I-Mab (the "Company") (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 China National Medical Products Administration (NMPA) has accepted the Company's IND application to initiate a phase 2 trial for enoblituzumab (also known as TJ271) in combination with pembrolizumab (Keytruda®) in patients with selected solid tumors in China. I-Mab has in-licensed the rights to exclusively develop and commercialize enoblituzumab in Greater China from MacroGenics (Nasdaq: MGNX).
Enoblituzumab is a highly differentiated humanized monoclonal antibody directed against B7-H3, a member of the B7 family of T-cell checkpoint regulators. B7-H3 plays a key role in regulating immune response against cancers and is widely expressed in multiple cancers. Its presence on tumors is associated with poor clinical prognosis. Enoblituzumab is engineered with an optimized Fc domain that enables a dual anti-tumor mechanism by antibody-dependent cell-mediated killing of cancer cells and enhanced T-cell immune response. There are increasing preclinical data generated by I-Mab and preliminary clinical evidence from MacroGenics supporting increased efficacy for the combination of enoblituzumab and PD-1 antibody against cancers.
Enoblituzumab has become one of the Company's core clinical assets. The phase 2 clinical trial in China will evaluate the efficacy of the combination of enoblituzumab and pembrolizumab. It is designed as a "basket" clinical trial involving non-small cell lung cancer (NSCLC), urothelial carcinoma, and other selected cancer types based on treatment signals observed in previous studies conducted by MacroGenics.
MacroGenics conducted multiple clinical studies of enoblituzumab for the treatment of cancers including squamous cell carcinoma of head and neck (SCCHN) and NSCLC, demonstrating enoblituzumab is well tolerated with observed efficacy signals. For example, data from a phase 1 cohort expansion study, presented at SITC 2018, have reported that enoblizutumab in combination with PD-1 antibody achieved an objective response rate (ORR) of 33.3% in SCCHN patients and of 35.7% in NSCLC patients with PD-L1 expression <1%. Currently, MacroGenics is conducting a phase 2 study of enoblituzumab in combination with retifanlimab (PD-1 antibody) or tebotelimab (PD-1 & LAG-3 bispecific DART® molecule) for first-line treatment of patients with recurrent or 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."
About Enoblituzumab
Enoblituzumab is an investigational Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of immune regulator proteins. B7-H3 is widely expressed by many different tumor types and may play a key role in regulating the immune response to various types of cancer. Enoblituzumab has been or is currently being evaluated in clinical trials as a monotherapy or in combination with anti-PD-1-based therapies in patients with B7-H3-expressing cancers. I-Mab Biopharma acquired the development and commercial rights from MacroGenics for Greater China.
About I-Mab
I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company w...
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