Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the
“Company”), a clinical-stage biopharmaceutical company leveraging
its extensive virology expertise to develop novel therapeutics that
target specific viral diseases, today announced pipeline updates
including its continued focus on its hepatitis B virus (HBV)
assets, imdusiran (AB-729) as a cornerstone therapy in a functional
cure treatment regimen for patients with chronic hepatitis B virus
(cHBV), as well as its oral PD-L1 inhibitor, AB-101. In addition,
the Company is discontinuing development of its oral RNA
destabilizer, AB-161, due to a pre-clinical toxicology finding not
related to peripheral neuropathy. There were no safety issues
reported in the healthy subjects that received single doses of
AB-161 in the Phase 1 clinical trial. The company is also
discontinuing its efforts to identify and develop a coronavirus
combination therapy that included AB-343 its Mpro candidate, due to
an unfavorable PK profile noted in the IND-enabling studies, and a
potential nsp12 polymerase inhibitor. These pipeline changes are
expected to extend the Company’s cash runway through Q3 2025.
The Company remains on track to report
preliminary data in the fourth quarter of this year from the Phase
2a clinical trial with imdusiran and Vaccitech’s VTP-300 in
patients with cHBV. In addition, the Company has dosed the first
subject in its Phase 1a/1b clinical trial with its oral PD-L1
inhibitor, AB-101, for HBV and expects preliminary data in the
first half of 2024.
“We are confident that our current clinical
focus on HBV and our most advanced clinical stage compounds,
imdusiran and AB-101, will best position us for success in our
mission to achieve a functional cure for HBV,” commented William
Collier, Arbutus President and Chief Executive Officer. “Imdusiran
has a strong foundation of safety and efficacy data, and we are
actively advancing multiple ongoing Phase 2a combination clinical
trials. We are also making progress on advancing AB-101, our oral
PD-L1 Inhibitor for HBV, which is highly potent with demonstrated
activity against PD-L1 in cells from chronic HBV subjects. We
recently dosed the first subject in our Phase 1a/1b clinical trial
for AB-101 and continue to believe that checkpoint inhibitors may
play a role in antiviral immune tolerance in cHBV.”
The AB-101-001 Phase 1a/1b double-blind,
randomized, placebo-controlled, clinical trial is designed to
investigate the safety, tolerability, pharmacokinetics (PK), and
pharmacodynamics (PD) of single and multiple oral doses of AB-101
for up to 28 days in healthy subjects and patients with cHBV.
The trial will be conducted in three parts starting with single
ascending doses in up to 64 healthy subjects, followed by multiple
ascending doses in up to 40 healthy subjects and culminating with
multiple doses in up to 60 patients with cHBV. Safety and
PK/PD assessments will be performed prior to dose escalation in all
study parts. Initial data from part one of the clinical trial are
expected in the first half of 2024.
These pipeline updates will not impact the
Company’s pending litigations. Arbutus will continue to protect and
defend its intellectual property, which is the subject of the
on-going lawsuits against Moderna and Pfizer/BioNTech. The Company
is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s
use of its patented LNP technology that was developed with great
effort and at a great expense, without which Moderna and
Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
Document production is currently on-going in the lawsuit against
Moderna with the claim construction hearing scheduled for February
7, 2024. There are no updates to the status of the Pfizer/BioNTech
lawsuit at this time.
About imdusiran
(AB-729)
Imdusiran 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. Imdusiran targets
hepatocytes using Arbutus’ novel covalently conjugated
N-Acetylgalactosamine (GalNAc) delivery technology enabling
subcutaneous delivery. Clinical data generated thus far has shown
single and multiple doses of imdusiran to be generally safe and
well-tolerated, while also providing meaningful reductions in
hepatitis B surface antigen and hepatitis B DNA. Imdusiran is
currently in multiple Phase 2a clinical trials.
About AB-101
AB-101 is our oral PD-L1 inhibitor candidate
that we believe will allow for controlled checkpoint blockade while
minimizing the systemic safety issues typically seen with
checkpoint antibody therapies. 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. Preclinical data
generated thus far indicates that AB-101 mediates re-activation of
exhausted HBV-specific T-cells from cHBV patients. We believe
AB-101, when used in combination with other approved and
investigational agents, could potentially lead to a functional cure
in patients chronically infected with HBV. AB-101 is currently
being evaluated in a Phase 1a/1b clinical trial. We have identified
compounds in our internal PD-L1 portfolio that could also be used
in oncology indications.
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 identify and develop novel therapeutics with
distinct mechanisms of action, which can be combined to provide a
functional cure for patients with chronic hepatitis B virus (cHBV).
We believe the key to success in developing a functional cure
involves suppressing HBV DNA, reducing surface antigen, and
boosting HBV-specific immune responses. Our pipeline of internally
developed, proprietary compounds includes an RNAi therapeutic,
imdusiran (AB-729) and an oral PD-L1 inhibitor, AB-101. Imdusiran
is the only RNAi that has generated meaningful clinical data
demonstrating an impact on both surface antigen reduction and
reawakening of the HBV-specific immune response. Imdusiran is
currently in two Phase 2a combination clinical trials. AB-101 is
currently being evaluated in a Phase 1a/1b clinical trial. We are
also 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; our
program updates; our belief that checkpoint inhibitors may play a
key role in antiviral immune tolerance in cHBV; 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 clinical trial design and 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; the potential for our
product candidates to achieve success in clinical trials; and our
expected financial condition, including the anticipated duration of
cash runways and timing regarding needs for additional
capital.
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 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: the risk that the program updates may not
materially extend the cash runway and may create a distraction or
uncertainty that may adversely affect our operating results,
business, or investor perceptions; 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; it
may take considerable time and expense to resolve the clinical hold
that has been placed on AB-101 by the FDA, and no assurance can be
given that the FDA will remove the clinical hold; Arbutus and its
collaborators may never realize the expected benefits of the
collaborations; and market shifts may require a change in strategic
focus; and risks related to the sufficiency of Arbutus’ cash
resources and its ability to obtain adequate financing in the
future for its foreseeable and unforeseeable operating expenses and
capital expenditures.
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
Lisa M. Caperelli Vice President, Investor
Relations Phone: 215-206-1822 Email:
lcaperelli@arbutusbio.com
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