Drug intelligence / Profile preview

izalontamab brengitecan + toripalimab

Development stage
Unknown
Lead developer
Biokin Pharmaceutical
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Yizekang + toripalimab is an investigational combination regimen consisting of izalontamab brengitecan (Yizekang; BL-B01D1), a first-in-class bispecific antibody-drug conjugate (ADC) targeting EGFR and HER3, and toripalimab (Loqtorzi; Tuoyi), a recombinant humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1). Izalontamab brengitecan consists of a bispecific antibody directed against EGFR and HER3, conjugated via a cathepsin-B cleavable linker to Ed-04, a proprietary topoisomerase I inhibitor payload. Toripalimab blocks the interaction of PD-1 with its ligands PD-L1 and PD-L2, thereby restoring T-cell-mediated anti-tumor immune responses. The combination of these two agents is designed to leverage the direct cytotoxic and immunogenic cell death-inducing properties of the bispecific ADC alongside the immune checkpoint inhibition of toripalimab to enhance anti-tumor efficacy. This combination is being evaluated in clinical trials for various advanced solid tumors, including a Phase III trial (PANKU-Breast04) for the first-line treatment of PD-L1-positive, locally recurrent, unresectable, or metastatic triple-negative breast cancer (TNBC).

Other names
BL-B01D1 + JS001BL-B01D1 + toripalimabBMS-986507 + JS001BMS-986507 + toripalimabiza-bren + JS001iza-bren + toripalimabizalontamab brengitecan + JS001izalontamab brengitecan + toripalimablunkangyilongtuomab + JS001lunkangyilongtuomab + toripalimabYizekang + LoqtorziYizekang + toripalimabYizekang + Tuoyi
02

Targets

EGFR (Epidermal growth factor receptor)PDCD1 (Programmed cell death protein 1 receptor)ERBB3 (Erb-b2 receptor tyrosine kinase 3)

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