I-Mab Biopharma (IMAB) Reports China NMPA Clearance for Phase 1 Study of TJ210/MOR210 in Patients with Advanced Solid Tumors

February 10, 2021 8:18 AM EST

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I-Mab (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for TJ210/MOR210 to initiate a phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ210/MOR210 monotherapy in patients with advanced solid tumors.

TJ210/MOR210 is a monoclonal antibody developed by MorphoSys that is directed against complement factor C5a receptor 1 (C5aR1). Produced in the tumoral microenvironment, its ligand C5a acts as a chemoattractant to recruit tumor-promoting cells such as myeloid-derived suppressor cells, M2 macrophages and neutrophils. TJ210/MOR210 is designed to induce anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells.

Preclinical studies have shown that targeting the C5aR-C5a axis exerts anti-tumor activity with immune checkpoint inhibitors. Furthermore, in vitro activity was observed for blocking the C5a/C5aR pathway also at very high C5a concentrations, leading to a long duration of action. TJ210/MOR210 demonstrated a good safety profile with no observed adverse effects up to the highest dose tested in non-clinical safety studies.

The phase 1 clinical trial is an open-label dose escalation study with multiple doses to evaluate the safety, tolerability, and PK/PD and preliminary efficacy of TJ210/MOR210 in subjects with relapsed or refractory advanced solid tumors. I-Mab is also conducting a phase 1 dose escalation clinical trial in patients with r/r advanced solid tumors in the U.S. The first patient in the U.S. study was dosed in January 2021.

"We are pleased to obtain the IND clearance for TJ210/MOR210 into clinical trials in China. Now with clinical trials both in the U.S. and China, we expect to accelerate this investigational drug development. The clinical data generated will enable us to further explore TJ210/MOR210's potentials in treating patients with cancers, especially those who failed with or relapsed from the existing therapies," said Dr. Joan Shen, CEO of I-Mab.

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