- Expanded Phase 1 monotherapy study of givastomig, a Claudin
18.2 X 4-1BB bispecific antibody immunostimulant, shows promising
single-agent activity in heavily pre-treated patients with gastric
cancers expressing Claudin 18.2 at low and high levels
- The recommended Phase 2 dose for givastomig was determined
to be 8-12 mg/kg; givastomig was well tolerated up to the highest
study doses
- A Phase 1b study, evaluating
givastomig in combination with standard-of-care treatment
(nivolumab + chemotherapy (FOLFOX)) in front-line gastric cancer
patients, is ongoing
ROCKVILLE, Md., Sept. 16,
2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the
"Company"), a U.S.-based, global biotech company exclusively
focused on the development of highly differentiated immunotherapies
for the treatment of cancer, today announced a poster presentation
highlighting encouraging top-line results from its ongoing Phase 1
clinical study (NCT04900818) of givastomig, a novel first-in-class/
Claudin18.2 (CLDN18.2) and 4-1BB bispecific antibody
immunostimulant, in patients with advanced cancers, especially
gastric cancers (including gastroesophageal carcinoma, or GEC) at
the European Society for Medical Oncology (ESMO) Congress 2024,
taking place in Barcelona,
Spain.
Givastomig (TJ033721 / ABL111) is a bispecific antibody
targeting Claudin 18.2-positive tumor cells that conditionally
activates T cells via the 4-1BB pathway in the tumor
microenvironment, where Claudin 18.2 is expressed. Givastomig
stands out among other Claudin 18.2-targeted therapies based on its
nonclinical findings of localized, conditional activation, even in
tumors with low levels of CLDN18.2 expression, and has exhibited a
favorable safety profile in clinical trial participants to
date.
"We believe givastomig has the potential to be a front-line
treatment option for patients with gastric cancers. Data presented
at ESMO 2024 show that givastomig demonstrated continued
monotherapy efficacy signals in heavily pre-treated patients,
especially gastric cancers with a range of Claudin 18.2 expression
levels and a strong overall safety
profile. Together, this profile supports our view
that givastomig has the potential to be a differentiated,
class-leading therapy," said Dr. Phillip
Dennis, MD, PhD, Chief Medical Officer of I-Mab. "The
first evaluation of givastomig as a front-line therapy for gastric
cancers is underway. The Phase 1b
dose expansion study will evaluate givastomig in combination with
standard-of-care, nivolumab plus chemotherapy. We continue to be
enthusiastic about the program, and we look forward to sharing the
results from this study in the second half of 2025."
Poster Title: Updated Safety and Efficacy from the Phase I
Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific
Antibody Immunostimulant, in Claudin 18.2 Positive
Advanced Gastroesophageal Carcinoma (GEC), Poster 1017
Data are based on the ongoing Phase 1 study that includes
results from the Phase 1a dose escalation segment presented at ESMO
2023 and additional data from the Phase 1b dose expansion segment. The Phase 1b segment will evaluate the safety, efficacy,
pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig.
The poster presents data on 43 patients with advanced
gastroesophageal carcinoma (GEC) who were enrolled in the dose
expansion study. Participants were required to have GEC tumors
centrally confirmed to be CLDN18.2-positive (CLDN18.2+), defined as
≥1% of tumor cells with ≥1+ intensity by immunohistochemistry
(IHC).
Key observations include:
Of the 43 patients with CLDN18.2+ GEC who received givastomig
monotherapy at doses ranging from 5 to 18 mg/kg, partial
responses were observed in seven patients (one at 5 mg/kg, one
at 8 mg/kg, four at 12 mg/kg, and one at 18 mg/kg) with an
objective response rate (ORR) of 16.3% (7/43
patients) for single agent givastomig. Five of the seven
patients who had achieved a partial response (71%) had
previously received a checkpoint inhibitor. Stable disease
(SD) was reported in 14 patients, which resulted in a disease
control rate ("DCR") of 48.8% (21/43 patients).
- No dose-limiting toxicity was reported up to 15 mg/kg Q2W and
18 mg/kg Q3W, and a maximum tolerated dose (MTD) was not
identified.
- The most common treatment-related adverse events (TRAEs) were
mainly grade 1 or 2.
- Givastomig exhibited a linear PK at doses ≥5 mg/kg and showed a
dose-dependent increase in soluble 4-1BB levels, reaching a plateau
at doses 8 mg/kg to 18 mg/kg.
- CLDN18.2 expression in responders ranged from 11% to 100%. Five
responders had received prior treatment of PD-(L)1 inhibitors.
A full copy of the poster is available on the I-Mab website
under the "Innovation – Publications & Presentations" tab.
About Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody
targeting Claudin 18.2-positive tumor cells. It conditionally
activates T cells in the tumor microenvironment where Claudin 18.2
is expressed using 4-1BB. Givastomig appears to maintain a strong
tumor binding property and anti-tumor activity, attributable to a
synergistic effect of proximal interaction with CLDN18.2 and 4-1BB,
while avoiding or minimizing liver toxicity and systemic
immunotoxicity commonly seen with other emerging 4-1BB product
candidates. 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. A Phase 1b study is ongoing evaluating combination
therapy with standard-of-care, nivolumab plus chemotherapy, in
patients with front-line gastric cancers, including
gastroesophageal cancer (NCT04900818).
The program is being jointly developed through a global
partnership with ABL Bio, in which I-Mab is the lead party and
shares worldwide rights, excluding China and South
Korea, equally with ABL Bio.
About I-Mab
I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company
exclusively focused on the development of highly differentiated
immunotherapies for the treatment of cancer. I-Mab has established
operations in Rockville,
Maryland. For more information, please
visit https://www.i-mabbiopharma.com and follow us
on LinkedIn and X.
Forward Looking Statements
This announcement 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", "plans", "potential",
"estimates", "confident", and similar terms or the negative
thereof. I-Mab may also make written or oral
forward-looking statements in its periodic reports to the U.S.
Securities and Exchange Commission (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. Statements that are not historical
facts, including statements about I-Mab's beliefs and
expectations, are forward-looking statements. Forward-looking
statements in this press release include statements regarding: the
potential benefits of givastomig; timing and progress of studies
and trials; and the availability of data and information from
ongoing studies and trials. Forward-looking statements involve
inherent risks and uncertainties that may cause actual results to
differ materially from those contained in these forward-looking
statements, including but 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 or may not support further development or New
Drug Application/Biologics License Application (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;
and 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, 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 SEC. 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