Vir Biotechnology Announces First Participant Dosed in New Phase 1 Trial Evaluating VIR-1388, an Investigational T Cell Vaccine for the Prevention of HIV
20 Settembre 2023 - 2:00PM
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the
first participant has been dosed in a Phase 1 trial evaluating the
safety, reactogenicity and immunogenicity of VIR-1388, an
investigational novel T cell vaccine for the prevention of human
immunodeficiency virus (HIV). The Company expects initial data from
the Phase 1 trial in the second half of 2024.
VIR-1388 is based on the human cytomegalovirus
(HCMV) vector platform and is designed to stimulate the body to
produce immune cells known as T cells that recognize several HIV
proteins in a way that differs from prior investigational HIV
vaccines. VIR-1388 was developed using applied learnings from
VIR-1111, the Company’s initial investigational proof-of-concept
HIV T cell vaccine based on HCMV.
“HIV continues to be a major global public
health challenge with no approved vaccines despite decades of
research efforts,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice
President, Clinical Research, Head of Chronic Infection. “The
initiation of our first clinical trial evaluating VIR-1388 is an
important clinical milestone in our pursuit of developing an HIV
vaccine and we are grateful to all our partners for their support
of this Phase 1 trial. We are hopeful that our unique approach will
help close the longstanding public health gap in HIV
prevention.”
The trial is supported by the National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health, and the Bill & Melinda Gates Foundation.
NIAID has provided funding throughout the product development
lifecycle of VIR-1388, and the Foundation has also supported the
Company’s development of therapies for the treatment of HIV, the
prevention of tuberculosis and the prevention of malaria. The Phase
1 trial of VIR-1388 will take place in both domestic and
international sites within the federally funded HIV Vaccine Trials
Network (HVTN) as study HVTN 142.
The HCMV vector is a weakened version of the
virus that is designed to deliver the HIV vaccine material to the
immune system without causing disease in the trial participants.
HCMV has been present in much of the global population for
centuries. Most people living with HCMV experience no symptoms and
are unaware that they are living with the virus. HCMV remains
detectable in the body for life, which suggests it has the
potential to deliver and then safely help the body retain HIV
vaccine material for a long period of time, potentially overcoming
the waning immunity observed with more short-lived vaccine
vectors.
According to the Joint United Nations Programme
on HIV/AIDS (UNAIDS), approximately 1.5 million people were newly
infected with HIV and around 650,000 people worldwide died from
AIDS-related deaths in 2021.
Design of the Phase 1 TrialThe
randomized, double-blind, placebo-controlled Phase 1 trial
(NCT05854381) is evaluating the safety, reactogenicity and
immunogenicity of three different doses of VIR-1388 compared with
placebo. The trial is designed to enroll approximately 95
participants ages 18 to 55 who are not living with HIV, with
existing antibodies specific to HCMV and in overall good health as
determined by medical history, physical exam and laboratory
tests.
The overall study design includes two parts.
Part A is a lead-in phase enrolling a limited number of
HCMV-positive persons of non-childbearing potential with a frequent
safety monitoring schedule. Part B will expand enrollment to a
broader population of HCMV-positive participants, including persons
of childbearing potential. An optional long-term follow-up study
will increase study participation for up to three years post first
dose.
About VIR-1388VIR-1388 is an
investigational subcutaneously administered HIV T cell vaccine
based on HCMV that has been designed to elicit abundant T cells
that recognize HIV proteins in a way that differs from prior
investigational HIV vaccines. VIR-1388 uses applied learnings from
VIR-1111, Vir’s initial investigational proof-of-concept HIV T cell
vaccine, with the goal of creating a safe and effective HIV
vaccine.
About VIR-1111VIR-1111 is an
investigational subcutaneously administered proof-of-concept HIV T
cell vaccine based on HCMV that has been designed to elicit
abundant T cells that recognize HIV epitopes in a way that differs
from prior HIV vaccines.
About Vir BiotechnologyVir
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 B and hepatitis delta
viruses, influenza A and B, human immunodeficiency virus and
COVID-19. Vir has several preclinical candidates in its pipeline,
including RSV/MPV and HPV. 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 safety and efficacy of VIR-1388; the timing,
design and enrollment of the Phase 1 clinical trial; Vir’s plans
and expectations for its HIV portfolio, including VIR-1388; and
risks and uncertainties associated with drug development and
commercialization. Many important factors may cause differences
between current expectations and actual results, including risks
that Vir may not fully enroll the Phase 1 trial; unexpected safety
or immune response data or results observed during the trial; 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.
Contacts:
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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