TIDMGSK
RNS Number : 8046U
GlaxoSmithKline PLC
07 December 2021
Issued: 07 December 2021, London UK and San Francisco US
Preclinical studies demonstrate sotrovimab retains activity
against the full combination of mutations in the spike protein of
the Omicron SARS-CoV-2 variant
-- New preclinical findings generated through in vitro testing
of sotrovimab against the complete pseudo-virus, updated to
bioRxiv
-- Data build on promising signal published last week,
underscoring the importance of sotrovimab for early treatment of
COVID-19
-- Sotrovimab is authorised and available for the treatment of
early COVID-19 in the US and multiple countries around the
world
LONDON and SAN FRANCISCO, Dec. XX, 2021 - GlaxoSmithKline plc
(LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today
announced an update to preclinical data on bioRxiv [1] , a preprint
server, demonstrating that sotrovimab, an investigational
monoclonal antibody, retains in vitro activity against the full
known Omicron spike protein, the new SARS-CoV-2 variant
(B.1.1.529). The preclinical data was generated through
pseudo-virus testing of the combined known mutations of the Omicron
variant, which included the maximum number of changes (37
mutations) identified to date in the spike protein. These findings
build on the initial preclinical data generated through
pseudo-virus testing, provided last week , showing sotrovimab
retained in vitro activity against key individual mutations of the
Omicron variant, including those found in the binding site of
sotrovimab. These data add to the growing body of preclinical
evidence demonstrating that sotrovimab retains activity against all
tested variants of concern.
George Scangos, PhD, Chief Executive Officer of Vir, said:
"Sotrovimab is the first monoclonal antibody to report preclinical
data demonstrating activity against all tested SARS-CoV-2 variants
of concern and interest to date, including Omicron, as well as the
still prevalent and highly contagious Delta variant. Given the less
than three-fold neutralization shift demonstrated in the
pre-clinical pseudo-virus assay, which falls below the FDA
authorized fact sheet guidance of less than a 5-fold change, we are
confident that sotrovimab will continue to provide significant
benefit for the early treatment of patients hoping to avoid the
most severe consequences of COVID-19."
Dr Hal Barron, Chief Scientific Officer and President R&D,
GSK, said: "From the outset of our collaboration with Vir we
hypothesized that sotrovimab would have a high barrier to
resistance and thus could deliver best-in-class potential for the
early treatment of patients with COVID-19. These pre-clinical data
demonstrate the potential for our monoclonal antibody to be
effective against the latest variant, Omicron, plus all other
variants of concern defined to date by the WHO, and we look forward
to discussing these results with regulatory authorities around the
world."
About sotrovimab
Sotrovimab is an investigational SARS-CoV-2 neutralising
monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2
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. Sotrovimab, which incorporates
Xencor, Inc.'s Xtend(TM) technology, has also 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.
Pre-clinical data, published in bioRxiv, demonstrate that
sotrovimab retains activity against all currently tested variants
of concern and interest of the SARS-CoV-2 virus as defined by WHO,
plus others, including but not limited to Delta (B.1.617.2), Delta
Plus (AY.1 or AY.2), Mu (B.1.621) and Omicron (B.1.1.529).
About the sotrovimab clinical development program
-- COMET-ICE : a phase III, multi-centre, double-blind,
placebo-controlled trial investigated an intravenous (IV) infusion
of sotrovimab in adults with mild-to-moderate COVID-19 at high risk
of progression to severe disease, who are not hospitalised and not
requiring oxygen. The final COMET-ICE trial results in the full
trial population of 1,057 participants demonstrated a 79% reduction
(adjusted relative risk reduction) (p<0.001) in hospitalisation
for more than 24 hours or death due to any cause by Day 29 compared
to placebo, meeting the primary endpoint of the trial. Interim data
were published in The New England Journal of Medicine on October
27, 2021, and final data were pre-published on November 8, 2021, on
medRxiv .
