Drug intelligence / Profile preview

SI-B001 + osimertinib

Development stage
Unknown
Lead developer
Biokin Pharmaceutical
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

SI-B001 + osimertinib is an investigational combination therapy being studied primarily for non-small cell lung cancer (NSCLC), particularly in patients who have progressed after prior EGFR-TKI treatment, those with non–TKI-sensitizing EGFR mutations, or EGFR exon20 insertion mutations. SI-B001 (also known as izalontamab) is a bispecific antibody that targets both EGFR (epidermal growth factor receptor) and HER3 (also known as ERBB3), disrupting both EGFR homodimer and EGFR-HER3 heterodimer formation and enhancing receptor down-regulation. Osimertinib is a third-generation, irreversible, oral EGFR tyrosine kinase inhibitor (TKI) that selectively inhibits EGFR-sensitizing mutations and the T790M resistance mutation. The combination is being evaluated in multi-center, open-label phase II/III clinical trials for safety, efficacy, and optimal dosing in NSCLC.

Other names
izalontamabSI-B001 plus osimertinibSI-B-001 plus osimertinibSI-B 001 plus osimertinibSI-B001 + Tagrisso
02

Targets

ERBB3 (Erb-b2 receptor tyrosine kinase 3)ABCG2 (Breast cancer resistance protein)ABCB1 (P-glycoprotein)EGFR T790M (Epidermal growth factor receptor T790M mutant)

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