BiTE®

IMMUNO-ONCOLOGY PLATFORM

THE BiTE® UNIVERSE IS EXPANDING WITH THE GOAL OF TARGETING MULTIPLE TUMOR TYPES

 

The BiTE® immuno-oncology platform offers versatility to potentially target any tumor-associated antigen

The BiTE® platform has the potential for off-the-shelf therapies. It is being studied across a wide range of settings, including in patients with high and low tumor burden, rapidly progressing disease, or across different treatment lines.1-3

BiTE® molecules under clinical investigation include the following targets1,4,5:
Tumor-associated antigen binding domains and T-cell binding domains
BCMA
CD19
CD33
DLL3
EGFRvlll
FLT3
MUC17
PSMA
CLDN18.2

BiTE® molecules are designed to bring T-cell innovation to more patients

  • Designed to target tumor-associated antigens1
  • Designed to lead to off-the-shelf therapies without the need for ex vivo manipulation of patients' cells1,2
  • Investigated for use as monotherapies and in combination with other treatments3,6,7

The BiTE® platform is being investigated across a broad set of cancers4

The BiTE® immuno-oncology platform has been studied in thousands of patients, many of whom have been followed for up to 5 years.8,9

With the BiTE® immuno-oncology platform, Amgen is driven to push the boundaries of science for patients with cancer by:

  • Leveraging innovative trial designs10
  • Investigating clinically relevant endpoints and outcomes11-13

Amgen is pioneering BiTE® technology to advance the immuno-oncology field and bring new therapeutic approaches to patients

Features of the BiTE® platform

Canonical BiTE® molecules are designed to be relatively small recombinant proteins that could be cleared through the kidney, with a typical serum half-life of a few hours.3,14

Currently, Amgen is designing BiTE® molecules with additional features, including a half-life extended (HLE) BiTE® molecule containing a fragment-crystallizable (Fc) domain.15 Adding an Fc portion to the BiTE® molecule is designed to extend the amount of time before it is eliminated from the body.14


AML: acute myeloid leukemia; BCMA: B-cell maturation antigen; BiTE: Bispecific T-cell Engager; CD: cluster of differentiation; CLDN18.2: Claudin-18 isoform 2; DLL3: delta-like protein 3; EGFRvIII: epidermal growth factor receptor variant III; FLT3: FMS-like tyrosine kinase 3; GBM: glioblastoma; GEJ: gastroesophageal junction; MRD: minimal residual disease; MUC17: mucin 17; NHL: non-Hodgkin's lymphoma; PSMA: prostate-specific membrane antigen; SCLC: small cell lung cancer.

References

1. Baeuerle PA, Kufer P, Bargou R. 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. Amgen. Amgen pipeline. https://www.amgenpipeline.com/-/media/themes/amgen/amgenpipeline-com/amgenpipeline-com/pdf/amgen-pipeline-chart.pdf. Accessed 4/8/2020. 5. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04260191. Accessed 4/21/2020. 6. Baeuerle PA, Reinhardt C. Cancer Res. 2009;69(12):4941-4944. 7. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02879695. Accessed 4/21/2020. 8. Data on file, Amgen; 2019. 9. Gökbuget N, Dombret H, Zugmaier G, et al. Oral presentation at: European Hematology Association Congress; June, 2019; Amsterdam, Netherlands. 10. Amgen Science. https://www.amgenscience.com/features/a-strategy-for-making-clinical-trials-more-successful. Accessed 4/21/2020. 11. Gökbuget N, Dombret H, Bonifacio M, et al. Blood. 2018;131(14):1522-1531. 12. Hoelzer D. Haematologica. 2015;100(7):855-858. 13. Harousseau JL, Avet-Loiseau H. J Clin Oncol. 2017;35(25):2863-2865. 14. Weidle UH, Tiefenthaler G, Weiss EH, et al. Cancer Genomics Proteomics. 2013;10(1):1-18. 15. Raum T, Munz M, Brozy J, inventors. US Patent 2017/0218077 A1. 8/3/2017.