-- COMET-TAIL : a phase III, randomised, multi-centre,
open-label, non-inferiority trial of intramuscular (IM) versus IV
administration of sotrovimab for the early treatment of
mild-to-moderate COVID-19 in high-risk non-hospitalised adult and
paediatric patients (12 years of age and older). The trial's
primary endpoint was met, and headline data demonstrated that IM
administered sotrovimab was non-inferior and offered similar
efficacy to IV administration for high-risk populations . The
companies plan to submit the complete COMET-TAIL data set to a
peer-reviewed journal for publication in the first quarter of
2022.
-- COMET-PEAK : a phase II, randomised, multi-centre,
parallel-group trial evaluating IV and IM administration of
sotrovimab in outpatients with mild-to-moderate COVID-19. Data
available to date from open-label Part B of the trial (500mg IV vs
500mg IM) demonstrated equivalence on the virological response
between the IM and IV arms. The companies plan to submit the
complete COMET-PEAK data set to a peer-reviewed journal for
publication in due course.
-- GSK and Vir are also partnering to assess the use of
sotrovimab in uninfected immunocompromised adults to determine
whether sotrovimab can prevent symptomatic COVID-19 infection. GSK
and Vir support investigator-sponsored studies and foster
scientific collaborations with experienced investigators and
networks involved in the continuum of care of immunocompromised
patients to understand the role sotrovimab for prophylaxis could
play in this population. Discussions with regulatory authorities
regarding the prophylaxis program will occur in due course.
About global access to sotrovimab
Sotrovimab is authorised for emergency use in the United States.
Xevudy (sotrovimab) received a positive scientific opinion under
Article 5(3) of Regulation 726/2004 from the Committee for Human
Medicinal Products in the EU, conditional marketing authorisation
by the UK Medicines and Healthcare Products Regulatory Agency,
provisional marketing authorisation in Australia, and conditional
marketing authorisation in Saudi Arabia. It has been approved via
the Special Approval for Emergency Pathway in Japan. Temporary
authorisations for sotrovimab have been granted in a dozen
countries.
GSK and Vir also recently submitted the Marketing Authorisation
Application to the European Medicines Agency for Xevudy for the
treatment of adults and adolescents (aged 12 years and over and
weighing at least 40kg) with coronavirus disease 2019 (COVID-19)
who do not require oxygen supplementation and who are at risk of
progressing to severe COVID-19.
Sotrovimab is supplied in several countries worldwide, including
through national agreements in the United States, United Kingdom,
Japan, Australia, Canada, Singapore, Switzerland, and the United
Arab Emirates. The companies have also signed a Joint Procurement
Agreement with the European Commission to supply doses of
sotrovimab. Additional agreements are yet to be announced due to
confidentiality or regulatory requirements.
Sotrovimab in the United States
The following is a summary of information for sotrovimab.
Healthcare providers in the US should review the Fact Sheets for
information about the authorized use of sotrovimab and mandatory
requirements of the EUA. Please see the Food and Drug
Administration ( FDA) Letter of Authorization , full Fact Sheet for
Healthcare Providers and full Fact Sheet for Patients, Parents, and
Caregivers .
Sotrovimab has been authorized by the US FDA for the emergency
use described below. Sotrovimab is not FDA-approved for this
use.
Sotrovimab is authorized only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use of sotrovimab under section 564(b)(1) of the
Act, 21 U.S.C. -- 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
Authorized Use
The U.S. FDA has issued an Emergency Use Authorization (EUA) to
permit the emergency use of the unapproved product sotrovimab for
the treatment of mild-to-moderate coronavirus disease 2019
(COVID-19) in adults and pediatric patients (12 years of age and
older weighing at least 40 kg) with positive results of direct
SARS-CoV-2 viral testing, and who are at high risk for progression
to severe COVID-19, including hospitalization or death.
Limitations of Authorized Use
Sotrovimab is not authorized for use in patients:
-- who are hospitalized due to COVID-19, OR
-- who require oxygen therapy due to COVID-19, OR
-- who require an increase in baseline oxygen flow rate due to
COVID-19 (in those on chronic oxygen therapy due to underlying
non-COVID-19 related comorbidity)
Benefit of treatment with sotrovimab has not been observed in
patients hospitalized due to COVID--19. SARS-CoV-2 monoclonal
antibodies may be associated with worse clinical outcomes when
administered to hospitalized patients with COVID--19 requiring high
flow oxygen or mechanical ventilation.
