Innovent Announces First Patient Dosed In Ph 1 Clinical Trial Of Bispecific Antibody

Innovent Biologics, Inc. (Innovent), a world-class biopharmaceutical Chinese company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced that the first patient has been successfully dosed in Phase 1 clinical trial (CIBI322A101) of the potentially first-in-class recombinant anti-CD47/PD-L1 bispecific antibody (IBI322) in China. CIBI322A101 is a Phase 1a/1b clinical study conducted in China to evaluate IBI322 in the treatment of patients with advanced malignancies. The primary objective of the study is to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI322 in patients with advanced malignancies who have failed standard therapy. IBI322 is a recombinant anti-CD47/PD-L1 bispecific antibody that blocks both the PD-1/PD-L1 and CD47/ SIRP-α pathways. Pre-clinical studies showed that IBI322 can effectively block CD47–SIRP-α interactions and induce macrophages to phagocytize CD47 expressed tumor cells, which is equivalent to anti-CD47 monoclonal antibody. IBI322, on the other way, effectively blocks the binding of PD-1 to PD-L1 and activates CD4+T lymphocyte, which is comparable to anti-PD-L1 monoclonal antibody. Because of PD-L1 expression on tumor cells, IBI322 can selectively bind to tumor cells more potent than anti-CD47 monoclonal antibody, thus reducing the possibility of bind to CD47 on red blood cells, which could ultimately reduce the toxicity associated with anti-CD47 antibodies. Therefore, IBI322 has better antitumor activity and a higher safety profile.

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