Arbutus Presents Corporate Update on Key Milestones
July 10 2018 - 7:00AM
First Subject Dosed in Phase 1 Study of AB-506,
Arbutus’ Second-Generation Capsid InhibitorAll-Oral Combination
Study of AB-506 and AB-452 Expected in 2019HBsAg Reduction Data
from ARB-1467 Expected in Q4Arbutus Spinout Genevant Enters
Transformative Partnership with Leading mRNA Therapeutics Company
BioNTech
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading
Hepatitis B Virus (HBV) therapeutic solutions company, today
announced updates on several key milestones in advance of the
company’s presentation at Roivant Pipeline Day in New York City
this afternoon. Those updates are as follows:
AB-506 (Capsid Inhibitor) and AB-452 (RNA Destabilizer)
Studies on Track to Support All-Oral Combination Study in
2019The first subject has been dosed in a clinical trial
of AB-506, Arbutus’ second-generation capsid inhibitor. The healthy
volunteer portion of an innovative Phase 1 study design will be
followed by dosing cohorts of HBV patients. The initiation of
dosing in HBV patients is expected later this year. Topline results
are expected by Q2 2019.
The regulatory filing for AB-452, Arbutus’ novel and proprietary
RNA destabilizer, is on track for submission in Q3, with subject
dosing to follow in Q4. Study completion is expected by Q3 2019.
AB-452 was discovered under the leadership of Arbutus’ Chief
Scientific Officer Dr. Michael J. Sofia, the Lasker Award-winning
inventor of sofosbuvir (SOVALDI®). Pending completion of the
monotherapy studies for AB-506 and AB-452, Arbutus expects to begin
an all-oral combination study in 2H 2019.
“The initiation of our first-in-human study with our
next-generation capsid inhibitor is a crucial milestone for Arbutus
because of the important role that a potent capsid inhibitor could
play in an all-oral therapeutic regimen,” said Dr. Sofia. “We are
especially excited about advancing our first-in-class RNA
destabilizer into a clinical study, setting up for an important
all-oral combination study in 2019. We have worked carefully over
the past two years to ensure that we are advancing our best and
most potent candidates into the clinic.”
ARB-1467 Interim Results Expected in Q4Arbutus
also announced that interim 6-week results from Arbutus’ ongoing
clinical study of ARB-1467 in combination with tenofovir and
PEG-IFN are expected in Q4. ARB-1467 is Arbutus’ first-generation
HBV-RNAi agent. The result of this study will inform small molecule
clinical combination studies planned for 2H 2019.
Patisiran Data and PDUFA Date Set for August 11,
2018Pivotal study results from Alnylam’s APOLLO Phase 3
trial of patisiran have been published in The New England Journal
of Medicine (NEJM). Patisiran is currently under Priority Review as
a Breakthrough Therapy with the U.S. Food and Drug Administration
(FDA). The FDA has set a PDUFA date of August 11, 2018. Successful
approval will trigger a royalty entitlement to Arbutus for the
proprietary LNP technology licensed by Arbutus to Alnylam for
patisiran.
Genevant Enters Transformative Partnership with
BioNTechGenevant, a recently-launched new company jointly
owned by Arbutus and Roivant Sciences, announced today that it
has entered into a strategic partnership with BioNTech AG, an
industry leader in mRNA therapy development. BioNTech and Genevant
will develop five mRNA products for rare diseases with high unmet
medical need under a 50/50 co-development and co-commercialization
collaboration. Genevant and BioNTech have also agreed a series of
exclusive licenses covering the application of Genevant’s
proprietary delivery technology to five oncology targets, for which
Genevant is eligible to receive significant commercial milestones.
This partnership advances Genevant’s goal of having 5-10 programs
in the clinic by 2020 across RNAi, mRNA, and gene editing
modalities and positions Genevant as a leader in the development of
RNA-based therapeutics.
“This is an exciting time for Arbutus with many pivotal
catalysts in the months ahead as we continue our mission of
delivering a curative treatment regimen for HBV,” said Dr. Mark J.
Murray, Arbutus’ President and Chief Executive Officer. “I am
especially excited about our opportunity to enter all-oral studies
in 2019, laying the groundwork for a potentially similar paradigm
shift in treatment as we saw in HCV over the past decade. I am also
proud of the work we have done to enable the development of
additional therapies at Alnylam and at Genevant while retaining
significant economic upside for Arbutus.”
About ArbutusArbutus Biopharma
Corporation is a publicly-traded (Nasdaq: ABUS) biopharmaceutical
company dedicated to discovering, developing, and commercializing a
cure for patients suffering from chronic Hepatitis B (HBV)
infection. Arbutus is developing multiple drug candidates, each of
which have the potential to improve upon the standard of care and
contribute to a curative combination regimen. For more information,
visit www.arbutusbio.com.
Forward-Looking Statements and
InformationThis 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 initiation of a second portion of dosing of AB-506 by
year-end, with completion of the study by Q2 2019; the regulatory
filing for AB-452 in Q3, with patient dosing to follow in Q4, and
study completion expected by Q3 2019; begin an oral combination
study of AB-506 and AB-452 in 2H 2019; the importance of a capsid
inhibitor in an oral curative HBV therapeutic regimen; interim
6-week results from Arbutus’ ongoing clinical study of ARB-1467 in
combination with tenofovir and PEG-IFN in Q4; small molecule
clinical combination studies in 2H 2019; completion of the FDA’s
review of patisiran by August 11, 2018, with potential royalties
for Arbutus if approved; BioNTech and Genevant developing five mRNA
products for rare diseases with high unmet medical need under a
50/50 co-development and co-commercialization collaboration;
Genevant’s goal of having 5-10 programs in the clinic by 2020
across RNAi, mRNA, and gene editing modalities; and discovering,
developing and commercializing a cure for patients suffering from
chronic HBV infection.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the timely receipt of
expected payments; the effectiveness and timeliness of preclinical
and clinical trials, and the usefulness of the data; the continued
demand for Arbutus’ assets; the timing of regulatory approvals; the
continued availability of key management personnel; 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.
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 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 drug candidate;
Arbutus and Genevant may not receive the necessary regulatory
approvals for the clinical development of their products on a
timely basis, if at all; expected payments, financings, and
royalties may not be as large or as timely as expected, if at all;
key management personnel may become unavailable; economic and
market conditions may worsen; and market shifts may require a
change in strategic focus.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus' Annual Report on
Form 10-K and Arbutus' continuous 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 MediaMark MurrayPresident and
CEOPhone: 604-419-3200 Email: ir@arbutusbio.com
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