Important Safety Information
CONTRAINDICATIONS
Sotrovimab is contraindicated in patients who have a history of
anaphylaxis to sotrovimab or to any of the excipients in the
formulation.
WARNINGS AND PRECAUTIONS
There are limited clinical data available for sotrovimab.
Serious and unexpected adverse events may occur that have not been
previously reported with sotrovimab use.
Hypersensitivity Including Anaphylaxis and Infusion-Related
Reactions
Serious hypersensitivity reactions, including anaphylaxis, have
been observed with administration of sotrovimab. If signs and
symptoms of a clinically significant hypersensitivity reaction or
anaphylaxis occur, immediately discontinue administration and
initiate appropriate medications and/or supportive care.
Infusion-related reactions, occurring during the infusion and up
to 24 hours after the infusion, have been observed with
administration of sotrovimab. These reactions may be severe or life
threatening.
Signs and symptoms of infusion-related reactions may include:
fever, difficulty breathing, reduced oxygen saturation, chills,
fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia,
bradycardia), chest pain or discomfort, weakness, altered mental
status, nausea, headache, bronchospasm, hypotension, hypertension,
angioedema, throat irritation, rash including urticaria, pruritus,
myalgia, vaso-vagal reactions (e.g., pre-syncope, syncope),
dizziness and diaphoresis.
Consider slowing or stopping the infusion and administer
appropriate medications and/or supportive care if an
infusion-related reaction occurs.
Hypersensitivity reactions occurring more than 24 hours after
the infusion have also been reported with the use of SARS-CoV-2
monoclonal antibodies under Emergency Use Authorization.
Clinical Worsening After SARS-CoV-2 Monoclonal Antibody
Administration
Clinical worsening of COVID -- 19 after administration of
SARS-CoV-2 monoclonal antibody treatment has been reported and may
include signs or symptoms of fever, hypoxia or increased
respiratory difficulty, arrhythmia (e.g., atrial fibrillation,
tachycardia, bradycardia), fatigue and altered mental status. Some
of these events required hospitalization. It is not known if these
events were related to SARS-CoV-2 monoclonal antibody use or were
due to progression of COVID -- 19.
Limitations of Benefit and Potential for Risk in Patients with
Severe COVID -- 19
Benefit of treatment with sotrovimab has not been observed in
patients hospitalized due to COVID -- 19. SARS-CoV-2 monoclonal
antibodies may be associated with worse clinical outcomes when
administered to hospitalized patients with COVID -- 19 requiring
high flow oxygen or mechanical ventilation. Therefore, sotrovimab
is not authorized for use in patients: who are hospitalized due to
COVID -- 19, OR who require oxygen therapy due to COVID -- 19 OR
who require an increase in baseline oxygen flow rate due to COVID
-- 19 in those on chronic oxygen therapy due to underlying non --
COVID -- 19 related comorbidity.
ADVERSE EVENTS
Hypersensitivity adverse reactions have been observed in 2% of
patients treated with sotrovimab and 1% with placebo in
COMET-ICE.
The most common treatment-emergent adverse events observed in
the sotrovimab treatment group in COMET-ICE were rash (1%) and
diarrhea (2%), all of which were Grade 1 (mild) or Grade 2
(moderate). No other treatment-emergent adverse events were
reported at a higher rate with sotrovimab compared to placebo.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are insufficient data to evaluate a drug-associated risk
of major birth defects, miscarriage or adverse maternal or fetal
outcome. Sotrovimab should be used during pregnancy only if the
potential benefit justifies the potential risk for the mother and
the fetus.
Lactation
There are no available data on the presence of sotrovimab in
human milk, the effects on the breastfed infant or the effects on
milk production. Individuals with COVID-19 who are breastfeeding
should follow practices according to clinical guidelines to avoid
exposing the infant to COVID-19.
About the GSK and Vir 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
will leverage 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 will also apply their combined expertise to research
SARS-CoV-2 and other coronavirus vaccines.
GSK commitment to tackling COVID-19
GSK's response to COVID-19 has been one of the broadest in the
industry, with potential treatments in addition to our vaccine
candidates in development with partner organisations.
