On December 3, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the first two patients have been dosed in the U.S. phase 2 dose expansion clinical study of its proprietary CD73 antibody uliledlimab (also known as TJD5) in combination with atezolizumab (Tecentriq) in patients with ovarian cancer and other selected advanced or metastatic solid tumors (Press release, I-Mab Biopharma, DEC 3, 2021, View Source [SID1234596467]).

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Uliledlimab is a novel, humanized CD73 antibody that binds to a unique epitope and completely inhibits CD73, reversing the adenosine-mediated immunosuppression in the tumor microenvironment and inhibiting tumor growth. CD73 has been implicated in immune escape by cancer cells and may contribute to tumor resistance to checkpoint immunotherapies, such as PD-(L)1 inhibitors. Uliledlimab has the unique property of not exhibiting the "hook effect," which potentially increases the therapeutic window and improves clinical efficacy compared to other CD73 antibodies. The phase 1 clinical data has demonstrated favorable safety and promising clinical activity for the combination of uliledlimab and atezolizumab in patients with advanced cancers.

This U.S. phase 2 dose expansion study is a multi-center, open-label trial that will explore the clinical activities of uliledlimab in combination with atezolizumab and potential biomarkers in patients with selected advanced or metastatic solid tumors. This clinical study will include a dose expansion cohort of patients with ovarian cancer resistant to platinum therapy, and a biomarker-driven "basket" cohort of patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), gastrointestinal cancer, triple-negative breast cancer (TNBC), or ovarian cancer with PD-L1 expression ³ 1%. Uliledlimab is undergoing clinical development in China and the U.S. in parallel with different focus of targeted patient populations. The clinical data from both geographies will be leveraged to accelerate global develoment towards pivotal clinical study in patients with selected solid tumor types.

"Uliledlimab has unique pharmacological properties which position it as the next-generation immuno-oncology agent," said Dr. Joan Shen, CEO of I-Mab. "We hope the data from this study will accelerate the clinical development towards registration and to address the needs of patients with immune checkpoint resistance."

Based on the results of the phase 1 study, the Company was able to determine the Recommended Phase 2 Dose (RP2D) which it is using for this phase 2 study. Upon completion of the phase 1 study earlier this year, I-Mab decided to conduct subsequent studies in the U.S under its own management.

I-Mab is also conducting a China phase 2 cohort expansion study of uliledlimab in combination with toripalimab (TUOYI), a PD-1 inhibitor, in patients with advanced or metastatic cancers who are refractory to or intolerant of all available therapies.

About Uliledlimab (TJD5)

Uliledlimab (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 tumor microenvironment. Uliledlimab is expected to offer clinical benefit 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.