Anti-Human GD2 (Dinutuximab) – Fc Muted™

Humanized antibody derived from mouse clone ch14.18

This biosimilar antibody is aseptically packaged and formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.2 - 7.4 with no carrier protein, potassium, calcium or preservatives added. Due to inherent biochemical properties of antibodies, certain products may be prone to precipitation over time. Precipitation may be removed by aseptic centrifugation and/or filtration.

Liquid

Recombinant biosimilar antibodies are manufactured in an animal free facility using only in vitro protein free cell culture techniques and are purified by a multi-step process including the use of protein A or G to assure extremely low levels of endotoxins, leachable protein A or aggregates.

Functional grade preclinical antibodies may be stored sterile as received at 2-8°C for up to one month. For longer term storage, aseptically aliquot in working volumes without diluting and store at ≤ -70°C. Avoid Repeated Freeze Thaw Cycles.

Research Use Only (RUO). Non-Therapeutic.

2-8°C Wet Ice

Dinutuximab activity is directed against human disialoganglioside (GD2).

Neuroblastoma is an extracranial childhood cancer that accounts for 12% of cancer deaths in children¹. Neuroblastomas highly express the antigen GD2, a glycolipid which assists in the attachment of tumor cells to the extracellular matrix².

Dinutuximab is a mouse-human chimeric monoclonal antibody to disialoganglioside (GD2) ³. Engagement of dinutuximab with GD2 triggers antibody dependent cell cytotoxicity and complement dependent cytotoxicity, the effectiveness of which is increased by coadministration with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-12), and 13-cis retinoic acid (isotretinoin).

Dinutuximab, also known as ch14.18, was developed as an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14.18 ⁴. Dinutuximab is composed of the variable heavy- and light-chain regions of the murine anti-GD2 mAb 14.18 and the constant regions of human IgG1 heavy-chain and κ light-chain. Dinutuximab is produced in the murine myeloma cell line SP2/O and has an approximate molecular weight of 150 kDa ⁵. Studies have also tested the efficacy of dinutuximab grown in Chinese hamster ovary (CHO) cells (ch14.18/CHO)^6,7.

GD2 is a cell surface glycolipid present in low concentrations on skin, neural or peripheral nerve cell surfaces. GD2 is overexpressed on neuroblastoma cells, most melanoma, and some other tumors.

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5. https:// www.unituxin.com/full-prescribing-information.pdf
6. Ladenstein R, Weixler S, Baykan B, et al. MAbs. 5(5):801-809. 2013.
7. Ladenstein R, Pötschger U, Valteau-Couanet D, et al. Lancet Oncol. 19(12):1617-1629. 2018.
8. Barker E, Mueller BM, Handgretinger R, et al. Cancer Res. 51(1):144–149. 1991.
9. Yu AL, Gilman AL, Ozkaynak MF, et al. N Engl J Med. 363(14):1324–1334. 2010.