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Monoclonal antibodies with clinical indications

Definitions

30 monoclonal antibodies and immunoadhesins approved for therapeutic use are on the market. For updated information query IMGT/mAb-DB (in Development status, select Phase M)

- 5 Murine muromonab-CD3
(1992)
ORTHOCLONE OKT3®
edrecolomab
(1995)
PANOREX®
capromab
(1996)
PROSTASCINT®
ibritumomab tiuxetan
(2002)
ZEVALIN®
blinatumomab
(2006)
BLINCYTO®
- 7 Chimeric abciximab
(1993)
REOPRO®
rituximab
(1997)
MABTHERA®/
RITUXAN®
basiliximab
(1998)
SIMULECT®
infliximab
(1998)
REMICADE®
cetuximab
(2004)
ERBITUX®
brentuximab vedotin
(2011)
ADCETRIS®
siltuximab
(2014)
SYLVANT™
- 18 Humanized palivizumab
(1998)
SYNAGIS®
trastuzumab
(1998)
HERCEPTIN®
alemtuzumab
(2001)
CAMPATH®/
MABCAMPATH®/
LEMTRADA®
omalizumab
(2003)
XOLAIR®
bevacizumab
(2004)
AVASTIN®
natalizumab
(2004)
TYSABRI®/
ANTEGREN® (formerly)
ranibizumab
(2006)
LUCENTIS®
eculizumab
(2007)
SOLIRIS®
certolizumab pegol
(2008)
CIMZIA®
tocilizumab
(2010)
ACTEMRA®/
RoACTEMRA®
pertuzumab
(2012)
PERJETA®
obinutuzumab
(2013)
GAZYVA®/
GAZYVARO®
trastuzumab emtansine
(2013)
KADCYLA®
pembrolizumab
(2014)
KEYTRUDA®
vedolizumab
(2014)
ENTYVIO™
elotuzumab
(2015)
EMPLICITI™
idarucizumab
(2015)
PRAXBIND®
mepolizumab
(2015)
NUCALA®
(formerly BOSATRIA®)
- 22 Human adalimumab
(2002)
HUMIRA®
pegfilgrastim
(2002)
NEULASTA®
panitumumab
(2006)
VECTIBIX®
romiplostim
(2008)
NPLATE®
canakinumab
(2009)
ILARIS®
golimumab
(2009)
SIMPONI® (SC injection)/
SIMPONI ARIA® (IV infusion)
ofatumumab
(2009)
ARZERRA®
ustekinumab
(2009)
STELARA®
denosumab
(2010)
XGEVA®/
PROLIA®
belimumab
(2011)
BENLYSTA®
ipilimumab
(2011)
YERVOY®
raxibacumab
(2012)
ABthrax®
efmoroctocog alfa
(2014)
ELOCTATE®/
ELOCTA™
eftrenonacog alfa
(2014)
ALPROLIX®
nivolumab
(2014)
OPDIVO®
ramucirumab
(2014)
CYRAMZA™
alirocumab
(2015)
PRALUENT®
asfotase alfa
(2015)
STRENSIQ™
daratumumab
(2015)
DARZALEX™
evolocumab
(2015)
REPATHA™
necitumumab
(2015)
PORTRAZZA™
secukinumab
(2015)
COSENTYX®
- 5 Immunoadhesin etanercept
(1998)
ENBREL®
abatacept
(2005)
ORENCIA®
rilonacept
(2008)
ARCALYST®
aflibercept
(2011)
ZALTRAP®/
EYLEA®
belatacept
(2011)
NULOJIX®

The INN is followed by the date of first FDA approval and the commercial mark(s).

Development status

These phases are defined by the FDA in the Code of Federal Regulations.

Tables below are from 2009. For updated information, query IMGT/mAb-DB, at the IMGT Home page.

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Murine monoclonal antibodies

Number of results: 36

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
abagovomab 8659 95
(2006)
57
(2007)
ACA125,
MEN-2234
Murine 8659 IgG1κ MUC16 (CA125, Homo sapiens cancer antigen 125; MUC-16; Mus musculus mAb OC125)Paratope of anti-, (idiotope) [Homo sapiens] Mus musculus 3D5 Menarini (Florence Italy) Ovarian cancers Phase III
arcitumomab 7417 74
(1995)
36
(1996)
IMMU-4Fab'-Tc99m CEA-SCAN™ Murine radiolabelled with Technetium-99m, Tc-99m IgG1 Fab' CEACAM5 (carcinoembryonic antigen; CEA; CD66e) [Homo sapiens] Mus musculus Immunomedics Inc. (Morris Plains NJ USA) Breast cancers Phase II (BLA) 103425 83 [b] [n]
Colorectal cancers (radiodiagnostic imaging of tumors) Withdrawn EC withdrawal (on holders request) November 2005, EC approval October 1996, FDA approval June 1996 Murine ascites, pepsin digestion Diagnostic Oncology
Lung cancers Phase III
biciromab 6867 66
(1991)
32
(1992)
99mTc-MH1 Fab',
MH1-Fab' imaging agent
Murine radiolabelled with Technetium-99m, Tc-99m Fab' Fibrin [Homo sapiens] Mus musculus American Biogenetic Sciences (Boston MA USA) Cardiovascular thrombosis (in vivo imaging agent) Phase I/II [b]
capromab 7201 70
(1993)
34
(1994)
7E11-C5.3,
pendetide
PROSTASCINT® Murine radiolabelled with Indium-111, In-111 IgG1κ PSMA (prostate specific membrane antigen) [Homo sapiens] Mus musculus EUSA Pharma (Doylestown PA USA) Prostate cancers Phase M FDA approval October 1996 Diagnostic Unknown (BLA) 103608 [b] [d] [n]
edobacomab 7056 69
(1993)
34
(1994)
E5™ Murine IgM Endotoxin C0246612 [Homo sapiens] Mus musculus Xoma (Berkeley CA USA) / Pfizer (New York NY USA) Gram-negative sepsis Phase III [e]
edrecolomab 7471 74
(1995)
36
(1996)
17-1A PANOREX® Murine IgG2a EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Mus musculus Centocor Inc. (Horsham PA USA) / GlaxoSmithKline (Brentford UK) Colon cancers Phase M approval (Germany) January 1995 Sp2/0 mouse myeloma cells Therapeutic Unknown C1554 [a] [e]
enlimomab 6964 70
(1993)
34
(1994)
BIRR-1 Murine IgG2a CD54 (intercellular adhesion molecule 1; ICAM1) [Homo sapiens] Mus musculus Boehringer Ingelheim Pharmaceuticals (Ridgefield CT USA) Stroke Phase II/III [a] [e]
Thermal injury Phase II
gavilimomab 8060 84
(2000)
46
(2001)
ABX-CBL Murine IgM CD147 [Homo sapiens] Mus musculus Abgenix (Fremont CA USA) Allograft rejection Phase II [a] [b] [52]
Graft-versus-host disease (GvHD) (steroid-refractory) Phase III
ibritumomab tiuxetan 7873 81
(1999)
43
(2000)
IDEC-2B8 ZEVALIN® Murine radiolabelled with Yttrium-90, Y-90 IgG1κ MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus Biogen IDEC Pharmaceuticals (Cambridge MA USA) / Schering AG (Berlin Germany) Non-Hodgkin's B cell lymphoma (NHL) Phase M FDA approval February 2002 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology (BLA) 125019 762 [j] [n]
igovomab 7433 77
(1997)
39
(1998)
Indimacis 125,
OC125 chelator DTPA
Murine radiolabelled with Indium-111, In-111 IgG1 F(ab')2 Tumor associated antigen CA125 [Homo sapiens] Mus musculus CIS Bio international (Bagnols/Cèze France) Ovarian cancers Withdrawn EC withdrawal (on holders request) September 1999, FDA approval September 1996 Diagnostic Unknown [d] [n]
imciromab 6605 66
(1991)
32
(1992)
R1D10 pentetate MYOSCINT® Murine radiolabelled with Indium-111, In-111 IgG2aκ Fab Cardiac myosin [Homo sapiens] Mus musculus Centocor Inc. (Horsham PA USA) / Eli Lilly (Indianapolis IN USA) Myocardial infarction (imaging agent) Withdrawn FDA withdrawal (too expensive to manufacture) February 1999, FDA approval July 1996 Murine ascites, pepsin digestion Diagnostic Unknown (BLA) 103634 [b] [d] [n]
inolimomab 7253 71
(1994)
35
(1995)
Murine IL2RA (interleukin-2 receptor, alpha; IL-2R; TAC; CD25) [Homo sapiens] Mus musculus OPI (Orphan Pharma International) (Dardilly France) Acute graft versus host disease Phase II/III
mitumomab 7934 82
(1999)
44
(2000)
BEC2 Murine IgG GD3 idiotype [Homo sapiens] Mus musculus Merck KgaA (Darmstadt Germany) / ImClone Systems Inc. (Somerville NJ USA) / Memorial Sloan-Kettering Cancer Center (New York NY USA) Cancers Phase III [a] [e] (9)
Melanoma Phase III
Small cell lung cancers (SCLC) Phase III
muromonab-CD3 6281 59
(1988)
29
(1989)
OKT3 ORTHOCLONE OKT3® Murine IgG2a CD3E (CD3 epsilon; Leu-4) [Homo sapiens] Mus musculus Ortho Biotech Products LP (Bridgewater NJ USA) Acute kidney transplant rejection (reversal) Phase M FDA approval September 1992 Murine ascites, hybridoma (BLA) 103463 C1321 [a] [b] [d] [j] [n]
Heart transplant rejection (reversal) Phase M FDA approval September 1992 Murine ascites, hybridoma
Liver transplantation (reversal) Phase M FDA approval September 1992 Murine ascites, hybridoma
odulimomab 7364 73
(1995)
36
(1996)
afolimomab,
anti-LFA1
ANTILFA® Murine IgG1 F(ab')2 ITGAL (INTEGRIN-ALPHA-L; LFA-1, lymphocyte function associated antigen 1; CD11a) [Homo sapiens] Mus musculus 25.3 Pasteur Mérieux (Lyon France) Allograft rejection Phase III not renewed April 2000, ATU (Temporary Authorizations for Use) August 1994 [a] [n]
oregovomab 8183 86
(2002)
48
(2002)
MAB-B43.13,
oregovamab
OVAREX® Murine IgG1κ Tumor associated antigen CA125 [Homo sapiens] Mus musculus B43.13 AltaRex Corp. (Edmonton AB Canada) Ovarian cancers Phase II C1784 [a]
racotumomab 8998 100
(2008)
62
(2009)
1E10 Murine 8998 IgG1κ Paratope of anti-(N-glycolylneuraminic acid (NeuGc, NGNA)-gangliosides GM3) Mus musculus IgM-kappa P3, (idiotope) [Homo sapiens] Mus musculus CMI (Center of Molecular Immunology) (Playa Cuba) Breast cancers Preclinical
Melanoma Preclinical
satumomab 6977 68
(1992)
33
(1993)
B72.3,
CYT-099 pendetide
ONCOSCINT® CR/OV Murine radiolabelled with Indium-111, In-111
chelator DTPA
IgG1 TAG 72 (tumour associated glycoprotein 72) [Homo sapiens] Mus musculus Cytogen Corp. (Princeton NJ USA) / Lonza Biologics (Basel Switzerland) Colorectal cancers Withdrawn FDA approval December 1992 Diagnostic Unknown [b] [n]
Ovarian cancers Withdrawn FDA approval December 1992
sulesomab 7519 75
(1996)
37
(1997)
IMMU-MN3 LEUKOSCAN® Murine radiolabelled with Technetium-99m, Tc-99m Fab' NCA 90 (10) [Homo sapiens] Mus musculus Immunomedics Inc. (Morris Plains NJ USA) Acute atypical appendicitis [b] [d] (10)
Inflammatory bowel disease (IBD) Phase II
Osteomyelitis
technetium (99mTc) fanolesomab 8150 86
(2002)
48
(2002)
NeutroSpec (formerly leuTech),
RB5
Murine radiolabelled with Technetium-99m, Tc-99m IgM CD15 [Homo sapiens] Mus musculus Palatin Technologies Inc. (Cranbury NJ USA) Appendicitis (Radionuclide imaging) Withdrawn FDA withdrawal (life-threatening adverse events) December 2005, FDA approval July 2004 (BLA) 103928 [j]
technetium (99mTc) nofetumomab merpentan 7542 76
(1996)
38
(1997)
Fab-Technetium Tc 99m,
NR-LU-10
VERLUMA® Murine radiolabelled with Technetium-99m, Tc-99m IgG2b Fab MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus NeoRx Corp. (Seattle WA USA) / Boehringer Ingelheim Pharmaceuticals (Ridgefield CT USA) / DuPont Merck Pharmaceutical (Billerica MA USA) Small cell lung cancers (SCLC) Withdrawn FDA approval August 1996 (BLA) 103769 [b] [d] [n]
tenatumomab 8832 98
(2007)
60
(2008)
ST2146 Murine 8832 IgG2b TNC (Tenascin C; HBX, hexabrachion) [Homo sapiens] Mus musculus SIGMA-TAU Industrie Farmaceutiche Riunite S.p.A. (Pomezia Italy) Cancers
tositumomab 7827 80
(1998)
42
(1999)
BEXXAR® Murine radiolabelled with Iodine-131, I-131 IgG2a MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus GlaxoSmithKline (Brentford UK) / Corixa Corp. (Seattle WA USA) Non-Hodgkin's B cell lymphoma (NHL) (Follicular CD20 positive, following chemotherapy relapse) Phase M FDA approval June 2003 Hybridoma (BLA) 125011 C2543 834 [j] [n]
14F7 Murine IgG1 IRP-2 (Iron Regulatory Protein 2) [Homo sapiens] Mus musculus Centre of Molecular Immunology (Havana Cuba) Unknown [p]
14G2a Murine IgG2a GD2 ganglioside [Homo sapiens] Mus musculus National Cancer Institute (Bethesda MD USA) Melanoma Phase I [e]
Solid tumors Phase I
177 Lu-J591,
HuJ591-GS
Murine radiolabelled with Lutetium-177, Lu-177 PSMA (prostate specific membrane antigen) [Homo sapiens] Mus musculus Weill Cornell Medical (New York NY USA) Metastatic prostate cancers (androgen-Independent) Phase I/II (23)
225.28S,
Tecnemab-K-1
Murine radiolabelled with Technetium-99m, Tc-99m F(ab')2, Fab/Fab2 mix HMW-MAA (High molecular weight-melanoma-associated antigen) [Homo sapiens] Mus musculus Sorin Radiofarmaci S.R.L. (Milan Italy) Cutaneous melanoma lesions Withdrawn EC withdrawal (on holders request) February 2000, EC approval April 1997, FDA approval September 1996 [d] [n]
COL-1 Murine CEACAM3, CGM1 [Homo sapiens] Mus musculus National Cancer Institute (Bethesda MD USA) Colorectal cancers Phase I [e]
Gastric cancers Phase I
CYT-356-Y-90 ONCOLTAD® Murine Mus musculus Cytogen Corp. (Princeton NJ USA) Prostate cancers (targeted radiotherapy) Phase II [e]
HNK20 Murine IgA RSV (respiratory syncytial virus), Fgp [Homo sapiens] Mus musculus OraVax Inc. (Cambridge MA USA) Respiratory Syncytial Virus (RSV) disease Phase III [a] [n]
ImmuRAIT-LL2 Murine radiolabelled with Iodine-131, I-131 IgG2a Mus musculus Immunomedics Inc. (Morris Plains NJ USA) Non-Hodgkin's B cell lymphoma (NHL) Phase I/II [e]
Lym-1 Murine IgG2a HLA-DR10 [Homo sapiens] Mus musculus Peregrine Pharmaceuticals Inc. (Tustin CA USA) Cancers Preclinical [p]
MAK-195F Murine F(ab')2 TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Mus musculus Abbott Laboratories (Abbott Park IL USA) / Knoll Pharmaceutical (Mount Olive NJ USA) Sepsis toxic shock Phase III [a] [b] [e]
MEDI-500,
T10B9
Murine IgM CD3 [Homo sapiens]
TRαβ (T cell receptor alpha/beta), complex [Homo sapiens]
Mus musculus MedImmune Inc. (Gaithersburg MD USA) Graft-versus-host disease (GvHD) Phase III [a]
RING SCAN Murine radiolabelled with Indium-111, In-111 TAG 72 (tumour associated glycoprotein 72) [Homo sapiens] Mus musculus Neoprobe Corp. (Dublin OH USA) Breast cancers [j]
Colon cancers
Rectal cancers
AVICIDIN® conjuguate with streptavidin using Pretarget™ technology (biotin) Murine radiolabelled with Yttrium-90, Y-90 EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Mus musculus NeoRx Corp. (Seattle WA USA) Colon cancers Phase II [e]
Non-Hodgkin's lymphoma (NHL) Phase I
Ovarian cancers Phase II
Prostate cancers Phase II

