Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company leveraging its extensive virology
expertise to develop novel therapeutics that target specific viral
diseases, and Vaccitech plc (Nasdaq: VACC), a clinical-stage
biopharmaceutical company engaged in the discovery and development
of novel immunotherapeutics and vaccines, today announced the first
patient dosed in a Phase 2a clinical trial. This trial will
evaluate Arbutus’ RNAi therapeutic candidate, AB-729, in
combination with Vaccitech’s T-cell stimulating immunotherapeutic,
VTP-300, and standard-of-care nucleos(t)ide reverse transcriptase
inhibitor (NA) therapy for the treatment of patients with
virologically-suppressed chronic HBV infection (cHBV).
Dr. Gaston Picchio, Chief Development Officer of
Arbutus, stated, “To-date, we believe AB-729 is the only RNAi to
show evidence of HBV-specific immune re-awakening. Through this
collaboration, we have a unique opportunity to assess if the triple
combination of AB-729, Vaccitech’s immunotherapeutic VTP-300 and NA
therapy further enhances HBV-specific immune T-cell responses
resulting in an incremental and sustainable reduction in HBsAg
beyond what we have already seen with AB-729 and NA therapy alone.
We are excited to explore these compounds in combination and we
look forward to seeing results from this promising study.”
Dr. Tom Evans, Chief Scientific Officer for
Vaccitech added, “Patients with HBV have high levels of HBsAg which
can exhaust the immune system and prevent the clearance of HBV. By
combining AB-729 with VTP-300, we are hoping to boost the immune
system to manage the virus on its own by both reducing HBsAg levels
and stimulating CD4+ and CD8+ T-cell responses in the liver.”
The randomized, multi-center, blinded, Phase 2a
clinical trial will evaluate the safety, antiviral activity and
immunogenicity of VTP-300 administered after AB-729 in
virologically-suppressed cHBV patients. The trial is designed to
enroll 40 cHBV patients. All patients will receive AB-729 (60mg
every 8 weeks) plus NA therapy for 24 weeks. At week 24, treatment
with AB-729 will stop. Patients will continue only their NA therapy
and will be randomized to receive either VTP-300 or placebo for an
additional 24 weeks. At week 48 all participants will be evaluated
for eligibility to either discontinue or remain on NA therapy.
About AB-729
AB-729 is an RNA interference (RNAi) therapeutic
specifically designed to reduce all HBV viral proteins and
antigens, including hepatitis B surface antigen, which is thought
to be a key prerequisite to enable reawakening of a patient’s
immune system to respond to the virus. AB-729 targets hepatocytes
using Arbutus’ novel covalently conjugated N-Acetylgalactosamine
(GalNAc) delivery technology that enables subcutaneous delivery.
Clinical data generated thus far has shown single- and multi-doses
of AB-729 to be generally safe and well-tolerated while providing
meaningful reductions in hepatitis B surface antigen and hepatitis
B DNA. AB-729 is currently in multiple Phase 2a clinical
trials.
About VTP-300
VTP-300 is a novel immunotherapy, dosed in a
prime-boost regimen, whereby the immune system is primed with an
adenovirus (ChAdOx1) and boosted with a pox virus (MVA). Both
vectors have been modified to improve safety, enhance the immune
response they induce and include HBV specific antigens including
core, polymerase and surface antigen. Clinical data generated to
date has demonstrated this regimen to be generally safe and
well-tolerated, that antigen specific T cell responses are
stimulated to each antigen and there were meaningful reductions in
hepatitis B surface antigen when this regimen is given alone or
when given in combination with a low dose of nivolimab at the
boost.
About HBV
Hepatitis B is a potentially life-threatening
liver infection caused by the hepatitis B virus (HBV). HBV can
cause chronic infection which leads to a higher risk of death from
cirrhosis and liver cancer. Chronic HBV infection represents a
significant unmet medical need. The World Health Organization
estimates that over 290 million people worldwide suffer from
chronic HBV infection, while other estimates indicate that
approximately 2.4 million people in the United States suffer from
chronic HBV infection. Approximately 820,000 people die every year
from complications related to chronic HBV infection despite the
availability of effective vaccines and current treatment
options.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is
a clinical-stage biopharmaceutical company leveraging its extensive
virology expertise to develop novel therapeutics that target
specific viral diseases. Our current focus areas include Hepatitis
B virus (HBV), SARS-CoV-2, and other coronaviruses. In HBV, we are
developing an RNAi therapeutic, oral capsid inhibitor, oral PD-L1
inhibitor, and oral RNA destabilizer that we intend to combine with
the aim of providing a functional cure for patients with chronic
HBV by suppressing viral replication, reducing surface antigen and
reawakening the immune system. We believe our lead compound,
AB-729, is the only RNAi therapeutic with evidence of immune
re-awakening. It is currently being evaluated in multiple phase 2
clinical trials. We also have an ongoing drug discovery and
development program directed to identifying novel, orally active
agents for treating coronavirus (including SARS-CoV-2). In
addition, we are exploring oncology applications for our internal
PD-L1 portfolio. For more information, visit
www.arbutusbio.com.
