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**ONO-4915** is a bispecific antibody developed by Ono Pharmaceutical in partnership with Merus that simultaneously targets **PD-1** on T cells and **CD19** on B cells. It suppresses T-cell and B-cell activation involved in autoimmunity via PD-1 signaling pathways, offering a novel immunotherapy approach for autoimmune diseases. A Phase 1 trial (jRCT2071240056) is ongoing in Japan to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy adults, with single intravenous or subcutaneous administration; study completion is estimated for FY2026.[1][2][4][7][9][10]
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