Monoclonal Antibodies - Short Note

Nomenclature of Monoclonal Antibodies.

For nomenclature the name of the MAB can be divided like this

Prefix (variable) --- target --- source ---mab[suffix] (monoclonal antibody)

The following guidelines have been developed for monoclonal antibodies:

1. The suffix -mab is used for monoclonal antibodies and fragments.

2. Identification of the animal source of the product is an important safety factor based on the number of products that may cause source-specific antibodies to develop in patients.

The following letters were approved as product source identifiers:

u	human
o	mouse
a	rat
zu	humanized
e	hamster
i	primate
xi	chimera
axo	rat/mouse
xizu	combination of humanized and chimeric chains

These identifiers are used as infixes preceding the -mab suffix stem, e.g.:

-umab (human)
-omab (mouse)
-ximab (chimera)
-zumab (humanized)

Subclasses

The general disease state subclass must be incorporated into the name by use of a code syllable. The following disease state subclasses were approved based on products currently before the Council. Additional subclasses will be added as necessary.

Disease or Target Class:

Old System:

New System:

In order to create a unique name, a distinct, compatible syllable should be selected as the starting prefix.

Sequence of stems: The order for combining the key elements is as follows: Infix representing the target disease state, the source of the product, and the monoclonal root -mab used as a suffix (eg, biciromab, satumomab, nebacumab, sevirumab, tuvirumab). When combining a target or disease infix stem with the source stem for chimeric monoclonal antibody, the last consonant of the target/disease syllable is dropped, eg:

TARGET	SOURCE	-MAB STEM	USAN
-cir-	-xi	-mab	abciximab
-lim-	-zu	-mab	daclizumab

Few FDA Approved Monoclonal antibodies:

Antibody	Type	Target	Indication (Targeted disease)
Abciximab (Q)	chimeric	inhibition of glycoprotein IIb/IIIa (Q)	Anti platelet
Adalimumab	human	inhibition of TNF-α signaling (Q)	Several auto-immune disorders
Alemtuzumab	humanized	CD52	Chronic lymphocytic leukemia
Basiliximab	chimeric	IL-2Rα receptor (CD25)	Transplant rejection
Belimumab	human	inihibition of B- cell activating factor	Systemic lupus erythematosus
Bevacizumab (Q)	humanized	Vascular endothelial growth factor (VEGF)	Colorectal cancer, Age related macular degeneration (off-label)
Brentuximab vedotin	Chimeric	CD30	Anaplastic large cell lymphoma (ALCL) and Hodgkin lymphoma
Canakinumab	Human	IL-1β	Cryopyrin-associated periodic syndrome (CAPS)
Cetuximab (Q)	chimeric	epidermal growth factor receptor	Colorectal cancer, Head and neck cancer
Certolizumab pegol	humanized	inhibition of TNF-α signaling	Crohn's disease
Daclizumab	humanized	IL-2Rα receptor (CD25)	Transplant rejection
Denosumab (Q)	Human	RANK Ligand inhibitor (Q)	Postmenopausal osteoporosis , Solid tumor`s bony metasteses
Eculizumab	humanized	Complement system protein C5	Paroxysmal nocturnal hemoglobinuria
Efalizumab	humanized	CD11a	Psoriasis
Gemtuzumab	humanized	CD33	Acute myelogenous leukemia (with calicheamicin)
Golimumab	Human	TNF-alpha inihibitor	Rheumatoid arthritis, Psoriatic arthritis, and Ankylosing spondylitis
Ibritumomab tiuxetan	murine	CD20	Non-Hodgkin lymphoma (with yttrium-90 or indium-111)
Infliximab (Q)	chimeric	inhibition of TNF-α signaling	Several autoimmune disorders
Ipilimumab ( MDX-101 )	Human	blocks CTLA-4	Melanoma
Muromonab-CD3	murine	T cell CD3 Receptor	Transplant rejection
Natalizumab	humanized	alpha-4 (α4) integrin,	Multiple sclerosis and Crohn's disease
Ofatumumab	Human	CD20	Chronic lymphocytic leukemia
Omalizumab (Q)	humanized	immunoglobulin E (IgE) (Q)	mainly allergy-related asthma
Palivizumab (Q)	humanized	an epitope of the RSV F protein	Respiratory Syncytial Virus (Q)
Panitumumab	human	epidermal growth factor receptor	Colorectal cancer
Ranibizumab	humanized	Vascular endothelial growth factor A (VEGF-A)	Macular degeneration
Rituximab (Q)	chimeric	CD20	Non-Hodgkin lymphoma
Tocilizumab ( or Atlizumab )	Humanised	Anti- IL-6R	Rheumatoid arthritis
Tositumomab	murine	CD20	Non-Hodgkin lymphoma
Trastuzumab (Q)	humanized	ErbB2 (Q)	Breast cancer (Q)