Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from
its robust hepatitis B virus (HBV) clinical trial program,
including results from an ongoing Phase 2 clinical trial of
VIR-2218, results from an ongoing Phase 1 clinical trial of
VIR-3434 and preclinical data evaluating both investigational
compounds as monotherapy and in combination. Data were presented in
one oral and two poster presentations at the International Liver
Congress™ (ILC) 2022, the Annual Meeting of the European
Association for the Study of the Liver (EASL).
In summary, data presented at ILC demonstrated
that a six-dose regimen of VIR-2218 provided greater and more
durable reductions in hepatitis B surface antigen (HBsAg) than a
two-dose regimen, with all participants achieving a >1 log10
IU/mL reduction during the trial. Phase 1 results evaluating
VIR-3434 showed that a single dose (6 mg, 18 mg, 75 mg or 300 mg)
resulted in a rapid reduction of HBsAg, with the largest and most
durable response noted with the 300 mg dose. Finally, preclinical
in vivo data demonstrated that the combination of both
investigational compounds resulted in greater HBsAg reductions than
either compound alone.
“The data presented at the International Liver
Congress 2022 continue to indicate that our therapeutic strategy of
combining an antiviral with an immunomodulator to restore
immunologic control in patients with chronic HBV is additive and
offers the potential for a functional cure,” said Carey Hwang,
M.D., Ph.D., Vir’s senior vice president, clinical research, head
of chronic infection. “As we continue to evaluate VIR-2218 and
VIR-3434, we are encouraged by the potential of these two
investigational medicines alone and in combination. These data,
alongside the anticipated initiation of Part B of the MARCH trial
by the end of June, are important milestones in our broad HBV
portfolio for which we expect multiple data readouts throughout
2022 and 2023.”
Hepatitis Portfolio Update
As part of its ongoing efforts to advance its
broad HBV portfolio, Vir expects to dose the first patient in Part
B of the Phase 2 MARCH (Monoclonal Antibody siRNA Combination
against Hepatitis B) trial evaluating VIR-2218 in combination with
VIR-3434 for 24 and 48 weeks, and in combination with interferon,
by the end of June. Previously reported results from Part A
demonstrated that VIR-3434 combined with VIR-2218 provided an
additional 2 log decline in HBsAg loss over the 3 log decrease with
VIR-2218 alone. No drug-related safety signals were observed.
Additional data from Part A are expected later this year. However,
with clinical trial sites in Ukraine and Moldova, the Company is
continuing to monitor the war in Ukraine for any potential impact
on timing.
Additional milestones expected in the second
half of 2022 include:
- Additional data from the Phase 2 trial of VIR-2218 in
combination with PEG-IFN-α.
- Initial data from the Phase 2 trial led by Brii Biosciences
evaluating VIR-2218 in combination with BRII-179, an
investigational T cell vaccine, for the potential treatment of
chronic HBV infection.
- The initiation of a Phase 2 platform trial of VIR-2218 in
combination with VIR-3434 in viremic patients (THRIVE/STRIVE
sub-protocols), with initial data expected in the second half of
2023.
- The initiation of a Phase 2 trial of VIR-2218 in combination
with VIR-3434 for the treatment of chronic hepatitis D virus (HDV)
infection, with initial data expected in 2023.
The Company also expects to report initial data from the Phase 2
trial evaluating various combinations of VIR-2218, selgantolimod
(GS-9688), Gilead Sciences, Inc.’s investigational TLR-8 agonist,
and nivolumab, an approved PD-1 inhibitor, as a potential cure
regimen for chronic HBV infection in the first half of 2023.
Summary of ILC 2022 Presentations
Oral Presentation – VIR-2218
Longer treatment duration of monthly VIR-2218
results in deeper and more sustained reductions in hepatitis B
surface antigen in participants with chronic hepatitis B infection
(Abstract #644)Young-Suk Lim, M.D., Ph.D.,
professor, Department of Gastroenterology and Liver
Center, Asan Medical Center, University of Ulsan College
of Medicine, Seoul, South Korea
Preliminary results from the ongoing Phase 2
trial evaluating the safety, tolerability, and antiviral activity
of two dosing regimens (two or six doses of VIR-2218 200 mg given
subcutaneously every four weeks) in 21 virally suppressed hepatitis
B e antigen (HBeAg)-positive or negative participants with chronic
HBV infection demonstrated:
- All participants in the 2- and
6-dose regimens achieved a >1 log10 IU/mL reduction in
HBsAg.
- The six-dose regimen was associated
with a greater mean maximum HBsAg reduction and more sustained
HBsAg reductions than the two-dose regimen with 73% of participants
receiving 6 doses of VIR-2218 maintaining ≥ 1 log10 IU/mL reduction
in HBsAg from baseline through 40 weeks after the last dose.
- There were no observable
differences in safety or tolerability between the two VIR-2218
dosing regimens. No serious treatment-emergent adverse events were
reported, and no trial participants discontinued
treatment.
