I-Mab Gets China NMPA Greenlight to Trial Combination Therapy in Solid Tumors

I-Mab, a Chinese biotech company specializing in immuno-oncology, announced the acceptance of China’s NMPA (National Medical Products Administration) for its Phase 2 clinical trial of enoblituzumab (TJ271) in combination with pembrolizumab (Keytruda) in China.

The phase 2 clinical trial will evaluate the efficacy of the combination of enoblituzumab with pembrolizumab in solid tumors from patients with non-small cell lung cancer (NSCLC), urothelial carcinoma, and other selected cancer types. The “basket” clinical trial is designed to test the therapies for patients from different disease groups.

Enoblituzumab Licensed to I-Mab in 2019

Enoblituzumab is a monoclonal antibody developed by MacroGenics. In the 2019 deal worth $150 million, I-Mab got the license from MacroGenics to develop and commercialize enoblituzumab in Greater China.

The mechanism of enoblituzumab is to target B7-H3 on the surface of T-cells. B7-H3 is a member of the B7 family immune regulators which is widely expressed in different tumor types. The distinctiveness of enoblituzumab is its optimized Fc domain, allowing it to target B7-H3 more precisely.

Clinical Development of Enoblituzumab

MacroGenics has conducted several trials on enoblituzumab, including the Phase 1 clinical study treating patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), and urothelial cancer.

MacroGenics is also conducting a Phase 2 trial evaluating the combination of enoblituzumab with retifanlimab (PD-1 antibody) or tebotelimab for first-line treatment of patients with metastatic SCCHN.

“With the initiation of the Phase 2 clinical trial we hope to accelerate the clinical development of enoblituzumab in Greater China,” said Dr. Joan Shen, CEO of I-Mab. “We will be leveraging the data from clinical trials conducted by MacroGenics to advance the clinical development of enoblituzumab for approval in Greater China.”

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Kathy Huang

We are, and will remain, perpetual newbies. - Kevin Kelly