic, geopolitical changes
or other external factors, and unexpected litigation or other
disputes.
GSK cautionary statement regarding forward-looking
statements
GSK
cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and as set out in GSK's "Principal risks and uncertainties" section
of the Q4 Results and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
[1] 2018-2019 flu season
data from the Centers for
Disease Control and Prevention.
2 Zhou et
al. Clinical Infectious
Diseases.
2012:54:1427-1436.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: February
17, 2021
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
|
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behalf
of GlaxoSmithKline plc
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