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I-Mab Begins Study of Uliledlimab Plus Tecentriq in Advanced Solid Tumors

NEW YORK – I-Mab said on Friday that it has dosed the first two patients in its US-based Phase II trial of uliledlimab plus atezolizumab (Genentech's Tecentriq) for advanced solid tumors.

The multi-cohort trial is designed to evaluate Shanghai-based I-Mab's CD73 antibody uliledlimab — also known as TJD5 — plus Genentech's PD-L1 checkpoint inhibitor as a treatment for multiple advanced or metastatic solid cancers. Cohorts will include ovarian cancer patients who are resistant to platinum-based chemo as well as a biomarker-selected cohort including patients with head and neck cancer, non-small cell lung cancer, gastrointestinal cancer, triple-negative breast cancer, and ovarian cancer expressing PD-L1 in at least 1 percent of tumor cells.

In addition to evaluating the drug combination's clinical activity, I-Mab will identify biomarkers of response to uliledlimab that may further inform the development of the treatment in select solid tumor indications.

Uliledlimab is designed to bind to and inhibit CD73, in turn inhibiting tumor growth and minimizing immunosuppression in the tumor microenvironment. The firm has paired its agent with atezolizumab based on the rationale that CD73 has a role in driving resistance to PD-L1/PD-1 checkpoint inhibitors and blocking it could improve patients' response to these agents.

According to I-Mab, uliledlimab may have improved clinical efficacy and a prolonged therapeutic window versus other CD73-directed antibodies. Phase I data showed that the drug combination has encouraging safety and clinical activity.

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

Beyond the US clinical trial, the firm is also evaluating uliledlimab plus the PD-1 inhibitor toripalimab (Junshi Biosciences' Tuoyi) in a Phase II trial in China for advanced, previously treated cancers.

Of note, last month, I-Mab announced a partnership with Roche to develop companion diagnostics for its investigational agents, focusing initially on developing an immunohistochemistry-based test for a solid tumor-associated antibody.