GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc.
(Nasdaq: VIR) today announced the submission of an application to
the US Food and Drug Administration (FDA) requesting an amendment
to the Emergency Use Authorization (EUA) for sotrovimab, an
investigational monoclonal antibody for the early treatment of
COVID-19, to include intramuscular (IM) administration. The EUA for
sotrovimab was granted by the FDA in May 2021 as an investigational
single-dose intravenous (IV) (500 mg) infusion SARS-CoV-2
monoclonal antibody for the early treatment of COVID-19, and the
companies are requesting an expansion to the EUA to also include IM
administration (500 mg).
Under the current EUA, sotrovimab can be used
for the treatment of mild-to-moderate 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.
This submission is based on the Phase 3,
randomized, open-label, non-inferiority COMET-TAIL trial, which
achieved its primary endpoint, demonstrating that 500mg IM
administration of sotrovimab (n=376) was non-inferior and offered
similar efficacy to 500 mg IV administration (n=378) for the early
treatment of mild-to-moderate COVID-19 in high-risk,
non-hospitalized adults and adolescents. Low rates of serious
adverse events (≤1% in both arms) were observed in the headline
data.
About SotrovimabSotrovimab is
an investigational SARS-CoV-2-neutralizing 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™
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.
About the Sotrovimab Clinical Development
Program
- COMET-ICE: a Phase 3, multi-center,
double-blind, placebo-controlled trial investigated IV infusion of
sotrovimab in adults with mild-to-moderate COVID-19 at high risk of
progression to severe disease, who are not hospitalized 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 hospitalization
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: an ongoing Phase 3,
randomized, multi-center, open-label, non-inferiority trial of IM
versus IV administration of sotrovimab for the early treatment of
mild-to-moderate COVID-19 in high-risk non-hospitalized adult and
pediatric patients (12 years of age and older). The trial’s primary
endpoint was met, and headline data demonstrated that 500mg
IM-administered sotrovimab was non-inferior and offered similar
efficacy to IV administration for high-risk populations. In the IM
administration (500mg) arm of the trial, there was a 2.7% rate of
progression to hospitalization for more than 24 hours or death
through Day 29 of the trial, compared to 1.3% in the IV
administration arm (also 500mg). The adjusted difference between
the IM and IV arms of the trial was 1.07% with a 95% confidence
interval (CI) of -1.25% to 3.39%. The upper bound of the 95% CI is
within the predetermined 3.5% non-inferiority margin set for the
trial’s primary endpoint. Low rates of serious adverse events
(≤1% in both arms) were observed in the headline data. The trial
originally included three arms: 500mg of sotrovimab given
intravenously, and two intramuscular arms, consisting of 500mg and
a low dose of 250mg. An independent safety monitoring committee
recommended enrollment in the 250mg arm be discontinued after a
greater number of hospitalizations in that arm was noted. The 500mg
dose arms were recommended to continue with enrollment as planned.
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 2, randomized,
multi-center, parallel group trial evaluating IV and IM
administration of sotrovimab in outpatients with mild-to-moderate
COVID-19. The companies plan to submit the full COMET-PEAK data set
to a peer-reviewed journal for publication.
- Additionally, GSK and Vir are 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 both experienced investigators and
networks, who are 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.
- Sotrovimab is also being studied by the University of Oxford
among patients hospitalized with COVID-19 in the United
Kingdom as part of the Randomized Evaluation of COVID-19
Therapy (RECOVERY) Trial.
Sotrovimab in the United
StatesThe 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 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 UseThe FDA has
issued an 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 40kg) 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
UseSotrovimab 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 COVID19. 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
CONTRAINDICATIONSSotrovimab is
contraindicated in patients who have a history of anaphylaxis to
sotrovimab or to any of the excipients in the formulation.
WARNINGS AND PRECAUTIONSThere
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 ReactionsSerious 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 AdministrationClinical 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‑19Benefit 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 EVENTSHypersensitivity
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
POPULATIONSPregnancyThere 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.
LactationThere 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
CollaborationIn 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-19GSK’s response to COVID-19 has been one of the
broadest in the industry, with potential treatments in addition to
the Company’s vaccine candidates in development with partner
organizations.
GSK is collaborating with several organizations
on COVID-19 vaccines by providing access to its adjuvant
technology. The Company is working with Sanofi SA, Medicago Inc.
and SK bioscience Co., Ltd. to develop adjuvanted, protein-based
vaccine candidates, and all are now in Phase 3 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, optimized 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-19Vir
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 GSKGSK is a science-led
global healthcare company. For further information please visit
www.gsk.com/aboutus.
About Vir BiotechnologyVir
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 Cautionary Statement Regarding
Forward-Looking StatementsGSK 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 2021 Q3 Results and any impacts of the COVID-19
pandemic.
Vir Forward-Looking
StatementsThis 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, and the clinical
development program for sotrovimab. 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.
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Registered Office:980 Great West RoadBrentford,
MiddlesexTW8 9GS
Vir Biotechnology Contacts:
Investors
Heather Rowe Armstrong
VP, Investor Relations
harmstrong@vir.bio
+1 415 915 4228
Media
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1 415 941 6746
GSK Inquiries:
Tim Foley
+44 (0) 20 8047 5502
(London)
Madeleine Breckon
+44 (0) 20 8047 5502
(London)
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 2406
(London)
Mick Readey
+44 (0) 7990 339653
(London)
Josh Williams
+44 (0) 7385 415719
(London)
Jeff McLaughlin
+1 215 751 7002
(Philadelphia)
Frannie DeFranco
+1 215 751 4855
(Philadelphia)
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