– Initial SOLSTICE data suggests the potential
of VIR-3434 + VIR-2218 to address the unmet need for a highly
efficacious hepatitis delta therapy –
– New MARCH Part B data demonstrate that
VIR-3434 may play an important role in achieving a functional cure
for chronic hepatitis B –
– Conference call scheduled for 1:45 p.m. PT /
4:45 p.m. ET, November 13, 2023 –
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced it will be
presenting new data from its ongoing Phase 2 SOLSTICE and MARCH
trials evaluating the potential clinical impact that VIR-3434, an
investigational monoclonal antibody (mAb), and VIR-2218, an
investigational small interfering ribonucleic acid (siRNA), could
have for chronic hepatitis delta (CHD) and chronic hepatitis B
(CHB) patients at the American Association for the Study of Liver
Diseases (AASLD) The Liver Meeting®. These include one
late-breaking oral presentation and one late-breaking poster
presentation.
Phase 2 SOLSTICE (CHD)
Initial data to be presented in a late-breaking oral
presentation from the ongoing Phase 2 SOLSTICE clinical trial
demonstrated that after three subcutaneous doses of either VIR-3434
or VIR-2218 monotherapy, six patients rolled over into combination
therapy with VIR-3434 and VIR-2218. Of the five participants
receiving combination therapy who have reached Week 12, 100% had
HDV RNA less than the lower limit of quantification1 with 80% (4 of
5) having undetectable HDV RNA2. To date, no participants receiving
the combination therapy or VIR-3434 monotherapy have experienced
ALT elevations relative to their baseline. ALT elevations >250
IU/ml were observed in two participants who received VIR-2218
monotherapy.
“Chronic hepatitis delta is the most aggressive form of viral
hepatitis. There are few treatment options for people living with
HDV infection. Undetectable HDV RNA is an important endpoint
associated with clinical benefit. These early results from SOLSTICE
are unprecedented, with 80% of participants being undetectable at
Week 12 of combination therapy,” said Tarik Asselah, M.D., Ph.D.,
Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy,
France, and at the University of Paris, and Head of Viral Hepatitis
at INSERM UMR1149, France. “If this result can be reproduced in a
much larger group of participants, I believe this potentially once
monthly therapy could be transformative for patients.”
“CHD impacts over 12 million people worldwide and approximately
100,000 people here in the United States,” said Phil Pang, M.D.,
Ph.D., Vir’s Executive Vice President, Chief Medical Officer. “This
data highlights Vir’s commitment to developing a game-changing
chronic suppressive therapy for this rare disease.”
The company expects to report additional SOLSTICE data for
VIR-3434 + VIR-2218 in the second quarter of 2024. The Company is
also evaluating VIR-3434 as monotherapy given twice monthly as part
of the SOLSTICE trial.
Phase 2 MARCH Part B (CHB)
A late-breaking poster presenting new data from the ongoing
MARCH Part B trial demonstrates that HBsAg loss rates at the end of
treatment (EOT) for the combination of VIR-3434 + VIR-2218 with and
without peginterferon alpha (PEG-IFN-α), when given for 24 weeks,
are approximately three times higher than the 5.6% EOT rate
previously reported for VIR-2218 + PEG-IFN-α. Specifically, at 24
weeks, 15.0% and 14.3% of participants achieved HBsAg loss at EOT
for VIR-3434 + VIR-2218 and VIR-2218 + VIR-3434 + PEG-IFN-α,
respectively. In addition, anti-HBs antibody titers > 10 mIU/mL
at EOT were detected in 52% (11 of 21) of participants in the
triple combination of VIR-3434 + VIR-2218 + PEG-IFN-α cohort versus
11% (2 of 18) with VIR-2218 + PEG-IFN-α.
“The higher proportion of participants achieving anti-HBs titers
with the addition of VIR-3434 to VIR-2218 and peginterferon alpha
strongly suggests that VIR-3434 not only contributes to HBsAg loss
through clearance of HBsAg, but also has the ability to reawaken
the immune system and generate HBV-specific immunity,” said Edward
Gane, M.D., Professor of Medicine at the University of Auckland,
New Zealand, and Chief Hepatologist, Transplant Physician and
Deputy Director of the New Zealand Liver Transplant Unit at
Auckland City Hospital. “This data implies VIR-3434 can function as
an immunostimulant.”
Post treatment data will also be presented, showing that two
participants with the highest peak anti-HBs titers who received 24
weeks of VIR-3434 + VIR-2218 + PEG-IFN-α maintained HBsAg loss
through post-treatment Week 12. Rebound of HBsAg after EOT was
observed in all other participants (19 of 21). The Company will
continue to follow all participants through post-treatment Week 24
and beyond.
The new MARCH Part B data builds upon the previously reported
VIR-2218 + PEG-IFN-α data in which the Company demonstrated the
potential for its siRNA VIR-2218 to enhance EOT and post-treatment
HBsAg loss rates: 30% of participants receiving up to 48 weeks of
combination therapy achieved EOT HBsAg loss and 16% achieved a
sustained HBsAg loss 24 weeks after EOT.
