Antibodies to watch in 2010

Figures & data

Table 1 Antineoplastic antibodies in Phase 3 studies

Sponsoring company	International non-proprietary name	Description	Indication of Phase 3 study	FDA designations for phase 3 study indication
Active Biotech Research	Naptumomab estafenatox	Anti-5T4 Fab; conj. to staph. enterotoxin A	Advanced renal cell carcinoma
Wyeth	Inotuzumab ozogamicin	Anti-CD22 IgG4; conj. to calicheamicin	Follicular non-Hodgkin lymphoma
Biogen idec	Galiximab	Anti-CD80 IgG1; primatized	Follicular non-Hodgkin lymphoma
Medarex/Bristol-Myers Squibb	Ipilimumab	Anti-CTLA-4 IgG1	Advanced melanoma	FT, O
Genmab	Zalutumumab	Anti-EGFR IgG1	Head and neck cancer	FT
Morphotek	Farletuzumab	Anti-folate receptor α IgG1	Ovarian cancer	O
Genentech	Trastuzumab-DM1	Anti-HER2 IgG1 conj. to DM1	Locally advanced or metastatic breast cancer
Genentech	Pertuzumab	Anti-HER2 IgG1	Metastatic breast cancer
Merck, Pierre Fabre	Dalotuzumab	Anti-IGF-1R IgG1; humanized	Metastatic colorectal cancer
Pfizer	Figitumumab	Anti-IGF-1R IgG2	Refractory lung cancer
Wilex AG	WX-G250	Anti-carbonic anhydrase ix IgG1; chimeric	Non-metastatic renal cell carcinoma	O
Bradmer Pharmaceuticals	Anti-tenascin 131I-mAb-81C6	Anti-tenascin IgG2b; murine, radiolabeled	Glioblastoma multiforme	O
Imclone Systems/Eli Lilly	Ramucirumab	Anti-VEGF-R2 (KDR) IgG1	Metastatic gastric or gastroesophageal junction adenocarcinoma; breast cancer

CTLA, cytotoxic T-lymphocyte-associated antigen; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; FT, fast track designation; HER2, human epidermal growth factor receptor; IGF-1R, insulin-like growth factor-1 receptor; O, orphan drug designation; international non-proprietary naming convention: -umab, human; -zumab, humanized; -ximab, chimeric or primatized; -momab, murine; Data current as of October 2009.

Table 2 FDA approved antineoplastic monoclonal antibodies

Generic name	Trade name	Target and type	Indication under review or first approved	FDA approval year
Ofatumumab	Arzerra	Anti-CD20; human IgG1	Chronic lymphocytic leukemia	2009
Tositumomab-I131	Bexxar	Anti-CD20; murine IgG2a	Non-Hodgkin lymphoma	2003
Ibritumomab tiuxetan	Zevalin	Anti-CD20; murine IgG1	Non-Hodgkin lymphoma	2002
Rituximab	Rituxan	Anti-CD20; chimeric IgG1	Non-Hodgkin’s lymphoma	1997
Gemtuzumab ozogamicin	Mylotarg	Anti-CD33; humanized IgG4	Acute myeloid leukemia	2000
Alemtuzumab	Campath-1H	Anti-CD52; humanized IgG1	Chronic myeloid leukemia	2001
Panitumumab	Vectibix	Anti-EGFR; human IgG2	Colorectal cancer	2006
Cetuximab	Erbitux	Anti-EGFR; chimeric IgG1	Colorectal cancer	2004
Trastuzumab	Herceptin	Anti-HER2; humanized IgG1	Breast cancer	1998
Bevacizumab	Avastin	Anti-VEGF; humanized IgG1	Colorectal cancer	2004

Note: Information current as of October 1, 2009; CD, cluster of differentiation; EGFR, epidermal growth factor receptor; FDA, US Food and Drug Administration; VEGF, vascular endothelial growth factor.

Table 3 Antibodies in Phase 3 studies of immunological disorders

Sponsoring company	International non-proprietary name	Description	Indication of Phase 3 study	FDA designations for Phase 3 study indication
Millennium/Takeda	Vedolizumab	Anti-alpha4beta7 integrin IgG1	Moderate-to-severe Crohn disease; ulcerative colitis
Human Genome Sciences, GlaxoSmithKline	Belimumab	Anti-B-lymphocyte stimulator IgG1	Systemic lupus erythematosus	FT
Genentech	Ocrelizumab	Anti-CD20 IgG1	Rheumatoid arthritis; systemic lupus erythematosus
Immunomedics/UCB	Epratuzumab	Anti-CD22 IgG1	Systemic lupus erythematosus	FT
Tolerx	Otelixizumab	Anti-CD3 IgG1	Type 1 diabetes mellitus	O
Macrogenics, Eli Lilly	Teplizumab	Anti-CD3 IgG1	Type 1 diabetes mellitus	O
Abbott	Briakinumab	Anti-IL12/23 IgG1	Plaque psoriasis
GlaxoSmithKline	Mepolizumab	Anti-IL5 IgG1	Hypereosinophilic syndrome	O
Ception Therapeutics	Reslizumab	Anti-IL5 IgG4	Eosinophilic esophagitis	O

CD, cluster of differentiation; FDA, US Food and Drug Administration; FT, fast track designation; O, orphan drug designation; International non-proprietary naming convention: -umab, human; -zumab, humanized; Data current as of October 2009.

