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 clinical data from the Company’s
lead HBV focused asset, imdusiran (AB-729), an RNAi therapeutic,
and preclinical data from its oral PD-L1 inhibitor program, will be
highlighted in oral and poster presentations, including a late
breaking poster presentation at The American Association for the
Study of Liver Diseases (AASLD) – The Liver
Meeting
® 2023, taking place from November 10-14,
2023 in Boston, MA.
Late-Breaking Abstract
Acceptance:Title: Preliminary
Pharmacodynamics and Safety of Repeat Dosing of Imdusiran (AB-729)
Followed by VTP-300 or Placebo in Virally-Suppressed, Non-Cirrhotic
Subjects with Chronic Hepatitis B (CHB)Authors:
Man-Fung Yuen, Kosh Agarwal, Stuart K. Roberts, Gin-Ho Lo, Chao-Wei
Hsu, Wan-Long Chuang, Chi-Yi Chen, Pei-yuan Su, Sam Galhenage,
Sheng-Shun Yang, Deana Antoniello, Emily Thi, Susanne O’Brien,
Louise Bussey, Elina Medvedeva, Timothy Eley, Deepa Patel, Tilly
Varughese, Christine Espiritu, Sharie Ganchua, Christina Iott, Mark
Anderson, Tiffany Fortney, Gavin Cloherty, Tom Evans, Karen
Sims
Regular Abstract
Acceptances:Abstract Number:
45559Title: Baseline Nucleotide Polymorphisms
Within HBV Target Site in Chronic Hepatitis B Subjects Do Not
Impact HBsAg Reductions Mediated by RNA Interference Therapeutic
AB-729 Presentation Type: Poster
#1459-CPresentation Time: Friday, November 10:
12:00 – 1:00 PM ET – Poster Hall CAuthors:
Christine Espiritu, Holly Micolochick Steuer, Andrzej Ardzinski,
Varun Sharma, Timothy Eley, Karen D. Sims, Amy C.H. Lee, Rene
Rijnbrand, Andrea Cuconati, Nagraj Mani, Angela M. Lam, Michael J.
Sofia, and Emily P. ThiData Summary:
Single nucleotide polymorphisms (SNPs) in the imdusiran (AB-729)
HBV target site were identified in sequences obtained from a
publicly available database and were observed at baseline in some
chronic HBV subjects in AB-729-001. In vitro testing in an HBV
cell-based model confirm retention of AB-729 activity against
tested variants suggesting that these SNPs have no apparent
influence on individual or mean HBsAg declines observed in subjects
treated with AB-729.
Abstract Number:
46646Title: Oral Small-Molecule Liver-Tropic PD-L1
Inhibitor Pharmacokinetics for the Treatment of Hepatocellular
CarcinomaPresentation Type: Poster
#4209APresentation Time: Monday, November 13: 1:00
– 2:00 PM ETAuthors: Arpita Mondal, Emily P Thi,
Ingrid Graves, Gavin Heffernan, Fran Xu, Seyma Ozturk, Amanda Pohl,
Kristi Y Fan, Andrew Cole, Troy O Harasym, Angela M Lam, and
Michael J SofiaData Summary: Treatment with
oral small-molecule PD-L1 inhibitors possessing liver-tropic
pharmacokinetic profiles was associated with increased efficacy and
tumor clearance in a novel humanized orthotopic HCC mouse model.
These data suggest that development of small-molecule PD-L1
inhibitors with biodistribution to the liver may provide benefit in
the treatment of HCC.
Abstract Number:
40653Title: Preliminary off-treatment responses
following 48 weeks of vebicorvir, nucleos(t)ide reverse
transcriptase inhibitor, and AB-729 combination in virologically
suppressed patients with hepatitis B e antigen negative chronic
hepatitis B: Analysis from an open-label Phase 2
studyPresentation Type: Oral
PresentationSession: Hepatitis B: New Therapies
for HBV and HDVPresentation Time: Sunday, November
12: 8:30 AMAuthors: Gerry MacQuillan, Magdy
Elkhashab, Krasimir Antonov, Zina Valaydon, Scott Davison, Scott
Fung, Catherine Vincent, Robert Bailey, Fei Chen, Curtis Cooper,
Stuart Roberts, Marie-Louise Vachon, Carla S. Coffin, Gail
Matthews, Mariana Radicheva, Steven J. Knox, Ran Yan, Emily P. Thi,
Calvin Chan, Jieming Liu, Katie Zomorodi, Timothy Eley, Luisa M.
Stamm, Karen Sims, Michele Anderson, Gaston Picchio, Grace Wang,
Rozalina Balabanska, Radoslava Tsrancheva, Jacob GeorgeData
Summary: Treatments were well tolerated. Available
data indicate that adding VBR to AB-729+NrtI does not result in
significantly greater on- or post-treatment improvements in markers
of active HBV infection vs AB-729+NrtI.
The poster presentations will available on
Arbutus’ website on November 10, 2023 and can be accessed through
the Publications section
at https://www.arbutusbio.com/publications/.
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
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 belief that AB-101 will allow for controlled checkpoint
blockade while minimizing the systemic safety issues typically seen
with checkpoint antibody therapies; our belief that development of
small-molecule PD-L1 inhibitors with biodistribution to the liver
may provide benefit in the treatment of HCC; our belief that
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; our belief that the key
to success in developing a functional cure for cHBV involves
suppressing HBV DNA, reducing surface antigen, and boosting
HBV-specific immune responses; 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 MediaLisa M. CaperelliVice
President, Investor RelationsPhone: 215-206-1822Email:
lcaperelli@arbutusbio.com
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