Innovent Biologics announced the first patient has been successfully dosed in a phase I clinical trial of anti-CD47 monoclonal antibody (IBI188) for patients with advanced malignancies.

The study is a phase I clinical study conducted in China to evaluate the safety, tolerability, and efficacy of IBI188 in the treatment of patients with advanced malignancies. The primary objectives are to evaluate the safety, tolerability, and phase II recommended doses of IBI188 as a monotherapy and in combination with other agents in subjects with advanced malignancy.

"CD47 is a 'don't eat me' signal; the CD47-SIRPα mechanism is hijacked in many malignant tumors to escape immune mediated clearance. Based on the promising safety and efficacy data from literature, we hope to validate the therapeutic value of IBI188 monoclonal antibody in advanced malignancies," said Professor Jun Zhu, from the Beijing Cancer Hospital.

"IBI188 is a pivotal product in our pipeline of cancer immunotherapies. CD47 is an important component of a critical inhibitory immune pathway but is different from T cell check point inhibitors such as PD-1, PD-L1 and CTLA-4. CD47 targets macrophages and suppresses phagocytosis by interacting and activating the inhibitory receptor SIRPα. Anti-CD47 mono therapy and combination therapy has shown promising efficacy in several types of solid tumor and in refractory/relapsed non-Hodgkin Lymphoma. We are preparing to advance IBI188 into subsequent clinical trials in a variety of cancers once its safety, tolerability and the recommended phase II dose are confirmed. We hope our efforts will give more patients the opportunity for tumor control or even cure," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

IBI188 is a fully human monoclonal antibody targeting CD47. In vitro and in vivo experiments have shown that IBI188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the "Don't Eat Me" signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. Innovent will launch several clinical trials to assess its safety and efficacy in multiple tumor types, including non-Hodgkin's lymphoma and ovarian cancer.

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