- AbbVie receives the option to license worldwide rights to
CUG252 from Cugene, a clinical-stage and potential best-in-class
Treg-selective IL-2 mutein, building on AbbVie's commitment to
developing novel therapies in immunology
- Cugene to complete a Phase 1a study in healthy volunteers
and to conduct a Phase 1b
study in patients with autoimmune/inflammatory
disease during the option period
NORTH CHICAGO,
Ill. and WALTHAM, Mass., May 16, 2022
/PRNewswire/ -- AbbVie (NYSE: ABBV) and Cugene Inc., a
clinical-stage biotechnology company focused on developing
next-generation precision immunology and oncology medicines to
treat autoimmune disease and cancer, today announced an exclusive
worldwide license option agreement for CUG252, a potential
best-in-class Treg-selective IL-2 mutein, as well as other novel
IL-2 muteins, for the potential treatment of autoimmune and
inflammatory diseases.
Selective IL-2 muteins have the potential to represent a major
advancement in the standard of care for patients with autoimmune
and inflammatory diseases. Cugene's lead candidate, CUG252, is an
engineered IL-2 mutein designed to selectively activate and expand
immune-suppressive Treg cells while reducing undesired IL-2
activity on other IL-2 receptor expressing cells for the treatment
of autoimmune diseases. CUG252 is currently in a Phase 1 study in
healthy volunteers.
"AbbVie is committed to developing novel therapies in immunology
where unmet needs remain for patients living with complex
autoimmune and inflammatory conditions," said Tom Hudson, MD, senior vice president, R&D,
chief scientific officer, AbbVie. "Our partnership with Cugene is
the latest in our efforts to develop and advance potential
next-generation therapies like CUG252."
"We are very pleased to partner with AbbVie, a global leader in
the development and commercialization of innovative immunology
therapies," said Luke Li, M.D.,
Chief Executive Officer of Cugene Inc. "AbbVie is an ideal partner
for CUG252, with their commitment to R&D, deep therapeutic area
expertise, and the global resources needed to maximize CUG252's
therapeutic potential for patients suffering from autoimmune
diseases. Today's agreement highlights Cugene's unique precision
engineering platform that has yielded multiple product candidates,
including CUG252. We look forward to collaborating with AbbVie to
transform clinical outcomes in autoimmune disease."
Under the terms of the agreement, Cugene will receive an upfront
payment of $48.5 million, and will
also be eligible to receive development and regulatory milestones
and a license option exercise payment if AbbVie exercises the
option. In addition, Cugene may also receive commercialization and
sales-based milestones and tiered royalties. AbbVie will receive an
option to obtain an exclusive license for certain IL-2 muteins,
including CUG252. During the option period, Cugene will conduct a
Phase 1b study in patients with
autoimmune/inflammatory disease. Upon exercise of the option,
AbbVie will conduct all future clinical development, manufacturing
and commercialization activities for CUG252.
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 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
About Cugene Inc.
Cugene is a clinical-stage biotechnology company focused on
developing next-generation precision immunology and oncology
medicines to treat autoimmune disease and cancer. Cugene is
advancing an armamentarium of precision immune therapeutics with
compelling target biology to improve patients' lives by utilizing
unique precision engineering technologies, including cytokine-based
TILKine™ and VitoKine multiproduct platforms. Cugene is backed by
world-class scientific and clinical advisors, a proven management
team, and a global healthcare focused investment fund. For more
information, visit us at www.cugene.com and follow Cugene on
LinkedIn.
Forward-Looking
Statements
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 2021 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.
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SOURCE AbbVie