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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. |
| References |
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1. Ahmed M, Hu J, Cheung NK. (2014)
Structure Based Refinement of a Humanized Monoclonal Antibody That Targets Tumor Antigen Disialoganglioside GD2. Front Immunol, 5: 372. [PMID:25177320] |
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2. Burki TK. (2018)
hu3F8 for resistant or recurrent neuroblastoma. Lancet Oncol, 19 (11): e583. [PMID:30269905] |
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3. Cheung IY, Kushner BH, Modak S, Basu EM, Roberts SS, Cheung NV. (2017)
Phase I trial of anti-GD2 monoclonal antibody hu3F8 plus GM-CSF: Impact of body weight, immunogenicity and anti-GD2 response on pharmacokinetics and survival. Oncoimmunology, 6 (11): e1358331. [PMID:29147617] |
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4. Cheung N-KV, Ahmed M, Zhao Q. (2019)
High affinity anti-GD2 antibodies. Patent number: US10167341B2. Assignee: Sloan Kettering Institute for Cancer Research. Priority date: 15/03/2013. Publication date: 01/01/2019. |
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5. Cheung NK, Guo H, Hu J, Tassev DV, Cheung IY. (2012)
Humanizing murine IgG3 anti-GD2 antibody m3F8 substantially improves antibody-dependent cell-mediated cytotoxicity while retaining targeting in vivo. Oncoimmunology, 1 (4): 477-486. [PMID:22754766] |
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6. Kushner BH, Cheung IY, Modak S, Basu EM, Roberts SS, Cheung NK. (2018)
Humanized 3F8 Anti-GD2 Monoclonal Antibody Dosing With Granulocyte-Macrophage Colony-Stimulating Factor in Patients With Resistant Neuroblastoma: A Phase 1 Clinical Trial. JAMA Oncol, 4 (12): 1729-1735. [PMID:30326045] |
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7. Nazha B, Inal C, Owonikoko TK. (2020)
Disialoganglioside GD2 Expression in Solid Tumors and Role as a Target for Cancer Therapy. Front Oncol, 10: 1000. [PMID:32733795] |
