On May 25, 2023 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported 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 (Press release, I-Mab Biopharma, MAY 25, 2023, View Source [SID1234632105]). The results will be reported in a poster presentation on June 3 at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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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 (Free ASCO Whitepaper) 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.