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Rat monoclonal antibodies

Number of results: 1

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
BT1-322 Rat IgG2b Rattus sp. BioTransplant (Charlestown MA USA) / MedImmune Inc. (Gaithersburg MD USA) Acute kidney transplant rejection Phase I/II [e] [n] [62]
Graft-versus-host disease (GvHD) Phase I/II

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Chimeric monoclonal antibodies

Number of results: 24

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
abciximab 7200 70
(1993)
34
(1994)
c7E3 REOPRO® Chimeric IgG1κ Fab CD41/CD61, INTEGRIN-ALPHA-IIb_BETA-3, αIIbβ3, GPIIbIIIa, Fibrinogen receptor [Homo sapiens] Mus musculus 7E3 Centocor Inc. (Horsham PA USA) / Eli Lilly (Indianapolis IN USA) Anti-platelet prevention of blood clots in the setting of high risk percutaneous transluminal coronary angioplasty Phase M FDA approval December 1994 Sp2/0 mouse myeloma cells (BLA) 103575 332 [a] [b] [e] [f] [j]
Refractory unstable angina when percutaneous coronary intervention is planned Phase M FDA approval November 1997 Sp2/0 mouse myeloma cells
basiliximab 7578 76
(1996)
38
(1997)
CHI621 SIMULECT® Chimeric IgG1κ IL2RA (interleukin-2 receptor, alpha; IL-2R; TAC; CD25) [Homo sapiens] Mus musculus CHI621 Novartis Pharmaceuticals Corp. (East Hanover NJ USA) Prevention
Renal transplant rejection
Phase M FDA approval May 1998 Sp2/0 mouse myeloma cells (BLA) 103764 440 [a] [b] [d] [f] [j] [56]
bavituximab 8734 95
(2006)
57
(2007)
Tarvacin ch3G4 Chimeric 8734 IgG1κ Phosphatidylserine [Homo sapiens] Mus musculus Peregrine Pharmaceuticals Inc. (Tustin CA USA) Hepatitis C Phase I [p]
Influenza Preclinical
Solid tumors Phase II
cetuximab 7906 82
(1999)
44
(2000)
Fab C225,
IMC-225
ERBITUX® Chimeric 7906 1yy8
1yy9
IgG1κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Mus musculus C225 Merck & Co., Inc. (Whitehouse Station NJ USA) (EU) / ImClone Systems Inc. (Somerville NJ USA) (US) Metastatic colorectal cancers Phase M FDA approval February 2004 Sp2/0 mouse myeloma cells (BLA) 125084 C1723 850 [a] [b] [e] [j]
clenoliximab 7615 77
(1997)
39
(1998)
CE9γ4PE,
IDEC-151
PRIMATIZED® Chimeric IgG4λ CD4 (p55) [Homo sapiens] Macaca fascicularis Biogen IDEC Pharmaceuticals (Cambridge MA USA) / GlaxoSmithKline (Brentford UK) Asthma Phase II [a] [b] (21)
Rheumatoid arthritis (RA) Phase II
galiximab 8339 89
(2003)
51
(2004)
IDEC-114 Chimeric IgG1λ CD80, B7 [Homo sapiens] Macaca fascicularis Biogen IDEC Pharmaceuticals (Cambridge MA USA) Non-Hodgkin's B cell lymphoma (NHL) Phase II C26447 [a] [g]
Psoriasis Phase II
Rheumatoid arthritis (RA)
infliximab 7602 77
(1997)
39
(1998)
cA2 REMICADE® Chimeric IgG1 TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Mus musculus A2 Centocor Inc. (Horsham PA USA) Ankylosing spondylitis (AS) Phase M FDA approval December 2004 Sp2/0 mouse myeloma cells (BLA) 103772 C1789 703
759
[a] [b] [d] [f] [j] [53] [54]
Treatment
Crohn's disease (CD)
Phase M FDA approval August 1998 Sp2/0 mouse myeloma cells
Psoriatic arthritis (PSA) Phase M FDA approval May 2005 Sp2/0 mouse myeloma cells
Rheumatoid arthritis (RA) Phase M FDA approval November 1999 Sp2/0 mouse myeloma cells
Ulcerative colitis Phase M FDA approval October 2006 Sp2/0 mouse myeloma cells
keliximab 7560 76
(1996)
38
(1997)
IDEC CE9.1/SB-210396 Chimeric IgG1λ CD4 (p55) [Homo sapiens] Macaca fascicularis Biogen IDEC Pharmaceuticals (Cambridge MA USA) Treatment
Rheumatoid arthritis (RA) (chronic)
(21)
lumiliximab 8443 90
(2004)
52
(2004)
IDEC-152,
P5E8
Chimeric IgG1κ FCER2 (Immunoglobulin E receptor type II; CD23) [Homo sapiens] Macaca fascicularis Biogen IDEC Pharmaceuticals (Cambridge MA USA) Allergic asthma Phase I C26448 [a] [h] [i]
Chronic Lymphocytic Leukemia (CLL) Phase I
otelixizumab 8864 98
(2007)
60
(2008)
ChAglyCD,
TRX4
Chimeric
Humanized
8864 IgG1 CD3E (CD3 epsilon; Leu-4) [Homo sapiens] Rattus sp. TolerRx (Cambridge CA USA) Psoriatic arthritis (PSA)
pagibaximab 8643 93
(2005)
55
(2006)
Chimeric IgG1κ lipoteichoic acid [Staphylococcus epidermidis] Mus musculus Unknown Unknown
priliximab 7263 72
(1994)
35
(1995)
cm-MT412 Chimeric IgG1κ CD4 (p55) [Homo sapiens] Mus musculus Centocor Inc. (Horsham PA USA) Crohn's disease (CD) Phase II
rituximab 7609 77
(1997)
39
(1998)
IDEC-C2B8 MABTHERA®
RITUXAN® (US, Canada and Japan)
Chimeric IgG1κ MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus IDEC-C2B8 Biogen IDEC Pharmaceuticals (Cambridge MA USA) / Genzyme Corp. (Cambridge MA USA) Treatment
Non-Hodgkin's B cell lymphoma (NHL) (Follicular CD20 positive, relapsed or refractory low grade)
Phase M FDA approval November 1997 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells (BLA) 103705
(BLA) 103737
C1702 349 [a] [b] [d] [f] [j] (18) [55]
Rheumatoid arthritis (RA) Phase M FDA approval March 2006 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells
siltuximab 9051 100
(2008)
62
(2009)
CLLB8,
CNTO 328
Chimeric 9051 IgG1κ IL6 (interleukin 6; IL-6) [Homo sapiens] Centocor Inc. (Horsham PA USA) Multiple myeloma Phase II
Neoplasms Phase I
Renal cell carcinoma (RCC) Phase II
volociximab 8600 93
(2005)
55
(2006)
Chimeric IgG4 INTEGRIN-ALPHA-5_BETA-1, α5β1, VLA5, Fibronectin receptor [Homo sapiens] Mus musculus p200-M Unknown Unknown C48426
131I-chTNT (Tumor Necrosis Therapy) -1/B COTARA® Chimeric radiolabelled with Iodine-131, I-131 Mus musculus Peregrine Pharmaceuticals Inc. (Tustin CA USA) Glioblastoma multiforme (GBM) Phase III [b]
Malignant glioma (brain cancers) Phase II
Solid tumors Phase II
14,18 Chimeric Mus musculus National Cancer Institute (Bethesda MD USA) Leukemia Phase II NCI trial [b] [e]
Melanoma Phase II NCI trial
Neuroblastoma Phase II NCI trial
Solid tumors Phase II NCI trial
90Y-cT84.66 Chimeric CEACAM5 (carcinoembryonic antigen; CEA; CD66e) [Homo sapiens] Mus musculus T84.66 Beckman Research Institute (Duarte CA USA) Cancers Phase I [p] [59]
ALG-991 Chimeric Mus musculus Allergene (San Mateo CA USA) Poison ivy Phase III [e]
Poison oak Phase III
BMS-182248,
BR96
Chimeric doxorubicin conjugated Lewis Y [Homo sapiens] Mus musculus Bristol-Myers Squibb (Princeton NJ USA) Breast cancers Phase II E.coli (Escherichia coli) [c] [e] [14]
Ovarian cancers Phase II E.coli (Escherichia coli)
IC14 Chimeric CD14 [Homo sapiens] Mus musculus 28C5 ICOS Corporation (Bothell WA USA) Sepsis toxic shock (severe) Phase I CHO (Chinese Hamster Ovary) cells [a] [b]
IMC-1C11 Chimeric VEGF (Vascular Endothelial Growth Factor) [Homo sapiens] ImClone Systems Inc. (Somerville NJ USA) Prevention
Angiogenesis
C2037
Lym-1 radiolabelled,
Oncolym
ONCOLYM® Chimeric radiolabelled with Iodine-131, I-131 IgG2a HLA-DR10 [Homo sapiens] Mus musculus Peregrine Pharmaceuticals Inc. (Tustin CA USA) / Alpha Therapeutic Corp. (Los Angeles CA USA) Non-Hodgkin's B cell lymphoma (NHL) Phase III [e] [p] (19)
CORSEVIN™ M Chimeric Fab Factor VII [Homo sapiens] Mus musculus Centocor Inc. (Horsham PA USA) / Corvas International Inc. (San Diego CA USA) Anticoagulant Phase I [a] [e]

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Humanized monoclonal antibodies

