Antibodies to watch in 2014

Figures & data

Table 1. Therapeutic antibody-based therapeutics in first regulatory review in US, EU or Japan

Sponsoring company	Name	Molecular format	Target	Location of regulatory review	Designations	Indication under review
Novartis	Secukinumab	Human IgG1	IL-17a	US, EU	S	Psoriasis
United Therapeutics Europe Ltd	Dinutuximab	Chimeric IgG1	GD2	EU	O (EU, US)	Brain cancer
Ono Pharma./Bristol-Myers Squibb	Nivolumab	Human IgG4	PD1	Japan	O (Japan)	Melanoma
Merck	Pembrolizumab	Humanized IgG4	PD1	US	P, BT	Melanoma

Note: Table compiled from information publically available as of May 21, 2014. Abbreviations: BT, US breakthrough therapy designation; CD, cluster of differentiation; EU, European Union; FT, US fast track designation; GD, disialoganglioside; IL, interleukin; INN, international non-proprietary name; NA, not applicable; O, orphan drug designation; P, priority review by US Food and Drug Administration; PD, programmed cell death; S, standard review by US Food and Drug Administration; US, United States.

Table 2. Therapeutic antibodies that recently* entered first Phase 3 clinical studies

Sponsoring company	INN or code name	Molecular format	Target(s)	Phase 3 indications
Regeneron, Sanofi	Dupilumab	Human IgG4	IL-4 receptor α	Atopic dermatitis
Chugai/Roche	SA237	Humanized IgG2; Fc engineered	IL-6 receptor	Neuromyelitis optica and NMO Spectrum Disorder
Hoffmann-La Roche	Etrolizumab	Humanized IgG1	β7 subunit of α4β7 and αEβ7 integrins	Ulcerative colitis
Genentech/ Roche	MPDL3280A	Human IgG1; Fc engineered	PD-L1	Non-small cell lung cancer
Peregrine	Bavituximab	Chimeric IgG1	Phosphatidyl-serine	Non-small cell lung cancer
Immunomedics	Clivatuzumab tetraxetan	Humanized IgG1; radio-labeled	MUC1/PAM4	Pancreatic cancer
Amgen	Blinatumomab	Murine; bispecific tandem single chain Fv	CD19, CD3	Acute lymphocytic leukemia

* December 2013-April 2014; table compiled from information publically available as of May 15, 2014. Abbreviations: CD, cluster of differentiation; Fc, crystallizable fragment; Fv, variable fragment; IL, interleukin; INN, international non-proprietary name; PD, programmed cell death