- Uliledlimab is a
differentiated monoclonal antibody designed to target CD73 and
promote stronger activation of patients' immune system against cancer
cells.
- In newly diagnosed
patients who were not eligible for
or declined chemotherapy treatment, 63% of the patients with
CD73High and PD-L1 TPS≥1% responded to the
combination therapy while the response rate was 31% in all
patients regardless of CD73 or PD-L1 expression.
- A strong correlation is observed between high CD73
expression in tumors and better clinical response,
particularly in patients with PD-L1 TPS≥1%, demonstrating the
potential role of CD73 as a predictive biomarker.
- A biomarker-guided pivotal trial is being
planned.
- Results from uliledlimab Phase 1b/2 clinical trial will be reported in a poster
presentation on June 3 at ASCO
2023.
GAITHERSBURG, Md. and SHANGHAI, May 25, 2023
/PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a
clinical-stage biopharmaceutical company committed to the
discovery, development, and commercialization of novel biologics,
today announced encouraging results from the Phase 1b/2 study (ClinialTrial.gov Identifier:
NCT04322006) evaluating uliledlimab, the Company's proprietary and
highly differentiated CD73 antibody, in combination with
toripalimab (TUOYI®), a PD-1 antibody, in patients with
treatment-naïve advanced non-small cell lung cancer (NSCLC), and
exploring the potential value of CD73 expression as a predictive
biomarker. The results will be
reported in a poster presentation on June
3 at the 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting.
The study is a dose expansion portion of a Phase 1b/2 trial evaluating the safety and efficacy of
the combination therapy and investigating the potential correlation
between tumor CD73 expression and clinical response for patients
with treatment-naïve advanced NSCLC.
As of April 14, 2023, a total of
70 patients were enrolled in the study. Uliledlimab demonstrated a
favorable safety profile up to 30mg/kg Q3W in combination with
toripalimab with most treatment-related adverse events (TRAEs)
being Grade 1 or Grade 2 in severity. In the efficacy evaluable
population (n=67), the objective response rate (ORR) was 31.3%
regardless of PD-L1 and CD73 expression. CD73High
was established as >40% of tumor or immune cells with ≥1+
staining intensity identified by
immunohistochemistry (IHC). The cutoff was determined through
receiver operating characteristic (ROC) analysis.
Notably, patients with CD73High exhibited a
higher ORR compared with those with CD73Low (53%
vs. 18%). The ORR further increased
to 63% in patients with both CD73High and PD-L1
tumor proportion score (TPS)≥1%, whereas patients with
CD73Low had an ORR of 20%. At the time of data
cutoff, with a median follow-up of 10.4 months, 18 out of 21
responders remained on treatment, and the median duration of
response (DOR) was not reached. Progression-free survival (PFS) and
overall survival (OS) data will be analyzed when the data are fully
mature.
"These results hold promise for the treatment of NSCLC patients,
as demonstrated by the favorable safety and efficacy outcomes,"
said Professor Yi-Long Wu, Principal
Investigator of the study and Professor of Guangdong Provincial
People's Hospital, Guangdong Academy of Medical Sciences and
Guangdong Lung Cancer Institute. "We are particularly excited about
the potential of CD73 expression as a predictive biomarker, which
is consistent with findings in our previous studies. The results
may transform how we personalize NSCLC treatment through
stratification by a predictive biomarker."
"The new results are compelling for uliledlimab as a new
treatment for NSCLC and its potential to make a meaningful impact
on patients' lives. We're particularly excited by the strong
correlation between high CD73 expression and clinical
response. With this finding, we are in a unique position to
apply CD73 as a predictive biomarker to raise the probability of
treatment success for NSCLC," said Dr. Andrew Zhu, President and Acting CEO of I-Mab.
"Building on encouraging results from this study, we intend to
commence a biomarker-guided pivotal trial with the aim of providing
these promising new treatment options to patients as quickly as we
can."
These data will be reported in a poster presentation, entitled
Uliledlimab and Toripalimab Combination Therapy in Treatment
Naïve Advanced NSCLC: Phase 1b/2
Clinical Trial Results Using CD73 as a Potential Predictive
Biomarker (Abstract #2570), at ASCO on June 3, 2023, from 8:00 a.m. – 11:00 a.m.
C.T. by Dr. Qing Zhou, Professor of Guangdong Provincial
People's Hospital.
About Uliledlimab
Uliledlimab (also known as TJD5) is a differentiated, humanized
antibody against CD73, an ecto-enzyme expressed on stromal cells
and tumors that converts extracellular adenosine monophosphate
(AMP) to adenosine. Adenosine, in turn, binds to adenosine
receptors on relevant immune cells and inhibits anti-tumor immune
responses in the tumor microenvironment. Uliledlimab is expected to
offer clinical benefits by suppressing tumor growth in concert with
checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is
effective in anti-tumor activities through a unique intra-dimer
binding, leading to differentiated and favorable functional
properties, as evident in preclinical studies.
About I-Mab
I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company
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-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 uliledlimab, the potential
implications of clinical data for patients, and I-Mab's advancement
of, and anticipated clinical development, regulatory milestones,
and commercialization of uliledlimab. 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
|
IR@i-mabbiopharma.com
|
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