Vir Biotechnology Announces Multiple Abstracts Highlighting New Hepatitis B and D Data Accepted for Presentation at EASL™ Congress 2023
07 Junho 2023 - 3:13AM
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that five
abstracts highlighting new data from the Company’s broad hepatitis
portfolio addressing both hepatitis B virus (HBV) and hepatitis D
virus (HDV) have been accepted for presentation at the annual
meeting of the European Association for the Study of the Liver,
EASL
™ Congress 2023, taking place in Vienna from
June 21-24.
“The accepted abstracts underscore the
progress Vir is making with our robust hepatitis B and D portfolio
and the potential impact the combination of VIR-3434 and VIR-2218
could have on both viruses,” said Phil Pang, M.D., Ph.D., Vir’s
Executive Vice President, Chief Medical Officer and Interim Head of
Research. “We look forward to sharing new data from our clinical
development programs that give us confidence in our approach toward
a functional cure for HBV and a treatment for the long-term
suppression of HDV.”
The late-breaker oral presentation, which was
accepted as the only HBV-focused late-breaker abstract, will
provide new data related to the safety and efficacy of VIR-2218
with or without pegylated interferon alfa (PEG-IFN-α) in
virally-suppressed participants with chronic HBV infection.
A second oral presentation will share follow-up
data from Part A of the Phase 2 MARCH trial. Originally presented
at the American Association for the Study of Liver Diseases (AASLD)
The Liver Meeting® in November 2022, Part A was designed to, and
successfully demonstrated, the on-treatment additivity of VIR-2218
and VIR-3434. Importantly, these short-duration Part A cohorts, in
which these investigational treatments were co-administered for
only four or 12 weeks, informed the protocol for Part B, which is
designed to evaluate whether VIR-3434 and VIR-2218, given with or
without PEG-IFN-α for 24 and 48 weeks, can result in a functional
cure for chronic HBV. Initial on-treatment data from the 24-week
cohorts are anticipated in the second half of 2023.
Finally, three poster presentations will focus
on the potential efficacy of VIR-2218 and VIR-3434 in preclinical
models of HDV, the pharmacokinetics of HBV monotherapy with
VIR-3434, and the eligibility and initiation of HBV treatment in a
real-world setting.
Presentation details are as follows:
Late-Breaker Oral Presentation
- Title: 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 (Oral Presentation
#LBO-02)Session: Late-Breaker
SessionDate: Saturday, June
24Time: 11:15-11:30 CEST (5:15-5:30 a.m.
EDT)Presenter: Prof. Man-Fung Yuen, M.D., Ph.D.,
D.Sc., Professor of Medicine, Queen Mary Hospital, School of
Clinical Medicine; State Key Laboratory of Liver Research, The
University of Hong Kong
Oral Presentation
- Title: 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 (Abstract #1273; Oral
Presentation #OS-031)Session: Viral hepatitis B/D
– New treatmentsDate: Thursday, June
22Time: 17:30-17:45 CEST (11:30-11:45 a.m.
EDT)Presenter: Prof. 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
Poster Presentations
- Title: VIR-2218 and VIR-3434 therapy is
efficacious in preclinical models of hepatitis delta virus
infection (Abstract #1333; Poster
#TOP-109)Session: Viral hepatitis B and D: New
therapies, unapproved therapies or strategiesDate:
Saturday, June 24Time: Available from 9:00 CEST
(from 3:00 a.m. EDT)Presenter: Florian Lempp,
Ph.D., Director, Virology, Vir Biotechnology
- Title: Single dose pharmacokinetics of
VIR-3434, a novel neutralizing monoclonal antibody, in participants
with chronic hepatitis B virus infection (Abstract #1305; Poster
#SAT-177)Session: Viral hepatitis B and D: New
therapies, unapproved therapies or strategiesDate:
Saturday, June 24Time: Available from 9:00 CEST
(from 3:00 a.m. EDT)Presenter: Sneha V. Gupta,
Ph.D., Director, Clinical Pharmacology, Vir Biotechnology
- Title: Treatment eligibility and initiation
among chronic hepatitis B patients in a real-world setting in the
United States (Abstract #2613; Poster
#WED-141)Session: Viral hepatitis B and D:
Clinical aspectsDate: Wednesday, June
21Time: Available from 9:00 CEST (from 3:00 a.m.
EDT)Presenter: Mark A. Schmidt, Ph.D., M.P.H.,
infectious disease epidemiologist, Kaiser Permanente Center for
Health Research
The EASL presentation abstracts 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 HBV and
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 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, preliminary data and 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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