Drug intelligence / Profile preview

NICE

Development stage
Unknown
Lead developer
Fundació Sant Joan de Déu
Modality
Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous
01

Overview

NICE is a chemo-immunotherapy regimen developed by Fundació Sant Joan de Déu (Hospital Sant Joan de Déu, Barcelona) for the treatment of relapsed or refractory high-risk neuroblastoma. The protocol combines naxitamab (a humanized monoclonal antibody targeting the GD2 antigen), sargramostim (recombinant human GM-CSF), and the ICE chemotherapy backbone, which consists of ifosfamide, carboplatin, and etoposide. Naxitamab exerts its antitumor effect through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), while sargramostim is administered to enhance the recruitment and activation of effector cells like granulocytes and macrophages to maximize the ADCC effect. The ICE components provide synergistic cytotoxic activity by inducing DNA damage and inhibiting topoisomerase II. This regimen is specifically indicated for patients with surgically unresectable refractory soft tissue disease or those who have failed prior anti-GD2 immunotherapy.

Brand names
DanyelzaLeukine
Other names
NICE regimenNICE protocolhu3F8 + GM-CSF + ICE
02

Targets

TOP2A (DNA topoisomerase II)CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)GD2DNA

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