Antibodies to watch in 2018

Figures & data

Table 1. Antibody therapeutics approved in the European Union or United States during 2017*.

International non-proprietary name	Brand name	Target; Format	Indication first approved	Date of first EU approval	Date of first US approval
Brodalumab	Siliq, Lumicef, Kyntheum	IL-17RA; Human IgG2	Plaque psoriasis	7/17/17	2/15/17
Avelumab	Bavencio	PD-L1; Human IgG1	Merkel cell carcinoma	9/18/17	3/23/17
Dupilumab	Dupixent	IL-4Rα; Human IgG4	Atopic dermatitis	9/27/17	3/28/17
Ocrelizumab	Ocrevus	CD20; Humanized IgG1	Multiple sclerosis	EC decision pending	3/29/17
Durvalumab	Imfinzi	PD-L1; Human IgG1	Bladder cancer	In review	5/1/17
Sarilumab	Kevzara	IL-6R; Human IgG1	Rheumatoid arthritis	6/23/17	5/22/17
Guselkumab	Tremfya	IL-23 p19; Human IgG1	Plaque psoriasis	11/23/17	7/13/17
Inotuzumab ozogamicin	Besponsa	CD22; Humanized IgG4; ADC	Acute lymphoblastic leukemia	6/29/17	8/17/17
Benralizumab	Fasenra	IL-5R α; Humanized IgG1	Asthma	EC decision pending	11/14/17
Emicizumab	Hemlibra	Factor IXa, X; Humanized IgG4, bispecific	Hemophilia A	In review	11/16/17

Table notes: Sarilumab's first global approval was granted in Canada on January 12, 2017; brodalumab's first global approval was granted in Japan on July 4, 2016. *Data available as of December 1, 2017

Abbreviations: ADC, antibody drug conjugate; CD, cluster of differentiation; EC, European Commission; EU, European Union; IL, interleukin; IgG, immunoglobulin G; PD-L1, programmed cell death 1.

Table 2. Antibody therapeutics in regulatory review in the European Union or United State^*.

International non-proprietary name	Brand name proposed	Target; Format	Indication under reviewed	Status in EU	Status in US
Ibalizumab	(Pending)	CD4; Humanized IgG4	HIV infection	NA	In review
Burosumab	(Pending)	FGF23; Human IgG1	X-linked hypophosphatemia	In review	In review
Tildrakizumab	(Pending)	IL-23 p19; Humanized IgG1	Plaque psoriasis	In review	In review
Caplacizumab	(Pending)	von Willebrand factor; Humanized Nanobody	Acquired thrombotic thrombocytopenic purpura	In review	NA
Erenumab	Aimovig	CGRP receptor; Human IgG2	Migraine prevention	In review	In review
Fremanezumab	(Pending)	CGRP; Humanized IgG2	Migraine prevention	NA	In review
Galcanezumab	(Pending)	CGRP; Humanized IgG4	Migraine prevention	In review	In review
Romosozumab	Evenity	Sclerostin; Humanized IgG2	Osteoporosis in postmenopausal women at increased risk of fracture	NA	In review
Mogamulizumab	Poteligeo	CCR4; Humanized IgG1	Cutaneous T cell lymphoma	In review	NA

* Data available as of December 1, 2017

Abbreviations: CGRP, Calcitonin gene-related peptide; CCR4, CC chemokine receptor 4; CD, cluster of differentiation; FGF23, fibroblast growth factor 23; HIV, human immunodeficiency virus; IL, interleukin; IgG, immunoglobulin G; NA, not approved or in review in the EU; not approved or information on review status not available in US.

Table 3. Antibody therapeutics in late-stage clinical studies for non-cancer indications.

