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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

MONOCLONAL
ANTIBODY

Natural antibodies serve as one of the immune system’s primary sentinels.1 These large Y-shaped molecules carry 2 variable domains (the Fab regions), which are designed to recognize and bind to specific antigens seen as threats. The targeted antigen might be a protein found on a pathogen or a protein marker found on malignant or infected cells. Antibodies also have an immune-stimulating domain (the Fc region) that helps to mount a broader immune response to threats flagged by antibodies.1,2

Monoclonal antibodies are bioengineered molecules that are designed to target specific proteins involved in disease.1 Like natural antibodies, they are potent and highly selective in terms of the targets they engage.1 They also tend to stay in the body longer than most other medicines, so in general, they need to be dosed less frequently.2 Antibody drugs can be used against targets that are outside cells or on the cell surface, but because of their size, they generally can’t reach targets inside cells.3

The regulatory approval pathway for biosimilars requires study of a single indication and permits extrapolation to other reference indications with scientific justification.4

C5, complement component 5; Fab, fragment antigen-binding; Fc, fragment crystallizable; FGFR2b, fibroblast growth factor receptor 2 isoform lllb; GEJ, gastroesophageal junction; PD-1, programmed cell death protein 1; PNH, paroxysmal nocturnal hemoglobinuria.

References
1. American Cancer Society. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/monoclonal-antibodies.html. Accessed 7/29/21. 2. Ryman JT, et al. CPT Pharmacometrics Syst Pharmacol. 2017;6:576-588. 3. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet. Accessed 7/29/21. 4. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product. Accessed 7/29/21. 5. Amgen Pipeline. https://www.amgenpipeline.com. Accessed 7/27/21. 6. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03818607. Accessed 7/29/21.
Molecule
Modality5
Target5
Areas of Investigation6
ABP 959
Modality5
MONOCLONAL
ANTIBODY
Target5
Areas of Investigation6
PHASE 3 (PNH)
CLINICAL COMPARABILITY
Molecule
Modality5
Target5
Areas of Investigation5
AMG 404
Modality5
MONOCLONAL
ANTIBODY
Target5
Areas of Investigation5
Molecule
Modality5
Target5
Areas of Investigation5
Bemarituzumab
Modality5
MONOCLONAL
ANTIBODY
Target5
Areas of Investigation5
PHASE 2 (GASTRIC OR GEJ CANCER)

The regulatory approval pathway for biosimilars requires study of a single indication and permits extrapolation to other reference indications with scientific justification.4

C5, complement component 5; Fab, fragment antigen-binding; Fc, fragment crystallizable; FGFR2b, fibroblast growth factor receptor 2 isoform lllb; GEJ, gastroesophageal junction; PD-1, programmed cell death protein 1; PNH, paroxysmal nocturnal hemoglobinuria.

References
1. American Cancer Society. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/monoclonal-antibodies.html. Accessed 7/29/21. 2. Ryman JT, et al. CPT Pharmacometrics Syst Pharmacol. 2017;6:576-588. 3. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet. Accessed 7/29/21. 4. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product. Accessed 7/29/21. 5. Amgen Pipeline. https://www.amgenpipeline.com. Accessed 7/27/21. 6. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03818607. Accessed 7/29/21.

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