NORTH CHICAGO, Ill., and
SHANGHAI, Sept. 4, 2020 /PRNewswire/ -- AbbVie (NYSE:
ABBV) and I-Mab (Nasdaq: IMAB) announced today that AbbVie and
I-Mab have signed a broad, global collaboration agreement for the
development and commercialization of lemzoparlimab (also known as
TJC4), an innovative anti-CD47 monoclonal antibody internally
discovered and developed by I-Mab for the treatment of multiple
cancers. In addition, the two partners have the potential to expand
the collaboration to additional transformative therapies.
Lemzoparlimab is one of the leading drug candidates among
I-Mab's proprietary and innovative pipeline. It is designed to
minimize inherent binding to normal red blood cells while
preserving its strong anti-tumor activity, a critical attribute in
potentially differentiating lemzoparlimab from other antibodies of
the same class currently in development. Topline results of the
recent phase 1 clinical trial confirm possible differentiation of
lemzoparlimab in drug safety and a more favorable pharmacokinetics
profile in cancer patients. Results have shown that lemzoparlimab
is well tolerated as a single agent at a dose range of up to 30
mg/kg without any priming dose. In all DLT-evaluable patients, no
dose-limiting toxicities or severe hematologic adverse events were
observed. Full data will be presented at an appropriate scientific
conference later this year.
"Cancer is the second-leading cause of death globally and the
need for novel cancer therapies has never been more acute. The
addition of I-Mab's novel CD47 programs complements our global
clinical strategy in hematology and immuno-oncology," said
Thomas J. Hudson, M.D., senior vice
president of R&D and chief scientific officer, AbbVie. "We have
been impressed with what I-Mab has been able to accomplish in
research and clinical development and we look forward to working
together to make a meaningful difference in the lives of millions
of patients globally."
"At the forefront of drug innovation, our goal at I-Mab has
always been to bring transformational therapies to patients
globally. This strategic collaboration reinforces I-Mab's leading
position in immuno-oncology and enables us to realize the full
potential of our innovation," said Jingwu
Zang, M.D., Ph.D., Founder, Honorary Chairman and Director
of I-Mab. "We are extremely proud to partner with AbbVie. By
leveraging the combined development strength of our companies, we
aim to speed lemzoparlimab to market for patients in need around
the world."
Collaboration Details
The collaboration established
today provides AbbVie with an exclusive global license, excluding
greater China, to develop and
commercialize lemzoparlimab. Both companies will collaborate to
design and conduct further global clinical trials to evaluate
lemzoparlimab in multiple cancers. I-Mab retains all rights to
develop and to commercialize lemzoparlimab in mainland China, Macau
and Hong Kong. The collaboration
also allows for potential collaboration on future CD47-related
therapeutic agents. Each party will have the opportunity subject to
further licenses to explore each other's related programs in their
respective territories.
The companies will share manufacturing responsibilities with
AbbVie being the primary manufacturer for global supply. The
collaboration will accelerate I-Mab's establishment of commercial
production operations in China.
Financial Terms
Under the terms of the agreement,
AbbVie will pay I-Mab $180 million in
an upfront payment to exclusively license lemzoparlimab, along with
$20 million in a milestone payment
based on the Phase 1 results, for a total of $200 million. In addition, I-Mab will be eligible
to receive up to $1.74 billion in
success-based milestone payments for lemzoparlimab, of which
$840 million are based on clinical
development and regulatory approval milestones, with the remainder
based on commercial milestones. Upon commercialization of
lemzoparlimab, AbbVie will also pay tiered royalties from
low-to-mid teen percentages on global net sales outside of greater
China.
Conference Call
I-Mab will hold a conference call in
English today, September 4, 2020, at
8:00 a.m. ET / 8:00 p.m. CST. The dial in numbers are:
United States: +1-888-346-8982
International: +1-412-902-4272
Mainland China: 400-120-1203
Hong Kong:
800-905-945
Conference ID: 10147681
A live webcast and an archived replay of the conference call can
be accessed on the Company's investor relations website at
http://ir.i-mabbiopharma.com.
