Form 6-K GLAXOSMITHKLINE PLC For: Dec 02
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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 December 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): ____
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™ 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 headline 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.
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GSK enquiries:
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Media
enquiries:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Madeleine
Breckon
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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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Nick
Stone
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+44 (0)
7717 618834
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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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Mick
Readey
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+44 (0)
7990 339653
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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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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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Vir Biotechnology Contacts:
Heather
Rowe
Armstrong
Cara Miller
VP,
Investor Relations
VP, Corporate Communications
+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.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
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.
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: December
02, 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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