Innovent Biologics has initiated dosing of anti-CD47 monoclonal antibody IBI188 in a Phase I clinical trial involving patients with advanced malignancies.
IBI188 is a fully human monoclonal antibody designed to target the CD47 antigen on tumour cells.
CD47 affects macrophages and suppresses phagocytosis of tumour cells through interaction and activation of the inhibitory SIRPα receptor.
In-vitro and in-vivo testing demonstrated that the product can bind to CD47, block the CD47-SIRPα signalling pathway, inhibit the ‘Don’t Eat Me’ signal, and promote the phagocytosis by macrophages.
The Phase I trial is designed to investigate the safety, tolerability, and efficacy of IBI188.
Primary objectives of the study are safety, tolerability, and Phase II recommended doses of the candidate as a monotherapy, as well as combination drug in patients with advanced malignancy.
The Phase Ia part of the trial will assess the priming and maintenance dose of IBI188 as monotherapy.
Innovent Biologics founder and CEO Michael Yu said: “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 checkpoint inhibitors such as PD-1, PD-L1 and CTLA-4.
“Anti-CD47 monotherapy and combination therapy has shown promising efficacy in several types of solid tumour and in refractory / relapsed non-Hodgkin lymphoma.”
The Chinese biopharmaceutical firm is planning to further evaluate IBI188’s safety and efficacy in multiple trials covering a variety of tumour types including non-Hodgkin’s lymphoma and ovarian cancer.
Yu added: “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 tumour control or even cure.”