Gilead Sciences, Inc. (NASDAQ: GILD) and Vir Biotechnology, Inc.
(NASDAQ: VIR) today announced that the companies have entered into
a clinical collaboration to evaluate novel therapeutic combination
strategies aimed at developing a functional cure for chronic
hepatitis B virus (HBV).
The companies plan to initiate a Phase 2 trial
evaluating combination therapy for both treatment-experienced and
treatment-naïve people living with HBV. The multi-arm trial will
evaluate different combinations of selgantolimod, Gilead’s
investigational TLR-8 agonist; VIR-2218, Vir’s investigational
small interfering ribonucleic acid (siRNA); and a
commercially-sourced, marketed PD-1 antagonist. People in the trial
with HBV treatment experience may also receive Gilead’s Vemlidy®
(tenofovir alafenamide fumarate, TAF). The primary outcome of the
study will be the proportion of patients achieving a functional
cure, defined as an off-therapy loss of hepatitis B surface antigen
(HBsAg) and HBV DNA from the serum.
Both companies retain full rights to their
individual product candidates and will discuss the potential path
forward for any future combination studies based on the outcome of
the Phase 2 trial.
“Gilead has a two-decade commitment to people
with hepatitis B and we have worked tirelessly to bring new
treatments forward with the goal of helping to improve their
lives,” said Anuj Gaggar, vice president, Clinical Research,
Virology at Gilead Sciences. “We believe that selgantolimod and
VIR-2218 have the potential to be best-in-class therapeutics and
could provide a compelling new combination approach to a functional
cure for HBV.”
“We are enthusiastic about this collaboration,”
said Phil Pang, M.D., Ph.D., chief medical officer of Vir
Biotechnology. “We believe a functional cure for the majority of
patients will require a reduction of the levels of circulating
viral proteins together with an immune boost to stimulate the
production of new T-cells that can bring the infection under
control. We believe that this collaboration with Gilead adds a
novel and significant new combination to our efforts to find a cure
for HBV.”
HBV affects more than 290 million people
worldwide. Globally, HBV is a leading cause of liver cancer and
each year it is estimated that more than 800,000 people die of
HBV-related liver disease. While current antiviral therapies result
in sustained HBV viral suppression, they rarely completely clear
the virus and therefore people with HBV require lifelong
therapy.
The safety and efficacy of selgantolimod and
VIR-2218 have not been established. They are investigational
compounds, not approved by the U.S. Food and Drug Administration
(FDA) or any other regulatory authority.
U.S. Important Safety Information and Indication for
VEMLIDY
IMPORTANT SAFETY INFORMATIONBOXED
WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS
B
- Discontinuation of anti-hepatitis B therapy, including
VEMLIDY, may result in severe acute exacerbations of hepatitis B.
Hepatic function should be monitored closely with both clinical and
laboratory follow-up for at least several months in patients who
discontinue anti-hepatitis B therapy, including VEMLIDY. If
appropriate, resumption of anti-hepatitis B therapy may be
warranted.
Warnings and Precautions
- Risk of Development of HIV-1 Resistance in HBV/HIV-1
Coinfected Patients: Due to this risk, VEMLIDY alone
should not be used for the treatment of HIV-1 infection. Safety and
efficacy of VEMLIDY have not been established in HBV/HIV-1
coinfected patients. HIV antibody testing should be offered to all
HBV-infected patients before initiating therapy with VEMLIDY, and,
if positive, an appropriate antiretroviral combination regimen that
is recommended for HBV/HIV-1 coinfected patients should be
used.
- New Onset or Worsening Renal
Impairment: Cases of acute renal failure and Fanconi
syndrome have been reported with the use of tenofovir prodrugs. In
clinical trials of VEMLIDY, there have been no cases of Fanconi
syndrome or proximal renal tubulopathy (PRT). Patients with
impaired renal function and/or taking nephrotoxic agents (including
NSAIDs) are at increased risk of renal-related adverse reactions.
Discontinue VEMLIDY in patients who develop clinically significant
decreases in renal function or evidence of Fanconi syndrome.
Monitor renal function in all patients – See Dosage and
Administration.
- Lactic Acidosis and Severe Hepatomegaly with
Steatosis: Fatal cases have been reported with the
use of nucleoside analogs, including tenofovir DF. Discontinue
VEMLIDY if clinical or laboratory findings suggestive of lactic
acidosis or pronounced hepatotoxicity develop, including
hepatomegaly and steatosis in the absence of marked transaminase
elevations.
