Antibodies to watch in 2016

Figures & data

Table 1. Novel antibody therapeutics first approved in 2015 in the EU or US.

INN	Brand name	Target; Molecular format	Indication	Status in EU	Status in US
Daratumumab	Darzalex	CD38; Human IgG1	Multiple myeloma	In review	Approved
Mepolizumab	Nucala	IL-5; Humanized IgG1	Severe eosinophilic asthma	Approved	Approved
Alirocumab	Praluent	PCSK9; Human IgG1	High cholesterol	Approved	Approved
Evolocumab	Repatha	PCSK9; Human IgG2	High cholesterol	Approved	Approved
Dinutuximab	Unituxin	GD2; Chimeric IgG1	Neuroblastoma	Approved	Approved
Idarucizumab	Praxbind	Dabigatran; Humanized Fab	Reversal of dabigatran-induced anticoagulation	Approved	Approved
Secukinumab	Cosentyx	IL-17a; Human IgG1	Psoriasis	Approved	Approved

Note: Secukinumab was approved in Japan in December 2014.

Abbreviations: EU, European Union; GD, glycolipid disialoganglioside; IL, interleukin; INN, international non-proprietary name; PCSK9, proprotein convertase subtilisin kexin type 9; US, United States.

Table 2. Antibody therapeutics in first regulatory review in the EU or US.

INN	Brand name	Target; Molecular format	Indication	Location of review
Necitumumab	(Pending)	EGFR; Human IgG1	Non-small cell lung cancer	EU, US
Elotuzumab	Empliciti	SLAMF7; Humanized IgG1	Multiple myeloma	EU, US
Brodalumab	(Pending)	IL-17R; Human IgG2	Psoriasis	EU
Ixekizumab	(Pending)	IL-17a; Humanized IgG4	Psoriasis	EU
Reslizumab	(Pending)	IL-5; Humanized IgG4	Asthma	EU, US
Begelomab	BEGEDINA	CD26; Murine IgG2b	Graft-vs-host disease	EU
Obiltoxaximab	Anthim	Protective antigen of B. anthracis exotoxin; Chimeric IgG1	Prevention of inhalational anthrax	US

Abbreviations: CD, cluster of differentiation; EGFR, epidermal growth factor receptor; EU, European Union; IL, interleukin; INN, international non-proprietary name; SLAM, signaling lymphocyte activation molecule; US, United States.

Table 3. Antibody therapeutics in Phase 2/3 or Phase 3 clinical studies of cancer indications.

Primary sponsoring company	INN or code name	Molecular format	Target	Most advanced phase	Phase 3 indication(s)
Pfizer	Inotuzumab ozogamicin	Humanized IgG4 ADC	CD22	Phase 3	Acute lymphoblastic leukemia
Viventia Bio	Oportuzumab monatox	Humanized scFv immunotoxin	EpCAM	Phase 3	Bladder cancer
MacroGenics	Margetuximab	Chimeric IgG1	HER2	Phase 3	Breast cancer
Merrimack Pharmaceuticals	MM-302	scFv-targeted liposome containing doxorubicin	HER2	Phase 2/3	Breast cancer
TG Therapeutics	Ublituximab	Chimeric IgG1	CD20	Phase 3	Chronic lymphocyticleukemia
XBiotech, Inc.	Xilonix	Human IgG1	IL-1 α	Phase 3	Colorectal cancer
AstraZeneca/ MedImmune	Moxetumomab pasudotox	Murine IgG1 dsFv immunotoxin	CD22	Phase 3	Hairy cell leukemia
Daiichi Sankyo	Patritumab	Human IgG1	HER3	Phase 3	NSCLC
Genentech	Onartuzumab	Humanized IgG1 Fab-Fc	cMet	Phase 3	NSCLC
Peregrine Pharmaceuticals	Bavituximab	Chimeric IgG1	Phosphatidylserine	Phase 3	NSCLC
Recombio SL	Racotumomab	Murine IgG1	GM3	Phase 3	NSCLC
EMD Serono	Avelumab	Human IgG1	PD-L1	Phase 3	NSCLC
Genentech	Atezolizumab	Humanized IgG1	PD-L1	Phase 3	NSCLC, bladder cancer, renal cell carcinoma, breast cancer
AstraZeneca/ MedImmune	Durvalumab (MEDI-4736)	Human IgG1	PD-L1	Phase 3	NSCLC, head and neck cancer
AstraZeneca/ MedImmune	Tremelimumab	Human IgG2	CTLA4	Phase 3	NSCLC, head and neck cancer
Immunomedics, Inc.	Clivatuzumab tetraxetan	Humanized IgG1	MUC5AC	Phase 3	Pancreatic cancer
Gilead Sciences	GS-5745	Humanized IgG4	MMP9	Phase 3	Gastric cancer or gastroesophageal junction adenocarcinoma

Data available as of November 16, 2015. Abbreviations: ADC, antibody-drug conjugate; CD, cluster of differentiation; CTLA, cytotoxic T-lymphocyte-associated protein; EpCAM, epithelial cellular adhesion molecule; GM, monosialodihexosylganglioside; HER, human epidermal growth factor receptor; Ig, immunoglobulin; IL, interleukin; INN, international non-proprietary name; MM, matrix metallopeptidase; MUC, mucin; NSCLC, non-small cell lung cancer; PD, programmed death.

Table 4. Antibody therapeutics in Phase 2/3 or Phase 3 clinical studies of non-cancer indications.