Primary sponsoring company	INN or code name	Molecular format	Target	Most advanced phase	Late-stage study indication(s)
Novartis	Crizanlizumab	Humanized IgG2	CD62 (aka P-selectin)	Phase 3	Sickle cell disease
LFB Group	Roledumab	Human IgG1	Rh D	Phase 2/3	Rhesus disease
Shire	Lanadelumab	Human IgG1	Plasma kallikrein	Phase 3	Hereditary angioedema attacks
Prothena Therapeutics Ltd.	NEOD001	Humanized IgG1	Amyloid	Phase 3	Primary systemic amyloidosis
Omeros Corporation	OMS721	Human mAb	MASP-2	Phase 3	Atypical hemolytic uremic syndrome
Alexion Pharmaceuticals Inc.	Ravulizumab (ALXN1210)	Humanized mAb	C5	Phase 3	Paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome
AstraZeneca/ MedImmune LLC	Tezepelumab	Human IgG2	Thymic stromal lympho-poietin	Phase 3	Severe uncontrolled asthma
AstraZeneca/ MedImmune LLC	Tralokinumab	Human IgG4	IL-13	Phase 3	Atopic dermatitis
Boehringer Ingelheim Pharmaceuticals, AbbVie	Risankizumab	Humanized IgG1	IL-23 p19	Phase 3	Psoriasis; Crohn's disease
AstraZeneca/MedImmune LLC	Anifrolumab	Human IgG1	IFN α, β, ω receptor 1	Phase 3	Systemic lupus erythematosus
Genentech	Etrolizumab	Humanized IgG1	α4-β7/αE-β7 integrin receptor	Phase 3	UC; Crohn's disease
Shire	SHP-647	Human IgG2	Mucosal addressin cell adhesion molecule	Phase 3	UC; Crohn's disease
R-Pharm	Olokizumab	Humanized IgG4	IL-6	Phase 3	Rheumatoid arthritis
AstraZeneca/MedImmune LLC	Inebilizumab	Humanized IgG1	CD19	Phase 2/3	Neuromyelitis optica and neuromyelitis optica spectrum disorders
Chugai Pharmaceuticals/Roche	Satralizumab	Humanized IgG2	IL-6R	Phase 3	Neuromyelitis optica and neuromyelitis optica spectrum disorders
NovImmune SA	Emapalumab	Human IgG1	IFN γ	Phase 2/3	Primary hemophagocytic lymphohistiocytosis
CytoDyn	PRO-140, PA14	Humanized IgG4	CCR5	Phase 2/3	HIV infection
Biogen	Aducanumab	Human IgG1	Amyloid β	Phase 3	Alzheimer's disease
Genentech	Crenezumab	Humanized IgG4	Amyloid β	Phase 3	Alzheimer's disease
Hoffmann-La Roche	Gantenerumab	Human IgG1	Amyloid β	Phase 3	Alzheimer's disease
Alder Biopharmaceuticals	Eptinezumab	Humanized IgG1	CGRP	Phase 3	Migraine prevention, chronic migraine
Regeneron Pharmaceuticals	Fasinumab	Human IgG4	NGF	Phase 3	Pain due to osteoarthritis of knee or hip, chronic low back pain
Pfizer; Eli Lilly & Company	Tanezumab	Humanized IgG2	NGF	Phase 3	Pain due to osteoarthritis of knee or hip, chronic low back pain, cancer pain due to bone metastasis
Horizon Pharma USA	Teprotumumab	Human IgG1	IGF-1R	Phase 3	Thyroid eye disease
Genentech	Lampalizumab	Humanized IgG1 Fab	Complement Factor D	Phase 3	Geographic atrophy associated with dry age-related macular degeneration
Novartis Pharmaceuticals Corp.	Brolucizumab	Humanized scFv	VEGF-A	Phase 3	Neovascular age-related macular degeneration

Note: Table includes only commercially developed monoclonal antibody therapeutics that have not previously been approved for any indication; updated December 1, 2017.

Abbreviations: C5, complement component 5; CCR, chemokine receptor; CD, cluster of differentiation; CGRP, calcitonin gene-related peptide; Fab, antigen-binding fragment; FGF, fibroblast growth factor; HIV, human immunodeficiency virus; IFN, interferon; IGF, insulin-like growth factor; IL, interleukin; INN, international non-proprietary name; MASP, mannose-binding protein-associated serine protease; NGF, nerve growth factor; Rh, rhesus; scFv, single-chain variable fragment; VEGF, vascular endothelial growth factor.

Table 4. Antibody therapeutics in late-stage clinical studies for cancer indications.