Poster Presentation – VIR-3434
Dose-dependent durability of hepatitis B surface
antigen reductions following administration of a single dose of
VIR-3434, a novel neutralizing vaccinal monoclonal antibody
(Abstract #654; Poster #SAT357)Kosh Agarwal, M.D., consultant
hepatologist and transplant physician, Institute of Liver
Studies at King’s College Hospital, and clinical
director, NIHR South London Clinical Research Network
Preliminary data from the placebo-controlled,
single ascending dose Phase 1 trial evaluating the safety,
tolerability, and antiviral activity of a single ascending dose of
VIR-3434 (6 mg, 18 mg 75 mg or 300 mg) administered subcutaneously
to 24 participants with HBeAg-negative chronic HBV infection with
eight weeks of follow-up, demonstrated:
- Most participants achieved a >1
log10 IU/mL reduction from baseline in HBsAg within one to three
days of dosing.
- A single dose of VIR-3434 6 mg, 18
mg, 75 mg or 300 mg demonstrated a rapid reduction in HBsAg, with
the largest and most durable HBsAg reductions observed in the 300
mg cohort.
- VIR-3434 was generally well
tolerated. All AEs reported were grade 1 or 2 in severity.
Poster Presentation – VIR-2218 in Combination with
VIR-3434
VIR-2218 plus VIR-3434 combination therapy
reduces hepatitis B virus surface antigen levels in
vivo (Abstract #3009; Poster #SAT434)Andrea Cathcart, Ph.D.,
director, Clinical Virology, Vir Biotechnology
The antiviral activity of VIR-2218 and VIR-3434
as monotherapy and in combination was evaluated in two separate in
vivo trials of an animal model of HBV infection. Antiviral activity
was determined by evaluating viral serum/plasma markers, including
HBV DNA, HBsAg and HBeAg. Results showed:
- In one trial, VIR-2218 monotherapy
led to a significant reduction in plasma HBsAg, HBeAg and HBV DNA
levels, and VIR-3434 monotherapy significantly reduced plasma
HBsAg. The combination of VIR-2218 and VIR-3434 further reduced
plasma HBsAg and HBV DNA levels compared with VIR-2218
monotherapy.
- In the other trial, VIR-3434
monotherapy resulted in a substantial decrease in serum HBsAg.
Treatment with the combination of VIR-2218 and VIR-3434 showed
greater reductions in HBsAg and a reduction in serum HBV DNA levels
over monotherapy.
About Chronic Hepatitis
BChronic hepatitis B virus (HBV) infection remains an
urgent global public health challenge associated with significant
morbidity and mortality. Approximately 300 million people around
the world are living with HBV and approximately 900,000 of them die
from associated complications each year. These patients are
significantly underserved by existing therapies with low functional
cure rates, lifelong daily therapy and poor tolerability. Vir
Biotechnology is working to achieve a functional cure for the
millions of people with HBV around the world through its broad and
differentiated portfolio.
About VIR-2218VIR-2218 is an
investigational subcutaneously administered HBV-targeting siRNA
that has the potential to stimulate an effective immune response
and have direct antiviral activity against HBV. It is the first
siRNA in the clinic to include Enhanced Stabilization Chemistry
Plus (ESC+) technology to enhance stability and minimize off-target
activity, which potentially can result in an increased therapeutic
index. VIR-2218 is the first asset in the Company’s collaboration
with Alnylam Pharmaceuticals, Inc. to enter clinical trials.
About VIR-3434VIR-3434 is an
investigational subcutaneously administered HBV-neutralizing
monoclonal antibody designed to block entry of all 10 genotypes of
HBV into hepatocytes and also to reduce the level of virions and
subviral particles in the blood. VIR-3434, which incorporates
Xencor’s Xtend™ and other Fc technologies, has been engineered to
potentially function as a T cell vaccine against HBV in infected
patients, as well as to have an extended half-life.
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 and hepatitis
D viruses, influenza A and human immunodeficiency virus. Vir
routinely posts information that may be important to investors on
its website.
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,” “expect,”
“anticipate,” “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 clinical data from
Vir’s ongoing trials of VIR-2218 and VIR-3434, the ability of
VIR-2218 and VIR-3434 (as monotherapies or combination therapies)
to treat and/or prevent chronic HBV infection, the timing, design
and enrollment plans for the Phase 2 MARCH trial, the timing of
Brii Biosciences Phase 2 trial evaluating VIR-2218 in a combination
trial with BRII-179, the timing of initial data from the
combination of VIR-2218 with TLR-8 agonist and nivolumab, Vir’s
plans for its HBV portfolio and clinical development programs,
clinical trials, including the enrollment of Vir’s clinical trials,
and data readouts.. Many factors may cause differences between
current expectations and actual results, including unexpected
safety or efficacy data or results observed during clinical trials,
difficulties in obtaining regulatory approval, difficulties in
collaborating with other companies, challenges in accessing
manufacturing capacity, clinical site activation rates or clinical
trial enrollment rates that are lower than expected, 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
(including the war in Ukraine) or other external factors and
unexpected litigation or other disputes. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. Results in early-stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. You should not place undue reliance on these statements,
or the scientific data presented. 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.
Contacts:
Investors
Heather Rowe Armstrong
VP, Investor Relations
harmstrong@vir.bio
+1-415-915-4228
Media
Carly Scaduto
Senior Director, Media Relations
cscaduto@vir.bio
+1 314-368-5189
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