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CS01 is a novel, next-generation agonistic monoclonal antibody targeting OX40 (CD134), a co-stimulatory receptor belonging to the tumor necrosis factor receptor superfamily (TNFRSF) that is expressed on activated CD4+ and CD8+ T cells. CS01 is engineered with an intermediate binding-affinity Fab region and a constant domain optimized for enhanced Fcγ receptor (FcγR) engagement. This specific design is intended to facilitate superior OX40 clustering and downstream signaling, which promotes T-cell proliferation and survival within the tumor microenvironment. By enhancing the effector function of T cells, CS01 aims to bolster anti-tumor immune responses in patients with advanced malignancies. It is currently being evaluated in investigator-initiated Phase 1/2 clinical trials for the treatment of locally advanced or metastatic solid tumors.
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