Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from
its robust hepatitis B and D virus (HBV and HDV) portfolio that
were presented at the EASL
™ (European Association
for the Study of the Liver) Congress.
Data presented in a late-breaker oral
presentation from a Phase 2 clinical trial demonstrated that when
VIR-2218, an investigational small interfering ribonucleic acid
(siRNA), was given for 24 or 48 weeks on top of a course of up to
48 weeks of pegylated interferon alpha (PEG-IFN-⍺) (cohorts 4 and 5
combined), 16% (5/31) achieved sustained HBsAg loss 24 weeks
following the end of treatment.
“While based on small numbers, this is one of
the highest rates of off-treatment response observed to-date and
strongly supports the hypothesis that adding an siRNA to an
immunomodulator has the potential to result in functional cure
rates higher than historically seen with PEG-IFN-⍺ alone,” said
Professor Man-Fung Yuen, M.D., Ph.D., D.Sc., Chief of the Division
of Gastroenterology and Hepatology, the University of Hong Kong, Li
Shu Fan Medical Foundation Professor in Medicine.
In a poster presentation, new pharmacokinetics
(PK) data support the safety, tolerability and antiviral activity
of a 300 mg dose of VIR-3434, an investigational monoclonal
antibody, which is being evaluated for the treatment of chronic HBV
and HDV infection across multiple ongoing clinical trials. In
addition, preclinical data presented in a separate poster showed
evidence of antiviral efficacy of VIR-2218 and VIR-3434 against HDV
infection by demonstrating reduced levels of HBsAg, HDV and HBV
viremia in vivo with the parental molecule of VIR-3434 as well as
reduced HBV antigens and secreted infectious HDV virions in vitro
with both single and combination therapies of VIR-2218 and
VIR-3434. These data further support the clinical development of
these investigational medicines for the treatment of HDV.
“I am very excited by the progress we are making
toward our goal of achieving HBV functional cure. Our data to-date
with VIR-2218 and PEG-IFN-⍺ support our hypothesis of using a
cocktail of antivirals combined with immunomodulators. I am very
much looking forward to learning how much impact VIR-3434, our
vaccinal monoclonal antibody, will have – either as a replacement
for PEG-IFN-⍺, or as an add on to VIR-2218 and PEG-IFN-⍺,” said
Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical
Research, Head of Chronic Infection. “Separately, our preclinical
data strongly support the development of VIR-2218 and VIR-3434,
either alone or in combination, to chronically suppress HDV
viremia.”
Summary of EASL Congress 2023
Presentations
Late-Breaker Oral Presentation –
VIR-2218 with or without PEG-IFN-α
Safety and efficacy of VIR-2218 with or
without pegylated interferon alfa in virally-suppressed
participants with chronic hepatitis B virus infection:
post-treatment follow-up (presentation #LBO-02)
Presenter: Man-Fung Yuen, M.D.,
Ph.D., D.Sc., Chief of the Division of Gastroenterology and
Hepatology, the University of Hong Kong, Li Shu Fan Medical
Foundation Professor in Medicine.
Phase 2 follow-up data from an open-label,
clinical trial (NCT04412863) evaluating VIR-2218 with or without
PEG-IFN-⍺ in virally-suppressed participants with chronic HBV
demonstrated:
- In participants receiving VIR-2218
for 24 or 48 weeks plus up to 48 weeks of PEG-IFN-⍺ (cohorts 4 and
5 combined), 26% (8/31) achieved HBsAg loss at the end of treatment
and 16% (5/31) sustained HBsAg loss 24 weeks after the end of
treatment.
- Across all cohorts, the four
participants with anti-HBs titers >500 mIU/mL at the end of
treatment achieved a sustained HBsAg loss at 24 weeks after the end
of treatment, suggesting the potential use of anti-HBs titers as an
on-treatment biomarker of off-treatment sustained response.
- Treatment with VIR-2218 alone and
in combination with PEG-IFN-⍺ was generally well tolerated. The
majority of adverse events were consistent with the known effects
of PEG-IFN-⍺ and resolved after the end of treatment. No serious
adverse events related to VIR-2218 were reported.
Oral Presentation – VIR-2218 in
Combination with VIR-3434
Safety and antiviral activity of short-duration
combinations of the investigational small interfering ribonucleic
acid (siRNA) VIR-2218 with the neutralizing, vaccinal monoclonal
antibody VIR-3434: post-treatment follow-up from the Phase 2 MARCH
trial (presentation #OS-031)
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
In Part A of the MARCH trial (NCT04856085),
participants were treated with short-duration combination therapy
with VIR-2218 and VIR-3434 for 5 or 12 weeks. Preliminary 48-week
post-treatment safety, tolerability and antiviral activity data
demonstrated:
- As previously shown, the
combination of VIR-2218 and VIR-3434 resulted in a 2.7-3.1 log10
IU/mL decline in HBsAg levels at the end of treatment. As expected,
no participants achieved on-treatment or off-treatment HBsAg loss,
consistent with the short duration of combination therapy
administered to these participants. Importantly, these
short-duration cohorts informed the protocol for Part B, which is
designed to evaluate whether VIR-3434 and VIR-2218, given with or
without PEG-IFN-⍺ for 24 to 48 weeks, can result in a functional
cure for chronic HBV infection.
- The majority of participants met
the criteria for discontinuing nucleotide reverse transcriptase
inhibitor (NRTI) therapy because they achieved all of the
following: HBsAg <100 log10 IU/mL and ≥1 log10 IU/mL reduction
from baseline HBsAg level; HBV DNA <LLOQ; HBeAg-negative and ALT
≤2 times the upper limit of normal. Of those participants, 67%
(4/6) remained off NRTI therapy as of the last available follow
up.