Primary sponsoring company	INN or code name	Molecular format	Target	Most advanced phase	Late-stage study indication(s)
Actinium Pharmaceuticals	I-131-BC8, Iomab-B	Murine IgG1, radiolabeled	CD45	Phase 3	Ablation of bone marrow prior to hematopoietic cell transplantation in AML patients
Sanofi	Isatuximab	Humanized* IgG1	CD38	Phase 3	Multiple myeloma
TG Therapeutics	Ublituximab	Chimeric IgG1	CD20	Phase 3	Chronic lymphocytic Leukemia, non-Hodgkin lymphoma, multiple sclerosis
AstraZeneca/ MedImmune LLC	Moxetumomab pasudotox	Murine IgG1 dsFv immunotoxin	CD22	Phase 3	Hairy cell leukemia
MorphoSys	XMAB-5574, MOR208	Humanized IgG1	CD19	Phase 2/3	Diffuse large B-cell lymphoma
Pfizer	Utomilumab	Human IgG2	4–1BB (CD137)	Phase 3	Diffuse large B-cell lymphoma
Hoffmann-La Roche	Polatuzumab vedotin	Humanized IgG1 ADC	CD79b	Phase 3	Diffuse large B-cell lymphoma
Viventia Bio	Oportuzumab monatox	Humanized scFv immunotoxin	EpCAM	Phase 3	Bladder cancer
Seattle Genetics	Enfortumab vedotin	Human IgG1 ADC	Nectin 4	Pivotal Phase 2	Urothelial cancer
Jiangsu HengRui Medicine Co., Ltd	Camrelizumab	Humanized IgG4	PD-1	Phase 2/3	Hepatocellular carcinoma, esophageal carcinoma
MacroGenics	Margetuximab	Chimeric IgG1	HER2	Phase 3	Breast cancer
Synthon Biopharmaceuticals BV	(vic-)trastuzumab duocarmazine	Humanized IgG1 ADC	HER2	Phase 3	Breast cancer
Immunomedics, Inc	Sacituzumab govitecan	IgG1 ADC	TROP-2 (epithelial glyco-protein-1)	Phase 3	Triple-neg. breast cancer
Celldex Therapeutics	Glembatumumab vedotin	Human IgG2 ADC	gpNMB	Pivotal Phase 2	gpNMB+ breast cancer, melanoma
Daiichi Sankyo	DS-8201	Humanized ADC	HER2	Pivotal Phase 2	HER2+ gastric or gastroesophageal junction adenocarcinoma
Gilead Sciences	Andecaliximab	Humanized* IgG4	MMP-9	Phase 3	Gastric cancer or gastroesophageal junction adenocarcinoma
AbbVie	Depatuxizumab mafodotin	IgG1 ADC	EGFR	Phase 2b/3	Glioblastoma
AstraZeneca/ MedImmune LLC	Tremelimumab	Human IgG2	CTLA-4	Phase 3	Non-small cell lung, head & neck, urothelial cancer, hepatocellular carcinoma
Recombio SL	Racotumomab	Murine IgG1	NGcGM3	Phase 3	Non-small cell lung cancer
Regeneron Pharmaceuticals	Cemiplimab	Human mAb	PD-1	Pivotal Phase 2; Phase 3	Cutaneous squamous cell carcinoma; non-small cell lung cancer, cervical cancer
Innovent Biologics (Suzhou) Co. Ltd.	IBI308	Human mAb	PD-1	Phase 3	Squamous cell non-small cell lung cancer
BeiGene	BGB-A317	Humanized mAb	PD-1	Phase 3	Non-small cell lung cancer
AbbVie	Rovalpituzumab tesirine	Humanized IgG1 ADC	DLL3	Phase 3	Small cell lung cancer
ImmunoGen	Mirvetuximab soravtansine	IgG1 ADC	Folate receptor 1	Phase 3	Epithelial ovarian cancer, peritoneal carcinoma, fallopian tube cancer
Biocad	BCD-100	Human mAb	PD-1	Phase 2/3	Melanoma
Novartis	PDR001	Humanized IgG4	PD-1	Phase 3	Melanoma
Philogen SpA	L19IL2/L19TNF	scFv immuno-conjugates	Fibronectin extra-domain B	Phase 3	Melanoma
Tracon	Carotuximab	Chimeric IgG1	Endoglin	Phase 3	Soft tissue sarcoma, angiosarcoma, renal cell carcinoma, wet age related macular degeneration

Note: Table includes only commercially developed monoclonal antibody therapeutics that have not previously been approved for any indication; updated December 1, 2017.

*Identified as humanized in published literature. See Parren PWHI, Carter PJ, Plückthun A. Changes to International Nonproprietary Names for antibody therapeutics 2017 and beyond: of mice, men and more. MAbs. 2017 Aug/Sep;9(6):898–906 (doi:10.1080/19420862.2017.1341029) for a review of changes to the World Health Organization and US Adopted Names Council's international non-proprietary name definitions that occurred between 2014 and 2017.

Abbreviations: ADC, antibody-drug conjugate; CD, cluster of differentiation; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; DLL3, delta-like protein 3; dsFv, disulfide-stabilized variable fragment; EGFR, epidermal growth factor receptor; EpCAM, epithelial cell adhesion molecule; gpNMB, glycoprotein non-metastatic gene B; HER2, human epidermal growth factor receptor 2; IL, interleukin; INN, international non-proprietary name; mAb, monoclonal antibody; MMP, matrix metallopeptidase; NGcGM3, Neu-glycolyl-GM3 ganglioside; PD-1, programmed death 1; PD-L1, programmed death ligand 1; scFv, single-chain variable fragment; TROP-2, Tumor-associated calcium signal transducer 2.