GAITHERSBURG, Md. and SHANGHAI, July 5, 2023
/PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a
clinical-stage biopharmaceutical company committed to the
discovery, development, and commercialization of pioneering
immunotherapies, today announced the publication of a
manuscript entitled "CLDN18.2 and 4-1BB bispecific antibody
givastomig exerts antitumor activity through CLDN18.2-expressing
tumor-directed T-cell activation" in the latest issue of
The Journal for Immuno-Therapy of
Cancer (JITC).
Givastomig is engineered to bind to CLDN18.2-expressing
cancer cells and co-stimulatory receptor 4-1BB on adjacent T cells,
with the aim of activating T cells specifically within
CLDN18.2-expressing tumors and triggering a potent tumor-killing
effect. This innovative approach offers the potential for
effective and targeted immuno-therapy in gastric cancer, a disease
characterized by a poor prognosis and limited treatment
options.
Results from this study demonstrated that 4-1BB+ T
cells co-exist in close proximity to CLDN18.2+ gastric
cancer cells in patients. Moreover, givastomig bound to tumor cells
across a wide range of CLDN18.2 expression levels and induced 4-1BB
activation only in the context of CLDN18.2 binding, indicating the
targeted effect of 4-1BB activation in the presence of
CLDN18.2+ cells. In the in vivo
CLDN18.2-expressing tumor model, givastomig induces localized
immune activation in tumors, increasing the ratio of
CD8+/Treg cells, resulting in superior anti-tumor
activity and long-lasting memory response against tumor
rechallenge.
"The findings from our research demonstrate the significant
potential of givastomig in treating gastric cancer patients with
varying levels of CLDN18.2 expression," said Dr. Lin Shen, Professor of Clinical Oncology at the
Beijing Cancer Hospital of Peking University, and Director of SIP
LifeLink Oncology Research Institute. "By activating 4-1BB
signaling in a CLDN18.2 engagement-dependent manner, givastomig can
avoid the risk of liver toxicity and systemic immune response
commonly observed with other 4-1BB stimulating agents in previous
clinical trials."
"We are excited to see this manuscript published in JITC, as it
showcases the innovative design and remarkable anti-tumor activity
in preclinical models of givastomig," said Dr. Andrew Zhu, President of I-Mab. "This molecule
has demonstrated promising results in this study by effectively
activating T cells and triggering a localized immune response
within the tumor microenvironment. With ongoing clinical studies,
we aim to build upon these findings and ultimately make this
innovative therapy accessible to patients with gastric cancer."
Givastomig is currently undergoing Phase 1 clinical studies both
in the U.S. and in China.
Encouragingly, the Phase 1 study has shown favorable safety profile
and promising efficacy signals thus far. The Company intends to
report additional clinical data from the study at a major medical
conference in the second half of the year.
About Givastomig
Givastomig, also known as TJ-CD4B/ABL111, is a Claudin 18.2 and
4-1BB bispecific antibody capable of binding to tumor cells
expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer
cells, and stimulating intra-tumoral T cells by the 4-1BB arm
designed to be activated only upon tumor engagement while silent
elsewhere. Givastomig effectively maintains a strong tumor binding
property and anti-tumor activity attributable to a synergistic
effect of both Claudin 18.2 antibody and 4-1BB antibody while
avoiding or minimizing liver toxicity and systemic immunotoxicity
commonly seen with 4-1BB antibodies as a drug class. Being
developed under collaboration between I-Mab and ABL Bio, a
clinical-stage biotechnology company in South Korea, givastomig is currently being
investigated in a phase 1 clinical study in the U.S. and
China. In March 2022, the U.S. Food and Drug Administration
(FDA) granted Orphan Drug Designation for givastomig for the
treatment of gastric cancer, including cancer of gastroesophageal
junction.
About I-Mab
I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company
focused on discovery, development, and 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-Proof-of-Concept and Fast-to-Market development
strategies through internal R&D and global partnerships and
commercial partnerships. I-Mab has established its global footprint
in Shanghai, Beijing, Hangzhou, Lishui and Hong Kong in China, and Maryland and San
Diego in the United States. For more information,
please visit http://www.i-mabbiopharma.com and follow I-Mab on
LinkedIn, Twitter, and WeChat.
I-Mab Forward Looking Statements
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 clinical studies of givastomig, the potential
implications of clinical data for patients, and I-Mab's advancement
of, and anticipated clinical development, regulatory milestones,
and commercialization of givastomig. 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 US 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.
I-Mab Contacts
Richard Yeh
|
Gigi Feng
|
Chief Operating
Officer, interim Chief Financial Officer
|
Chief Communications
Officer
|
IR@i-mabbiopharma.com
|
PR@i-mabbiopharma.com
|
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