A telephone replay will be available approximately two hours
after the conclusion of the call by dialing +1-877-344-7529 (U.S.),
1-412-317-0088 (International). The conference ID number for the
replay is 10147681. The replay will be available through
September 9, 2020.
About CD47 and Lemzoparlimab
CD47 is a cell surface
protein over-expressed in a wide variety of cancers and can act to
protect tumors by delivering a "don't eat me" signal to otherwise
tumor-engulfing macrophages. CD47 antibody blocks this signal
and enables macrophages to attack tumor cells, making it a
potentially promising cancer drug. However, development of CD47
antibody as a cancer therapy is hampered by its hematologic side
effects, such as severe anemia, caused by natural binding of CD47
antibody to red blood cells. In a scientific breakthrough,
scientists at I-Mab have discovered a unique CD47 antibody,
lemzoparlimab, that works efficiently to target tumor cells while
exerting a minimal untoward effect on red blood cells to avoid
severe anemia.
Lemzoparlimab's hematologic safety advantage and superb
anti-tumor activities have been demonstrated previously in a series
of robust pre-clinical studies. Today, the results of phase 1
clinical trial provide further clinical validation of this
differentiation in patients with cancer. I-Mab continues to advance
a combination study of lemzoparlimab with Keytruda® for solid tumor
and with Rituxan® for lymphoma in US, in addition to an on-going
clinical trial in patients with AML in China.
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. For
more information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on Twitter, Facebook,
LinkedIn or Instagram.
About I-Mab
I-Mab (Nasdaq: IMAB) is a dynamic, global
biotech company exclusively focused on discovery, development and
soon commercialization of novel or highly differentiated biologics
in the therapeutic areas of immuno-oncology and autoimmune
diseases. The Company's mission is to bring transformational
medicines to patients around the world through innovation. I-Mab's
innovative pipeline of more than 10 clinical and pre-clinical stage
drug candidates is driven by the Company's Fast-to-PoC
(Proof-of-Concept) and Fast-to-Market development strategies
through internal R&D and global partnerships. The Company is on
track to transitioning from a clinical stage biotech company toward
a fully integrated global biopharmaceutical company with
cutting-edge R&D capabilities, world-class GMP manufacturing
facility and commercial capability. I-Mab has offices in
Beijing, Shanghai, Hong
Kong and Maryland,
United States. For more
information, please visit http://ir.i-mabbiopharma.com
Forward Looking Statements for 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.
Forward Looking Statements for I-Mab
This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and other
federal securities laws, including statements regarding data from
the lemzoparlimab (TJC4) Phase I trial, the potential implications
of clinical data for patients, and I-Mab's advancement of, and
anticipated clinical development, regulatory milestones and
commercialization of lemzoparlimab (TJC4). Actual results may
differ materially from those indicated in the forward-looking
statements as a result of various important factors, including but
not limited to I-Mab's ability to demonstrate the safety and
efficacy of its drug candidates; the clinical results for its drug
candidates, which may not support further development or NDA/BLA
approval; the content and timing of decisions made by the relevant
regulatory authorities regarding regulatory approval of I-Mab's
drug candidates; I-Mab's ability to achieve commercial success for
its drug candidates, if approved; I-Mab's ability to obtain and
maintain protection of intellectual property for its technology and
drugs; I-Mab's reliance on third parties to conduct drug
development, manufacturing and other services; I-Mab's limited
operating history and I-Mab's ability to obtain additional funding
for operations and to complete the development and
commercialization of its drug candidates; and the impact of the
COVID-19 pandemic on the Company's clinical development, commercial
and other operations, as well as those risks more fully discussed
in the "Risk Factors" section in I-Mab's most recent annual report
on Form 20-F, as well as discussions of potential risks,
uncertainties, and other important factors in I-Mab's subsequent
filings with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to I-Mab, and I-Mab undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
may be required by law.
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SOURCE AbbVie