About Vaccitech
Vaccitech (“the Company”) is a clinical-stage
biopharmaceutical company engaged in the discovery and development
primarily of novel immunotherapies for the treatment of chronic
infectious diseases, cancer, autoimmunity and diseases where the T
cell arm of the immune system is believed to play an important
role. The company’s proprietary platforms include modified simian
adenoviral vectors (ChAdOx1 and ChAdOx2), other viral vectors
including the well-validated Modified Vaccinia Ankara (MVA) and
synthetic nano-particle technologies (SNAPvax™ and Syntholytic™).
The combination of different technologies in a mix and match
approach (heterologous prime-boost) consistently generates
significantly higher magnitudes of T cells compared with other
technologies and approaches. The company has a broad pipeline of
both clinical and preclinical stage therapeutic programs to treat
solid tumors, chronic viral infections, as well as a few
prophylactic viral vaccine programs. Vaccitech co-invented a
COVID-19 vaccine with the University of Oxford, now approved for
use in many territories and exclusively licensed worldwide to
AstraZeneca through Oxford University Innovation, or OUI. Vaccitech
is entitled to receive a share of all milestones and royalty income
received by OUI from AstraZeneca.
Forward-Looking Statements and
Information
This press release contains forward-looking
statements within the meaning of the Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
and forward-looking information within the meaning of Canadian
securities laws (collectively, forward-looking statements).
Forward-looking statements in this press release include statements
about our future development plans for our product candidates; the
expected cost, timing and results of our clinical development plans
and clinical trials with respect to our product candidates; our
expectations and goals for our collaboration with Vaccitech and any
potential benefits related thereto; and the potential for our
product candidates to achieve success in clinical trials.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of preclinical studies and clinical trials, and the
usefulness of the data; the timeliness of regulatory approvals; the
continued demand for Arbutus’ assets; and the stability of economic
and market conditions. While Arbutus considers these assumptions to
be reasonable, these assumptions are inherently subject to
significant business, economic, competitive, market and social
uncertainties and contingencies, including uncertainties and
contingencies related to the ongoing COVID-19 pandemic.
Additionally, there are known and unknown risk
factors which could cause Arbutus’ actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements contained herein. Known risk factors
include, among others: anticipated pre-clinical studies and
clinical trials may be more costly or take longer to complete than
anticipated, and may never be initiated or completed, or may not
generate results that warrant future development of the tested
product candidate; Arbutus or Vaccitech may elect to change its
strategy regarding its product candidates and clinical development
activities; Arbutus may not receive the necessary regulatory
approvals for the clinical development of Arbutus’ products;
economic and market conditions may worsen; Arbutus and its
collaborators may never realize the expected benefits of the
collaborations; market shifts may require a change in strategic
focus; and the ongoing COVID-19 pandemic could significantly
disrupt Arbutus’ or Vaccitech’s clinical development
programs.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus’ Annual Report on
Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’
continuous and periodic disclosure filings, which are available at
www.sedar.com and at www.sec.gov. All forward-looking statements
herein are qualified in their entirety by this cautionary
statement, and Arbutus disclaims any obligation to revise or update
any such forward-looking statements or to publicly announce the
result of any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments,
except as required by law. Arbutus Contact
Information
Investors and Media
William H. Collier President and CEOPhone:
267-469-0914 Email: ir@arbutusbio.com Lisa M.
Caperelli Vice President, Investor Relations Phone:
215-206-1822 Email: lcaperelli@arbutusbio.com
Vaccitech Contact Information
Media:
Katja Stout, Scius Communications (EU)Direct: +44 (0)
7789435990Email: katja@sciuscommunications.com
Katie Larch / Robert Flamm, Ph.D., Burns McClellan, Inc.
(U.S.)Email: klarch@burnsmc.com / rflamm@burnsmc.com
Investors:
Georgy Egorov, VaccitechEmail: IR@vaccitech.co.uk
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