Explore a selection of our essential drug information below, or:
Identification
- Generic Name
- Catumaxomab
- DrugBank Accession Number
- DB06607
- Background
Catumaxumab is a trifunctional monoclonal antibody developed for use in cancer treatment. It has affinity for T-cells, accessory immune cells, and cancer cells. Catumaxumab was initially authorized for market by the European Medicines Agency in April 2009 for the treatment of malignant ascites 3. Its market authorization was withdrawn in the EU in June 2017 at the manufacturer's request due to the company's insolvency. Catumaxumab was approved for market in Canada in May 2012 for the same condition Label. It is currently available under the brand name Removab.
- Type
- Biotech
- Groups
- Approved, Investigational, Withdrawn
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Structure
- Protein Chemical Formula
- Not Available
- Protein Average Weight
- 150511.0 Da (Intact Mass)
- Sequences
- Not Available
- Synonyms
- Catumaxomab
Pharmacology
- Indication
For use in the management of malignant ascites tumours via intraperitoneal infusion where standard therapy is not available or feasible Label.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Management of Ascites, malignant •••••••••••• •• •••••••• •••••••• •••••••• •••••••••••••• •••••••••• ••••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Catumaxomab brings cancer cells, T cells, and accessory immune cells into close proximity and stimulates activation and of immune cells Label,1. This facilitates immune system-mediated destruction of the cancer cells.
- Mechanism of action
Catumaxomab contains epitopes for human CD3 and human epithelial cell adehesion molecule. It also has an intact immunoglobulin gamma constant region allowing it to bind to Fcγ I, IIa, and III receptors Label,1. By binding to CD3 on killer T cells, EpCAM on cancer cells, and Fcγ receptors on accessory immune cells like macrophages and NK cells, Catumaxomab brings immune cells into close proximity to EpCAM positive cancer cells. As a functional antibody, Catumaxomab also stimulates bound NK cells to release cytotoxic mediators like granzyme or bound macrophages to phagocytose the cancer cell. Phagocytosed cancer cells can be processed and have their antigens presented on major histocompatibililty complex II to activate helper T cells and contribute to humoural immunity and activation of killer T cells against EpCAM postive cancer cells. These macrophages also release inflammatory cytokines to attract additional immune cells to EpCAM positive tissues. When antibodies reach higher concentrations, they can stimulate complement-mediated cytotoxicity against EpCAM positive cancer cells. Bound killer T cells are activated resulting in proliferation and release of cytotoxic mediators resulting in antibody-dependent cell-mediated cytotoxicity against the cancer cell.
Target Actions Organism ALow affinity immunoglobulin gamma Fc region receptor II-a agonistHumans ALow affinity immunoglobulin gamma Fc region receptor III-A agonistHumans ALow affinity immunoglobulin gamma Fc region receptor III-B agonistHumans AT-cell surface glycoprotein CD3 epsilon chain agonistHumans AHigh affinity immunoglobulin gamma Fc receptor I agonistHumans NEpithelial cell adhesion molecule ligandHumans - Absorption
Catumaxomab has an observed bioavailability of 82% 2. This value decreases as the EpCAM positive tumour load and number of immune cells in the peritoneal cavity increases. While some Catumaxomab escapes into systemic circulation, most localizes to EpCAM positive tissues. Tmax is 19 h.
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Catumaxomab has an apparent half life of elimination of 2.5 days Label.
- Clearance
Not Available
- Adverse Effects
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As a mouse/rat hybrid antibody, Catumaxomab can produce immunogenicity in other species 1. No acute toxicity was found in mice using an analog with an anti-mouse CD3 paratope in place of Catumaxomab's anti-human CD3 paratope. A transient decrease in serum leukocytes has been observed but is attributed to migration of immune cells into EpCAM positive tissues. Data specific to Catumaxomab is extremely limited as its specificity for human protein requires data from human subjects Label.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Catumaxomab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Catumaxomab. Aducanumab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Aducanumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Catumaxomab. Alirocumab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Alirocumab. - Food Interactions
- Not Available
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Removab Injection, solution, concentrate 10 microgram Intraperitoneal Neovii Biotech 2020-12-16 2017-06-02 EU 
Removab Solution 0.1 mg / mL Intraperitoneal Fresenius Biotech Gmbh Not applicable Not applicable Canada 
Removab Injection, solution, concentrate 50 microgram Intraperitoneal Neovii Biotech 2020-12-16 2017-06-02 EU Removab Solution 0.1 mg / mL Intraperitoneal Fresenius Biotech Gmbh Not applicable Not applicable Canada
Categories
- ATC Codes
- L01FX03 — Catumaxomab
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Antibodies
- Antibodies, Monoclonal
- Antineoplastic Agents
- Antineoplastic and Immunomodulating Agents
- Bispecific Monoclonal Antibodies
- Blood Proteins
- Cancer immunotherapy
- Gastrointestinal Agents
- Globulins
- Immunoglobulins
- Immunoproteins
- Immunotherapy
- Monoclonal antibodies and antibody drug conjugates
- Proteins
- Serum Globulins
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans
Chemical Identifiers
- UNII
- M2HPV837HO
- CAS number
- 509077-98-9
References
- Synthesis Reference
Seimetz D, Lindhofer H, Bokemeyer C. Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010;36(6):458-67.
Lindhofer H, Mocikat R, Steipe B, Thierfelder S. Preferential species-restricted heavy/light chain pairing in rat/mouse quadromas. Implications for a single-step purification of bispecific antibodies. J Immunol. 1995;155(1):219-25.
