IAE0972

IAE0972 is a novel immunocytokine drug candidate developed by Sunho China Biopharmaceutical to address immune cell exhaustion in cancer immunotherapy and overcome limitations of current EGFR-based monoclonal antibodies. It is the world’s first EGFR-IL10 immunocytokine to receive IND approval from both the FDA and NMPA. The molecule consists of a monovalent anti-EGFR antibody fragment fused with a homodimer of interleukin-10 (IL-10), designed using SunHo's proprietary Armed ImmunoCytokine (AIC) platform. This structure allows targeted delivery of IL-10 to the tumor microenvironment via EGFR binding, where IL-10 acts as a potent activator of antigen-specific CD8+ T cells, restoring their function and enhancing anti-tumor immunity while preserving the tumor-inhibitory effects of EGFR blockade. The asymmetric design aims to reduce off-target toxicity on normal tissues with low EGFR expression and extend IL-10 half-life for improved efficacy. Preclinical studies have shown favorable tolerability and reduced skin toxicity compared to traditional EGFR therapies.