Number of results: 127

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
afutuzumab 9043 99
(2008)
GA101 Humanized 9043 IgG1κ MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus B-ly1 Biogen IDEC Pharmaceuticals (Cambridge MA USA) / F. Hoffmann-La Roche Ltd. (Basel Switzerland) / Genentech Inc. (S. San Francisco CA USA) Non-Hodgkin's B cell lymphoma (NHL) [p]
alacizumab pegol 8976 98
(2007)
60
(2008)
CDP791,
g165 DFM-PEG
Humanized 8976 Fab' KDR (kinase insert domain receptor; VEGFR2, Vascular endothelial growth factor receptor 2; VEGF-R2; FLK1; CD309) [Homo sapiens] Mus musculus Celltech, UCB (Brussels Belgium) Unknown
alemtuzumab 8005 83
(2000)
45
(2001)
Campath-1H,
LDP-03
CAMPATH® (US)
MABCAMPATH® (EU)
Humanized 8005 1bey
1ce1
IgG1κ CD52 [Homo sapiens] Rattus norvegicus YTH34.5HL Berlex Inc. (Wayne NJ USA) (US) / Genzyme Corp. (Cambridge MA USA) (EU) / Millennium Pharmaceuticals Inc. (Cambridge MA USA) (EU/US) B cell chronic lymphocytic leukemia (B-CLL) Phase M FDA approval May 2001 CHO (Chinese Hamster Ovary) cells Therapeutic Immunology, Oncology (BLA) 103948 C1681 702 [a] [b] [c] [19]
Kidney transplant rejection Phase I/II CHO (Chinese Hamster Ovary) cells
Multiple sclerosis (MS) Phase I/II CHO (Chinese Hamster Ovary) cells
anrukinzumab 8942 98
(2007)
60
(2008)
IMA-638 Humanized 8942 IgG1 IL13 (interleukin 13; IL-13) [Homo sapiens] Mus musculus IMA-638 Wyeth Pharmaceuticals (Madison NJ USA) Asthma Phase II
apolizumab 8210 87
(2002)
49
(2003)
REMITOGEN™
SMART™ 1D10
Humanized IgG1 HLA-DRB (HLA-DR beta) [Homo sapiens] Mus musculus PDL (Protein Design Labs) BioPharma (Fremont CA USA) B cell chronic lymphocytic leukemia (B-CLL) (refractory) Phase II C2228 [b]
Non-Hodgkin's B cell lymphoma (NHL) Phase II
bapineuzumab 8624 93
(2005)
55
(2006)
Humanized IgG1 Beta amyloid (β-amyloid) [Homo sapiens] Mus musculus AAB-001 Wyeth Pharmaceuticals (Madison NJ USA) Alzheimer's disease Phase III
bevacizumab 8017 83
(2000)
45
(2001)
12-IgG1,
F(ab)-12 IgG1,
Fab-12 IgG1,
rhuMAb-VEGF
AVASTIN® Humanized 8017 1bj1 IgG1 VEGF-A (Vascular Endothelial Growth Factor A) [Homo sapiens] Mus musculus muMAb-VEGF A.4.6.1 Genentech Inc. (S. San Francisco CA USA) (EU) Breast cancers (metastatic HER2 negative) Phase M FDA approval February 2008 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology (BLA) 125085 851 [a] [b] (20)
Metastatic carcinoma of the colon and rectum Phase M FDA approval February 2004 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology
Metastatic colorectal cancers Phase M FDA approval June 2006 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology
Metastatic non-small cell lung cancers Phase M FDA approval October 2006 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology
Genentech Inc. (S. San Francisco CA USA) / NIH (Bethesda MD USA) Renal cancers Phase II NCI trial
bivatuzumab 7965 83
(2000)
45
(2001)
Humanized Boehringer Ingelheim Pharmaceuticals (Ridgefield CT USA) Squamous cancers Phase I Market discontinued (skin toxicity) February 2005
cantuzumab mertansine 8223 89
(2003)
51
(2004)
SB408075,
huC242-DMI
Humanized Mus musculus GlaxoSmithKline (Brentford UK) / ImmunoGen Inc. (Cambridge MA USA) Colorectal cancers Phase I/II [b]
Non-small-cell lung cancers Phase I/II
Pancreatic cancers Phase I/II
cedelizumab 7567 77
(1997)
39
(1998)
ORTHOCLONE OKT4 A Humanized IgG CD4 (p55) [Homo sapiens] Mus musculus Ortho Biotech Products LP (Bridgewater NJ USA) Treatment
CD4 mediated autoimmune diseases
Phase II [a] [b]
Prevention
Organ transplant allograft rejection
Phase II
certolizumab pegol 8448 90
(2004)
52
(2004)
CDP870,
PHA-738144
CIMZIA® Humanized PEGylated Fab' TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Mus musculus Celltech, UCB (Brussels Belgium) Crohn's disease (CD) Phase M FDA approval April 2008 (BLA) 125160
Rheumatoid arthritis (RA) Phase III
citatuzumab bogatox 9046 99
(2008)
61
(2009)
VB6-845 Humanized
Immunotoxin
Bougainvillea spectabilis Willd bouganin 9046 Fab EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Mus musculus Humanized Viventia Biotechnologies Inc. (Mississauga ON Canada) Solid tumors Phase I
dacetuzumab 8959 98
(2007)
60
(2008)
SGN-40,
huS2C
Humanized 8959 IgG1 CD40 (tumor necrosis factor receptor superfamily member 5; TNFRSF5) [Homo sapiens] Mus musculus Genentech Inc. (S. San Francisco CA USA) / Seattle genetics, Inc. (Bothell WA USA) Diffuse large B-cell lymphoma (DLBCL) Phase II [p]
Multiple myeloma Phase I
Non-Hodgkin's lymphoma (NHL) Phase I
daclizumab 7164 78
(1997)
40
(1998)
ZENAPAX® Humanized IgG1 IL2RA (interleukin-2 receptor, alpha; IL-2R; TAC; CD25) [Homo sapiens] Mus musculus 1H4 F. Hoffmann-La Roche Ltd. (Basel Switzerland) (EU) Prevention
Acute kidney transplant rejection
Phase M FDA approval December 1997 Sp2/0 mouse myeloma cells Therapeutic Immunology (BLA) 103749 C1569 359 [b] [c] [j] [46] [50]
PDL (Protein Design Labs) BioPharma (Fremont CA USA) Asthma Phase II
Blood cancers Phase II
Graft-versus-host disease (GvHD) Phase II
Liver transplantation Phase II
Pediatric kidney transplantation Phase I/II
Psoriasis Phase II
Tropical spastic paraparesis (model for multiple sclerosis) Phase I/II
Ulcerative colitis Phase II
Uveitis Phase I/II
eculizumab 8231 87
(2002)
49
(2003)
5G1.1 SOLIRIS™ Humanized IgG C5 (complement 5) [Homo sapiens] Mus musculus Alexion Pharmaceuticals Inc. (New Haven CT USA) Dermatomyositis Phase I/II (BLA) 125166 C48386 945 [a] [b]
Nephritis Phase II
Paroxysmal nocturnal hemoglobinuria (PNH) Phase M FDA approval March 2007 Therapeutic Unknown
Psoriasis Phase I/II
Rheumatoid arthritis (RA) Phase II
efalizumab 8122 85
(2001)
47
(2002)
hu1124 RAPTIVA® Humanized IgG1κ ITGAL (INTEGRIN-ALPHA-L; LFA-1, lymphocyte function associated antigen 1; CD11a) [Homo sapiens] Mus musculus Genentech Inc. (S. San Francisco CA USA) (EU/US) / Merck Serono International S.A. (Geneva Switzerland) (EU) / Xoma (Berkeley CA USA) (US) Psoriasis (infection in chronic moderate to severe plaque) Withdrawn FDA withdrawal (risk of developing progressive multifocal leukoencephalopathy) March 2009, FDA approval October 2003 CHO (Chinese Hamster Ovary) cells Therapeutic Immunology (BLA) 125075 C68831 [a] [b] [j]
elotuzumab 9074 100
(2008)
62
(2009)
HuLuc63,
PDL-063,
PDL063
Humanized 9074 IgG1κ SLAM7 (SLAM family member 7; CD2 subset 1; CS1; CRACC, CD2-like receptor-activating cytotoxic cells; 19A24; CD319) [Homo sapiens] Homo sapiens PDL (Protein Design Labs) BioPharma (Fremont CA USA) Multiple myeloma Phase I
epratuzumab 7920 82
(1999)
44
(2000)
hLL2 LYMPHOCIDE™ Humanized radiolabelled with Yttrium-90, Y-90 IgG1 CD22 (BL-CAM) [Homo sapiens] Mus musculus Immunomedics Inc. (Morris Plains NJ USA) Non-Hodgkin's B cell lymphoma (NHL) Phase I/II C1887 [a] [b] [e]
Systemic lupus erythematosus (SLE)
etaracizumab 8862 99
(2008)
61
(2009)
MEDI-522,
hLM60
VITAXIN® Humanized 8862 IgG1 ITGAV/ITGB3 (INTEGRIN-ALPHA-V_BETA-3; αvβ3; CD51/CD61; CD51/GPIIIa; CD51/platelet membrane glycoprotein IIIa; VNR, vitronectin receptor; AlphaVbeta3 integrin) [Homo sapiens] Mus musculus LM609 MedImmune Inc. (Gaithersburg MD USA) Metastatic melanoma Phase II [a]
Sarcoma Phase II
farletuzumab 9067 100
(2008)
62
(2009)
M3,
MORAb-003
Humanized 9067 IgG1κ FOLR1 (folate receptor 1; FR-alpha, folate receptor alpha; FBP, adult folate-binding protein) ovarian tumor-associated antigen MOv18 [Homo sapiens] Homo sapiens Morphotek Inc. (Exton PA USA) Ovarian cancers Phase II EC Orphan drug April 2008
felvizumab 7623 77
(1997)
39
(1998)
SB 209763 Humanized IgG1 RSV (respiratory syncytial virus) [virus] Mus musculus Centocor Inc. (Horsham PA USA) / GlaxoSmithKline (Brentford UK) / Scotgen Biopharmaceuticals Ltd. (Aberdeen UK) Treatment
Respiratory Syncytial Virus (RSV) disease (Prophylaxis)
Phase III [e]
fontolizumab 8264 87
(2002)
49
(2003)
Humanized IgG1 IFNG (interferon gamma; IFN gamma) [Homo sapiens] Mus musculus Novartis Pharmaceuticals Corp. (East Hanover NJ USA) / PDL (Protein Design Labs) BioPharma (Fremont CA USA) Crohn's disease (CD) Phase I/II
gemtuzumab 8024 83
(2000)
45
(2001)
CMA-676 MYLOTARG® Humanized calicheamicin conjugated IgG4κ CD33 (SIGLEC3; SIGLEC-3; gp67; p67) [Homo sapiens] Mus musculus p67,6 Wyeth Pharmaceuticals (Madison NJ USA) Acute myeloid leukemia (AML) (CD33 positive) Phase M FDA approval May 2000 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells Therapeutic Hematology, Oncology (NDA) 021174 842 [f] [j] (17)
ibalizumab 8818 97
(2007)
59
(2008)
Hu5A8,
TNX-355
Humanized 8818 IgG4 CD4 (p55) [Homo sapiens] Mus musculus Tanox Inc. (Houston TX USA) AIDS, HIV infection Phase II [l]
labetuzumab 8127 85
(2001)
47
(2002)
hMN14 CEACIDE™ Humanized IgG CEACAM5 (carcinoembryonic antigen; CEA; CD66e) [Homo sapiens] Mus musculus Immunomedics Inc. (Morris Plains NJ USA) Colorectal cancers Phase I/II C2043 [b]
lintuzumab 7580 76
(1996)
38
(1997)
HuM195,
Huma195-gelonin,
SGN-33,
SGN-70
ZAMYL™
SMART™ M195
Humanized IgG CD33 (SIGLEC3; SIGLEC-3; gp67; p67) [Homo sapiens] Mus musculus PDL (Protein Design Labs) BioPharma (Fremont CA USA) / Seattle genetics, Inc. (Bothell WA USA) Acute myeloid leukemia (AML) Phase III Sp2/0 mouse myeloma cells (ATCC CRL 1581) [b] [32]
Autoimmune diseases Phase I Sp2/0 mouse myeloma cells (ATCC CRL 1581)
Myelodysplastic syndrome Phase II Sp2/0 mouse myeloma cells (ATCC CRL 1581)
matuzumab 8103 88
(2003)
50
(2003)
EMD-72000,
EMD72000
Humanized IgG1 EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB), (epitope on external domain) [Homo sapiens] Mus musculus 425 Merck Serono International S.A. (Geneva Switzerland) / Takeda Pharmaceutical Co. Ltd. (Osaka Japan) Treatment
Lung cancers
Phase II [c] [k] [4]
Treatment
Stomach cancer
Phase II
mepolizumab 7876 81
(1999)
43
(2000)
SB-240563 Bosatria® Humanized IL5 (interleukin 5; IL-5) [Homo sapiens] Mus musculus Centocor Inc. (Horsham PA USA) / GlaxoSmithKline (Brentford UK) Asthma Phase II [a]
Atopic dermatitis Phase II
Hypereosinophilic syndrome (HES) Phase III
milatuzumab 8922 98
(2007)
60
(2008)
MEDI-115,
hLL1
Humanized 8922 IgG1 CD74 (major histocompatibility complex class II invariant chain) [Homo sapiens] Mus musculus MedImmune Inc. (Gaithersburg MD USA) Multiple myeloma
motavizumab 8693 95
(2006)
57
(2007)
MEDI-524 NUMAX® Humanized 8693 IgG1κ RSV (respiratory syncytial virus)
F glycoprotein (fusion protein)
Mus musculus MedImmune Inc. (Gaithersburg MD USA) Prevention
Respiratory Syncytial Virus (RSV) disease
Phase III [p]
natalizumab 7716 79
(1998)
41
(1999)
AN100226m TYSABRI®
ANTEGREN® (formerly)
Humanized IgG1 INTEGRIN-ALPHA-4_BETA-1, α4β1, VLA4, VCAM1 receptor [Homo sapiens] Mus musculus Biogen IDEC Pharmaceuticals (Cambridge MA USA) / Elan Pharmaceuticals International Ltd. (Dublin Ireland) Acute and chronic inflammatory condtions COS cells transient expression (BLA) 125104 869 [a] [b] [c] [e] [j] [k] (3) (4) [7]
Colitis Phase II
Crohn's disease (CD) Phase M FDA approval January 2008 NSO mouse myeloma cells Therapeutic Unknown
Multiple sclerosis (MS) Phase M FDA SBLA reintroduced June 2006, Market suspension (three patients developed progressive multifocal leukoencephalopathy (PML)) February 2005, FDA approval November 2004 NSO mouse myeloma cells Therapeutic Immunology
nimotuzumab 8545 94
(2005)
56
(2006)
Theraloc,
hR3
THERACIM® (India, China, Cuba, Argentina, Columbia) Humanized IgG1κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Mus musculus YM BioScienecs Inc. (Mississauga Canada) Glioma cancers Phase M EMEA withdrawal December 2008, EMEA Orphan drug September 2004 NSO mouse myeloma cells Therapeutic Unknown C2733 [n]
Head cancers Phase M NSO mouse myeloma cells Therapeutic Unknown
Lung cancers Phase II
Metastatic pancreatic cancers Phase II
Neck cancers Phase M NSO mouse myeloma cells Therapeutic Unknown
Pancreatic cancers Phase M EMEA Orphan drug June 2008 NSO mouse myeloma cells Therapeutic Unknown
ocrelizumab 8636 94
(2005)
56
(2006)
2H7 Humanized IgG1 MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus Biogen IDEC Pharmaceuticals (Cambridge MA USA) / F. Hoffmann-La Roche Ltd. (Basel Switzerland) / Genentech Inc. (S. San Francisco CA USA) Lupus nephritis Phase III C66250
Multiple sclerosis (MS) (relapsing remitting) Phase II
Rheumatoid arthritis (RA) Phase III
