Arbutus Biopharma Announces Issuance of a New Key U.S. Patent Related to AB-729
August 30 2022 - 7:30AM
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 that the United States Patent and
Trademark Office (USPTO) issued U.S. Patent No. 11,427,823, which
provides composition of matter patent protection for Arbutus’
AB-729 RNAi therapeutic product. The patent is expected to provide
Arbutus with exclusivity for AB-729 out to at least April 2038.
“We are pleased to be granted this key patent by
the USPTO which expands our intellectual property estate and adds a
level of protection for a fundamental asset of our chronic
hepatitis B virus (cHBV) portfolio,” said William Collier,
President and Chief Executive Officer of Arbutus Biopharma. “AB-729
is our lead clinical-stage asset that we believe is capable of
being a cornerstone agent in the treatment regimen to provide a
functional cure for patients with cHBV.”
AB-729 is currently in multiple Phase 2a
clinical trials. 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, and evidence of immune
re-awakening. Furthermore, AB-729 has shown achievement of
virologic control in five cHBV patients after discontinuing
treatment with AB-729 and nucleos(t)ide analog (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.
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 a
RNAi therapeutic, an oral capsid inhibitor, an oral PD-L1
inhibitor, and an oral RNA destabilizer to potentially identify a
combination regimen 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 the expected protection from the new patent; 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; 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 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 patent protection; 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 CEO Phone: 267-469-0914Email:
ir@arbutusbio.comLisa M. CaperelliVice President, Investor
RelationsPhone: 215-206-1822Email: lcaperelli@arbutusbio.com
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