Adverse ReactionsMost common adverse reactions
(incidence ≥5%; all grades) were headache, abdominal pain, cough,
back pain, fatigue, nausea, arthralgia, diarrhea, and
dyspepsia.
Drug Interactions
- Coadministration of VEMLIDY with drugs that reduce renal
function or compete for active tubular secretion may increase
concentrations of tenofovir and the risk of adverse reactions.
- Coadministration of VEMLIDY is not recommended with the
following: oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifampin, rifapentine, or St. John’s wort. Such coadministration is
expected to decrease the concentration of tenofovir alafenamide,
reducing the therapeutic effect of VEMLIDY. Drugs that strongly
affect P-glycoprotein (P-gp) and breast cancer resistance protein
(BCRP) activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more
information on potentially significant drug interactions, including
clinical comments.
Dosage and Administration
- Testing Prior to Initiation: HIV
infection.
- Prior to or when initiating, and during
treatment: On a clinically appropriate schedule,
assess serum creatinine, estimated creatinine clearance, urine
glucose, and urine protein in all patients. In patients with
chronic kidney disease, also assess serum phosphorus.
- Dosage in Adults: 1 tablet taken once
daily with food.
- Renal Impairment: Not recommended in
patients with end stage renal disease (ESRD; eCrCl <15 mL/min)
who are not receiving chronic hemodialysis; in patients on chronic
hemodialysis, on hemodialysis days, administer VEMLIDY after
completion of hemodialysis treatment.
- Hepatic Impairment: Not recommended in
patients with decompensated (Child-Pugh B or C) hepatic
impairment.
INDICATIONVEMLIDY is indicated for the
treatment of chronic hepatitis B virus (HBV) infection in adults
with compensated liver disease.
Please click here to see full Prescribing Information
for VEMLIDY, including BOXED WARNING.
About Gilead SciencesGilead Sciences, Inc. is a
research-based biopharmaceutical company that discovers, develops
and commercializes innovative medicines in areas of unmet medical
need. The company strives to transform and simplify care for people
with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead
Sciences, please visit the company’s website at www.gilead.com.
About Vir Biotechnology
Vir 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 SARS-CoV-2,
hepatitis B virus, influenza A, human immunodeficiency virus and
tuberculosis. For more information, please visit www.vir.bio.
Gilead Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are subject to risks, uncertainties and
other factors, including the risk that Gilead may not realize the
potential benefits of the collaboration with Vir Biotechnology, the
possibility of unfavorable results from clinical trials involving
Vemlidy and selgantolimod and the possibility that Gilead may be
unable to initiate or complete one or more of such trials in the
currently anticipated timelines or at all. Further, it is possible
that Gilead may make a strategic decision to discontinue
development of selgantolimod and any combination therapies, or that
the parties may make a strategic decision to discontinue their
collaboration at any time, and as a result, selgantolimod and any
combination therapies may never be successfully commercialized.
These risks, uncertainties and other factors could cause actual
results to differ materially from those referred to in the
forward-looking statements. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2020, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
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 “aim,” “will,” “may,”
“potential,” “plan,” “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. Each of these forward-looking statements involves
risks and uncertainties. Actual results may differ materially from
these forward-looking statements. Forward-looking statements
contained in this press release include statements regarding the
clinical collaboration between Vir and Gilead Sciences, the ability
to develop a functional cure for chronic HBV, the initiation of a
Phase 2 trial of VIR-2218 to evaluate it as a combination therapy,
VIR-2218’s ability to stimulate an effective immune response and
the effects of including ESC+. Many factors may cause differences
between current expectations and actual results, including
unexpected safety, tolerability, or immunogenicity data or results
observed during the Phase 2 trial, challenges in clinical site
activation rates or clinical trial enrollment rates that are lower
than expected, the failure to achieve the primary outcome of the
study, 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.
U.S. Prescribing Information for Vemlidy
including BOXED WARNING, is available at
www.gilead.com.
Vemlidy, Gilead and the Gilead logo are
registered trademarks of Gilead Sciences, Inc., or its related
companies.
Contact:
Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications
nravindran@vir.bio
+1-415-506-5256
Media
Cara Miller
VP, Corporate Communications
cmiller@vir.bio
+1-415-941-6746
Investors, Gilead
Monica Tellado
+1-650-522-5132
Media, Gilead
Darcy Bowman
+353 (87) 382-6777
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