Table 4 Monoclonal antibodies in FDA review or approved as treatments for immunological indications

Generic name	Trade name	Target and type	Indication under consideration or first approved	FDA approval year
Eculizumab	Soliris	Anti-C5; humanized IgG2/4	Paroxysmal nocturnal hemoglobinuria	2007
Muromonab-CD3	Orthoclone Okt3	Anti-CD3; murine IgG2a	Reversal of kidney transplant rejection	1986
Basiliximab	Simulect	Anti-IL2R; chimeric IgG1	Prevention of kidney transplant rejection	1998
Daclizumab	Zenapax	Anti-IL2R; humanized IgG1	Prevention of kidney transplant rejection	1997
Efalizumab	Raptiva	Anti-CD11a; humanized IgG1	Psoriasis	2003^#
Tocilizumab	Actemra*	Anti-IL6R; humanized IgG1	Rheumatoid arthritis	Pending
Ustekinumab	Stelara	Anti-IL12/23; human IgG1	Psoriasis	2009
Canakinumab	Ilaris	Anti-IL1β; human IgG1	Muckle-Wells syndrome	2009
Omalizumab	Xolair	Anti-IgE; humanized IgG1	Asthma	2003
Natalizumab	Tysabri	Anti-α4 integrin; humanized IgG4	Multiple sclerosis	2004
Golimumab	Simponi	Anti-TNFα; human IgG1	Rheumatoid and psoriatic arthritis, ankylosing spondylitis	2009
Certolizumab pegol	Cimzia	Anti-TNFα; humanized Fab, pegy-lated	Crohn disease	2008
Adalimumab	Humira	Anti-TNFα; human IgG1	Rheumatoid arthritis	2002
Infliximab	Remicade	Anti-TNFα; chimeric IgG1	Crohn disease	1998

Note: Information current as of October 1, 2009; *Proposed trade name; ^#Voluntarily withdrawn from US market in April 2009; C5, complement 5; CD, cluster of differentiation; FDA, US Food and Drug Administration; IL, interleukin; TNF, tumor necrosis factor.

Table 5 Antibodies in Phase 3 studies as treatments for non-traditional indications

Sponsoring company	International non-proprietary name	Description	Indication of Phase 3 study	FDA designations for Phase 3 study indication
Biosynexus	Pagibaximab	Anti-lipoteichoic acid IgG1	Prevention of staphylococcal sepsis in very low birth weight neonates	O
Lilly	Solanezumab	Anti-amyloid beta IgG1	Alzheimer disease
Wyeth, Janssen	Bapineuzumab	Anti-amyloid beta IgG1	Alzheimer disease	FT
Pfizer	Tanezumab	Anti-nerve growth factor IgG2	Pain associated with osteoarthritis of the knee or hip; lower back pain

FDA, US Food and Drug Administration; FT, fast track designation; O, orphan drug designation; International non-proprietary naming convention: -zumab, humanized; -ximab, chimeric or primatized; Data current as of October 2009.

Table 6 Antibodies in FDA review or approved as treatments for non-traditional indications

Generic name	Trade name	Target and type	Indication under consideration or first approved	FDA approval year
Raxibacumab	ABThrax*	Anti-B. anthrasis PA; human IgG1	Anthrax infection	Pending
Abciximab	Reopro	Anti-GPIIb/IIIa; chimeric IgG1 Fab	Prevention of blood clots in angioplasty	1994
Denosumab	Prolia*	Anti-RANK-L; human IgG2	Bone loss	Pending
Motavizumab	Numax*	Anti-RSV; humanized IgG1	Prevention of respiratory syncytial virus infection	Pending
Palivizumab	Synagis	Anti-RSV; humanized IgG1	Prevention of respiratory syncytial virus infection	1998
Ranibizumab	Lucentis	Anti-VEGF; humanized IgG1 Fab	Macular degeneration	2006

Note: Information current as of November 1, 2009; *Proposed trade name; FDA, US Food and Drug Administration; GP, glycoprotein; PA, protective antigen; RANK-L, receptor activator of NFκb ligand; RSV, respiratory syncytial virus; TNF, tumor necrosis factor.