GSK is collaborating with several organisations on COVID-19
vaccines by providing access to our adjuvant technology. We are
working with Sanofi SA, Medicago Inc. and SK bioscience Co., Ltd.
to develop adjuvanted, protein-based vaccine candidates, and all
are now in phase III clinical trials. The use of an adjuvant can be
of particular importance in a pandemic since it may reduce the
amount of vaccine protein required per dose, allowing more vaccine
doses to be produced and contributing to protecting more people in
need.
GSK is also working with mRNA specialist, CureVac NV, to jointly
develop next - generation, optimised mRNA vaccines for COVID-19
with the potential to address multiple emerging variants in one
vaccine.
GSK is also exploring treatments for COVID-19 patients,
collaborating with Vir Biotechnology to investigate monoclonal
antibodies that could be used as therapeutic or preventive options
for COVID-19.
Vir's commitment to COVID-19
Vir was founded with the mission of addressing the world's most
serious infectious diseases. In 2020, Vir responded rapidly to the
COVID-19 pandemic by leveraging our unique scientific insights and
industry - leading antibody platform to explore multiple monoclonal
antibodies as potential therapeutic or preventive options for
COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir
advanced into the clinic. It was carefully selected for its
demonstrated promise in preclinical research, including an
anticipated high barrier to resistance and potential ability to
both block the virus from entering healthy cells and clear infected
cells. Vir is continuing to pursue novel therapeutic and
prophylactic solutions to combat SARS-CoV -2 and future coronavirus
pandemics, both independently and in collaboration with its
partners.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/aboutus .
About Vir Biotechnology
Vir Biotechnology is a commercial-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 .
Reference
(1) Cathcart AL, Havenar-Daughton C, Lempp FA, et al. The dual
function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate
potent in vitro and in vivo activity against SARS-CoV-2. bioRxiv .
2021. Updated manuscript submitted and online pre-print publication
pending.
GSK inquiries:
Media inquiries: Tim Foley +44 (0) 20 8047 (London)
5502
Madeleine Breckon +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor inquiries: Nick Stone +44 (0) 7717 618834 (London)
Sonya Ghobrial +44 (0) 7392 784784 (Consumer)
James Dodwell +44 (0) 20 8047 (London)
2406
Mick Readey +44 (0) 7990 339653 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
Vir Biotechnology Contacts:
Heather Rowe Armstrong Cara Miller
VP, Investor Relations VP, Corporate Communications
harmstrong@vir.bio cmiller@vir.bio
+1 415 915 4228 +1 415 941 6746
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 in the Company's
Annual Report on Form 20-F for 2020, GSK's Q3 Results and any
impacts of the COVID-19 pandemic.
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, but are not
limited to, statements regarding the ability of sotrovimab to treat
and/or prevent COVID-19 either through IV or IM administration,
Vir's collaboration with GSK, plans to progress regulatory
submissions globally, including with the FDA regarding the existing
EUA for sotrovimab, planned discussions with other global
regulatory agencies, the timing of availability of clinical data,
program updates and data disclosures, the clinical development
program for sotrovimab, and the ability of sotrovimab to maintain
activity against circulating variants of concern and interest,
including Omicron. 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 Vir's competitors, changes in expected or
existing competition, delays in or disruptions to Vir's business or
clinical trials due to the COVID-19 pandemic, geopolitical changes
or other external factors, and unexpected litigation or other
disputes. Other factors that may cause actual results to differ
from those expressed or implied in the forward-looking statements
in this press release are discussed in Vir's filings with the U.S.
Securities and Exchange Commission, including the section titled
"Risk Factors" contained therein. Except as required by law, Vir
assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
Registered in England & Wales:
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Registered Office:
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Brentford, Middlesex
TW8 9GS
[1] Cathcart AL, Havenar-Daughton C, Lempp FA, et al. The dual
function monoclonal antibodies VIR-7831 and VIR-7832 demonstrate
potent in vitro and in vivo activity against SARS-CoV-2. bioRxiv.
2021. Updated manuscript submitted and online pre-print publication
pending.
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END
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