Eli Lilly and Company (NYSE: LLY), Vir Biotechnology, Inc. (NASDAQ:
VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced a
collaboration to evaluate a combination of two COVID-19 therapies
in low-risk patients with mild to moderate COVID-19. Lilly has
expanded its ongoing BLAZE-4 trial to evaluate the administration
of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as
GSK4182136) 500mg, two neutralizing antibodies that bind to
different epitopes of the SARS-CoV-2 spike protein. This unique
collaboration marks the first time that monoclonal antibodies from
separate companies will be brought together to explore potential
outcomes.
Bamlanivimab is a neutralizing antibody directed
against the spike protein of SARS-CoV-2 designed to block viral
attachment and entry into human cells, thus neutralizing the
virus. Bamlanivimab emerged from the collaboration between
Lilly and AbCellera to create antibody therapies for the prevention
and treatment of COVID-19. Bamlanivimab is authorized for emergency
use for the treatment of mild to moderate COVID-19 in patients who
are at high risk for progressing to severe COVID-19 and/or
hospitalization.
VIR-7831 is a dual-action monoclonal antibody
that was selected for clinical development based on its potential
to both block viral entry into healthy cells and clear infected
cells, as well as its potential to provide a high barrier to
resistance. In pre-clinical trials, the antibody has shown the
ability to neutralize the SARS-CoV-2 live virus by binding to an
epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the
epitope is highly conserved, which may make it more difficult for
escape mutants to develop. Vir and GSK are advancing VIR-7831 as
part of their collaboration to research and develop solutions for
coronaviruses, including SARS-CoV-2.
“Bamlanivimab is a potent antibody – with data
from multiple Phase 2 and 3 clinical trials, which have
demonstrated robust evidence for both treating and preventing
COVID-19,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief
scientific officer and president of Lilly Research Laboratories.
“With a virus like SARS-CoV-2, it’s expected that variants could
emerge that require new therapeutic options, which is why Lilly is
studying bamlanivimab together with other neutralizing antibodies,
including etesevimab. Adding VIR-7831 to our study is an important
part of our commitment to develop therapies to treat current and
future strains of COVID-19 until vaccines are widely available and
utilized.”
“We believe that VIR-7831 has significant
potential as a single agent, and we are optimistic about the
pending interim data from two Phase 3 trials evaluating its
potential for early treatment and in hospitalized patients,” said
George Scangos, Ph.D., chief executive officer of Vir. “As the
virus continues to evolve, we, along with Lilly and GSK, share the
view that we should pursue all possibilities to help end the
pandemic and maximize the number of lives that can be saved. This
trial is a first step to assess whether the administration of
VIR-7831, with its high barrier to resistance and potent effector
function, alongside bamlanivimab, which has strong outcomes data in
early treatment, can provide potential benefits beyond
monotherapy.”
“Despite the significant progress on vaccines,
there remains an urgent patient need for multiple therapeutic
approaches to prevent the more severe consequences of COVID-19,”
said Dr. Hal Barron, chief scientific officer and president R&D
of GSK. “Partnering with Lilly to study VIR-7831 with bamlanivimab
will provide the scientific community with further data on the
important role these therapies could play in reducing the impact of
this devastating pandemic.”
Bamlanivimab alone has been granted Emergency
Use Authorization (EUA) by the U.S. Food and Drug Administration
(FDA) based on interim data from the Phase 2 BLAZE-1 trial, which
was published in the New England Journal of Medicine. These data
show the therapy may help patients clear the virus and reduce
COVID-19-related hospitalizations when given early in the disease
course. The safety and efficacy of bamlanivimab is being evaluated
with other neutralizing antibodies to provide a possible safeguard
against potential viral resistance.
VIR-7831 is an investigational compound, not
approved by the U.S. FDA or any other regulatory authority.
VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE
(COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care
Early) trial for the early treatment of COVID-19 in adults at high
risk of hospitalization.
Important Information about
bamlanivimabBamlanivimab has not been approved by the FDA
for any use. It is not known if bamlanivimab is safe and effective
for the treatment of COVID-19.
Bamlanivimab is authorized under an Emergency
Use Authorization only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency
use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C §
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.
Healthcare providers should review the Fact
Sheet for information on the authorized use of bamlanivimab and
mandatory requirements of the EUA. Please see the FDA Letter of
Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet
for Patients, Parents, and Caregivers (English) (Spanish).
Authorized Use and Important Safety
InformationBamlanivimab 700 mg injection is authorized for
use under EUA for 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 progressing to severe COVID-19 and/or
hospitalization.
Limitations of Authorized Use
- Bamlanivimab 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
bamlanivimab has not been observed in patients hospitalized due to
COVID-19. Monoclonal antibodies, such as bamlanivimab, may be
associated with worse clinical outcomes when administered to
hospitalized patients requiring high flow oxygen or mechanical
ventilation with COVID-19.
Important Safety
InformationThere are limited clinical data available for
bamlanivimab. Serious and unexpected adverse events may occur that
have not been previously reported with bamlanivimab use.
