Drug intelligence / Profile preview

BL-B01D1 + pembrolizumab

Development stage
Phase 2
Lead developer
SystImmune
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

BL-B01D1 + pembrolizumab is a combination therapy being developed by Sichuan Baili Pharmaceutical Co., Ltd. for the treatment of advanced biliary tract cancer. BL-B01D1 is a first-in-class bispecific antibody-drug conjugate (ADC) that simultaneously targets the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It consists of the bispecific antibody izalontamab conjugated to ED-04, a novel topoisomerase I inhibitor payload, via a cleavable linker with a drug-to-antibody ratio (DAR) of 8. Pembrolizumab is a humanized monoclonal antibody that blocks the programmed cell death protein 1 (PD-1) receptor, an immune checkpoint. This combination aims to leverage the targeted cytotoxicity of the ADC against tumor cells expressing EGFR/HER3 and the immune-potentiating effects of checkpoint inhibition to improve outcomes in patients with biliary tract malignancies.

Other names
BL-B01D1 plus pembrolizumabBL-B-01D1 plus pembrolizumabBL-B 01D1 plus pembrolizumabizalontamab-ED-04 + pembrolizumab
02

Targets

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

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