Systemic lupus erythematosus (SLE) Phase III
omalizumab 8039 84
(2000)
46
(2001)
IGE25,
olizumab,
rhuMab-E25
XOLAIR® Humanized IgG1κ IgE, CH3 [Homo sapiens] Mus musculus MaE11 Genentech Inc. (S. San Francisco CA USA) / Novartis Pharmaceuticals Corp. (East Hanover NJ USA) / Tanox Inc. (Houston TX USA) Allergic asthma Phase M CHO (Chinese Hamster Ovary) cells Therapeutic Immunology (BLA) 103976 C29299 [a] [b] [l]
Severe persistent asthma Phase M FDA approval (for subcutaneous use) June 2003 CHO (Chinese Hamster Ovary) cells Therapeutic Immunology
oportuzumab monatox 9045 100
(2008)
62
(2009)
VB4-845 PROXINIUM™
VICINIUM™
Humanized
Immunotoxin
Pseudomonas aeruginosa exotoxin A 9045 scFv EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Homo sapiens Viventia Biotechnologies Inc. (Mississauga ON Canada) Bladder cancers Phase II FDA Orphan drug (US) February 2005
Head cancers Phase II/III FDA Orphan drug (US) February 2005
Neck cancers Phase II/III FDA Orphan drug (US) February 2005
otelixizumab 8864 98
(2007)
60
(2008)
ChAglyCD,
TRX4
Chimeric
Humanized
8864 IgG1 CD3E (CD3 epsilon; Leu-4) [Homo sapiens] Rattus sp. TolerRx (Cambridge CA USA) Psoriatic arthritis (PSA)
palivizumab 7753 79
(1998)
41
(1999)
MEDI-493 SYNAGIS® Humanized 2hwz IgG1κ RSV (respiratory syncytial virus)
F glycoprotein (fusion protein)
Mus musculus Abbott Laboratories (Abbott Park IL USA) (EU) / MedImmune Inc. (Gaithersburg MD USA) (US) Respiratory Syncytial Virus (RSV) disease (prophylaxis of lower respiratory tract disease in pediatric patients) Phase M AMM Market authorization (Abbott) August 1999, FDA approval June 1998 NSO mouse myeloma cells Therapeutic Pulmonary, Respiratory diseases (BLA) 103770 C2625 447 [a] [b] [d] [j] [49]
pascolizumab 8227 87
(2002)
49
(2003)
SB-240683 Humanized IL4 (interleukin 4; IL-4) [Homo sapiens] Mus musculus Centocor Inc. (Horsham PA USA) / GlaxoSmithKline (Brentford UK) Allergy Phase II [a]
Asthma Phase II
pertuzumab 8380 89
(2003)
51
(2004)
rhuMAB 2C4 OMNITARG™ Humanized 8380 1l7i
1s78
IgG1κ ERBB2 (Epidermal Growth Factor Receptor 2; HER-2; p185c-erbB2; NEU; EGFR2) [Homo sapiens] Mus musculus Genentech Inc. (S. San Francisco CA USA) Breast cancers Phase III C38692
Prostate cancers Phase II
pexelizumab 8153 85
(2001)
47
(2002)
5G1.1-SC Humanized scFv C5 (complement 5) [Homo sapiens] Mus musculus Alexion Pharmaceuticals Inc. (New Haven CT USA) Cardiopulmonary bypass Phase III [a]
Myocardial infarction Phase II
ranibizumab 8313 90
(2004)
52
(2004)
Fab-12 variant Y0317,
RhuFab
LUCENTIS® Humanized 8313 1cz8 Fab VEGF-A (Vascular Endothelial Growth Factor A) [Homo sapiens] Mus musculus muMAb-VEGF A.4.6.1 Genentech Inc. (S. San Francisco CA USA) / Novartis Pharmaceuticals Corp. (East Hanover NJ USA) Neovascular (wet) age related macular degeneration (AMD) Phase M FDA approval June 2006 E.coli (Escherichia coli) Therapeutic Ophthalmology (BLA) 125156 904
ruplizumab 8014 83
(2000)
45
(2001)
BG-9588,
hu5c8
Antova™ Humanized IgG1κ CD40LG (CD40 ligand; CD40L; TNFSF5, tumor necrosis factor ligand superfamily member 5; TRAP, tumor necrosis factor related activation protein) [Homo sapiens] Mus musculus Biogen IDEC Pharmaceuticals (Cambridge MA USA) Allograft rejection Phase I/II [a]
Systemic lupus erythematosus (SLE) Phase II
siplizumab 8251 87
(2002)
49
(2003)
MEDI-507 Humanized CD2 (LFA-2, Lymphocyte function antigen 2) [Homo sapiens] Rattus sp. BT1-322 BioTransplant (Charlestown MA USA) / MedImmune Inc. (Gaithersburg MD USA) Acute kidney transplant rejection Phase I/II [a] [b]
Graft-versus-host disease (GvHD) Phase II
MedImmune Inc. (Gaithersburg MD USA) Psoriasis Phase II
solanezumab 9097 100
(2008)
62
(2009)
LY2062430 Humanized 9097 IgG1κ Amyloid-beta (Abeta) peptide soluble monomer [Homo sapiens] Homo sapiens Eli Lilly (Indianapolis IN USA) Alzheimer's disease Phase II
sontuzumab 8438 94
(2005)
56
(2006)
AS1402,
huHMFG-1
Humanized IgG1 MUC1 (mucin1; CD227; PEM, polymorphic epithelial mucin) [Homo sapiens]
Episialin [Homo sapiens]
Mus musculus Antisoma (London UK) Breast cancers Phase I
tadocizumab 8651 94
(2005)
56
(2006)
C4G1,
YM-337
Humanized 8651 IgG1 CD41/CD61, INTEGRIN-ALPHA-IIb_BETA-3, αIIbβ3, GPIIbIIIa, Fibrinogen receptor, platelet [Homo sapiens] Mus musculus PDL (Protein Design Labs) BioPharma (Fremont CA USA) / Yamanouchi USA (White Plains NY USA) Platelet aggregation Phase II [b]
tanezumab 8941 99
(2008)
61
(2009)
RN624 Humanized 8941 IgG2 NGF (nerve growth factor; NGFB, beta polypeptide) [Homo sapiens] Mus musculus Pfizer (New York NY USA) Chronic pain Phase II
Severe acute Phase II
teplizumab 8869 97
(2007)
59
(2008)
MGA031,
hOKT3-gamma-1 (Ala-Ala),
humanized OKT3
Humanized 8869 IgG1κ CD3E (CD3 epsilon; Leu-4) [Homo sapiens] Mus musculus OKT3 MacroGenics Inc. (Rockville MD USA) Type 1 diabetes Phase I/II CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells, COS-1 cells transient expression and larger scale preparation in roller bottles [c] [37]
tigatuzumab 8979 98
(2007)
60
(2008)
CS-1008,
TRA-8
Humanized 8979 IgG1 TNFRSF10B (tumor necrosis factor receptor superfamily member 10B; DR5, death receptor 5; TRAIL-R2, TNF-related apoptosis-inducing ligand receptor 2; TR-2; CD262) [Homo sapiens] Mus musculus Daiichi Sankyo Inc. (Parsippany NJ USA) Unknown
tocilizumab 8394 90
(2004)
52
(2004)
MRA,
atlizumab,
rhPM-1
ACTEMRA™
RoACTEMRA® (EU)
Humanized IgG1κ IL6R (interleukin 6 receptor; IL-6R) [Homo sapiens] Mus musculus Chugai pharmaceuticals Co. Ltd. (Japan) / F. Hoffmann-La Roche Ltd. (Basel Switzerland) (EU) Lymphoproliferative disorder giant lymph node hyperplasia (Castleman's disease) Phase III NDA approval April 2005 CHO (Chinese Hamster Ovary) DHFR cells H-C-955 L04AC07 [c] (5) [38]
Multiple myeloma CHO (Chinese Hamster Ovary) DHFR cells
Rheumatoid arthritis (RA) Phase III EMEA approval November 2008 CHO (Chinese Hamster Ovary) DHFR cells Therapeutic Unknown
toralizumab 8232 87
(2002)
49
(2003)
E6040,
IDEC-131
Humanized CD40LG (CD40 ligand; CD40L; TNFSF5, tumor necrosis factor ligand superfamily member 5; TRAP, tumor necrosis factor related activation protein) [Homo sapiens] Mus musculus Biogen IDEC Pharmaceuticals (Cambridge MA USA) / Eisai Co. Ltd. (Tokyo Japan) Multiple sclerosis (MS) Phase II [a] [b]
Systemic lupus erythematosus (SLE) Phase I
trastuzumab 7637 78
(1997)
40
(1998)
4D5V8,
Herceptin
HERCEPTIN® Humanized 7637 1n8z IgG1κ ERBB2 (Epidermal Growth Factor Receptor 2; HER-2; p185c-erbB2; NEU; EGFR2) [Homo sapiens] Mus musculus 4D5 F. Hoffmann-La Roche Ltd. (Basel Switzerland) (EU) / Genentech Inc. (S. San Francisco CA USA) (US) Breast cancers (as adjuvant) Phase III CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells (BLA) 103792 C1647 485 [a] [b] [d] [e] [j] [48]
Metastatic breast cancers overexpressing ERBB2 Phase M AMM Market authorization (Roche) August 2000, FDA approval October 1998 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells Therapeutic Oncology
Non-small-cell lung cancers Phase II CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells
tucotuzumab celmoleukin 8652 94
(2005)
56
(2006)
EMD 273066,
KSA-Interleukin-2,
huKS-IL2
Humanized IgG1 mAb huKS - interleukin 2 EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) Merck Serono International S.A. (Geneva Switzerland) Ovarian cancers Phase II
Small cell lung cancers (SCLC) Phase II
vedolizumab 9093 100
(2008)
62
(2009)
LDP-02,
LDP02,
MLN-02,
MLN0002,
MLN02
Humanized 9093 IgG1κ INTEGRIN-ALPHA-4_BETA-7, α4β7, LPAM-1 (lymphocyte Peyer's patch adhesion molecule 1) [Homo sapiens] Homo sapiens MRC Technology (UK) / Genentech Inc. (S. San Francisco CA USA) / Millennium Pharmaceuticals Inc. (Cambridge MA USA) Inflammatory bowel disease (IBD) Phase II [a] [b] [k]
Ulcerative colitis Phase II
veltuzumab 8932 98
(2007)
60
(2008)
IMMU-106,
hA20
Humanized 8932 IgG1 MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus MedImmune Inc. (Gaithersburg MD USA) Non-Hodgkin's lymphoma (NHL) Phase I
visilizumab 8054 84
(2000)
46
(2001)
HuM291 NUVION®
SMART™ anti-CD3
Humanized IgG2 CD3E (CD3 epsilon; Leu-4) [Homo sapiens] Mus musculus PDL (Protein Design Labs) BioPharma (Fremont CA USA) Allograft rejection Phase I/II C2687 [a] [b]
Autoimmune diseases Phase I
Intravenous steroid-refractory ulcerative colitis (IVSR-UC) Phase I/II
Kidney transplantation Phase II
Psoriasis Phase I/II
yttrium (90Y) tacatuzumab tetraxetan 8484 91
(2004)
55
(2006)
hAFP-31 Humanized radiolabelled with Yttrium-90, Y-90 IgG1 Alpha fetoprotein (α-fetoprotein) [Homo sapiens] Mus musculus Unknown Unknown
0.5B,
0.5beta
Humanized IgG1 HIV-1 (human immunodeficiency virus), IIIB gp120 V3 loop [virus] Mus musculus MRC Technology (UK) / Kaketsuken (Kumamoto Japan) Prevention and treatment
AIDS, HIV infection
Preclinical COS cells transient expression [c] [k] (1) [1]
15 Humanized 4F2, CD98hc (CD98 heavy chain), FRP-1 (fusion regulatory protein 1) [Homo sapiens] Mus musculus MRC Technology (UK) / Merck KgaA (Darmstadt Germany) Cancers
1B4 Humanized IgG4 ITGB2 (INTEGRIN-BETA-2; CD18) [Homo sapiens] Mus musculus Merck & Co., Inc. (Whitehouse Station NJ USA) / NIH (Bethesda MD USA) Acute inflammatory disease CV1P cells [c] [2]
3α4D10 Humanized IgG1 Toxin, (epitope ARGFAK) [Clostridium perfringens] Mus musculus Scotgen Biopharmaceuticals Ltd. (Aberdeen UK) / University of Aberdeen (Aberdeen UK) Gas gangrene YB2/0 rat myeloma cells [c] [3]
4D5,
DOTA-4D5 conjugated
Humanized radiolabelled with Yttrium-90, Y-90
radiolabelled with Indium-111, In-111
IgG1κ ERBB2 (Epidermal Growth Factor Receptor 2; HER-2; p185c-erbB2; NEU; EGFR2), extracellular domain [Homo sapiens] Mus musculus 4D5 Genentech Inc. (S. San Francisco CA USA) Breast cancers (overexpressing ERBB2) Adenovirus transformed human embryonic 293 kidney cells [c] [47]
Ovarian cancers (overexpressing ERBB2) Adenovirus transformed human embryonic 293 kidney cells
5c8 Humanized CD40LG (CD40 ligand; CD40L; TNFSF5, tumor necrosis factor ligand superfamily member 5; TRAP, tumor necrosis factor related activation protein) [Homo sapiens] Mus musculus MRC Technology (UK) / Biogen IDEC Pharmaceuticals (Cambridge MA USA) Autoimmune diseases [k]
Inflammation
60,3 Humanized IgG1 ITGB2 (INTEGRIN-BETA-2; CD18) [Homo sapiens] Mus musculus Bristol-Myers Squibb (Princeton NJ USA) Myocardial infarction Ag8.653 mouse myeloma cells [c] (2) [5]
7F11C7,
CTM01
Humanized IgG4 MUC1 (mucin1; CD227; PEM, polymorphic epithelial mucin) [Homo sapiens] Mus musculus Celltech, UCB (Brussels Belgium) Breast cancers [c] (6) (7) [18]
Ovarian cancers NSO mouse myeloma cells, Transient in CHO (Chinese Hamster Ovary) L761h cells
A4.6.1 Humanized IgG1 VEGF (Vascular Endothelial Growth Factor) [Homo sapiens] Mus musculus Genentech Inc. (S. San Francisco CA USA) Cancers E.coli (Escherichia coli) [c] [6]
ABC-48,
CY-174
Humanized SELP (P-selectin; CD62P) [Homo sapiens] Mus musculus MRC Technology (UK) / Cytel Corporation (San Diego CA USA) Inflammation Preclinical [k]
ABC-88,
CY-178
Humanized SELE (E-selectin; CD62E) [Homo sapiens] Mus musculus MRC Technology (UK) / Cytel Corporation (San Diego CA USA) Inflammation [k]
AD-159 Humanized HIV (human immunodeficiency virus), gp120 [virus] Mus musculus Tanox Inc. (Houston TX USA) AIDS, HIV infection Phase I/II [a]
AD-439 Humanized HIV (human immunodeficiency virus), gp120 V3 loop [virus] Mus musculus Tanox Inc. (Houston TX USA) AIDS, HIV infection Phase II [a] [e]
AS1409,
BC1-IL12,
huBC1-huIL12
Humanized mAb huBC1 - interleukin 12 ED-B (extra domain B) of fibronectin [Homo sapiens] Antisoma (London UK) Melanoma Phase I
Renal cancers Phase I
AT13/5 Humanized IgG1 CD38 [Homo sapiens] Mus musculus Tenovus Research (UK) / Wellcome (London UK) Multiple myeloma CHO (Chinese Hamster Ovary) cells, NSO mouse myeloma cells [c] [8]
AUK12-20 Humanized IgG1 IL6R (interleukin 6 receptor; IL-6R) [Homo sapiens] Mus musculus MRC Technology (UK) / Chugai pharmaceuticals Co. Ltd. (Japan) / Osaka University Medical School (Osaka Japan) IL6 dependent tumors COS cells transient expression [c] [k] (5) [9]
Anti-TAC 90 Υ-HAT Humanized radiolabelled with Yttrium-90, Y-90 Mus musculus National Cancer Institute (Bethesda MD USA) Lymphoma Phase I