Primary sponsoring company	INN or code name	Molecular format	Target	Most advanced phase	Phase 3 indication(s)
Ablynx	Caplacizumab	Humanized nanobody	von Willebrand factor	Phase 3	Acquired thromboticthrombocytopenicpurpura
Pfizer	Bococizumab	Humanized IgG2	PCSK9	Phase 3	High cholesterol
ProthenaTherapeutics Ltd.	NEOD001	Humanized IgG1	Amyloid	Phase 3	Primary systemicamyloidosis
LFB Group	Roledumab	Human IgG1	Rhesus D	Phase 2/3	Rh disease
Janssen Research and Development, LLC	Guselkumab	Human IgG1	IL-23 p19 subunit	Phase 3	Psoriasis
Merck Sharp andDohme Corp	Tildrakizumab	Humanized IgG1	IL-23 p19 subunit	Phase 3	Psoriasis
Janssen Research and Development, LLC	Sirukumab	Human IgG1	IL-6	Phase 3	Rheumatoid arthritis, giant cell arteritis
Chugai Pharmaceuticals/ Roche	Emicizumab	Humanized bispecific IgG4	Factor IXa, Factor X	Phase 3	Hemophilia A
AstraZeneca/MedImmune	Benralizumab	Humanized IgG1	IL-5 receptor	Phase 3	Asthma, chronic obstructive pulmonary disease
Genentech	Lebrikizumab	Humanized IgG4	IL-13	Phase 3	Asthma
AstraZeneca/MedImmune	Tralokinumab	Human IgG4	IL-13	Phase 3	Asthma
RegeneronPharmaceuticals	Dupilumab	Human IgG4	IL-4 receptor α	Phase 3	Atopic dermatitis, asthma
AstraZeneca/MedImmune	Inebilizumab	Humanized IgG1	CD19	Phase 2/3	Neuromyelitis optica and neuromyelitis optica spectrum disorders
Chugai Pharmaceuticals/Roche	SA237	Humanized IgG2	IL-6 receptor	Phase 3	Neuromyelitis optica and neuromyelitis optica spectrum disorders
Xoma	Gevokizumab	Humanized IgG2	IL-1 β	Phase 3	Pyodermagangrenosum
AstraZeneca/ MedImmune	Anifrolumab	Human IgG1	IF α, β, omega receptor 1	Phase 3	Systemic lupus erythematosus
UCB, Inc.	Epratuzumab	Humanized IgG1	CD22	Phase 3	Systemic lupus erythematosus
Genentech	Etrolizumab	Humanized IgG1	Alpha4-beta7/alphaE-beta7integrin receptor	Phase 3	Ulcerative colitis, Crohn's disease
Genentech	Ocrelizumab	Humanized IgG1	CD20	Phase 3	Multiple sclerosis
Novartis Pharmaceuticals Corp.	Bimagrumab	Human IgG1	Activin A receptor type IIB	Phase 2/3	Sporadic inclusion body myositis
TaiMed Biologics Inc.	Ibalizumab	Humanized IgG4	CD4	Phase 3	HIV infection
CytoDyn	PRO-140, PA14	Humanized IgG4	CCR5	Phase 2/3	HIV infection
Regeneron	REGN2222	Human IgG1	RSV F protein	Phase 3	RSV infection prevention
Ultragenyx Pharmaceutical; Kyowa Hakko Kirin Co.	KRN23	Human IgG1	Fibroblast growth factor 23	Phase 3	X-linked hypophosphatemia
Biogen	Aducanumab	Human IgG1	Amyloid β	Phase 3	Alzheimer disease
Eli Lilly & Company	Solanezumab	Humanized IgG1	Amyloid β	Phase 3	Alzheimer disease
Hoffmann-La Roche	Gantenerumab	Human IgG1	Amyloid β	Phase 3	Alzheimer disease
Eli Lilly & Company	LY2951742	Humanized IgG4	CGRP	Phase 3	Chronic or episodic cluster headache
Alder Biopharma.	ALD403	Humanized IgG1	CGRP	Phase 3	Episodic migraine prevention
Amgen	AMG 334	Human IgG2	CGRP receptor	Phase 3	Migraine prevention
Pfizer; Eli Lilly & Company	Tanezumab	Humanized IgG2	Nerve growth factor	Phase 3	Chronic low back pain, cancer pain due to bone metastasis
Regeneron Pharmaceuticals	Fasinumab	Human IgG4	Nerve growth factor	Phase 2/3	Pain due to osteoarthritis of knee or hip
Janssen Research and Development, LLC	Fulranumab	Human IgG2	Nerve growth factor	Phase 3	Pain due to osteoarthritis of knee or hip
Genentech	Lampalizumab	Humanized IgG1 Fab	Complement factor D	Phase 3	Geographic atrophy
Novartis Pharmaceuticals Corp.	Brolucizumab	Humanized scFv	VEGF-A	Phase 3	Neovascular age-related maculardegeneration
UCB, Amgen	Romosozumab	Humanized IgG2	Sclerostin	Phase 3	Osteoporosis

Abbreviations: CD, cluster of differentiation; CGRP, Calcitonin gene-related peptide; Fab, antigen-binding fragment; HIV, human immunodeficiency virus; Ig, immunoglobulin; IL, interleukin; INN, international non-proprietary name; PCSK9, proprotein convertase subtilisin kexin type 9; RSV, respiratory syncytial virus; scFv, single-chain variable fragment; VEGF, vascular endothelial growth factor.