Drug intelligence / Profile preview

izalontamab brengitecan + almonertinib

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

Overview

izalontamab brengitecan + almonertinib is a combination therapy being investigated for the treatment of non-small cell lung cancer (NSCLC), specifically as a neoadjuvant treatment for patients with resectable stage II-IIIB EGFR-mutation positive disease. The regimen consists of izalontamab brengitecan (BL-B01D1), a first-in-class bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3, and almonertinib (aumolertinib), a third-generation EGFR tyrosine kinase inhibitor (TKI). Izalontamab brengitecan utilizes a bispecific antibody linked to a camptothecin-derivative payload (Ed-04), which acts as a topoisomerase I inhibitor, with a drug-to-antibody ratio of 8. Almonertinib provides targeted inhibition of EGFR-sensitizing and resistance mutations. This combination is currently being evaluated in a Phase II clinical trial sponsored by Sichuan University (West China Hospital) to assess its safety and efficacy in the neoadjuvant and adjuvant settings.

Other names
izalontamab brengitecan + aumolertinibBL-B01D1 + aumolertinib
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)ERBB3 (Erb-b2 receptor tyrosine kinase 3)TOP1 (DNA Topoisomerase I)

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