BAT STIMUMAB™ Humanized IgG1 T cell transmembrane protein [Homo sapiens] Mus musculus MRC Technology (UK) / CureTech (Yavne Israel) Cancers Preclinical [k]
BAY 103356,
BAY W 3356,
CDP571
Humicade™ Humanized IgG4 TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Mus musculus Celltech, UCB (Brussels Belgium) Crohn's disease (CD) Phase II [a]
Rheumatoid arthritis (RA) Phase II
BC-1 Humanized ED-B (extra domain B) of fibronectin [Homo sapiens] Mus musculus MRC Technology (UK) / Antisoma (London UK) Angiogenesis Preclinical [k] [51]
BIW-8405,
MEDI-563
Humanized IgG1 afucosylated IL5RA (interleukin 5 receptor alpha) [Homo sapiens] MedImmune Inc. (Gaithersburg MD USA) Asthma Phase II
BMA 031 Humanized IgG1 TRαβ (T cell receptor alpha/beta) [Homo sapiens] Mus musculus Behringwerke Aktiengesellschaft (Marburg Germany) / Genzyme Corp. (Cambridge MA USA) Autoimmunity Sp2/0 mouse myeloma cells [c] [13]
Graft-versus-host disease (GvHD) Sp2/0 mouse myeloma cells
Transplantation Sp2/0 mouse myeloma cells
BW431/26 Humanized IgG3 CEACAM5 (carcinoembryonic antigen; CEA; CD66e) [Homo sapiens] Mus musculus Behringwerke Aktiengesellschaft (Marburg Germany) / MRC Laboratory of Molecular Biology (Cambridge UK) Treatment
Breast cancers
BHK cells (ATCC CCL 10) [c] [15]
Treatment
Colorectal cancers
BHK cells (ATCC CCL 10)
Treatment
Lung cancers
BHK cells (ATCC CCL 10)
BrE-3 Humanized IgG1 MUC1 (mucin1; CD227; PEM, polymorphic epithelial mucin) [Homo sapiens] Mus musculus Cancer Research Fund of Contra Costa (Walnut Creek CA USA) / NIH (Bethesda MD USA) Breast cancers Sp2/0-Ag14 mouse myeloma cells [c] [16]
C21/AL-90,
HU-901,
TNX-901
Humanized IgE [Homo sapiens] Mus musculus MRC Technology (UK) / Novartis (Basel Switzerland) / Tanox Inc. (Houston TX USA) Peanut allergy (severe) Phase II [b] [k] [l]
CAMPATH-9 Humanized CD4 (p55) [Homo sapiens] Rattus sp. Pathology Dept., University of Cambridge (Cambridge UK) Establishment of immunological tolerance state CHO (Chinese Hamster Ovary) Dihydrofolate reductase-deficient cells [c] [20]
CC49 Humanized IgG1 TAG 72 (tumour associated glycoprotein 72) [Homo sapiens] Mus musculus NIH (Bethesda MD USA) Cancers Sp2/0 mouse myeloma cells Diagnostic, Therapeutic Unknown [c] [e] [17]
CDP850 Humanized SELE (E-selectin; CD62E) [Homo sapiens] Mus musculus Celltech, UCB (Brussels Belgium) Psoriasis Phase I [a]
CE25/B7 Humanized CEACAM5 (carcinoembryonic antigen; CEA; CD66e) [Homo sapiens] Mus musculus MRC Technology (UK) / Novartis Pharmaceuticals Corp. (East Hanover NJ USA) Cancers [k]
Fd138-80 Humanized IgG1 HSV (herpes simple virus), gD glycoprotein [virus] Mus musculus PDL (Protein Design Labs) BioPharma (Fremont CA USA) / University of Alabama (Tuscaloosa AL USA) Neutralisation activity of HSV-1 Sp2/0 mouse myeloma cells [c] [24]
Fd79 Humanized IgG1 HSV (herpes simple virus), gB glycoprotein [virus] Mus musculus PDL (Protein Design Labs) BioPharma (Fremont CA USA) / University of Alabama (Tuscaloosa AL USA) Neutralisation activity of HSV-1 Sp2/0 mouse myeloma cells [c] [24]
H17E2 Humanized IgG1 PLAP-like testicular alkaline phosphatase [Homo sapiens]
PLAP (placental alkaline phosphatase; EC 3.1.3.1) [Homo sapiens]
Mus musculus Unilever (UK) Treatment
Ovarian cancers
NSO mouse myeloma cells [c] [25]
Treatment
Testicular cancers
NSO mouse myeloma cells
H52 Humanized IgG1 ITGB2 (INTEGRIN-BETA-2; CD18) [Homo sapiens] Mus musculus Genentech Inc. (S. San Francisco CA USA) Potential to ameliorate deleterious immunological and inflammatory processes E.coli (Escherichia coli) [c] [26]
HCMV16 Humanized IgG1 HCMV (human cytomegalovirus), gH envelope glycoprotein [virus] Mus musculus Royal Free Hospital School of Medicine (London UK) / Scotgen Biopharmaceuticals Ltd. (Aberdeen UK) / University of Aberdeen (Aberdeen UK) Prevention and treatment
Human cytomegalovirus (HCMV) (infections in immunocompromised patients (Passive immunisation either alone or in combination with antiviral agents))
NSO mouse myeloma cells, YB2/0 rat myeloma cells [c] [27]
HCMV37 Humanized IgG1 HCMV (human cytomegalovirus), gB envelope glycoprotein [virus] Mus musculus Scotgen Biopharmaceuticals Ltd. (Aberdeen UK) / University of Aberdeen (Aberdeen UK) Human cytomegalovirus (HCMV) (Herpes infections in immunocompromised individuals) YB2/0 rat myeloma cells [c] [28]
HMFG1 Humanized IgG1 MUC1 (mucin1; CD227; PEM, polymorphic epithelial mucin), (epitope PDTR) [Homo sapiens] Mus musculus The Netherlands CRC Labs (Nottingham UK) / Unilever (UK) Neoplasms of epithelial origin, particularly carcinomas of breast, ovary, cervix, bronchus, and gastrointestinal tract NSO mouse myeloma cells [c] (7) [29]
Hu23F2G LEUKARREST™ Humanized Mus musculus ICOS Corporation (Bothell WA USA) Ischemic stroke Phase III [b]
ICM3 Humanized ICAM3 (intercellular adhesion molecule 3; CD50; ICAM-3) [Homo sapiens] Mus musculus ICOS Corporation (Bothell WA USA) Psoriasis Phase I/II [a]
JES1-39D10 Humanized IgG4 IL5 (interleukin 5; IL-5) [Homo sapiens] Rattus sp. Schering-Plough (Kenilworth NJ USA) / University of Alabama (Tuscaloosa AL USA) IL5 induced eosinophils diseases (eg asthma) COS cells transient expression [c] [30]
KB001 HUMANEERED™ Humanized Fab' PcrV (located at the tip of the syringe-like TTSS (Type Three Secretion System)) [virus] Mus musculus KaloBios Pharmaceuticals Inc. (Palo Alto CA USA) Pseudomonas aeruginosa infections Phase I/II [p]
LDP-01,
MLNM2201
Humanized IgG ITGB2 (INTEGRIN-BETA-2; CD18) [Homo sapiens] Mus musculus Millennium Pharmaceuticals Inc. (Cambridge MA USA) Allograft rejection (in kidney transplantation) [a] [b]
Stroke Phase I/II
M22 Humanized IgG1 FCGR1 (FCGR1A, FCGR1B, FCGR1C) (Fc gamma RI; CD64) [Homo sapiens] Mus musculus Dartmouth Medical School (Hanover NH USA) / Medarex (Princeton NJ USA) / Scotgen Biopharmaceuticals Ltd. (Aberdeen UK) Immunotherapy directed against human high affinity receptor for the Fc portion of IgG NSO mouse myeloma cells [c] [33]
M4 Humanized IgG1 TAG 72 (tumour associated glycoprotein 72), (epitope sialosyl-Tn) [Homo sapiens] Mus musculus University of Saskatchewan (Saskatchewan Canada) Colorectal cancers Sp2/0-Ag14 mouse myeloma cells [c] [12]
Gastric cancers Sp2/0-Ag14 mouse myeloma cells
Ovarian cancers Sp2/0-Ag14 mouse myeloma cells
MDX-CD4 Humanized IgG CD4 (p55) [Homo sapiens] Mus musculus Eisai Co. Ltd. (Tokyo Japan) / Genmab A/S (Copenhagen Denmark) / Medarex (Princeton NJ USA) Rheumatoid arthritis (RA) Phase I [a]
ME361 Humanized GD2 ganglioside [Homo sapiens] Mus musculus MRC Technology (UK) / Merck KgaA (Darmstadt Germany) Cancers
MEDI-528 Humanized IgG1 IL9 (interleukin 9; IL-9) [Homo sapiens] MedImmune Inc. (Gaithersburg MD USA) Asthma Phase II
MK-0646 Humanized IgG1 IGF1R (insulin-like growth factor 1 receptor; IGF-1R; CD221) [Homo sapiens] Merck & Co., Inc. (Whitehouse Station NJ USA) Solid tumors Phase I
MaE11 Humanized IgG1 IgE [Homo sapiens] Mus musculus Genentech Inc. (S. San Francisco CA USA) IgE mediated allergies Adenovirus transformed human embryonic 293 kidney cells [c] [34]
MikB1 Humanized IgG1 IL2RB (interleukin-2 receptor, beta; IL-2R; p70; CD122) [Homo sapiens] Mus musculus F. Hoffmann-La Roche Ltd. (Basel Switzerland) (EU) / Kyoto-Katsura Hospital (Kyoto Japan) / National Cancer Institute (Bethesda MD USA) / PDL (Protein Design Labs) BioPharma (Fremont CA USA) Prevention
Allograft rejection (in conjunction with humanized anti-Tac)
Sp2/0 mouse myeloma cells [c] [35]
Autoimmune diseases Sp2/0 mouse myeloma cells
Graft-versus-host disease (GvHD) Sp2/0 mouse myeloma cells
PRO542 Humanized HIV (human immunodeficiency virus), gp120 [virus] Mus musculus Genzyme Corp. (Cambridge MA USA) / Progenics Pharmaceuticals Inc. (Tarrytown NY USA) AIDS, HIV infection Phase I/II [a]
RSV19 Humanized IgG1 RSV (respiratory syncytial virus), fusion protein (F glycoprotein) [virus] Mus musculus AFRC Inst. Animal Health (UK) / Scotgen Biopharmaceuticals Ltd. (Aberdeen UK) / University of Aberdeen (Aberdeen UK) Respiratory Syncytial Virus (RSV) disease (acute respiratory illness in young children) YB2/0 rat myeloma cells (from ATCC) [c] [39]
SCH55700 Humanized IL5 (interleukin 5; IL-5) [Homo sapiens] Mus musculus Celltech, UCB (Brussels Belgium) / Schering AG (Berlin Germany) Allergy Phase I [a]
Asthma Phase I
SK2 Humanized IgG1 IL6 (interleukin 6; IL-6) [Homo sapiens] Mus musculus Chugai pharmaceuticals Co. Ltd. (Japan) / F. Hoffmann-La Roche Ltd. (Basel Switzerland) AIDS, HIV infection CHO (Chinese Hamster Ovary) cells, COS-7 cells transient expression [c] [40]
Cardiac myxoma CHO (Chinese Hamster Ovary) cells, COS-7 cells transient expression
Increased levels of IL6 in sepsis CHO (Chinese Hamster Ovary) cells, COS-7 cells transient expression
Rheumatoid arthritis (RA) CHO (Chinese Hamster Ovary) cells, COS-7 cells transient expression
T84.66 M5A,
hT84.66
Humanized CEACAM5 (carcinoembryonic antigen; CEA; CD66e) [Homo sapiens] Mus musculus T84.66 Beckman Research Institute (Duarte CA USA) Metastatic colorectal cancers [p] [58]
TES-C21 Humanized IgG1 IgE, free and bound to B cells [Homo sapiens] Mus musculus Ciba-Geigy AG (Basel Switzerland) / MRC Laboratory of Molecular Biology (Cambridge UK) Immediate-type hypersensitivities COS cells transient expression, NSO mouse myeloma cells [c] [41]
XOMA 052 Humanized IgG2 IL1B (interleukin 1 beta; IL-1B) [Homo sapiens] Mus musculus Xoma (Berkeley CA USA) Type 2 diabetes [p]
YFC51.1 Humanized IgG1
IgG4
ITGB2 (INTEGRIN-BETA-2; CD18) [Homo sapiens] Rattus sp. Cambridge University (Cambridge UK) / Wellcome (London UK) Prevention
Influx of leukocytes in Sepsis or reperfusion injury, adult respiratory distress syndrome and graft rejection
COS cells transient expression, NSO mouse myeloma cells [c] (2) [43]
YTH12.5 Humanized IgG1 CD3E (CD3 epsilon; Leu-4) [Homo sapiens] Rattus sp. Cambridge University (Cambridge UK) Autoimmunity CHO (Chinese Hamster Ovary) DHFR cells [c] [44]
Organ rejection CHO (Chinese Hamster Ovary) DHFR cells
T cell lymphoma CHO (Chinese Hamster Ovary) DHFR cells
anti-B4 Humanized IgG1 CD19 (B lymphocyte surface antigen B4; Leu-12) [Homo sapiens] Mus musculus ImmunoGen Inc. (Cambridge MA USA) / University Bath (Bath UK) B cell malignancies COS cells transient expression [c] [45]
anti-CD18 Humanized F(ab')2 ITGB2 (INTEGRIN-BETA-2; CD18) [Homo sapiens] Mus musculus Genentech Inc. (S. San Francisco CA USA) Acute myocardial infarction Phase II [a] [b]
anti-IL4 Humanized IL4 (interleukin 4; IL-4) [Homo sapiens] Mus musculus PDL (Protein Design Labs) BioPharma (Fremont CA USA) Asthma Phase I [b]
huN901-DM1 Humanized IgG1 NCAM1 (neural cell adhesion molecule 1; CD56; NCAM-1) [Homo sapiens] Mus musculus ImmunoGen Inc. (Cambridge MA USA) / University Bath (Bath UK) Small cell lung cancers (SCLC) CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells [c] [36]
humanized B1-8 Humanized IgE Hapten NP-cap (4-hydroxy-3-nitrophenacethyl caproic acid) [Homo sapiens]
NIP-cap (3-iodo-4-hydroxy-5-nitrophenyl-acetyl caproic acid) [Homo sapiens]
Mus musculus B1-8 MRC Laboratory of Molecular Biology (Cambridge UK) Unknown Proof of concept Stably transformed J558L cells [c] [10]
humanized D1.3 Humanized IgG1
IgG2
Lysozyme [Homo sapiens] Mus musculus D1.3 MRC Laboratory of Molecular Biology (Cambridge UK) Unknown Proof of concept J558L mouse myeloma cells, NSO mouse myeloma cells [c] [21] [22]
humanized DX48 Humanized IgG1 Digoxin [Homo sapiens] Rattus sp. DX48 Wellcome (London UK) Unknown Proof of concept [c] [23]
humanized K20 Humanized IgG1 ITGB1 (INTEGRIN-BETA-1; CD29) [Homo sapiens] Mus musculus MuK20 INSERM (Montpellier France) / LIGM (Montpellier France) Immunosuppression Insect cells, NSO mouse myeloma cells [c] [31]
mu-39.1 Humanized HIV-1 (human immunodeficiency virus) [virus] Mus musculus MRC Technology (UK) / Kaketsuken (Kumamoto Japan) AIDS, HIV infection [k]
ALLOMUNE™ Humanized CD2 (LFA-2, Lymphocyte function antigen 2) [Homo sapiens] Mus musculus BioTransplant (Charlestown MA USA) Hodgkin's disease (HD) Phase I [b]
Non-Hodgkin's B cell lymphoma (NHL) (refractory) Phase I
PROTOVIR™ Humanized IgG1 HCMV (human cytomegalovirus) [virus] Mus musculus Novartis Pharmaceuticals Corp. (East Hanover NJ USA) / PDL (Protein Design Labs) BioPharma (Fremont CA USA) Human cytomegalovirus (HCMV) Phase III [a]

