TIDMGSK
RNS Number : 3493U
GlaxoSmithKline PLC
02 December 2021
EMBARGOED UNTIL: Thursday, 2 December 2021 at 7:02am GMT/ 2:02am
EST
Preclinical data demonstrate sotrovimab retains activity against
key Omicron mutations, new SARS-CoV-2 variant
-- Preclinical data demonstrate sotrovimab, authorised in
multiple countries around the world, retains activity against all
tested variants of concern, including key mutations of Omicron
-- Data to be confirmed by further in vitro pseudo-virus testing
GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced an update to bioRxiv , a preprint
server, with preclinical data demonstrating that sotrovimab, an
investigational monoclonal antibody, retains activity against key
mutations[1] of the new Omicron SARS-CoV-2 variant (B.1.1.529),
including those found in the binding site of sotrovimab. These data
were generated through pseudo-virus testing of specific individual
mutations found in Omicron. To date, sotrovimab has demonstrated
ongoing activity against all tested variants of concern and
interest defined by the World Health Organization (WHO). The
companies are now completing in vitro pseudo-virus testing to
confirm the neutralising activity of sotrovimab against the
combination of all the Omicron mutations with the intent to provide
an update by the end of 2021.
George Scangos, PhD, Chief Executive Officer of Vir, said :
"Sotrovimab was deliberately designed with a mutating virus in
mind. By targeting a highly conserved region of the spike protein
that is less likely to mutate, we hoped to address both the current
SARS-CoV-2 virus and future variants that we expected would be
inevitable. This hypothesis has borne out again and again - with
its ongoing ability to maintain activity against all tested
variants of concern and interest to date, including key mutations
found in Omicron, as demonstrated by preclinical data. We have
every expectation that this positive trend will continue and are
working rapidly to confirm its activity against the full
combination sequence of Omicron."
Dr Hal Barron, Chief Scientific Officer and President R&D,
GSK, said : "Since the beginning of the pandemic, we have been
working with Vir to combine our scientific expertise and
technologies to deliver an enduring treatment option for patients
with COVID-19. Though early, these pre-clinical data support our
long-held view on the potential for sotrovimab to maintain its
activity as the virus continues to mutate. We are pleased that this
treatment option is available to patients in the US and many other
countries, and are working to expand access worldwide."
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'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.
Updated in vitro data, published in bioRxiv , demonstrate that
sotrovimab retains activity against all current 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 key mutations of Omicron
(B.1.1.529).
About the sotrovimab clinical development programme
-- 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 27 October
2021 and final data were pre-published on 8 November 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 h eadline data demonstrated that
intramuscularly administered sotrovimab was non-inferior and
offered similar efficacy to intravenous 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 investigate the use of
sotrovimab in uninfected immunocompromised adults to determine
whether sotrovimab can prevent symptomatic COVID-19 infection. GSK
and Vir are supporting investigator-sponsored studies and fostering
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 programme will take place 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 (CHMP) in the EU, has been granted a
provisional marketing authorisation in Australia, and conditional
marketing authorisation in Saudi Arabia. In Japan, it has been
approved via the Special Approval for Emergency Pathway. Temporary
authorisations for sotrovimab have been granted in a dozen
countries.
-- GSK and Vir also recently submitted the Marketing
Authorisation Application (MAA) to the European Medicines Agency
for Xevudy (sotrovimab) for the treatment of adults and adolescents
(aged 12 years and over and weighing at least 40 kg) 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
United Arab Emirates. We 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 U.S. should review the Fact Sheets for
information about the authorised 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 U.S. 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 (eg, 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 (eg, 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 (eg, 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, GSK and Vir 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 S.A., 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 N.V., 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/about-us .
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.
GSK enquiries:
Media enquiries: 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 Nick Stone +44 (0) 7717 (London)
enquiries: 618834
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
James Dodwell +44 (0) 20 8047 (London)
2406
Mick Readey +44 (0) 7990 (London)
339653
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 key mutations of 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.
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[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.
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