HLE BiTE® technology: enhancing features of the BiTE® platform

Engaging the natural power of T cells with BiTE® Technology

Bispecific T Cell Engager (BiTE®) technology is designed to overcome cancer cells' evasion of the immune system by engaging patients own T cells to directly target cancer cells. BiTE® molecules are engineered to target a selected tumor antigen and CD3 found on T cells.1,3

BiTE® technology has been shown to activate the cytotoxic potential of T cells and lead to sustained T cell response and cancer cell apoptosis.1,4

Download a copy of BiTE The Engager™, an educational resource on BiTE® technology.

Extending the benefits of BiTE® technology

Canonical BiTE® molecules are designed to be relatively small recombinant proteins that are cleared through the kidney, with a serum half-life of a few hours. Currently, the protein engineers at Amgen are designing BiTE® molecules with enhanced features, including a half-life extended (HLE) BiTE® molecule containing a fragment-crystallizable (Fc) domain. Adding an Fc portion to the BiTE® molecule is designed to extend the amount of time before it is eliminated from the body.1-3,5-7

It is anticipated that these HLE BiTE® molecules could potentially be infused less frequently.7,8

HLE BiTE® molecules are under investigation to target12:
Clinical trials are underway in several cancers, including12:

BCMA: B cell maturation antigen; BiTE: Bispecific T Cell Engager; CD: cluster of differentiation; DLL3: delta-like canonical Notch ligand 3; EGFR: epidermal growth factor receptor; FLT3: fms-like tyrosine kinase 3; HLE: half-life extended; PSMA: prostate-specific membrane antigen.


1. Baeuerle PA, Kufer P, Curr Opin Mol Ther. 2009;11(1):22-30. 2. Frankel SR, Baeuerle PA. Curr Opin Chem Biol. 2013;17(3):385-392. 3. Yuraszeck T, Kasichayanula S, Benjamin JE. Clin Pharmacol Ther. 2017;101(5):634-645. 4. Nagorsen D, Baeuerle PA. Exp Cell Res. 2011;317(9):1255-1260. 5. Thakur A, Huang M, Lum LG. Blood Rev. 2018;32(4):339-347. 6. Raum T, Münz M, Brozy J, inventors. 7. Weidle UH, Tiefenthaler G, Weiss EH, Georges G, Brinkmann U. Cancer Genomics Proteomics. 2013;10(1):1-18. 8. Arvedson TL, Balazs M, Bogner P, et al. Cancer Res. 2017;77(suppl 13):Abstract 55. 9. Ferrone S, Whiteside TL. Surg Oncol Clin N Am. 2007;16:755-774. 10. Baeuerle PA, Reinhardt C. Cancer Res. 2009;69(12):4941-4944. 11. Brischwein K, Schlereth B, Guller B, et al. Mol Immunol. 2006;43(8):1129-1143. 12. Q2 2019 pipeline, Amgen. https://www.amgenpipeline.com/~/media/amgen/full/www-amgenpipeline-com/charts/amgen-pipeline-chart.ashx. Accessed 8/1/2019.