up

Human monoclonal antibodies

Number of results: 55

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
adalimumab 7860 82
(1999)
44
(2000)
D2E7 HUMIRA® (EU/US)
TRUDEXA® (EU)
Human IgG1κ TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Homo sapiens Abbott Laboratories (Abbott Park IL USA) (EU/US) Psoriatic arthritis (PSA) Phase M FDA approval December 2002 CHO (Chinese Hamster Ovary) cells (BLA) 125057 H-C-481 L04AB04 814 [a] [j] (12) [12]
Rheumatoid arthritis (RA) Phase M FDA approval December 2002 CHO (Chinese Hamster Ovary) cells
Cambridge Antibody Technology (Cambridge UK) (US) / BASF (Ludwigshafen Germany) Rheumatoid arthritis (RA) Phase I/II CHO (Chinese Hamster Ovary) cells
adecatumumab 8449 90
(2004)
52
(2004)
MT201 Human IgG1 EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Homo sapiens Micromet AG (Munich Germany) Breast cancers Phase II [p]
Prostate cancers Phase II
bertilimumab 8332 88
(2003)
50
(2003)
CAT-213,
iCo-008
Human IgG4κ CCL11 (Chemokine ligand 11; eotaxin1) [Homo sapiens] Homo sapiens Cambridge Antibody Technology (CAT) library (Cambridge UK) iCo Therapeutics Inc. (Vancouver BC Canada) Severe ocular allergies Phase I
canakinumab 8836 97
(2007)
59
(2008)
ACZ885 ILARIS® Human 8836 IgG1κ IL1B (interleukin 1 beta; IL-1B) [Homo sapiens] Homo sapiens Novartis Pharmaceuticals Corp. (East Hanover NJ USA) Cryopyrin-Associated Periodic Syndromes (CAPS) (including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 4 and older) Phase M FDA approval June 2009 Therapeutic Hereditary inflammatory diseases (BLA) 125319
Novartis (Basel Switzerland) Rheumatoid arthritis (RA)
cixutumumab 9099 100
(2008)
62
(2009)
IMC-A12 Human 9099 IgG1λ IGF1R (insulin-like growth factor 1 receptor; IGF-1R; CD221) [Homo sapiens] Homo sapiens ImClone Systems Inc. (Somerville NJ USA) Solid tumors Phase I
conatumumab 9029 99
(2008)
61
(2009)
AMG 655,
TRAIL-R2mAb,
XG1-048 v w
Human 9029 IgG1 TNFRSF10B (tumor necrosis factor receptor superfamily member 10B; DR5, death receptor 5; TRAIL-R2, TNF-related apoptosis-inducing ligand receptor 2; TR-2; CD262) [Homo sapiens] Homo sapiens Amgen (Thousand Oaks CA USA) Cancers Phase I
Non-small-cell lung cancers
denosumab 8653 94
(2005)
56
(2006)
AMG162 Human IgG2 TNFSF11 (tumor necrosis factor ligand superfamily member 11; RANKL, receptor activator for nuclear factor kappa B ligand; human osteoclast differentiation factor) [Homo sapiens] Homo sapiens Amgen (Thousand Oaks CA USA) Postmenopa osteoporosis Phase I C61313
efungumab 8658 95
(2006)
57
(2007)
HSP90mab Mycograb® Human 8658 scFv Heat shock protein 90 homolog from yeast [Candida albicans] Homo sapiens Supplier: Onicon Chemical Co. Ltd. (HangZhou China) / NeuTec Pharma plc (Manchester UK) Unknown EMEA refusal of marketing March 2007
figitumumab 9085 100
(2008)
62
(2009)
CP-751871 Human 9085 IgG2κ IGF1R (insulin-like growth factor 1 receptor; IGF-1R; CD221) [Homo sapiens] Homo sapiens 2.13.2 Pfizer (New York NY USA) Non-small-cell lung cancers Phase I C52187
Solid tumors Phase I
foravirumab 9053 99
(2008)
61
(2009)
CR4098 Human 9053 IgG1λ Rabies virus glycoprotein [Homo sapiens] Homo sapiens Crucell (CN Leiden Netherlands) Rabies prophylaxis Phase II Therapeutic Unknown (27)
gantenerumab 8894 97
(2007)
59
(2008)
R1450 Human 8894 IgG1 Amyloid peptides Aβ42 and Aβ40 [Homo sapiens] Homo sapiens F. Hoffmann-La Roche Ltd. (Basel Switzerland) Alzheimer's disease
golimumab 8497 91
(2004)
53
(2005)
CNTO 148 SIMPONI™ Human IgG1κ TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Homo sapiens Centocor Ortho Biotech Inc. (Malvern PA USA) Ankylosing spondylitis (AS) Phase M FDA approval April 2009 Therapeutic Immunology (BLA) 125289
Psoriatic arthritis (PSA) (fully human) Phase M FDA approval April 2009 Therapeutic Immunology
Rheumatoid arthritis (RA) Phase M FDA approval April 2009 Therapeutic Immunology
ipilimumab 8568 94
(2005)
56
(2006)
MDX-010 Human IgG1κ CTLA4 [Homo sapiens] Homo sapiens Bristol-Myers Squibb (Princeton NJ USA) / Medarex (Princeton NJ USA) Melanoma Phase II/III C2654
iratumumab 8713 94
(2005)
56
(2006)
MDX-060 Human IgG1κ TNFRSF8 (tumor necrosis factor receptor superfamily member 8; CD30) [Homo sapiens] Homo sapiens Medarex (Princeton NJ USA) Anaplastic large cell lymphoma (ALCL) Phase II
Hodgkin's disease (HD) Phase II FDA Orphan drug October 2004
lerdelimumab 7882 83
(2000)
45
(2001)
CAT-152,
Trabio
Human IgG4 TGFB2 (transforming growth factor beta 2) [Homo sapiens] Homo sapiens Cambridge Antibody Technology (CAT) library (Cambridge UK) Cambridge Antibody Technology (Cambridge UK) Glaucoma surgery Phase III [a] [12]
lexatumumab 8753 95
(2006)
57
(2007)
HGS-ETR2 Human 8753 IgG1λ TNFRSF10B (tumor necrosis factor receptor superfamily member 10B; DR5, death receptor 5; TRAIL-R2, TNF-related apoptosis-inducing ligand receptor 2; TR-2; CD262) [Homo sapiens] Homo sapiens HGSI (Human Genome Sciences Inc.) (Rockville MD USA) Cancers Phase I C64621 [p]
lucatumumab 8887 98
(2007)
60
(2008)
CHIR-12,12,
HCD122
Human 8887 IgG1 CD40 (tumor necrosis factor receptor superfamily member 5; TNFRSF5) [Homo sapiens] Homo sapiens Novartis Pharmaceuticals Corp. (East Hanover NJ USA) / Xoma (Berkeley CA USA) Chronic Lymphocytic Leukemia (CLL) Phase I [p]
Multiple myeloma Phase I
mapatumumab 8635 93
(2005)
55
(2006)
HGS-ETR1,
TRM-1
Human IgG1 TRAIL-R1 (Tumor necrosis apoprosis Inducing ligand Receptor 1), agonistic antibody [Homo sapiens] Homo sapiens Cambridge Antibody Technology (Cambridge UK) / HGSI (Human Genome Sciences Inc.) (Rockville MD USA) Colorectal cancers Phase II C61502
Lung cancers, Lung cancers (non small-cell) Phase II
Non-Hodgkin's lymphoma (NHL) Phase II
metelimumab 8087 86
(2002)
48
(2002)
CAT-192 Human IgG4κ TGF-1 (Transforming Growth Factor 1) [Homo sapiens] Homo sapiens Cambridge Antibody Technology (CAT) library (Cambridge UK) Genzyme Corp. (Cambridge MA USA) / Cambridge Antibody Technology (Cambridge UK) Diffuse scleroderma Phase I/II [12]
Fibrotic diseases Phase I/II
Scarring Phase I/II
nebacumab 6658 66
(1991)
32
(1992)
HA-1A,
centoxin,
septomonab
Human IgM Endotoxin C0246612 [Homo sapiens] Homo sapiens CSL Behring (King of Prussia PA USA) Gram-negative sepsis
necitumumab 9083 100
(2008)
62
(2009)
11F8,
IMC-11F8
Human 9083 IgG1κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Homo sapiens ImClone Systems Inc. (Somerville NJ USA) Metastatic colorectal cancers Phase II
Solid tumors Phase I
ofatumumab 8606 93
(2005)
55
(2006)
HuMax-CD20® Arzerra™ Human IgG1κ MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Homo sapiens Genmab A/S (Copenhagen Denmark) / GlaxoSmithKline (Brentford UK) Chronic Lymphocytic Leukemia (CLL) (Refractory) Phase III SBLA April 2009 C66952
Non-Hodgkin's lymphoma (NHL) Withdrawn withdrawal (by manufacture) January 1993
Rheumatoid arthritis (RA) Phase III
panitumumab 8499 91
(2004)
53
(2005)
ABX-EGF,
E7.6.3
VECTIBIX™ Human IgG2κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Homo sapiens XenoMouse™ Amgen (Thousand Oaks CA USA) Colorectal cancers Phase M FDA approval September 2006 CHO (Chinese Hamster Ovary) cells (BLA) 125147 C1857 933 [b] [n] (11) (13)
Abgenix (Fremont CA USA) Lung cancers Phase IV (PA) Biopharmaceuticals in the U.S. and European Markets New entries in the 4th edition. CHO (Chinese Hamster Ovary) cells
Prostate cancers Phase IV (PA) Biopharmaceuticals in the U.S. and European Markets New entries in the 4th edition. CHO (Chinese Hamster Ovary) cells
Renal cancers Phase IV (PA) Biopharmaceuticals in the U.S. and European Markets New entries in the 4th edition. CHO (Chinese Hamster Ovary) cells
panobacumab 8888 100
(2008)
62
(2009)
Aerumab 11 Human 8888 IgMκ Pseudomonas aeruginosa serotype IATS O11 [bacteria] Homo sapiens Kenta Biotech Ltd (Berne Switzerland) Treatment
Hospital acquired pneumonia caused by serotype 011 positive Pseudomonas aeruginosa
Phase I
rafivirumab 9052 99
(2008)
61
(2009)
CR57 Human 9052 IgG1 Rabies virus glycoprotein [Homo sapiens] Homo sapiens Crucell (CN Leiden Netherlands) Rabies prophylaxis Phase II Therapeutic Unknown (27)
ramucirumab 9098 100
(2008)
62
(2009)
1121B,
IMC-1121B
Human 9098 IgG1κ KDR (kinase insert domain receptor; VEGFR2, Vascular endothelial growth factor receptor 2; VEGF-R2; FLK1; CD309) [Homo sapiens] Homo sapiens ImClone Systems Inc. (Somerville NJ USA) Tumor vasculature Phase I [p]
regavirumab 7250 71
(1994)
35
(1995)
TI-23 Human IgG1κ Herpesvirus 5 glyco-protein B [Homo sapiens] Homo sapiens Teijin America Inc. (New York NY USA) / Teijin Ltd. (Tokyo Japan) Acute CMV diseases Phase I [e]
robatumumab 9092 100
(2008)
62
(2009)
19D12,
SCH 717454,
SCH717454
Human 9092 IgG1κ IGF1R (insulin-like growth factor 1 receptor; IGF-1R; CD221) [Homo sapiens] Homo sapiens Medarex (Princeton NJ USA) Blood cancers Preclinical
Colon sarcoma Phase II
stamulumab 8683 94
(2005)
56
(2006)
MYO-029 Human IgG1 GDF-8 (growth differentiation factor 8) [Homo sapiens] Homo sapiens Wyeth Pharmaceuticals (Madison NJ USA) / Cambridge Antibody Technology (Cambridge UK) Muscular dystrophy Phase I/II
tremelimumab 8716 94
(2005)
59
(2008)
CP-675206 Human IgG2 CTLA4 [Homo sapiens] Homo sapiens 11.2.1 Abgenix (Fremont CA USA) / Pfizer (New York NY USA) Melanoma C49085
tuvirumab 6559 66
(1991)
32
(1992)
anti-hepatitis B Human HBV (hepatitis B virus) [virus] Homo sapiens PDL (Protein Design Labs) BioPharma (Fremont CA USA) Hepatitis B (Chronic active) Phase II [e]
Liver transplant patients with end-stage renal disease due to chronic hepatitis B infection Phase I/II
ustekinumab 8954 99
(2008)
61
(2009)
CNTO 1275,
TT-20
Human 8954 IgG1 IL12 (interleukin 12; IL-12) [Homo sapiens]
IL23 (interleukin 23; IL-23) [Homo sapiens]
Homo sapiens Centocor Inc. (Horsham PA USA) / Medarex (Princeton NJ USA) Crohn's disease (CD) Phase III
Inflammation Phase III
Multiple sclerosis (MS) Phase II
Psoriasis Phase III
votumumab 7165 70
(1993)
34
(1994)
88BV59,
CTAA16.88m Ab radioimmune conjugate,
HUMASPECT
Human radiolabelled with Technetium-99m, Tc-99m IgG3κ Carcinoma associated antigen [Homo sapiens] Homo sapiens Organon Teknika Corp. (Durham NC USA) / KS Biomedix Ltd (Guildford UK) Colon cancers Withdrawn EC withdrawal (Not renewed by KS Biomedix) September 2003, EC approval September 1998 C2066 [d]
Rectum cancer Withdrawn EC withdrawal (Not renewed by KS Biomedix) September 2003, EC approval September 1998
zalutumumab 8605 93
(2005)
55
(2006)
HuMax-EGFr HuMaX-EGFR™ Human IgG1κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Homo sapiens Genmab A/S (Copenhagen Denmark) Head cancers Phase III C64620
Neck cancers Phase III
zanolimumab 8298 90
(2004)
52
(2004)
HuMax-CD4 HuMax-CD4® Human IgG1κ CD4 (p55) [Homo sapiens] Homo sapiens Genmab A/S (Copenhagen Denmark) / Medarex (Princeton NJ USA) Cutaneous T cell lymphoma (CTCL) Phase III
Non-cutaneous T cell lymphoma (NCTCL) Phase II
ziralimumab 8061 84
(2000)
46
(2001)
ABX-RB2 Human BSG (Basigin; CD147) [Homo sapiens] Homo sapiens XenoMouse™ Abgenix (Fremont CA USA) Autoimmune diseases Preclinical
Graft-versus-host disease (GvHD) Preclinical
Solid organ transplantation Preclinical
ABT-874 Human IgG1λ IL12B (interleukin 12 beta; IL-12B; IL12 p40; CMLF p40; NKSF2) [Homo sapiens] Homo sapiens Cambridge Antibody Technology (CAT) library (Cambridge UK) Abbott Laboratories (Abbott Park IL USA) Crohn's disease (CD) Phase I [p]
Multiple sclerosis (MS) Phase I
Psoriasis Phase II
ABX-IL8 Human IgG2 IL8 (interleukin 8; IL-8) [Homo sapiens] Homo sapiens Abgenix (Fremont CA USA) Angiogenesis Preclinical [a] [b] (11)
Melanoma Preclinical
Psoriasis Phase II
Rheumatoid arthritis (RA) Phase II
AGS-PSCA,
MK-4721
Human IgG1κ PSCA (prostate stem cell antigen) [Homo sapiens] Homo sapiens XenoMouse™ Merck & Co., Inc. (Whitehouse Station NJ USA) / Agensys (Santa Monica CA USA) Bladder cancers Phase I [p]
Pancreatic cancers Phase I
Prostate cancers Phase I
AL-901 Human IgE [Homo sapiens] Homo sapiens Genentech Inc. (S. San Francisco CA USA) / Novartis Pharmaceuticals Corp. (East Hanover NJ USA) / Tanox Inc. (Houston TX USA) Allergic asthma Phase II [e]
Allergic rhinitis Phase II
AMG 479 Human IGF1R (insulin-like growth factor 1 receptor; IGF-1R; CD221) [Homo sapiens] Homo sapiens Amgen (Thousand Oaks CA USA) Cancers Phase I [p]
CAT-354 Human IL13 (interleukin 13; IL-13) [Homo sapiens] Homo sapiens Cambridge Antibody Technology (CAT) library (Cambridge UK) MedImmune Inc. (Gaithersburg MD USA) Severe asthma Phase II
GC-1008 Human IgG4κ TGFB (Transforming Growth Factor Beta) [Homo sapiens] Homo sapiens Genzyme Corp. (Cambridge MA USA) / Cambridge Antibody Technology (Cambridge UK) Idiopathic pulmonaly fibrosis Phase I
HuMax-IL15 Human Il15 (interleukin 15; IL-15) [Homo sapiens] Homo sapiens Genmab A/S (Copenhagen Denmark) / Immunex Corporation Amgen (Thousand Oaks CA USA) Celiac disease Phase I/II
Inflammatory arthritis diseases Phase I/II
Inflammatory bowel disease (IBD) Phase I/II
Psoriasis Phase I/II
HuMax-Lymphoma Human IL15R (interleukin 15 receptor; IL-15R) [Homo sapiens] Homo sapiens Genmab A/S (Copenhagen Denmark) / Immunex Corporation Amgen (Thousand Oaks CA USA) Lymphoma Preclinical
HuMax-TAC™ Human IL2RA (interleukin-2 receptor, alpha; IL-2R; TAC; CD25) [Homo sapiens] Homo sapiens Genmab A/S (Copenhagen Denmark) Autoimmune disorders Preclinical
Transplant rejection Preclinical
J695 Human IL12 (interleukin 12; IL-12) [Homo sapiens] Homo sapiens Cambridge Antibody Technology (Cambridge UK) (US) / BASF (Ludwigshafen Germany) Crohn's disease (CD) [12]
Multiple sclerosis (MS)
Rheumatoid arthritis (RA)
MDX-33 Human FCGR1 (FCGR1A, FCGR1B, FCGR1C) (Fc gamma RI; CD64) [Homo sapiens] Homo sapiens Medarex (Princeton NJ USA) / CSL Behring (King of Prussia PA USA) Autoimmune diseases Phase I [a] [b]
Idiopathic thrombocytopenic purpura Phase I
MOR101 Human Fab CD54 (intercellular adhesion molecule 1; ICAM1) [Homo sapiens] Homo sapiens MorphoSys (Martinsried/Pla Germany) Deep dermal burn Preclinical [n] (22)
MOR102 Human IgG4 Fab CD54 (intercellular adhesion molecule 1; ICAM1) [Homo sapiens] Homo sapiens MorphoSys (Martinsried/Pla Germany) Psoriasis Preclinical [n] (22)
MOR103 Human Homo sapiens MorphoSys (Martinsried/Pla Germany) Rheumatoid arthritis (RA) Phase I [n] (22)
MOR202 Human IgG1 CD38 [Homo sapiens] Homo sapiens MorphoSys (Martinsried/Pla Germany) Multiple myeloma Preclinical [n] (22)
MORAb-009 Human IgG1 Morphotek Inc. (Exton PA USA) Pancreatic cancers Phase II EC Orphan drug April 2008
MORAb-028 Human IgM G-28, a cell surface antigen glycolipid [Homo sapiens] Homo sapiens Morphotek Inc. (Exton PA USA) / CMC Biopharmaceuticals (Copenhagen Denmark) Melanoma [p]
OST 577 OSTAVIR™ Human HBV (hepatitis B virus) [virus] Homo sapiens Novartis Pharmaceuticals Corp. (East Hanover NJ USA) / PDL (Protein Design Labs) BioPharma (Fremont CA USA) Hepatitis B Phase II [a]

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Immunotoxins

Number of results: 14

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
citatuzumab bogatox 9046 99
(2008)
61
(2009)
VB6-845 Humanized
Immunotoxin
Bougainvillea spectabilis Willd bouganin 9046 Fab EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Mus musculus Humanized Viventia Biotechnologies Inc. (Mississauga ON Canada) Solid tumors Phase I
dorlimomab aritox 6516 66
(1991)
32
(1992)
4197X-RA,
MDX-RA (Ricin A)
Immunotoxin Houston Biotechnology (The Woodlands TX USA) Prevention
Secondary cataract
Phase II [b] [e]
Medarex (Princeton NJ USA) Unknown Phase III
naptumomab estafenatox 8598 96
(2006)
58
(2007)
ABR-217620,
ANYARA,
TTS CD3
Immunotoxin 8598 IgG1κ Fab TPBG (trophoblast glycoprotein; 5T4) [Homo sapiens] Mus musculus Active Biotech AB (Lund Sweden) Renal cell carcinoma (RCC)
oportuzumab monatox 9045 100
(2008)
62
(2009)
VB4-845 PROXINIUM™
VICINIUM™
Humanized
Immunotoxin
Pseudomonas aeruginosa exotoxin A 9045 scFv EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Homo sapiens Viventia Biotechnologies Inc. (Mississauga ON Canada) Bladder cancers Phase II FDA Orphan drug (US) February 2005
Head cancers Phase II/III FDA Orphan drug (US) February 2005
Neck cancers Phase II/III FDA Orphan drug (US) February 2005
B3 (dsFv) -PE (Pseudomonas aeruginosa exotoxin A)38,
LMB-9
Immunotoxin Lewis Y [Homo sapiens] Mus musculus Humanized National Cancer Institute (Bethesda MD USA) Solid tumors Phase I E.coli strain BL21 (as inclusion bodies) [b] [c] [11]
BL22,
RFB4 (dsFv) -PE (Pseudomonas aeruginosa exotoxin A)38
Immunotoxin IgGκ CD22 (BL-CAM) [Homo sapiens] National Cancer Institute (Bethesda MD USA) Leukemia Phase I NCI trial [b]
Lymphoma Phase I NCI trial
CAT-8015 Immunotoxin CD22 (BL-CAM) MedImmune Inc. (Gaithersburg MD USA) Acute lymphocytic leukemia (ALL) Phase I
Chronic Lymphocytic Leukemia (CLL) Phase I
Hairy cell Leukemia (HCL) Phase I
CMB-401,
hCTMO1-calicheamicin
Immunotoxin MUC1 (mucin1; CD227; PEM, polymorphic epithelial mucin) [Homo sapiens] Homo sapiens Wyeth Pharmaceuticals (Madison NJ USA) Ovarian cancers (epithelial) Phase I [e] (25)
ONCOLYSIN B Immunotoxin ImmunoGen Inc. (Cambridge MA USA) B cell leukemias Phase II Market discontinued March 1997 [e]
B cell lymphoma Phase III Market discontinued March 1997
Ex vivo treatment of autologous bone marrow and subsequent reinfusion (in patients with B cell leukemias and lymphomas) Phase I/II Market discontinued March 1997
ONCOLYSIN CD6 Immunotoxin ImmunoGen Inc. (Cambridge MA USA) T cell malignancies Phase I/II [e]
ONCOLYSIN M Immunotoxin ImmunoGen Inc. (Cambridge MA USA) Ex vivo treatment of autologous bone marrow and subsequent reinfusion (in patients with AML) Phase I/II [e]
Myeloid leukemia Phase I/II
ONCOLYSIN S Immunotoxin ImmunoGen Inc. (Cambridge MA USA) Small cell lung cancers (SCLC) Phase II [e]
anti-Tac(Fv)-PE (Pseudomonas aeruginosa exotoxin A)38 Immunotoxin IL2R (interleukin 2 receptor; IL-2R; p55) [Homo sapiens] National Cancer Institute (Bethesda MD USA) Leukemia Phase I NCI trial [b] (24)
Lymphoma Phase I NCI trial
anti-Tac(Fv)-PE (Pseudomonas aeruginosa exotoxin A)40 Immunotoxin IL2R (interleukin 2 receptor; IL-2R; p56) [Homo sapiens] National Cancer Institute (Bethesda MD USA) Cancers [m]

