- Alpine Immune Sciences grants AbbVie option
to license worldwide rights to ALPN-101, a phase 2-ready,
first-in-class dual CD28/ICOS costimulation antagonist, building on
AbbVie’s commitment to developing novel therapies in Immunology
- Alpine Immune Sciences to receive $60 million
in an upfront cash payment; eligible to receive up to $805 million
for exercise of the option and success-based development,
regulatory and commercial milestones
- Alpine Immune Sciences to conduct a phase 2
study in systemic lupus erythematosus during the option period
- Alpine will host a conference call today at
8:30 a.m. ET -
Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading
clinical-stage immunotherapy company focused on developing
innovative treatments for cancer and autoimmune/inflammatory
diseases, and AbbVie Inc. (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced an exclusive worldwide
option and license agreement for ALPN-101, a first-in-class dual
CD28/ICOS costimulation antagonist.
CD28 and ICOS are key costimulatory molecules that likely play
critical roles in multiple autoimmune and inflammatory diseases.
ALPN-101 is a potent inhibitor of both CD28 and ICOS pathways with
demonstrated efficacy in multiple preclinical disease models,
superior to blockade of either pathway alone. Favorable safety and
tolerability, pharmacokinetics and pharmacodynamics have been
observed in a first-in-human study in adult healthy volunteers.
“We are very pleased to partner ALPN-101 with AbbVie, a world
leader in the development and commercialization of innovative
immunology therapies,” said Mitchell H. Gold, M.D., Executive
Chairman and Chief Executive Officer of Alpine Immune Sciences.
“AbbVie is an ideal partner for ALPN-101, with the therapeutic area
expertise, R&D commitment, and global resources needed to
maximize ALPN-101’s potential for patients suffering from
autoimmune diseases. Today’s agreement validates our unique
Directed Evolution platform that has yielded multiple product
candidates, including ALPN-101. We look forward to working with our
colleagues at AbbVie to potentially transform clinical outcomes in
systemic lupus erythematosus, a disease with currently few
appealing treatment options.”
“AbbVie’s expertise in Immunology has led to remarkable
breakthroughs in the treatment of autoimmune diseases,” said Tom
Hudson, M.D., Senior Vice President and Chief Scientific Officer,
AbbVie. “ALPN-101’s dual mechanism of action has compelling
potential as a next-generation treatment in systemic lupus
erythematosus and other autoimmune diseases. We are excited to
partner with the team at Alpine on the development of this novel
therapeutic.”
Under the terms of the agreement, Alpine will receive an upfront
payment of $60 million, and will also be eligible to receive up to
an aggregate of $805 million for exercise of the option and
success-based development, regulatory and commercial milestones. In
addition, Alpine is eligible to receive tiered royalties on net
sales of ALPN-101. In exchange, AbbVie will receive an option to an
exclusive license for ALPN-101. During the option period, Alpine
will conduct a phase 2 study in systemic lupus erythematosus. Upon
exercise of the option, AbbVie will conduct all future clinical
development, manufacturing and commercialization activities for
ALPN-101.
Alpine Immune Sciences will host a conference call today at 8:30
a.m. ET to discuss the option and license agreement and outline the
company’s strategic focus moving forward.
Conference Call and Webcast Details
Alpine Immune Sciences will host a conference call today at 8:30
a.m. ET to discuss today’s announcement. To access the live call by
phone, dial (800) 816-3005 (domestic) or (857) 770-0069
(international) using participant passcode 3770288. To access a
live webcast of the call, please visit the Investor Relations
section of the Alpine Immune Sciences website at
www.alpineimmunesciences.com. The recorded webcast will be
available for replay for approximately 30 days following the
call.
About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. is committed to leading a new wave
of immune therapeutics, creating potentially powerful
multifunctional immunotherapies to improve patients’ lives via
unique protein engineering technologies. Alpine is backed by
world-class research and development capabilities, a highly
productive scientific platform, and a proven management team. For
more information, visit www.alpineimmunesciences.com. Follow
@AlpineImmuneSci on Twitter and LinkedIn.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people’s lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women’s health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Alpine Immune Sciences, Inc:
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
not based on historical fact and include statements regarding our
platform technology and potential therapies; the timing of and
results from clinical trials and pre-clinical development
activities, including those related to our collaboration with
AbbVie; clinical and regulatory objectives and the timing thereof;
the potential efficacy, safety profile, future development plans,
addressable market, regulatory success, and commercial potential of
our product candidates, including those related to our
collaboration with AbbVie; our ability to achieve milestones in our
collaboration with AbbVie; the progress and potential of our other
ongoing development programs; the efficacy of our clinical trial
designs; expectations regarding our other ongoing collaborations;
and our ability to successfully develop and achieve milestones in
our development programs. Forward-looking statements generally
include statements that are predictive in nature and depend upon or
refer to future events or conditions and include words such as
“may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and
other similar expressions, among others. These forward-looking
statements are based on current assumptions that involve risks,
uncertainties, and other factors that may cause actual results,
events, or developments to be materially different from those
expressed or implied by such forward-looking statements. These
risks and uncertainties, many of which are beyond our control,
include, but are not limited to: clinical trials may not
demonstrate safety and efficacy of any of our or our collaborators’
product candidates; our ongoing discovery and pre-clinical efforts
may not yield additional product candidates; our discovery-stage
and pre-clinical programs may not advance into the clinic or result
in approved products; any of our or our collaborators’ product
candidates may fail in development, may not receive required
regulatory approvals, or may be delayed to a point where they are
not commercially viable; we may not achieve additional milestones
in our proprietary or partnered programs; the impact of expanded
product development and clinical activities on operating expenses;
the impact of competition; adverse conditions in the general
domestic and global economic markets, including as a result of the
ongoing COVID-19 pandemic; as well as the other risks identified in
our filings with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date hereof and we
undertake no obligation to update forward-looking statements, and
readers are cautioned not to place undue reliance on such
forward-looking statements.
AbbVie:
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words “believe,” “expect,”
“anticipate,” “project” and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie’s acquisition of Allergan
plc (“Allergan”), failure to promptly and effectively integrate
Allergan’s businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, “Risk Factors,” of
AbbVie's 2019 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200618005246/en/
Alpine Immune Sciences, Inc.: Media: Julie Normart, W20
Group 559-974-3245 jnormart@w2ogroup.com
Investors: Laurence Watts, Gilmartin Group, LLC.: 619-916-7620
laurence@gilmartinir.com
AbbVie Media: Adelle Infante 847-938-8745
adelle.infante@abbvie.com
Investors: Liz Shea 847-935-2211 liz.shea@abbvie.com
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