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Abbreviations:

4-1BB, tumor necrosis factor receptor superfamily member 9; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; APRIL, a proliferation inducing ligand; BAFF, B-cell activating factor from the tumor necrosis factor family; BAK, Bcl-2 homologous antagonist killer; BAX, Bcl-2-associated X protein; BCL-2, B-cell lymphoma 2; BCMA, B-cell maturation antigen; BCR, B-cell receptor; BH, Bcl-2 homology domain; BiTE, Bispecific T-cell Engager; C5, complement component 5; CD, cluster of differentiation; CIT, chemotherapy-induced thrombocytopenia; CLDN18.2, Claudin-18 isoform 2; DARPin, designed ankyrin repeat proteins; DLBCL, diffuse large B-cell lymphoma; DLL3, delta-like protein 3; EGFR, epidermal growth factor receptor; EGFRvIII, epidermal growth factor receptor variant III; Fab, fragment antigen-binding; FAP, fibroblast activation protein; Fc, fragment crystallizable; FLT3, fms-like tyrosine kinase 3; GEJ, gastroesophageal junction; GM-CSF, granulocyte-macrophage colony-stimulating factor; GvHD, graft versus host disease; HCC, hepatocellular carcinoma; HLE, half-life extended; IL-2R, interleukin 2 receptor; IL-21R, interleukin 21 receptor; IL-2Rα, interleukin 2 receptor alpha; KRAS, Kirsten rat sarcoma; MAC, membrane attack complex; MCL-1, myeloid cell leukemia-1; mCRPC, metastatic castration-resistant prostate cancer; MetMel, metastatic melanoma; MM, multiple myeloma; MOA, mechanism of action; MUC17, mucin 17; NHL, non-Hodgkin's lymphoma; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, programmed cell death ligand 1; PD-L2, programmed cell death ligand 2; PNH, paroxysmal nocturnal hemoglobinuria; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; RAS, rat sarcoma; R/R, relapsed or refractory; SCLC, small cell lung cancer; STEAP1, six-transmembrane epithelial antigen of prostate 1; TPO, thrombopoietin; TPO-R, thrombopoietin receptor; Treg, regulatory T cell.

Amgen Oncology
Pipeline

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SOLID MALIGNANCIES

MALIGNANCIES

TARGETS

HEMATOLOGIC DISEASES

DISEASES

TARGETS

PIPELINE

BITE® PLATFORM

BIOSIMILARS

MODALITIES

HLE BiTE® PLATFORM

Amgen is the pioneer of BiTE® (Bispecific T-cell Engager) technology, which is designed to overcome cancer cells’ evasion of the immune system by engaging patients’ own T cells to directly target cancer cells.1,2 BiTE® molecules are engineered from two flexibly linked, single-chain antibodies, with one designed to specifically target a selected tumor-associated antigen and the other targeting CD3 found on T cells.2 This versatile technology is engineered with the goal of delivering off-the-shelf therapies that direct patients‘ own T cells to target a tumor-associated antigen, activating their cytotoxic potential.2,3

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.1,4 Currently, Amgen is designing half-life extended (HLE) BiTE® molecules containing fragment-crystallizable (Fc) domains. Adding an Fc portion to a BiTE® molecule is designed to extend the amount of time before it is eliminated from the body.4,5

With HLE BiTE® molecules, Amgen continues to accelerate the investigation of BiTE® platform with the goal of enhancing patient experience and therapeutic potential.1,4,6,7

AML, acute myeloid leukemia; BCMA, B-cell maturation antigen; CD, cluster of differentiation; CLDN18.2, Claudin-18 isoform 2; DLL3, delta-like ligand 3; FLT3, FMS-like tyrosine kinase 3; GEJ, gastroesophageal junction; MM, multiple myeloma; MUC17, mucin 17; NEPC, neuroendocrine prostate cancer; PSMA, prostate-specific membrane antigen; SCLC, small cell lung cancer.

References
1. Yuraszeck T, et al. Clin Pharmacol Ther. 2017;101:634-645. 2. Baeuerle PA, et al. Curr Opin Mol Ther. 2009;11:22-30. 3. Frankel SR, et al. Curr Opin Chem Biol. 2013;17:385-392. 4. Weidle UH, et al. Cancer Genomics Proteomics. 2013;10:1-18. 5. Raum T, et al, inventors. US Patent 2017/0218077A1. August 3, 2017. 6. Baeuerle PA, et al. Cancer Res. 2009;69:4941-4944. 7. Arvedson TL, et al. Cancer Res. 2017;77(suppl 13): Abstract 55. 8. Amgen Pipeline. https://www.amgenpipeline.com. Accessed 9/10/20. 9. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03792841. Accessed 9/10/20. 10. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04117958. Accessed 9/22/20. 11. ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT04702737. Accessed 4/15/21. 12. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04260191. Accessed 9/10/20. 13. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03287908. Accessed 9/10/20.
Molecule
Modality8,9
Target8,9
Areas of Investigation8,9
AMG 160
Modality8,9
HLE BiTE® PLATFORM
Target8,9
Areas of Investigation8,9
Molecule
Modality8
Target10
Areas of Investigation8
AMG 199
Modality8
HLE BiTE® PLATFORM
Target10
Areas of Investigation8
Molecule
Modality8
Target8
Areas of Investigation8
AMG 427
Modality8
HLE BiTE® PLATFORM
Target8
Areas of Investigation8
Molecule
Modality8
Target8
Areas of Investigation8
AMG 673
Modality8
HLE BiTE® PLATFORM
Target8
Areas of Investigation8
Molecule
Modality8
Target8
Areas of Investigation8,11
AMG 757
Modality8
HLE BiTE® PLATFORM
Target8
Areas of Investigation8,11
Molecule
Modality12
Target12
Areas of Investigation12
AMG 910
Modality12
HLE BiTE® PLATFORM
Target12
Areas of Investigation12
Molecule
Modality8,13
Target8,13
Areas of Investigation8,13
Pavurutamab (AMG 701)
Modality8,13
HLE BiTE® PLATFORM
Target8,13
Areas of Investigation8,13

AML, acute myeloid leukemia; BCMA, B-cell maturation antigen; CD, cluster of differentiation; CLDN18.2, Claudin-18 isoform 2; DLL3, delta-like ligand 3; FLT3, FMS-like tyrosine kinase 3; GEJ, gastroesophageal junction; MM, multiple myeloma; MUC17, mucin 17; NEPC, neuroendocrine prostate cancer; PSMA, prostate-specific membrane antigen; SCLC, small cell lung cancer.

References
1. Yuraszeck T, et al. Clin Pharmacol Ther. 2017;101:634-645. 2. Baeuerle PA, et al. Curr Opin Mol Ther. 2009;11:22-30. 3. Frankel SR, et al. Curr Opin Chem Biol. 2013;17:385-392. 4. Weidle UH, et al. Cancer Genomics Proteomics. 2013;10:1-18. 5. Raum T, et al, inventors. US Patent 2017/0218077A1. August 3, 2017. 6. Baeuerle PA, et al. Cancer Res. 2009;69:4941-4944. 7. Arvedson TL, et al. Cancer Res. 2017;77(suppl 13): Abstract 55. 8. Amgen Pipeline. https://www.amgenpipeline.com. Accessed 9/10/20. 9. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03792841. Accessed 9/10/20. 10. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04117958. Accessed 9/22/20. 11. ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT04702737. Accessed 4/15/21. 12. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04260191. Accessed 9/10/20. 13. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03287908. Accessed 9/10/20.

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