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Immunoadhesins

Number of results: 9

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
abatacept 8495 91
(2004)
53
(2005)
BMS-188667,
CTLA4-Ig
ORENCIA® Immunoadhesin CTLA4-IGHG1 Fc CD80, B7 [Homo sapiens]
CD86 [Homo sapiens]
Homo sapiens Bristol-Myers Squibb (Princeton NJ USA) Graft-versus-host disease (GvHD) (solid organ transplant) Phase I CHO (Chinese Hamster Ovary) cells (BLA) 125118 888 [j] [n] (16)
Psoriasis Phase I CHO (Chinese Hamster Ovary) cells
Rheumatoid arthritis (RA) Phase M FDA approval December 2005 CHO (Chinese Hamster Ovary) cells
T cell co-stimulation modulator Phase M FDA approval December 2005 CHO (Chinese Hamster Ovary) cells
aflibercept 8739 95
(2006)
57
(2007)
VEGF Trap Immunoadhesin 8739 Vascular endothelial growth factor receptor 1, (VEGFR1, FLT1, TRT) - VEGFR2 (KDR, FLK1, CD309)-IGHG1 Fc VEGF (Vascular Endothelial Growth Factor) [Homo sapiens] Homo sapiens Regeneron Pharmaceuticals Inc. (Tarrytown NY USA) / Sanofi-Aventis (Paris France) Ovarian cancers Phase II [p]
alefacept 8059 84
(2000)
46
(2001)
AMEVIVE® Immunoadhesin Leucocyte function associated antigen 3 (LFA3)-IGHG1 Fc CD2 (LFA-2, Lymphocyte function antigen 2) [Homo sapiens] Homo sapiens Biogen Canada Inc. (Mississauga ON Canada) Severe chronic plaque psoriasis Phase M FDA approval January 2003 CHO (Chinese Hamster Ovary) cells (BLA) 125036 820 [j] [n]
atacicept 8669 95
(2006)
57
(2007)
TACI-Fc,
TACI-Ig
Immunoadhesin 8669 Tumor necrosis factor receptor superfamily member 13B, (TNFR13B, TACI (Transmembrane Activator and CAML Interactor), CD267)-IGHG1 Fc TNFSF13B (Tumor necrosis factor superfamily 13B; BAFF, B cell activating factor; BLyS, B lymphocyte activator; CD257; TNFS13, tumor necrosis factor superfamily 13; APRIL, a proliferation-including ligand; CD256) Homo sapiens Merck Serono International S.A. (Geneva Switzerland) / ZymoGenetics Inc. (Seattle WA USA) Multiple myeloma Phase I [p]
Non-Hodgkin's lymphoma (NHL) Phase I
Rheumatoid arthritis (RA) Phase II
Systemic lupus erythematosus (SLE) Phase II
baminercept 8944 98
(2007)
60
(2008)
BG9924,
TT-47
Immunoadhesin 8944 Tumor necrosis factor receptor superfamily member 3 (TNFRSF3, lymphotoxin beta receptor, LTBR, TNFCR)-IGHG1 Fc LTBR (lymphotoxin beta receptor; TNFRSF3, tumor necrosis factor receptor superfamily member 3; TNFCR)-IGHG1 Fc [Homo sapiens] Homo sapiens Biogen IDEC Pharmaceuticals (Cambridge MA USA) Inflammatory bowel disease (IBD)
Rheumatoid arthritis (RA)
belatacept 8627 93
(2005)
59
(2008)
BMS-224818,
LEA29Y
Immunoadhesin CTLA4-IGHG1 Fc CTLA4 [Homo sapiens] Bristol-Myers Squibb (Princeton NJ USA) Rheumatoid arthritis (RA)
briobacept 8963 98
(2007)
60
(2008)
BR3-Fc,
SS-79
Immunoadhesin 8963 TNFRSF13C (tumor necrosis factor receptor superfamily member 13C, BAFFR, BR3, B cell activating factor receptor, CD268)-IGHG1 Fc TNFRSF13C (tumor necrosis factor receptor superfamily member 13C; BAFFR; BR3, B cell activating factor receptor; CD268)-IGHG1 Fc [Homo sapiens] Homo sapiens Genentech Inc. (S. San Francisco CA USA) Rheumatoid arthritis (RA) Phase I
etanercept 7783 81
(1999)
43
(2000)
TNFR-immunoadhesin ENBREL® Immunoadhesin Tumor necrosis factor receptor (TNFR) alpha - IGHG1 Fc TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Homo sapiens Immunex Corporation Amgen (Thousand Oaks CA USA) Psoriatic arthritis (PSA) Phase M FDA approval February 2002 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells (BLA) 103795 737 [f] [j] [n] (15)
Rheumatoid arthritis (RA) Phase M FDA approval November 1998 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells
rilonacept 8750 95
(2006)
57
(2007)
ARCALYST™ Immunoadhesin 8750 Interleukin-1 receptor accessory protein (IL1RAP)-type 1 interleukin-1 receptor-IGHG1 Fc IL1 (interleukin 1; IL-1) [Homo sapiens] Homo sapiens Regeneron Pharmaceuticals Inc. (Tarrytown NY USA) Autoinflammatory diseases (BLA) 125249 [p]
Treatment
Cryopyrin-Associated Periodic Syndromes (CAPS) (including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS))
Phase M FDA approval February 2008 Therapeutic Hereditary inflammatory diseases
Osteoarthritis
Rheumatoid arthritis (RA)

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Bispecific monoclonal antibodies

Number of results: 7

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
blinatumomab 9028 100
(2008)
62
(2009)
BITE MT-103,
MEDI-538/MT103,
bscCD19xCD3
Bispecific 9028 scFv-scFv CD19 (B lymphocyte surface antigen B4; Leu-12) [Homo sapiens]
CD3E (CD3 epsilon; Leu-4) [Homo sapiens]
Homo sapiens MedImmune Inc. (Gaithersburg MD USA) (US) B cell lymphoma Phase I Discontinued March 2009, FDA Orphan drug (for indolent B cell lymphoma) January 2006 [p]
catumaxomab 8406 93
(2005)
55
(2006)
Removab® Bispecific
Hybrid
IgG2a (Ho-3/TP-A-01/TPBs01) [Mus musculus]
IgG2b (26/II/6-1.2/TPBs01) [Rattus sp.]
CD3E (CD3 epsilon; Leu-4) [Homo sapiens]
EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens]
rat-murine hybrid (triomab®) Fresenius Biotech GmbH (Bad Homburg Germany) Gastric cancers Phase II/III EC Orphan drug November 2006 [o]
Malignant ascites Phase II/III EC Orphan drug November 2006
Ovarian cancers Phase II/III EC Orphan drug November 2006
ertumaxomab 8407 93
(2005)
55
(2006)
Rexomun® Bispecific
Hybrid
IgG2a (2502A/TP-A-02/TPBs03) [Mus musculus]
IgG2b (26/II/6-1.2/TPBs01) [Rattus sp.]
CD3E (CD3 epsilon; Leu-4) [Homo sapiens]
ERBB2 (Epidermal Growth Factor Receptor 2; HER-2; p185c-erbB2; NEU; EGFR2) [Homo sapiens]
rat-murine hybrid (triomab®) Fresenius Biotech GmbH (Bad Homburg Germany) Breast cancers Phase II [o]
4D5 and UCHT1,
trastuzumab coupled with UCHT1 F(ab')2
Bispecific F(ab')2, chemically coupled with 4D5 (trastuzumab) CD3E (CD3 epsilon; Leu-4) [Homo sapiens]
ERBB2 (Epidermal Growth Factor Receptor 2; HER-2; p185c-erbB2; NEU; EGFR2) [Homo sapiens]
Mus musculus Charing Cross Sunley Research Centre (UK) / Genentech Inc. (S. San Francisco CA USA) / ICRF (UK) Cancers (overexpressing ERBB2) Adenovirus transformed human embryonic 293 kidney cells [c] [42]
520C9XH22,
MDX-210
Bispecific Fab (520C9)
IgG1 (H22)
CD3E (CD3 epsilon; Leu-4) [Homo sapiens]
FCGR1 (FCGR1A, FCGR1B, FCGR1C) (Fc gamma RI; CD64) [Homo sapiens]
Partially Humanized Ciba-Geigy AG (Basel Switzerland) / Medarex (Princeton NJ USA) All HER2-positive malignancies Phase I/II [e]
MDX-220 Bispecific TAG 72 (tumour associated glycoprotein 72) [Homo sapiens] Partially Humanized Genmab A/S (Copenhagen Denmark) / Medarex (Princeton NJ USA) Acute myeloid leukemia (AML) Phase I
MDX-447 Bispecific EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Partially Humanized Genmab A/S (Copenhagen Denmark) / Medarex (Princeton NJ USA) Cancers Phase II

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Hybrid monoclonal antibodies

Number of results: 2

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
catumaxomab 8406 93
(2005)
55
(2006)
Removab® Bispecific
Hybrid
IgG2a (Ho-3/TP-A-01/TPBs01) [Mus musculus]
IgG2b (26/II/6-1.2/TPBs01) [Rattus sp.]
CD3E (CD3 epsilon; Leu-4) [Homo sapiens]
EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens]
rat-murine hybrid (triomab®) Fresenius Biotech GmbH (Bad Homburg Germany) Gastric cancers Phase II/III EC Orphan drug November 2006 [o]
Malignant ascites Phase II/III EC Orphan drug November 2006
Ovarian cancers Phase II/III EC Orphan drug November 2006
ertumaxomab 8407 93
(2005)
55
(2006)
Rexomun® Bispecific
Hybrid
IgG2a (2502A/TP-A-02/TPBs03) [Mus musculus]
IgG2b (26/II/6-1.2/TPBs01) [Rattus sp.]
CD3E (CD3 epsilon; Leu-4) [Homo sapiens]
ERBB2 (Epidermal Growth Factor Receptor 2; HER-2; p185c-erbB2; NEU; EGFR2) [Homo sapiens]
rat-murine hybrid (triomab®) Fresenius Biotech GmbH (Bad Homburg Germany) Breast cancers Phase II [o]

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Antibodies and immunoadhesins approved for therapeutic use and on the market (in 2009)

