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I-Mab Garners Regulatory Permission to Study Enoblituzumab, Keytruda Combo in Solid Tumors in China

NEW YORK – I-Mab said on Monday the investigational new drug submission for its monoclonal antibody enoblituzumab was approved by the Center for Drug Evaluation within China's National Medical Products Administration (NMPA).

The approval will allow I-Mab to begin a Phase II basket trial in China for enoblituzumab in combination with pembrolizumab (Merck's Keytruda) in patients with B7-H3-expressing solid tumors, such as non-small cell lung and urothelial cancers. Patients with tumors that express B7-H3, an immune regulator, tend to respond poorly to neoadjuvant therapies, according to I-Mab.

I-Mab, based in Shanghai, licensed enoblituzumab from MacroGenics in 2019 to develop and commercialize the drug in Greater China. In an earlier study by MacroGenics, the combination of enoblituzumab and a PD-1 antibody showed activity against certain cancers, including NSCLC and head and neck cancer.

MacroGenics, based in Rockville, Maryland, is also studying enoblituzumab with its anti-PD-1 therapies retifanlimab or tebotelimab in a Phase II trial involving patients with recurrent or metastatic head and neck cancer.