Drug intelligence / Profile preview

Dinutuximab beta

Development stage
Phase 3
Lead developer
Apeiron Biologics
Modality
Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Dinutuximab beta is a chimeric monoclonal antibody (IgG1) used for the treatment of high-risk neuroblastoma in pediatric patients aged 12 months and above. It is produced in Chinese hamster ovary (CHO) cells through recombinant DNA technology. It specifically targets the disialoganglioside GD2, which is overexpressed on neuroblastoma cells but has restricted expression on normal tissues. By binding to GD2, dinutuximab beta activates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), leading to apoptosis and inhibition of tumor cell proliferation. In the presence of human effector cells, it mediates the lysis of human neuroblastoma and melanoma cell lines. It is indicated after induction chemotherapy, myeloablative therapy, and autologous stem cell transplantation in patients who have achieved at least a partial response. The antibody is administered over five consecutive cycles, either as an 8-hour infusion daily for 5 days or as a continuous infusion for 10 days per cycle. Clinical data from the SIOPEN HRNBL1 trial showed significant improvements in 5-year overall survival (increased from 50% to 65%) and event-free survival. Side effects include neurotoxicity, likely due to reactivity with GD2 on peripheral nerve fibers, often requiring pain management.

Brand names
QarzibaDinutuximab beta Apeiron
Other names
monoclonal antibody ch14.18/CHOanti-GD2 antibody ch14.18/CHOdinutuximab-beta
02

Targets

GD2

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