Drug intelligence / Profile preview

anbenitamab + HB1801

Development stage
Phase 3
Lead developer
AlphaMab Oncology
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules, Nanoparticles → Drug Delivery Systems
Administration
Intravenous
01

Overview

anbenitamab + HB1801 is an investigational combination regimen consisting of anbenitamab (KN026), a HER2-targeted bispecific antibody, and HB1801, an albumin-bound nanoparticle formulation of docetaxel. Anbenitamab binds to two non-overlapping epitopes of the HER2 receptor (ECD2 and ECD4), promoting receptor clustering, endocytosis, and lysosomal degradation, while also enhancing antibody-dependent cell-mediated cytotoxicity (ADCC). HB1801 is a solvent-free, albumin-bound nanoparticle formulation of the taxane chemotherapy docetaxel, designed to avoid hypersensitivity reactions associated with conventional docetaxel vehicles (polysorbate 80 and ethanol). The combination is being co-developed by Alphamab Oncology and CSPC Pharmaceutical Group (via its subsidiary JMT-Bio Technology) for the treatment of HER2-positive breast cancer in neoadjuvant, adjuvant, and first-line metastatic settings. In the phase 3 HEALER trial for first-line advanced breast cancer, the combination significantly improved progression-free survival compared to the standard trastuzumab, pertuzumab, and docetaxel (THP) regimen. In the phase 3 Neo-Healer trial, it demonstrated a significantly higher total pathological complete response rate in the neoadjuvant setting.

Other names
KN026 + HB1801anbenitamab + albumin-bound docetaxelanbenitamab plus HB1801anbenitamab plus albumin-bound docetaxel
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)TUBB (Tubulin (alpha and beta subunits))

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