“It is important to remember that while these are small
participant numbers, this immunologic data is the first evidence
that, when part of a combination regimen, our vaccinal antibody
VIR-3434 has the potential to play an important role in
facilitating a functional cure for patients living with chronic
hepatitis B. I am therefore very much looking forward to seeing
what will happen when VIR-3434 and VIR-2218 are given, with and
without peginterferon alpha, for 48 weeks,” said Pang. “What has
been repeatedly observed with peginterferon immunotherapy is that
the majority of the benefit occurs after the first 24 weeks of
treatment. Thus, we may be seeing just the beginnings of the
potential of our regimens.”
The Company is on track for sharing the MARCH Part B 48-week EOT
data in the fourth quarter of 2024.
Late-Breaker Oral Presentation – Phase 2 SOLSTICE
The Monoclonal Antibody VIR-3434 And siRNA VIR-2218 for the
Treatment of Chronic Hepatitis D Virus: Preliminary Results from
the Phase 2 SOLSTICE Trial (Abstract #5004) Date:
Monday, November 13 at 3:00 p.m. ET Presenter: Tarik
Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital
Beaujon, APHP, Clichy, France, and at the University of Paris, and
Head of Viral Hepatitis at INSERM UMR1149, France
Late-Breaker Poster Presentation – Phase 2 MARCH Part
B
VIR-2218 and VIR-3434 With or Without Pegylated Interferon
Alfa-2A for the Treatment of Chronic HBV Infection: End of
Treatment (EOT) Results After 24 Weeks of Therapy (March Study Part
B) (Abstract #48500) Date: Monday, November 13 at 1:00
p.m. ET Presenter: Edward Gane, M.D., Professor of Medicine
at the University of Auckland, New Zealand, and Chief Hepatologist,
Transplant Physician and Deputy Director of the New Zealand Liver
Transplant Unit at Auckland City Hospital
The abstracts for these and the other six AASLD presentations
are available under Events & Presentations in the Investors
section of the Vir website here. The final presentations will be
posted after 3:30 pm ET today.
Vir will host an investor conference call to discuss the Phase 2
CHD & CHB AASLD data at 1:45 p.m. Pacific Time / 4:45 p.m.
Eastern Time on November 13th. A live webcast will be available on
https://investors.vir.bio and will be archived on www.vir.bio for
30 days.
About Chronic Hepatitis B
Chronic hepatitis B (CHB) infection remains an urgent global
public health challenge associated with significant morbidity and
mortality. Approximately 300 million people around the world are
living with CHB, 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/or poor tolerability. Vir is
working to achieve a functional cure for the millions of people
with CHB around the world through its broad and differentiated
portfolio.
About Chronic Hepatitis Delta
Chronic hepatitis delta (CHD) infection occurs as a simultaneous
co-infection or super-infection with chronic hepatitis B. An
estimated 12 million people globally are infected with CHD,
representing approximately 5% of those infected with CHB. CHB-CHD
co-infection is considered the most severe form of chronic viral
hepatitis due to more rapid progression toward hepatocellular
carcinoma and liver-related death.
About VIR-3434
VIR-3434 is an investigational subcutaneously administered
antibody designed to block entry of hepatitis B and hepatitis delta
viruses into hepatocytes and 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 hepatitis B virus
and hepatitis delta virus, as well as to have an extended
half-life. VIR-3434 was identified using Vir’s proprietary
monoclonal antibody discovery platform.
About VIR-2218
VIR-2218 is an investigational subcutaneously administered
hepatitis B virus-targeting small interfering ribonucleic acid
(siRNA) that Vir believes has the potential to stimulate an immune
response and have direct antiviral activity against hepatitis B
virus and hepatitis delta virus. 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 could 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 Biotechnology, Inc.
Vir Biotechnology, Inc. is an immunology company focused on
combining cutting-edge technologies to treat and prevent infectious
diseases and other serious conditions. Vir has assembled two
technology platforms that are designed to stimulate and enhance the
immune system by exploiting critical observations of natural immune
processes. Its current clinical development pipeline consists of
product candidates targeting hepatitis delta and hepatitis B
viruses and human immunodeficiency virus. Vir has several
preclinical candidates in its pipeline, including those targeting
influenza A and B, COVID-19, RSV/MPV and HPV. 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 Vir’s
strategy and plans, the potential clinical effects of VIR-3434 and
VIR-2218, the potential benefits, safety and efficacy of VIR-3434
and VIR-2218 (as monotherapies and as combination therapies with
and without PEG-IFN-α), data from Vir’s multiple ongoing trials
evaluating VIR-3434 and VIR-2218, Vir’s plans and expectations for
its HBV and HDV portfolios, and risks and uncertainties associated
with drug development and commercialization. Many factors may cause
differences between current expectations and actual results,
including unexpected safety or efficacy data or results observed
during clinical trials or in data readouts; the occurrence of
adverse safety events; risks of unexpected costs, delays or other
unexpected hurdles; difficulties in collaborating with other
companies; 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. 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.
1 The lower limit of quantitation (LLOQ) of HDV RNA is <63
IU/mL and the limit of detection (LOD) is 14 IU/mL. 2 Undetectable
HDV RNA is defined as < limit of detection, 14 IU/mL or ≥ 2
log10 IU/mL decrease from baseline.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231110130371/en/
Media Carly Scaduto Senior Director, Media Relations
cscaduto@vir.bio +1-314-368-5189
Investors Sasha Damouni Ellis Executive Vice President,
Chief Corporate Affairs Officer sdamouni@vir.bio
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