- I-Mab enters clinical collaboration with Bristol Myers
Squibb to evaluate Claudin 18.2 x 4-1BB bispecific antibody
givastomig in combination with nivolumab and chemotherapy for the
treatment of gastric and esophageal cancer.
- Collaboration builds on promising safety and efficacy data
from the givastomig monotherapy study reported at the European
Society of Medical Oncology Congress 2023.
ROCKVILLE, Md., June 5, 2024
/PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a
U.S.-based, global biotech company, exclusively focused on the
development and potential commercialization of highly
differentiated immunotherapies for the treatment of cancer, today
announced that it has entered into a clinical trial collaboration
and supply agreement with Bristol Myers Squibb (NYSE: BMY). The
collaboration will evaluate the combination of givastomig, an
investigational Claudin 18.2 x 4-1BB bispecific antibody jointly
developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers
Squibb's immune checkpoint inhibitor, nivolumab, and chemotherapy
(FOLFOX or CAPOX), as a potential first-line treatment for patients
with advanced Claudin 18.2-positive gastric and esophageal
cancers.
Under the terms of the agreement, the study will be a
multi-national Phase 1 study conducted by I-Mab. Bristol
Myers Squibb will supply nivolumab.
Nivolumab is an immune checkpoint inhibitor that is designed to
block the PD-L1 protein on cancer cells from binding to PD-1,
enhancing T-cell function and resulting in improved anti-tumor
responses.
"We are pleased to enter into this clinical collaboration
agreement with Bristol Myers Squibb as we embark on the next stage
of givastomig's development to explore the significant promise of
this bispecific antibody in a triple-therapy regimen," said Raj
Kannan, CEO of I-Mab. "The study builds on the encouraging
single-agent activity and safety we have observed with givastomig
as presented at ESMO 2023. We remain optimistic that givastomig in
combination with nivolumab and chemotherapy will drive potent
anti-tumor activity in specific tumors, and we look forward to
accelerating progress in the clinic."
About Givastomig
Givastomig, also known as TJ-CD4B/ABL111 or TJ033721, is a
bispecific antibody designed to bind to Claudin 18.2 (CLDN18.2) as
a tumor engager and 4-1BB as a conditional T-Cell activator.
Givastomig uniquely binds to tumor cells expressing various levels
of CLDN18.2, including gastric cancer and pancreatic cancer cells,
and conditionally activates intra-tumoral T-cells at the tumor site
through 4-1BB. Givastomig appears to effectively maintain a strong
tumor binding property and anti-tumor activity attributable to a
synergistic effect of both CLDN18.2 antibody and 4-1BB antibody
while avoiding or minimizing liver toxicity and systemic
immunotoxicity commonly seen with 4-1BB antibodies as a drug class.
Developed through a 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 the
gastroesophageal junction.
About I-Mab
I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company,
exclusively focused on the development and potential
commercialization of highly differentiated immunotherapies for the
treatment of cancer.
I-Mab has established operations in the U.S. in Rockville, Maryland, and in San Diego, California. For more
information, please
visit https://www.i-mabbiopharma.com and follow us
on LinkedIn and X.
I-Mab Forward Looking Statements
This press release contains forward-looking statements. These
statements are made under the "safe harbor" provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These
forward-looking statements can be identified by terminology such as
"will", "expects", "believes", "designed to", "anticipates",
"future", "intends", "plan", "promise", "potential", "estimate",
"confident", "explore", "optimistic about", "look forward to" and
similar terms or the negative thereof. Statements that are not
historical facts, including statements about I-Mab's beliefs and
expectations, are forward-looking statements. The forward-looking
statements in this press release include, without limitation,
statements regarding: the anticipated terms, objectives, and
potential of the clinical collaboration with Bristol Myers Squibb,
including in the evaluation of Claudin 18.2 x 4-1BB bispecific
antibody givastomig in combination with nivolumab and chemotherapy
as a potential first-line treatment of gastric and esophageal
cancer; the potential of nivolumab to enhance T-cell function and
improve anti-tumor responses; the plan to explore the promise of
givastomig in a triple-therapy regimen through the clinical
collaboration; the potential implications of givastomig for
patients; and I-Mab's anticipated clinical development and
potential commercialization of givastomig. These forward-looking
statements involve inherent risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied in such forward-looking statements. These risks and
uncertainties include, but are not limited to, the following:
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 New Drug
Application/Biologics License Application 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 discussions of potential risks, uncertainties, and
other important factors in I-Mab's most recent annual report on
Form 20-F and I-Mab's subsequent filings with the U.S. Securities
and Exchange Commission (the "SEC"). I-Mab may also make written or
oral forward-looking statements in its periodic reports to the SEC,
in its annual report to shareholders, in press releases and other
written materials, and in oral statements made by its officers,
directors, or employees to third parties. All forward-looking
statements are based on information currently available to I-Mab.
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
Investors &
Media
|
Tyler Ehler
|
Senior Director,
Investor Relations
|
IR@imabbio.com
|
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SOURCE I-Mab Biopharma