Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage
biopharmaceutical company leveraging its extensive virology
expertise to develop novel therapeutics that target specific viral
diseases, today announced data from i) two separate clinical trials
evaluating its RNAi therapeutic, AB-729, in a Phase 1a/1b clinical
trial (AB-729-001) and in a combination Phase 2a clinical trial
with a capsid inhibitor, and ii) a preclinical study of its oral
PD-L1 inhibitor, AB-101. All of the data will be presented as
poster presentations at AASLD – The Liver Meeting being held in
Washington, DC, November 4-8, 2022.
“Based on the compilation of safety and efficacy
data achieved to-date, we are confident in AB-729’s potential role
as a cornerstone agent in a curative combination treatment for
chronic hepatitis B virus infection (cHBV), said William Collier,
Arbutus’ President and Chief Executive Officer. “We believe AB-729
is the only RNAi therapeutic in development for hepatitis B virus
that has clinically shown its ability to suppress HBV DNA, reduce
HBsAg and immunologically control HBV – three pillars that we
consider to be key to developing a functional cure for HBV.”
AB-729-001 Clinical Trial Data In the AB-729-001
clinical trial, patients with cHBV who completed 48 weeks of
treatment with AB-729, and 24 weeks later met protocol-defined
criteria to also stop nucleos(t)ide analogue (NA) therapy, were
evaluated during an extended follow-up period to assess HBV
biomarkers and ALT levels. Nine patients entered the follow-up
period, currently ranging from 12 to 44 weeks, after stopping all
therapies.
Select key findings:
- No evidence of clinical/biochemical
relapse has been detected in the nine patients who have
discontinued AB-729 and NA therapy.
- HBsAg remains at 1.05 to 2.35 log10
below pre-trial levels in all nine patients.
- Three patients experienced
transient HBV DNA elevations that spontaneously resolved without
intervention, which further supports AB-729's potential for
immunological control.
- One patient restarted NA therapy at
the investigator’s request after the week 20 visit; no ALT
elevation or safety signals were observed.
- Eight patients remain off NA
therapy and are continuing to be followed for an additional two
years to monitor for sustained viral response and functional
cure.
Dr. Gaston Picchio, Chief Development Officer of
Arbutus Biopharma, stated, “I remain impressed with the longer
follow up data we generated from our AB-729-001 trial. The data
continues to demonstrate that AB-729 is capable of achieving
long-lasting control of HBV biomarker levels after discontinuation
of nucleoside therapy, most likely as a result of AB-729-induced
HBV-specific immunological control. Based on the attributes of
AB-729 that we have seen thus far, I believe that AB-729 will be a
major contributor to future HBV curative regimens.”
In the same trial, a cohort of seven HBeAg
positive patients who received 90 mg of AB-729 every 8 weeks
(Cohort K) was also assessed. All patients in Cohort K had HBsAg
levels of <100 IU/mL during AB-729 treatment or follow-up, with
two patients reaching HBsAg below levels of quantitation on
multiple visits. All seven patients had detectable HBeAg and
therefore did not meet the protocol-defined NA discontinuation
criteria. One patient reached HBeAg less than lower levels of
quantitation (LLOQ) intermittently. No safety events were noted
during the follow-up period for this cohort.
AB-729 + VBR Phase 2a Clinical Trial Preliminary
Data Arbutus and Assembly Biosciences, Inc. are conducting a Phase
2a clinical trial evaluating AB-729 in combination with Assembly’s
first-generation HBV core inhibitor, vebicorvir (VBR), and NA
therapy in cHBV patients. Preliminary data from sixty-five patients
randomized to receive AB-729+VBR+NA (n=32), AB-729+NA (n=17) or
VBR+NA (n=16) for 48 weeks showed that adding VBR to AB-729+NA does
not result in greater on-treatment improvements in markers of HBV
infection as compared to AB-729+NA alone. The addition of VBR did
not negatively impact the reduction of HBsAg in the triple
combination arm. All regimens were generally safe and
well-tolerated in this trial. The patients are continuing to be
followed.
AB-101 Preclinical DataA preclinical study was
conducted to assess the ability of monotherapy and combination
treatment with AB-101, a small molecule oral PD-L1 inhibitor, and
an HBV-targeting RNAi agent, to reinvigorate HBV-specific T-cell
activity in an HBV mouse model. The results showed that monotherapy
with AB-101 reduced PD-L1 in liver immune cells, confirming liver
target engagement of the compound. Combination treatment with
AB-101 and an HBV targeting GalNAc-siRNA agent resulted in
activation and increased frequency of HBV-specific T-cells and
greater anti-HBsAg antibody production.
Dr. Michael J. Sofia, Chief Scientific Officer
of Arbutus Biopharma, stated, “The HBV immune enhancement seen with
AB-101 further supports our development strategy of using AB-101 in
combination with AB-729 and other approved and investigational
agents to potentially achieve a functional cure in cHBV patients.
We are currently conducting IND-enabling studies with AB-101 that
we anticipate completing this year.”
The above poster presentations can be accessed
through the Publications section of the Arbutus website at
https://www.arbutusbio.com/publications/.
AB-836 Clinical Update As mentioned in our press
release dated June 25, 2022, Arbutus decided to dose a new cohort
of healthy volunteers for a longer period in the AB-836-001
clinical trial to clarify the earlier safety signal seen in cHBV
patients in the same trial. In this healthy volunteer arm, two
subjects dosed with AB-836 experienced low grade ALT elevations
after more than 20 days of dosing, causing the Company to stop
dosing. Based on these additional safety findings, the Company has
decided to discontinue clinical development of AB-836.
Conference Call and Webcast:
Arbutus will hold a conference call and webcast on Friday, November
4 at 8:45 AM Eastern Time. To dial-in for the conference call by
phone, please register using the following link: Registration Link.
A live webcast of the conference call can be accessed through the
Investors section of Arbutus' website at www.arbutusbio.com.
An archived webcast will be available on the
Arbutus website after the event.
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 enabling subcutaneous delivery. Clinical data
generated thus far has shown single- and multi-doses of AB-729 to
be generally safe and well-tolerated, while also providing
meaningful reductions in hepatitis B surface antigen and hepatitis
B DNA. AB-729 is currently in multiple Phase 2a clinical
trials.
About AB-101
Immune checkpoints such as PD-1/PD-L1 play an
important role in the induction and maintenance of immune tolerance
and in T-cell activation. We have identified a class of small
molecule oral PD-L1 inhibitors that we believe will allow for
controlled checkpoint blockade, enable oral dosing, and mitigate
systemic safety issues typically seen with checkpoint antibody
therapies. Our lead oral PD-L1 inhibitor candidate, AB-101, is
currently in IND-enabling studies. We believe AB-101, when used in
combination with other approved and investigational agents, could
potentially allow us to realize our mission of achieving a
functional cure for HBV chronically infected patients. We are also
exploring oncology applications for our internal PD-L1
portfolio.
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. To address HBV,
we are developing a RNAi therapeutic, an oral capsid inhibitor, an
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.
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 with respect to the release of data from our clinical
trials and the expected timing thereof; our expectations and goals
for our collaborations with third parties 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 and patent
litigation matters.
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 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; uncertainties associated
with litigation generally and patent litigation specifically;
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’ 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.
Contact Information
Investors and Media
William H. CollierPresident and CEOPhone: 267-469-0914Email:
ir@arbutusbio.com
Lisa CaperelliVice President, Investor Relations Phone:
215-206-1822Email: lcaperelli@arbutusbio.com
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Arbutus Biopharma (NASDAQ:ABUS)
Historical Stock Chart
From Sep 2023 to Sep 2024