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 Company will be presenting three
posters with clinical data from its lead clinical compound, AB-729,
an RNAi therapeutic, and its preclinical oral PD-L1 inhibitor,
AB-101, at The American Association for the Study of Liver Diseases
(AASLD) – The Liver Meeting
® 2022, taking place
from November 4-8, 2022 in Washington, DC.
Poster #1:
Title: Hepatitis B viral
control maintained during extended follow up of HBeAg- chronic
hepatitis B subjects who discontinued nucleos(t)ide analogue (NA)
therapy after completion of AB-729 treatment, and in HBeAg+
subjects still on NA therapy
Poster Number: 5047
Abstract Number: 38876
Presentation Type:
Late-Breaking Poster Presentation
Presentation Time: Monday,
November 7: 1:00 – 2:00 PM ET
Authors: Man-Fung Yuen, Jacinta
Holmes, Simone I Strasser, Apinya Leerapun, Wattana
Sukeepaisarnjaroen, Pisit Tangkijvanich, Varun Sharma, Elina
Medvedeva, Emily P Thi, Gastón Picchio, Timothy Eley, Karen D
Sims
Data Summary: Data
is being reported on nine patients who have completed from 16 to 40
weeks of follow-up after discontinuing both AB-729 and NA therapy.
No patients met the protocol-defined NA restart criteria. At the
last available timepoint, all HBV DNA levels were <1000 IU/mL
and HBsAg levels for all patients remained well below pre-study
levels. In conclusion, NA-therapy discontinuation after
NA+AB-729 treatment was well-tolerated in HBeAg negative subjects
who achieved HBsAg <100 IU/mL and resulted in sustained low HBV
DNA and HBsAg levels up to 40 weeks off all therapy. These results
suggest new viral set points via immune control.
Poster #2:
Title: Combination Treatment
with HBV-Targeting GalNAc-siRNA and Small-Molecule PD-L1 Inhibitor
Increases HBV-Specific Immune Responses in a Chronic Hepatitis B
Infection Mouse Model
Poster Number: 1000 - 1999
Abstract Number: 1221
Presentation Type: Poster
Presentation Time: Friday,
November 4: 12:00 – 1:00 PM ET
Authors: Emily P Thi, Ingrid
Graves, Arpita Mondal, Andrew G Cole, Gavin Heffernan, Christina L
Iott, Seyma Ozturk, Sharie C Ganchua, Dan Nguyen, Kim Stever,
Kristi Y Fan, Jorge G Quintero, Steven G Kultgen, Amanda Pohl, Troy
O Harasym, Angela M Lam, and Michael J Sofia
Data Summary: Pre-clinical
data showing that the combination of an HBV-targeting RNAi and
AB-101 in mice infected with HBV, results in increased production
of HBV-specific T-cells compared to administering an RNAi or AB-101
alone.
Poster #3:
Title: Evaluation of the
Vebicorvir, NRTI and AB-729 Combination in virologically Suppressed
Patients with HBeAg Negative Chronic Hepatitis B Virus Infection:
Interim Analysis from an Open Label Phase 2 Study
Poster Number: 5064
Abstract Number: 38874
Presentation Type:
Late-Breaking Poster Presentation
Presentation Time:
Monday, November 7: 1:00 PM – 2:00 PM
Authors: Jacob George, Diana
Stefanova-Petrova, Krasimir Antonov, Zina Valaydon, Scott Davison,
Scott Fung, Fei Chen, Curtis Cooper, Stuart Roberts, Marie-Louise
Vachon, Carla S Coffin, Brian Conway, Gail Matthews, Mariana
Radicheva, Steven J Knox, Ran Yan, Emily P Thi, Calvin Chan,
Jieming Liu, Katie Zomorodi, Timothy Eley, Michele Anderson, Karen
Sims, Luisa M Stamm, Gaston Picchio, Grace Wang, Rozalina
Balabanska, Gerry MacQuillan, Magdy Elkhashab
Data Summary: Sixty-five
patients were randomized to receive VBR (Vebicorvir)+729+NA
(Nucleoside Analogue) (n=32), VBR+NA (n=16) or 729+NA (n=17) for 48
weeks. The preliminary data indicate that adding VBR to AB-729+NA
does not result in greater on-treatment improvements in markers of
active HBV infection as compared to AB-729+NA alone. All regimens
were safe and well-tolerated.
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 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
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.com
Lisa M. CaperelliVice President, Investor
RelationsPhone: 215-206-1822Email: lcaperelli@arbutusbio.com
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