Hypersensitivity Including Anaphylaxis
and Infusion-Related ReactionsThere is a potential for
serious hypersensitivity reaction, including anaphylaxis, with
administration of bamlanivimab. 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 have been observed
with administration of bamlanivimab. Signs and symptoms of
infusion-related reactions may include:
- fever, chills, nausea, headache,
bronchospasm, hypotension, angioedema, throat irritation, rash
including urticaria, pruritus, myalgia, dizziness.
If an infusion-related reaction occurs, consider
slowing or stopping the infusion and administer appropriate
medications and/or supportive care.
Limitations of Benefit and Potential
Risk in Patients with Severe COVID-19Benefit of treatment
with bamlanivimab has not been observed in patients hospitalized
due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may
be associated with worse clinical outcomes when administered to
hospitalized patients requiring high flow oxygen or mechanical
ventilation with COVID-19. See Limitations of Authorized Use.
Adverse EventsAdverse events
reported in at least 1% of BLAZE-1 clinical trial participants on
bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea
(1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2%
vs 1%) and Vomiting (1% vs 3%).
Use in Specific
PopulationsPregnancyThere are
insufficient data on the use of bamlanivimab during pregnancy.
Bamlanivimab should only be used during pregnancy if the potential
benefit outweighs the potential risk for the mother and the
fetus.
BreastfeedingThere are no
available data on the presence of bamlanivimab in human or animal
milk, the effects on the breastfed infant, or the effects on milk
production. Breastfeeding individuals with COVID-19 should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID-19.
About BLAZE-4BLAZE-4
(NCT04634409) is a randomized, double-blind, placebo-controlled
trial designed to assess the efficacy and safety of bamlanivimab
alone, and bamlanivimab with other neutralizing antibodies
including VIR-7831 (GSK4182136) versus placebo for the treatment of
symptomatic COVID-19 in the outpatient setting. Across all
treatment arms, the trial will enroll an estimated 1,000
participants in the United States and Puerto Rico.
The primary outcome measure is percentage of
participants who have a viral load greater than 5.27 at day 7.
Additional endpoints include change from baseline to day 7 in
SARS-CoV-2 viral load, percentage of participants who experience
COVID-related hospitalization, ER visit or death from baseline
through day 29, as well as safety.
About bamlanivimabBamlanivimab
is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb)
directed against the spike protein of SARS-CoV-2. It is designed to
block viral attachment and entry into human cells, thus
neutralizing the virus, potentially treating COVID-19. Bamlanivimab
emerged from the collaboration between Lilly and AbCellera to
create antibody therapies for the prevention and treatment of
COVID-19. Lilly scientists rapidly developed the antibody in less
than three months after it was discovered by AbCellera and the
scientists at the National Institute of Allergy and Infectious
Diseases (NIAID) Vaccine Research Center. It was identified from a
blood sample taken from one of the first U.S. patients who
recovered from COVID-19.
Lilly has successfully completed a Phase 1 study
of bamlanivimab in hospitalized patients with COVID-19
(NCT04411628). A Phase 2/3 study in people recently diagnosed
with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is
ongoing. A Phase 3 study of bamlanivimab for the prevention of
COVID-19 in residents and staff at long-term care facilities
(BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is
being tested in the National Institutes of Health-led ACTIV-2 study
in ambulatory COVID-19 patients.
Bamlanivimab is authorized in the U.S. for the
treatment of mild to moderate COVID-19 in adults and pediatric
patients 12 years and older with a positive COVID-19 test, who are
at high risk for progressing to severe COVID-19 and/or
hospitalization. Bamlanivimab should be administered as soon as
possible after a positive COVID-19 test and within 10 days of
symptom onset.
About etesevimab Etesevimab (LY-CoV016, also
known as JS016) is a recombinant, fully human monoclonal
neutralizing antibody, which specifically binds to the SARS-CoV-2
surface spike protein receptor binding domain with high affinity
and can block the binding of the virus to the ACE2 host cell
surface receptor. Point mutations were introduced into the native
human IgG1 antibody to mitigate effector function. Lilly licensed
etesevimab from Junshi Biosciences after it was jointly developed
by Junshi Biosciences and Institute of Microbiology, Chinese
Academy of Science (IMCAS). Junshi Biosciences leads development
in Greater China, while Lilly leads development in the rest of
the world.
Lilly has successfully completed a Phase 1 study
(NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate
the safety, tolerability, pharmacokinetics and immunogenicity. A
Phase 2/3 study in people recently diagnosed with COVID-19 in the
ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi
Biosciences has completed a similar Phase 1 study in healthy
volunteers in China and has initiated Phase 1b/2 trials in COVID-19
patients globally.
About VIR-7831 /
GSK4182136VIR-7831 (GSK4182136) is an investigational
dual-action 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 which 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.
The COMET clinical development program for
VIR-7831 includes a planned Phase 3 trial for the prevention of
symptomatic infection. VIR-7831 is also being evaluated in a
sub-trial of the National Institutes of Health’s (NIH) Accelerating
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program
Phase 3 clinical trial. This trial is designed to evaluate the
safety and efficacy of VIR-7831 for the treatment of hospitalized
adults with COVID-19.
