Drug intelligence / Profile preview

IBI363

Development stage
Phase 3
Lead developer
Innovent Biologics
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

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].

Other names
PD-1/IL-2 bispecific antibodyPD-1/IL-2 fusion protein
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)IL2RA (Interleukin-2 receptor alpha subunit)

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