Number of results: 30

INN (International Nonproprietary Name) INN Num. INN Prop. list INN Rec. list Common name Proprietary name IMGT/mAb-DB section Radiolabelled/ Conjugated IMGT/ 2D IMGT/ 3D Isotype and format Fusion protein format Specificity (target)
[origin]
Origin clone species Origin clone name Company Clinical indication Development status Regulatory agency status and year Expression Application Clinical domain FDA number EMEA number ATC code NCI number Drug number Citations/ Notes/ References
abatacept 8495 91
(2004)
53
(2005)
BMS-188667,
CTLA4-Ig
ORENCIA® Immunoadhesin CTLA4-IGHG1 Fc CD80, B7 [Homo sapiens]
CD86 [Homo sapiens]
Homo sapiens Bristol-Myers Squibb (Princeton NJ USA) Graft-versus-host disease (GvHD) (solid organ transplant) Phase I CHO (Chinese Hamster Ovary) cells (BLA) 125118 888 [j] [n] (16)
Psoriasis Phase I CHO (Chinese Hamster Ovary) cells
Rheumatoid arthritis (RA) Phase M FDA approval December 2005 CHO (Chinese Hamster Ovary) cells
T cell co-stimulation modulator Phase M FDA approval December 2005 CHO (Chinese Hamster Ovary) cells
abciximab 7200 70
(1993)
34
(1994)
c7E3 REOPRO® Chimeric IgG1κ Fab CD41/CD61, INTEGRIN-ALPHA-IIb_BETA-3, αIIbβ3, GPIIbIIIa, Fibrinogen receptor [Homo sapiens] Mus musculus 7E3 Centocor Inc. (Horsham PA USA) / Eli Lilly (Indianapolis IN USA) Anti-platelet prevention of blood clots in the setting of high risk percutaneous transluminal coronary angioplasty Phase M FDA approval December 1994 Sp2/0 mouse myeloma cells (BLA) 103575 332 [a] [b] [e] [f] [j]
Refractory unstable angina when percutaneous coronary intervention is planned Phase M FDA approval November 1997 Sp2/0 mouse myeloma cells
adalimumab 7860 82
(1999)
44
(2000)
D2E7 HUMIRA® (EU/US)
TRUDEXA® (EU)
Human IgG1κ TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Homo sapiens Abbott Laboratories (Abbott Park IL USA) (EU/US) Psoriatic arthritis (PSA) Phase M FDA approval December 2002 CHO (Chinese Hamster Ovary) cells (BLA) 125057 H-C-481 L04AB04 814 [a] [j] (12) [12]
Rheumatoid arthritis (RA) Phase M FDA approval December 2002 CHO (Chinese Hamster Ovary) cells
Cambridge Antibody Technology (Cambridge UK) (US) / BASF (Ludwigshafen Germany) Rheumatoid arthritis (RA) Phase I/II CHO (Chinese Hamster Ovary) cells
alefacept 8059 84
(2000)
46
(2001)
AMEVIVE® Immunoadhesin Leucocyte function associated antigen 3 (LFA3)-IGHG1 Fc CD2 (LFA-2, Lymphocyte function antigen 2) [Homo sapiens] Homo sapiens Biogen Canada Inc. (Mississauga ON Canada) Severe chronic plaque psoriasis Phase M FDA approval January 2003 CHO (Chinese Hamster Ovary) cells (BLA) 125036 820 [j] [n]
alemtuzumab 8005 83
(2000)
45
(2001)
Campath-1H,
LDP-03
CAMPATH® (US)
MABCAMPATH® (EU)
Humanized 8005 1bey
1ce1
IgG1κ CD52 [Homo sapiens] Rattus norvegicus YTH34.5HL Berlex Inc. (Wayne NJ USA) (US) / Genzyme Corp. (Cambridge MA USA) (EU) / Millennium Pharmaceuticals Inc. (Cambridge MA USA) (EU/US) B cell chronic lymphocytic leukemia (B-CLL) Phase M FDA approval May 2001 CHO (Chinese Hamster Ovary) cells Therapeutic Immunology, Oncology (BLA) 103948 C1681 702 [a] [b] [c] [19]
Kidney transplant rejection Phase I/II CHO (Chinese Hamster Ovary) cells
Multiple sclerosis (MS) Phase I/II CHO (Chinese Hamster Ovary) cells
basiliximab 7578 76
(1996)
38
(1997)
CHI621 SIMULECT® Chimeric IgG1κ IL2RA (interleukin-2 receptor, alpha; IL-2R; TAC; CD25) [Homo sapiens] Mus musculus CHI621 Novartis Pharmaceuticals Corp. (East Hanover NJ USA) Prevention
Renal transplant rejection
Phase M FDA approval May 1998 Sp2/0 mouse myeloma cells (BLA) 103764 440 [a] [b] [d] [f] [j] [56]
bevacizumab 8017 83
(2000)
45
(2001)
12-IgG1,
F(ab)-12 IgG1,
Fab-12 IgG1,
rhuMAb-VEGF
AVASTIN® Humanized 8017 1bj1 IgG1 VEGF-A (Vascular Endothelial Growth Factor A) [Homo sapiens] Mus musculus muMAb-VEGF A.4.6.1 Genentech Inc. (S. San Francisco CA USA) (EU) Breast cancers (metastatic HER2 negative) Phase M FDA approval February 2008 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology (BLA) 125085 851 [a] [b] (20)
Metastatic carcinoma of the colon and rectum Phase M FDA approval February 2004 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology
Metastatic colorectal cancers Phase M FDA approval June 2006 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology
Metastatic non-small cell lung cancers Phase M FDA approval October 2006 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology
Genentech Inc. (S. San Francisco CA USA) / NIH (Bethesda MD USA) Renal cancers Phase II NCI trial
canakinumab 8836 97
(2007)
59
(2008)
ACZ885 ILARIS® Human 8836 IgG1κ IL1B (interleukin 1 beta; IL-1B) [Homo sapiens] Homo sapiens Novartis Pharmaceuticals Corp. (East Hanover NJ USA) Cryopyrin-Associated Periodic Syndromes (CAPS) (including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 4 and older) Phase M FDA approval June 2009 Therapeutic Hereditary inflammatory diseases (BLA) 125319
Novartis (Basel Switzerland) Rheumatoid arthritis (RA)
capromab 7201 70
(1993)
34
(1994)
7E11-C5.3,
pendetide
PROSTASCINT® Murine radiolabelled with Indium-111, In-111 IgG1κ PSMA (prostate specific membrane antigen) [Homo sapiens] Mus musculus EUSA Pharma (Doylestown PA USA) Prostate cancers Phase M FDA approval October 1996 Diagnostic Unknown (BLA) 103608 [b] [d] [n]
certolizumab pegol 8448 90
(2004)
52
(2004)
CDP870,
PHA-738144
CIMZIA® Humanized PEGylated Fab' TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Mus musculus Celltech, UCB (Brussels Belgium) Crohn's disease (CD) Phase M FDA approval April 2008 (BLA) 125160
Rheumatoid arthritis (RA) Phase III
cetuximab 7906 82
(1999)
44
(2000)
Fab C225,
IMC-225
ERBITUX® Chimeric 7906 1yy8
1yy9
IgG1κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Mus musculus C225 Merck & Co., Inc. (Whitehouse Station NJ USA) (EU) / ImClone Systems Inc. (Somerville NJ USA) (US) Metastatic colorectal cancers Phase M FDA approval February 2004 Sp2/0 mouse myeloma cells (BLA) 125084 C1723 850 [a] [b] [e] [j]
daclizumab 7164 78
(1997)
40
(1998)
ZENAPAX® Humanized IgG1 IL2RA (interleukin-2 receptor, alpha; IL-2R; TAC; CD25) [Homo sapiens] Mus musculus 1H4 F. Hoffmann-La Roche Ltd. (Basel Switzerland) (EU) Prevention
Acute kidney transplant rejection
Phase M FDA approval December 1997 Sp2/0 mouse myeloma cells Therapeutic Immunology (BLA) 103749 C1569 359 [b] [c] [j] [46] [50]
PDL (Protein Design Labs) BioPharma (Fremont CA USA) Asthma Phase II
Blood cancers Phase II
Graft-versus-host disease (GvHD) Phase II
Liver transplantation Phase II
Pediatric kidney transplantation Phase I/II
Psoriasis Phase II
Tropical spastic paraparesis (model for multiple sclerosis) Phase I/II
Ulcerative colitis Phase II
Uveitis Phase I/II
eculizumab 8231 87
(2002)
49
(2003)
5G1.1 SOLIRIS™ Humanized IgG C5 (complement 5) [Homo sapiens] Mus musculus Alexion Pharmaceuticals Inc. (New Haven CT USA) Dermatomyositis Phase I/II (BLA) 125166 C48386 945 [a] [b]
Nephritis Phase II
Paroxysmal nocturnal hemoglobinuria (PNH) Phase M FDA approval March 2007 Therapeutic Unknown
Psoriasis Phase I/II
Rheumatoid arthritis (RA) Phase II
edrecolomab 7471 74
(1995)
36
(1996)
17-1A PANOREX® Murine IgG2a EPCAM (epithelial cell adhesion molecule; TACSTD1, Tumor-associated calcium signal transducer 1; GA733-2, gastrointestinal tumor-associated protein 2; EGP-2, epithelial glycoprotein 2; Ep-CAM, epithelial cell adhesion molecule; KSA; KS1/4 antigen; M4S; tumor antigen 17-1A; CD326; EpCAM) [Homo sapiens] Mus musculus Centocor Inc. (Horsham PA USA) / GlaxoSmithKline (Brentford UK) Colon cancers Phase M approval (Germany) January 1995 Sp2/0 mouse myeloma cells Therapeutic Unknown C1554 [a] [e]
etanercept 7783 81
(1999)
43
(2000)
TNFR-immunoadhesin ENBREL® Immunoadhesin Tumor necrosis factor receptor (TNFR) alpha - IGHG1 Fc TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Homo sapiens Immunex Corporation Amgen (Thousand Oaks CA USA) Psoriatic arthritis (PSA) Phase M FDA approval February 2002 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells (BLA) 103795 737 [f] [j] [n] (15)
Rheumatoid arthritis (RA) Phase M FDA approval November 1998 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells
gemtuzumab 8024 83
(2000)
45
(2001)
CMA-676 MYLOTARG® Humanized calicheamicin conjugated IgG4κ CD33 (SIGLEC3; SIGLEC-3; gp67; p67) [Homo sapiens] Mus musculus p67,6 Wyeth Pharmaceuticals (Madison NJ USA) Acute myeloid leukemia (AML) (CD33 positive) Phase M FDA approval May 2000 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells Therapeutic Hematology, Oncology (NDA) 021174 842 [f] [j] (17)
golimumab 8497 91
(2004)
53
(2005)
CNTO 148 SIMPONI™ Human IgG1κ TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Homo sapiens Centocor Ortho Biotech Inc. (Malvern PA USA) Ankylosing spondylitis (AS) Phase M FDA approval April 2009 Therapeutic Immunology (BLA) 125289
Psoriatic arthritis (PSA) (fully human) Phase M FDA approval April 2009 Therapeutic Immunology
Rheumatoid arthritis (RA) Phase M FDA approval April 2009 Therapeutic Immunology
ibritumomab tiuxetan 7873 81
(1999)
43
(2000)
IDEC-2B8 ZEVALIN® Murine radiolabelled with Yttrium-90, Y-90 IgG1κ MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus Biogen IDEC Pharmaceuticals (Cambridge MA USA) / Schering AG (Berlin Germany) Non-Hodgkin's B cell lymphoma (NHL) Phase M FDA approval February 2002 CHO (Chinese Hamster Ovary) cells Therapeutic Oncology (BLA) 125019 762 [j] [n]
infliximab 7602 77
(1997)
39
(1998)
cA2 REMICADE® Chimeric IgG1 TNF (tumor necrosis factor; TNFA, TNF-alpha; TNFSF2) [Homo sapiens] Mus musculus A2 Centocor Inc. (Horsham PA USA) Ankylosing spondylitis (AS) Phase M FDA approval December 2004 Sp2/0 mouse myeloma cells (BLA) 103772 C1789 703
759
[a] [b] [d] [f] [j] [53] [54]
Treatment
Crohn's disease (CD)
Phase M FDA approval August 1998 Sp2/0 mouse myeloma cells
Psoriatic arthritis (PSA) Phase M FDA approval May 2005 Sp2/0 mouse myeloma cells
Rheumatoid arthritis (RA) Phase M FDA approval November 1999 Sp2/0 mouse myeloma cells
Ulcerative colitis Phase M FDA approval October 2006 Sp2/0 mouse myeloma cells
muromonab-CD3 6281 59
(1988)
29
(1989)
OKT3 ORTHOCLONE OKT3® Murine IgG2a CD3E (CD3 epsilon; Leu-4) [Homo sapiens] Mus musculus Ortho Biotech Products LP (Bridgewater NJ USA) Acute kidney transplant rejection (reversal) Phase M FDA approval September 1992 Murine ascites, hybridoma (BLA) 103463 C1321 [a] [b] [d] [j] [n]
Heart transplant rejection (reversal) Phase M FDA approval September 1992 Murine ascites, hybridoma
Liver transplantation (reversal) Phase M FDA approval September 1992 Murine ascites, hybridoma
natalizumab 7716 79
(1998)
41
(1999)
AN100226m TYSABRI®
ANTEGREN® (formerly)
Humanized IgG1 INTEGRIN-ALPHA-4_BETA-1, α4β1, VLA4, VCAM1 receptor [Homo sapiens] Mus musculus Biogen IDEC Pharmaceuticals (Cambridge MA USA) / Elan Pharmaceuticals International Ltd. (Dublin Ireland) Acute and chronic inflammatory condtions COS cells transient expression (BLA) 125104 869 [a] [b] [c] [e] [j] [k] (3) (4) [7]
Colitis Phase II
Crohn's disease (CD) Phase M FDA approval January 2008 NSO mouse myeloma cells Therapeutic Unknown
Multiple sclerosis (MS) Phase M FDA SBLA reintroduced June 2006, Market suspension (three patients developed progressive multifocal leukoencephalopathy (PML)) February 2005, FDA approval November 2004 NSO mouse myeloma cells Therapeutic Immunology
nimotuzumab 8545 94
(2005)
56
(2006)
Theraloc,
hR3
THERACIM® (India, China, Cuba, Argentina, Columbia) Humanized IgG1κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Mus musculus YM BioScienecs Inc. (Mississauga Canada) Glioma cancers Phase M EMEA withdrawal December 2008, EMEA Orphan drug September 2004 NSO mouse myeloma cells Therapeutic Unknown C2733 [n]
Head cancers Phase M NSO mouse myeloma cells Therapeutic Unknown
Lung cancers Phase II
Metastatic pancreatic cancers Phase II
Neck cancers Phase M NSO mouse myeloma cells Therapeutic Unknown
Pancreatic cancers Phase M EMEA Orphan drug June 2008 NSO mouse myeloma cells Therapeutic Unknown
omalizumab 8039 84
(2000)
46
(2001)
IGE25,
olizumab,
rhuMab-E25
XOLAIR® Humanized IgG1κ IgE, CH3 [Homo sapiens] Mus musculus MaE11 Genentech Inc. (S. San Francisco CA USA) / Novartis Pharmaceuticals Corp. (East Hanover NJ USA) / Tanox Inc. (Houston TX USA) Allergic asthma Phase M CHO (Chinese Hamster Ovary) cells Therapeutic Immunology (BLA) 103976 C29299 [a] [b] [l]
Severe persistent asthma Phase M FDA approval (for subcutaneous use) June 2003 CHO (Chinese Hamster Ovary) cells Therapeutic Immunology
palivizumab 7753 79
(1998)
41
(1999)
MEDI-493 SYNAGIS® Humanized 2hwz IgG1κ RSV (respiratory syncytial virus)
F glycoprotein (fusion protein)
Mus musculus Abbott Laboratories (Abbott Park IL USA) (EU) / MedImmune Inc. (Gaithersburg MD USA) (US) Respiratory Syncytial Virus (RSV) disease (prophylaxis of lower respiratory tract disease in pediatric patients) Phase M AMM Market authorization (Abbott) August 1999, FDA approval June 1998 NSO mouse myeloma cells Therapeutic Pulmonary, Respiratory diseases (BLA) 103770 C2625 447 [a] [b] [d] [j] [49]
panitumumab 8499 91
(2004)
53
(2005)
ABX-EGF,
E7.6.3
VECTIBIX™ Human IgG2κ EGFR (Epidermal Growth Factor Receptor; ERBB1; HER1; ERBB) [Homo sapiens] Homo sapiens XenoMouse™ Amgen (Thousand Oaks CA USA) Colorectal cancers Phase M FDA approval September 2006 CHO (Chinese Hamster Ovary) cells (BLA) 125147 C1857 933 [b] [n] (11) (13)
Abgenix (Fremont CA USA) Lung cancers Phase IV (PA) Biopharmaceuticals in the U.S. and European Markets New entries in the 4th edition. CHO (Chinese Hamster Ovary) cells
Prostate cancers Phase IV (PA) Biopharmaceuticals in the U.S. and European Markets New entries in the 4th edition. CHO (Chinese Hamster Ovary) cells
Renal cancers Phase IV (PA) Biopharmaceuticals in the U.S. and European Markets New entries in the 4th edition. CHO (Chinese Hamster Ovary) cells
ranibizumab 8313 90
(2004)
52
(2004)
Fab-12 variant Y0317,
RhuFab
LUCENTIS® Humanized 8313 1cz8 Fab VEGF-A (Vascular Endothelial Growth Factor A) [Homo sapiens] Mus musculus muMAb-VEGF A.4.6.1 Genentech Inc. (S. San Francisco CA USA) / Novartis Pharmaceuticals Corp. (East Hanover NJ USA) Neovascular (wet) age related macular degeneration (AMD) Phase M FDA approval June 2006 E.coli (Escherichia coli) Therapeutic Ophthalmology (BLA) 125156 904
rilonacept 8750 95
(2006)
57
(2007)
ARCALYST™ Immunoadhesin 8750 Interleukin-1 receptor accessory protein (IL1RAP)-type 1 interleukin-1 receptor-IGHG1 Fc IL1 (interleukin 1; IL-1) [Homo sapiens] Homo sapiens Regeneron Pharmaceuticals Inc. (Tarrytown NY USA) Autoinflammatory diseases (BLA) 125249 [p]
Treatment
Cryopyrin-Associated Periodic Syndromes (CAPS) (including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS))
Phase M FDA approval February 2008 Therapeutic Hereditary inflammatory diseases
Osteoarthritis
Rheumatoid arthritis (RA)
rituximab 7609 77
(1997)
39
(1998)
IDEC-C2B8 MABTHERA®
RITUXAN® (US, Canada and Japan)
Chimeric IgG1κ MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus IDEC-C2B8 Biogen IDEC Pharmaceuticals (Cambridge MA USA) / Genzyme Corp. (Cambridge MA USA) Treatment
Non-Hodgkin's B cell lymphoma (NHL) (Follicular CD20 positive, relapsed or refractory low grade)
Phase M FDA approval November 1997 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells (BLA) 103705
(BLA) 103737
C1702 349 [a] [b] [d] [f] [j] (18) [55]
Rheumatoid arthritis (RA) Phase M FDA approval March 2006 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells
tositumomab 7827 80
(1998)
42
(1999)
BEXXAR® Murine radiolabelled with Iodine-131, I-131 IgG2a MS4A1 (membrane-spanning 4-domains subfamily A member 1; CD20; B1, B lymphocyte surface antigen; Leu-16; Bp35) [Homo sapiens] Mus musculus GlaxoSmithKline (Brentford UK) / Corixa Corp. (Seattle WA USA) Non-Hodgkin's B cell lymphoma (NHL) (Follicular CD20 positive, following chemotherapy relapse) Phase M FDA approval June 2003 Hybridoma (BLA) 125011 C2543 834 [j] [n]
trastuzumab 7637 78
(1997)
40
(1998)
4D5V8,
Herceptin
HERCEPTIN® Humanized 7637 1n8z IgG1κ ERBB2 (Epidermal Growth Factor Receptor 2; HER-2; p185c-erbB2; NEU; EGFR2) [Homo sapiens] Mus musculus 4D5 F. Hoffmann-La Roche Ltd. (Basel Switzerland) (EU) / Genentech Inc. (S. San Francisco CA USA) (US) Breast cancers (as adjuvant) Phase III CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells (BLA) 103792 C1647 485 [a] [b] [d] [e] [j] [48]
Metastatic breast cancers overexpressing ERBB2 Phase M AMM Market authorization (Roche) August 2000, FDA approval October 1998 CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells Therapeutic Oncology
Non-small-cell lung cancers Phase II CHO (Chinese Hamster Ovary) MTX (methotrexate resistant) cells

up

IMGT citations:
[a] Mike's Immunoglobulin Structure/Function: Antibodies for Therapeutic Applications.
[b] PhRMA: New Medicines in Development: Biotechnology: A 2000Survey.
[c] José Saldanha: Humanization bY Design.
[d] Biopharmaceutical Benchmarks, Nature Biotechnology,18, 831-833 (2000).
[e] The antibodies, vol 6, ed. Zanetti M. and Capra J.D., Harwood academic publishers, Amsterdam, The Netherlands, pp 4-8 (2000).
[f] Information provided by Mitchell Reff, IDEC Pharmaceuticals.
[g] Schopf, R.E., Curr. Opin. Investig. Drugs, 2, 635-638 (2001).
[h] CLL Topics .
[i] Rosenwasser, L.J. et al., J. Allergy Clin. Immunol., 112, 563-570 (2003).
[j] Marie-Paule Lefranc, IMGT (26/12/2005).
[k] Information provided by Tarran Jones (08/02/2002) and from the AERES Biomedical web site (08/01/2004).
[l] Information from the Tanox Inc. web site (08/01/2004).
[m] Krietman RJ et al. PNAS 87, 8291-8295 (1990).
[n] Yan Wu and Marie-Paule Lefranc, IMGT (20/12/2006).
[o] Yan Wu and Marie-Paule Lefranc, IMGT, following information from Christian Behrens. (20/04/2007).
[p] Yan Wu and Marie-Paule Lefranc, IMGT (29/06/2007).
IMGT glossary:
AMM: Autorisation de Mise sur le Marche (Market authorization)
Discontinued: Discontinued
EC: European Commission
EMEA: European Medicines Agency for the Evaluation of Medical Products
FDA: Food and Drug Administration
NCI: National Cancer Institute
NDA: New Drug Application
SBLA: Supplemental Biologics License Application
IMGT notes:
(1) Since the monoclonal antibody is type-specific it will be limited to certain patients.
(2) A different epitope is recognized by YFC51.1 and 60.3.
(3) Later Celltech produced IgG4.
(4) Stable expressing cell line made at Celltech (UK).
(5) A different epitope is recognized by AUK12-20 and PM-1.
(6) IgG4 has an amino acid change S241>P to allow complete disulfide bridge formation at the hinge.
(7) HMFG (Human Milk Fat Globule).
(8) Original mouse mAb from Tanox, Inc. (TX).
(9) BEC2 is an anti-idiotypic mAb. By mimicking the GD3 tumour associated antigen, BEC2 appears to stimulate a stronger immune response than natural GD3.
(10) Surface granulocyte nonspecific cross-reacting antigen.
(11) Human Ig from transgenic XenoMouse (Abgenix).
(12) Human antibodies derived from phage display human antibody libraries.
(13) Biopharmaceuticals in the U.S. and European Markets New entries in the 4th edition.
(14) No more information on 23/02/02. Development seems halted.
(15) Fusion protein of the soluble ligand-binding domain of the tumor necrosis factor receptor p75 (TNFrp75) and of the Fc of a human IgG1.
(16) Cytotoxin T lymphocyte-associated antigen 4-Immunoglobulin G1 fragment fusion protein.
(17) Calicheamicin is a cytotoxin antitumor antibiotic, isolated from fermentation of a bacterium, Micromonospora echino spora, ssp. calichensis.
(18) Rituximab proprietary name is RITUXAN® in the USA, Canada and Japan, and MABTHERA® in the other countries.
(19) Previously Techniclone Corp.
(20) The VH domain of ranibizumab (1cz8) differs from the VH domain of bevacizumab (1bj1) by four amino acid changes: VH [CDR1-IMGT: T29>D, N36>H, CDR3-IMGT: H109>Y, S112.2>T] and the V-KAPPA domain by one amino acid change M4>L.
(21) Clenoliximab derives from keliximab. The two antibodies share the same variable domains. In June 1997, IDEC and SmithKline Beecham suspended a clinical trial of a different anti-CD4 antibody (PRIMATIZED™ IDEC-CE9.1). In that trial, CD4 cell depletion was noted in a subset of patients, though no serious side effects were reported. The constant human IGHG1 from keliximab has been changed to human IGHG4. Moreover the IGHG4 contains two amino acid changed S10>P (hinge) and L1.2>E (CH2), according to the IMGT unique numbering [57].
(22) Generated from HuCAL® (Human Combinatorial Antibody Library).
(23) J591 is a deimmunized antibody (Biovation, Ltd., Lonza Biologics, Plc.), chelated with DOTA (1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid) (BZL biologics, Inc., Framingham, MA, USA) for allowing labelling with 177Lu, 90Y and 111In [60].
(24) US patent 5863745.
(25) mAb covalently linked to 2-3 molecules of calicheamicin.
(26) motavizumab derived from palivizumab.
(27) used with foravirumab/rafivirumab in cocktail.
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