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Synonyms: DANYELZA® | hu3F8 | naxitamab-gqgk
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  |
| 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 | |
