Full Press Release Details
I-Mab Announces Encouraging
Phase 1b/2 Study Results of Patients with Advanced NSCLC
Receiving Uliledlimab
and Toripalimab Combination Therapy at ASCO 2023
GAITHERSBURG, MD. and SHANGHAI, China -
May 25, 2023 - 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-na ve 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-na ve 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
"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 Na ve 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.
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.
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
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