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TitleB7-H3-mediated cis-inhibition of EGFR by a tumor-selective bispecific antibody enhances anti-tumor efficacy and minimizes toxicities.
Journal, issue, pagesNat Commun, Vol. 17, Issue 1, Year 2026
Publish dateFeb 24, 2026
AuthorsJian Guan / Tiongsun Chia / Bin Li / Tianyu Zhu / Zhengguang Liao / Junjie Deng / Fenggen Fu / Weiwei Wu / Chengtao Liu / Ya Liu / Ninghuan Li / Lili Yue / Lei Cao / Jia Lu / Mengjia Zhu / Xiaomin Ling / Huilin Zheng / Shuming Lin / Li Li / Shuaixiang Zhou / Kaijie He /
PubMed AbstractTherapeutic targeting of epidermal growth factor receptor (EGFR) in solid tumors faces significant limitations due to on-target/off-tumor toxicities, underscoring the urgent need for tumor-selective ...Therapeutic targeting of epidermal growth factor receptor (EGFR) in solid tumors faces significant limitations due to on-target/off-tumor toxicities, underscoring the urgent need for tumor-selective anti-EGFR therapies. Comprehensive bioinformatics and histopathological analyses identify marked upregulation of B7-H3 across EGFR-positive malignancies, contrasting with its minimal expression in healthy tissues. Leveraging an unbiased functional screen of bispecific antibodies (bsAbs) combining diverse B7-H3 and EGFR binders, we develop IBI334, a EGFR/B7-H3 bsAb exhibiting exceptional tumor selectivity. In preclinical models, IBI334 outperforms conventional EGFR antibodies by demonstrating superior EGFR occupancy, enhanced ligand-blocking efficacy, accelerated receptor degradation, and potent suppression of downstream EGFR signaling. Mechanistic studies demonstrate B7-H3-mediated cis-inhibition. The human B7-H3 extracellular domain (ECD) in complex with anti-B7-H3 Fab is resolved by cryo-EM, revealing critical residues for the antibody-B7-H3 interaction. IBI334 demonstrates robust antitumor activity in vitro and in vivo across EGFR-driven tumor models and synergized effectively with KRAS inhibitors. Toxicological evaluations in non-human primates reveals a favorable safety profile, with no EGFR-related adverse effects observed at doses up to 120 mg/kg over 4 weeks. Supported by these preclinical findings, IBI334 has advanced to a phase 1 clinical trial (NCT05774873) for advanced/metastatic solid tumors.
External linksNat Commun / PubMed:41735305 / PubMed Central
MethodsEM (single particle)
Resolution2.98 - 3.67 Å
Structure data

63503

9ly5

EMDB-63503, PDB-9ly5:
antibody 20G5 Fab in complex with human B7-H3 (IgC)
Method: EM (single particle) / Resolution: 2.98 Å

63505

9ly6

EMDB-63505, PDB-9ly6:
antibody 20G5 (Fab')2 in complex with human B7-H3
Method: EM (single particle) / Resolution: 3.67 Å

Source
  • homo sapiens (human)
KeywordsANTITUMOR PROTEIN/IMMUNE SYSTEM / B7-H3 / antibody / complex / ANTITUMOR PROTEIN-IMMUNE SYSTEM complex

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