BiTE®

IMMUNO-ONCOLOGY PLATFORM

Amgen is committed to advancing the field of immuno-oncology

Despite recent advances in immuno-oncology, not enough patients benefit from current treatments. Therefore, additional immuno-oncology options are needed to address both hematologic malignancies and solid tumors.

Considerations for addressing the unmet need

Designed to be readily available to patients

Ensure broad patient access

Management of treatment and patient care costs

Limit the impact of burden of care

The BiTE® immuno-oncology platform offers versatility to potentially target any tumor-specific 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:
BCMA
CD19
CD33
DLL3
EGFRvlll
FLT3
PSMA

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

  • Designed to target tumor-specific antigens1
  • Designed to lead to off-the-shelf therapies without the need for ex-vivo manipulation of patient’s cells1,2
  • Investigated for use as monotherapies and in combination with other treatments3,5,6

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.7,8

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

  • Leveraging innovative trial designs9
  • Investigating clinically relevant endpoints and outcomes such as MRD negativity and long-term survival10-12

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 are cleared through the kidney, with a typical serum half-life of a few hours.3,13

Currently, Amgen is designing BiTE® molecules with additional features, including a half-life extended (HLE) BiTE® molecule containing a fragment-crystallizable (Fc) domain.14 Adding an Fc portion to the BiTE® molecule is designed to extend the amount of time before it is eliminated from the body.13


AML: acute myeloid leukemia; BCMA: B-cell maturation antigen; BiTE: bispecific T Cell Engager; CD: cluster of differentiation; DLL3: delta like canonical Notch ligand 3; EGFRvIII: epidermal growth factor receptor variant III; FLT3: FMS-like tyrosine kinase 3; GBM: glioblastoma; NHL: non-Hodgkin 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. Q1 2020 pipeline, Amgen. https://www.amgenpipeline.com/-/media/themes/amgen/amgenpipeline-com/amgenpipeline-com/pdf/amgen-pipeline-chart.pdf. Accessed 2/19/2020. 5. Baeuerle PA, Reinhardt C. Cancer Res. 2009;69(12):4941-4944. 6. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02879695. Accessed 2/19/2020. 7. Data on file, Amgen; 2019. 8. Gökbuget N, Dombret H, Zugmaier G, et al. Oral presentation at: European Hematology Association Congress; June, 2019; Amsterdam, Netherlands. 9. Amgen Science. https://www.amgenscience.com/features/a-strategy-for-making-clinical-trials-more-successful. Accessed 2/19/2020. 10. Gökbuget N, Dombret H, Bonifacio M, et al. Blood. 2018;131(14):1522-1531. 11. Hoelzer D. Haematologica. 2015;100(7):855-858. 12. Harousseau JL, Avet-Loiseau H. J Clin Oncol. 2017;35(25):2863-2865. 13. Weidle UH, Tiefenthaler G, Weiss EH, et al. Cancer Genomics Proteomics. 2013;10(1):1-18. 14. Raum T, Munz M, Brozy J, inventors. US Patent 2017/0218077 A1. 8/3/2017.