About Lilly’s COVID-19
EffortsLilly is bringing the full force of its scientific
and medical expertise to attack the coronavirus pandemic around the
world. Existing Lilly medicines are being studied to understand
their potential in treating complications of COVID-19, and the
company is collaborating with partner companies to discover novel
antibody treatments for COVID-19. Lilly is testing both single
antibody therapy as well as combinations of antibodies as potential
therapeutics for COVID-19. Visit Lilly’s COVID-19 disease area page
for resources related to Lilly's COVID-19 efforts.
GSK commitment to tackling
COVID-19GSK’s response to COVID-19 has been one of the
broadest in the industry with potential treatments and vaccine
candidates in development.
GSK is collaborating with several organisations
working on promising COVID-19 vaccines by providing access to our
adjuvant technology. In a collaboration with Sanofi that brings
together two of the world’s largest vaccine companies, GSK is
developing an adjuvanted recombinant protein-based COVID-19 vaccine
candidate with a phase 2b study expected to start in February 2021.
GSK also is collaborating with Medicago and Clover
Biopharmaceuticals on adjuvanted, protein-based vaccine candidates,
which are progressing into late-stage clinical trials. The use of
an adjuvant is of particular importance in a pandemic situation
since it may reduce the amount of vaccine protein required per
dose, allowing more vaccine doses to be produced and therefore
contributing to protecting more people.
GSK is also exploring potential therapeutic or
treatment options for COVID-19 patients. We are collaborating with
Vir Biotechnology to research and develop solutions for
coronaviruses, including SARS-CoV-2, the virus that causes
COVID-19. Currently, collaborating on the phase 3 clinical
development of VIR-7831 (GSK4182136), a dual-action monoclonal
antibody that has shown the ability in preclinical trials to both
neutralize SARS-CoV-2 live virus in vitro and in vivo and kill
already infected cells.
About Eli Lilly and
Company Lilly is a global health care leader that unites
caring with discovery to create medicines that make life better for
people around the world. We were founded more than a century ago by
a man committed to creating high-quality medicines that meet real
needs, and today we remain true to that mission in all our work.
Across the globe, Lilly employees work to discover and bring
life-changing medicines to those who need them, improve the
understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us
at www.lilly.com and www.lilly.com/news.
About Vir BiotechnologyVir
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 hepatitis B virus, influenza A,
SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more
information, please visit www.vir.bio.
About GSKGSK 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.
Lilly Cautionary Statement Regarding
Forward-Looking StatementsThis press release contains
forward-looking statements (as that term is defined in the Private
Securities Litigation Reform Act of 1995) about bamlanivimab
(LY-CoV555) as a potential treatment for patients with or at risk
of infection from COVID-19, alone and in combination with other
neutralizing antibodies, including VIR-7831 and etesevimab
(LY-CoV016), Lilly’s development plans and collaboration efforts,
and reflects Lilly's current beliefs and expectations. However, as
with any such undertaking, there are substantial risks and
uncertainties in the process of drug research, development and
commercialization and in drug collaborations. Among other
things, there can be no guarantee that future study results
will be consistent with the results to date, that bamlanivimab
alone or administered with VIR-7831or etesevimab will prove to be a
safe and effective treatment or preventative for COVID-19, that
bamlanivimab alone or administered with VIR-7831 or etesevimab will
receive regulatory approvals or additional authorizations, that
patients will volunteer to participate in a study of bamlanivimab
alone or administered with VIR-7831 or etesevimab or achieve
positive outcomes or that Lilly and its partners can provide an
adequate supply of bamlanivimab alone or administered with VIR-7831
or etesevimab in all circumstances. For a further discussion
of these and other risks and uncertainties that could cause actual
results to differ from Lilly's expectations, please see Lilly's
most recent Forms 10-K and 10-Q filed with the U.S. Securities and
Exchange Commission. Lilly undertakes no duty to update
forward-looking statements.
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
statements regarding the potential benefits of VIR-7831 as a single
agent and in combination with bamlanivimab in the treatment of
COVID-19, the potential benefits of participating in the BLAZE-4
trial, and the potential benefits of Vir, Lilly, and GSK’s
collaboration in addressing the current COVID-19 pandemic and
future outbreaks of the disease. Many factors may cause differences
between current expectations and actual results, including delays
or failures in planned patient enrollment or retention, clinical
site activation rates or clinical trial enrollment rates that are
lower than expected, 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’s 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 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 Q3 Results and
any impacts of the COVID-19 pandemic.
Contact:
Investors, Vir
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications
nravindran@vir.bio
+1-415-506-5256
Media, Vir
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1-415-941-6746
Investors, Lilly
Kevin Hern
hern_kevin_r@lilly.com
+1-317-277-1838
Media, Lilly
Molly McCully
mccully_molly@lilly.com
+1-317-478-5423
Media, Lilly
Dani Barnhizer
dbarnhizer@lilly.com
+1-317-607-6119
Investors, GSK
Jeff McLaughlin
jeffrey.r.mclaughlin@gsk.com
+1-215-751-7002
Media, GSK
Lyndsay Meyer
lyndsay.m.meyer@gsk.com
+1-202-302-4595
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