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IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein developed by Innovent Biologics. It is designed to simultaneously block the PD-1 immune checkpoint and activate an engineered IL-2 pathway, specifically targeting and rejuvenating exhausted tumor-specific T cells. The IL-2 arm of IBI363 maintains affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, aiming to enhance anti-tumor efficacy while minimizing toxicity. The PD-1 binding arm not only blocks the PD-1/PD-L1 pathway but also selectively delivers the modified IL-2 signal to T cells co-expressing both targets, resulting in more precise activation of this subpopulation. Preclinical and early clinical studies have demonstrated robust antitumor activity in various solid tumors—including those resistant to prior immunotherapy—and a favorable safety profile[3][4][5][7].
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