naxitamab   Click here for help

GtoPdb Ligand ID: 11341

Synonyms: DANYELZA® | hu3F8 | naxitamab-gqgk
Approved drug
naxitamab is an approved drug (FDA (2020))
Compound class: Antibody
Comment: Naxitamab (hu3F8) is a humanized monoclonal antibody that targets ganglioside GD2 that was developed by Y-mAbs Therapeutics for potential to treat high risk neuroblastoma [1-2]. GD2 is a sialised glycosphingolipid cell adhesion molecule, that is highly expressed on neuroectoderm-derived tumours and sarcomas, including neuroblastoma, retinoblastoma, melanoma and small cell lung cancer [7]. Naxitamab stimulates antibody-dependent cell-mediated cytotoxicity (ADCC) against GD2-expressing tumour cells [5].
Protein BLAST analysis of the peptide sequences of the heavy and light chains from the INN submission for naxitamab, show 100% matches with sequences in patent US10167341B2, which claims 'High affinity anti-GD2 antibodies' [4]. From sequence comparisons, naxitamab would appear to be referred to as hu3F8V1 in this patent.
No information available.
Summary of Clinical Use Click here for help
Naxitamab (hu3F8) was granted FDA approval in November 2020, for use in combination with GM-CSF, to treat relapsed/refractory high-risk neuroblastoma in the bone or bone marrow, in certain adult and pediatric patients, The EMA granted naxitamab orphan designation as a treatment for neuroblastoma in November 2018 (EU/3/18/2094).
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT04560166 IT With or Without Naxitamab and GM CSF in Patients With High-Risk Neuroblastoma Phase 3 Interventional Y-mAbs Therapeutics
NCT04501757 Naxitamab and GM-CSF in People With Neuroblastoma Expanded Access Memorial Sloan Kettering Cancer Center
NCT03363373 Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow Phase 2 Interventional Y-mAbs Therapeutics
NCT02502786 Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma Phase 2 Interventional Memorial Sloan Kettering Cancer Center
NCT01757626 Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma Phase 1/Phase 2 Interventional Memorial Sloan Kettering Cancer Center 3,6