- Combination treatment with VIR-2218
and VIR-3434 was generally well tolerated and was associated
primarily with mild adverse events. All treatment-related adverse
events were Grade 1, with no study discontinuations.
Poster Presentations – VIR-2218,
VIR-3434
VIR-2218 and VIR-3434 therapy is efficacious in
preclinical models of hepatitis delta virus infection (poster
#TOP-109)
Presenter: Florian Lempp,
Ph.D., Director, Virology, Vir Biotechnology
Preclinical in vivo and in vitro models
evaluating the efficacy of VIR-2218 and VIR-3434 for the treatment
of HDV infection showed:
- VIR-3434 targets the conserved
antigenic loop within HBsAg present on both HBV and HDV virions and
neutralized HDV infection with >10,000-fold higher potency than
HBV-specific immunoglobulins in vitro.
- In vivo, the parental molecule of
VIR-3434 reduced the levels of HBsAg, HDV and HBV viremia in
HBV/HDV-coinfected liver-chimeric mice.
- Single and combination treatments
with VIR-2218 and VIR-3434 of HBV/HDV-coinfected primary human
hepatocytes in vitro reduced HBV antigens as well as secreted
infectious HDV virions. Evaluation of such in vivo combinations is
currently ongoing.
Single dose pharmacokinetics of VIR-3434, a novel
neutralizing monoclonal antibody, in participants with chronic
hepatitis B virus infection (poster #SAT-177)
Presenter: Sneha V. Gupta,
Ph.D., Director, Clinical Pharmacology, Vir Biotechnology
A randomized, double-blind, placebo-controlled,
Phase 1 single-ascending dose study (NCT05484206) evaluating the
safety, tolerability, antiviral activity and PK of VIR-3434 in
patients with chronic HBV infection demonstrated:
- Consistent with prior studies, the
highest and most durable free VIR-3434 exposure was observed with
the 300 mg dose, regardless of baseline HBsAg level. Other doses
studied included 6 mg, 18 mg and 75 mg.
- Baseline HBsAg had a moderate
impact in free VIR-3434 PK exposure, with lower PK exposures in
participants with higher baseline HBsAg, which is suggestive of
target-mediated drug disposition.
- VIR-3434 has a shorter terminal
half-life and was cleared faster in participants with higher
baseline HBsAg. At the 300 mg dose level, median apparent clearance
was 609 mL/day in participants with HBsAg ≤3,000 IU/mL versus 883
mL/day in participants with >3,000 IU/mL.
Treatment eligibility and initiation among chronic
hepatitis B patients in a real-world setting in the United States
(poster #WED-141)
Presenter: Mark A. Schmidt,
Ph.D., M.P.H., Infectious Disease Epidemiologist, Kaiser Permanente
Center for Health Research
A retrospective analysis using electronic
medical records from two healthcare delivery systems in the U.S.
from January 1, 2000, to December 31, 2021, looking at treatment
eligibility and time to treatment initiation among patients with
chronic HBV infection showed:
- Among all 3,283 patients with
untreated chronic HBV infection at cohort entry, 343 (10%)
initiated treatment during the study period.
- Only 60% of those defined as
treatment-eligible initiated chronic HBV treatment, although the
median time for treatment to be initiated was within a year of
being determined eligible.
- For untreated patients with chronic
HBV infection who are not in a well-defined immunological disease
state (“grey area”) entering care, healthcare providers can expect
roughly 20% will become treatment eligible, and of these, half will
progress in about a year.
The EASL presentations can be accessed under
Events & Presentations in the Investors section of the Vir
website here.
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/or poor tolerability. Vir is
working to achieve a functional cure for the millions of people
with HBV around the world through its broad and differentiated
portfolio.
About Chronic Hepatitis
DChronic hepatitis D virus (HDV) infection occurs as a
simultaneous co-infection or super-infection with hepatitis B virus
(HBV). An estimated 12 million people globally are infected with
HDV, representing approximately 5% of those infected with HBV.
HDV-HBV 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-2218 VIR-2218 is an
investigational subcutaneously administered HBV-targeting siRNA
that Vir believes has the potential to stimulate an effective
immune response and have direct antiviral activity against
hepatitis B virus (HBV) and hepatitis D virus (HDV). 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-3434VIR-3434 is an
investigational subcutaneously administered antibody designed to
block entry of hepatitis B and hepatitis D viruses (HBV and HDV)
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 HBV and HDV, 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 D
viruses, influenza A and human immunodeficiency virus. Vir
routinely posts information that may be important to investors on
its website.
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,” “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-2218 and VIR-3434;
preliminary data of VIR-2218 in combination with VIR-3434; the
potential benefits, safety and efficacy of VIR-2218, VIR-3434,
VIR-2218 in combination with VIR-3434 and VIR-2218 and VIR-3434 in
combination with PEG-IFNα; the initial results of the MARCH
clinical trial evaluating the combination of VIR-2218 and VIR-3434;
Vir’s expectations related to the potential success of its current
and future clinical development programs for HBV and HDV; Vir’s
plans and expectations for its HBV portfolio; and risks and
uncertainties associated with drug development and
commercialization. Many important factors may cause differences
between current expectations and actual results, including the
MARCH trial 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.
Contact:
Carly Scaduto
Senior Director, Media Relations
cscaduto@vir.bio
+1-314-368-5189
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