- General References
- Seimetz D, Lindhofer H, Bokemeyer C: Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010 Oct;36(6):458-67. doi: 10.1016/j.ctrv.2010.03.001. Epub 2010 Mar 27. [Article]
- Ruf P, Kluge M, Jager M, Burges A, Volovat C, Heiss MM, Hess J, Wimberger P, Brandt B, Lindhofer H: Pharmacokinetics, immunogenicity and bioactivity of the therapeutic antibody catumaxomab intraperitoneally administered to cancer patients. Br J Clin Pharmacol. 2010 Jun;69(6):617-25. doi: 10.1111/j.1365-2125.2010.03635.x. [Article]
- EMA: Removab Withdrawal from Market [Link]
- External Links
- Wikipedia
- Catumaxomab
- FDA label
- Download (394 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample data3 Completed Treatment Ascites, Malignant / Cancer / Carcinoma / Neoplasm 1 somestatus stop reason just information to hide 3 Recruiting Treatment Neoplasm of Stomach 1 somestatus stop reason just information to hide 2 Completed Treatment Abdominal wall neoplasm / Fallopian Tube Neoplasms / Ovarian Cancer 1 somestatus stop reason just information to hide 2 Completed Treatment Ascites, Malignant 1 somestatus stop reason just information to hide 2 Completed Treatment Epithelial Ovarian Cancer / Ovarian Cancer 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution, concentrate Intraperitoneal 10 microgram Injection, solution, concentrate Intraperitoneal 50 microgram Injection, solution, concentrate Intravenous Solution Intraperitoneal 0.1 mg / mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- Binds to the Fc region of immunoglobulins gamma. Low affinity receptor. By binding to IgG it initiates cellular responses against pathogens and soluble antigens. Promotes phagocytosis of opsonized antigens
- Specific Function
- Igg binding
- Gene Name
- FCGR2A
- Uniprot ID
- P12318
- Uniprot Name
- Low affinity immunoglobulin gamma Fc region receptor II-a
- Molecular Weight
- 35000.42 Da
References
- Seimetz D, Lindhofer H, Bokemeyer C: Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010 Oct;36(6):458-67. doi: 10.1016/j.ctrv.2010.03.001. Epub 2010 Mar 27. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- Receptor for the invariable Fc fragment of immunoglobulin gamma (IgG). Optimally activated upon binding of clustered antigen-IgG complexes displayed on cell surfaces, triggers lysis of antibody-coated cells, a process known as antibody-dependent cellular cytotoxicity (ADCC). Does not bind free monomeric IgG, thus avoiding inappropriate effector cell activation in the absence of antigenic trigger (PubMed:11711607, PubMed:21768335, PubMed:22023369, PubMed:24412922, PubMed:25786175, PubMed:25816339, PubMed:28652325, PubMed:8609432, PubMed:9242542). Mediates IgG effector functions on natural killer (NK) cells. Binds antigen-IgG complexes generated upon infection and triggers NK cell-dependent cytokine production and degranulation to limit viral load and propagation. Involved in the generation of memory-like adaptive NK cells capable to produce high amounts of IFNG and to efficiently eliminate virus-infected cells via ADCC (PubMed:24412922, PubMed:25786175). Regulates NK cell survival and proliferation, in particular by preventing NK cell progenitor apoptosis (PubMed:29967280, PubMed:9916693). Fc-binding subunit that associates with CD247 and/or FCER1G adapters to form functional signaling complexes. Following the engagement of antigen-IgG complexes, triggers phosphorylation of immunoreceptor tyrosine-based activation motif (ITAM)-containing adapters with subsequent activation of phosphatidylinositol 3-kinase signaling and sustained elevation of intracellular calcium that ultimately drive NK cell activation. The ITAM-dependent signaling coupled to receptor phosphorylation by PKC mediates robust intracellular calcium flux that leads to production of pro-inflammatory cytokines, whereas in the absence of receptor phosphorylation it mainly activates phosphatidylinositol 3-kinase signaling leading to cell degranulation (PubMed:1825220, PubMed:23024279, PubMed:2532305). Costimulates NK cells and trigger lysis of target cells independently of IgG binding (PubMed:10318937, PubMed:23006327). Mediates the antitumor activities of therapeutic antibodies. Upon ligation on monocytes triggers TNFA-dependent ADCC of IgG-coated tumor cells (PubMed:27670158). Mediates enhanced ADCC in response to afucosylated IgGs (PubMed:34485821)
- Specific Function
- Igg binding
- Gene Name
- FCGR3A
- Uniprot ID
- P08637
- Uniprot Name
- Low affinity immunoglobulin gamma Fc region receptor III-A
- Molecular Weight
- 29088.895 Da
References
- Seimetz D, Lindhofer H, Bokemeyer C: Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010 Oct;36(6):458-67. doi: 10.1016/j.ctrv.2010.03.001. Epub 2010 Mar 27. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- Receptor for the Fc region of immunoglobulins gamma. Low affinity receptor. Binds complexed or aggregated IgG and also monomeric IgG. Contrary to III-A, is not capable to mediate antibody-dependent cytotoxicity and phagocytosis. May serve as a trap for immune complexes in the peripheral circulation which does not activate neutrophils
- Specific Function
- Gpi anchor binding
- Gene Name
- FCGR3B
- Uniprot ID
- O75015
- Uniprot Name
- Low affinity immunoglobulin gamma Fc region receptor III-B
- Molecular Weight
- 26242.67 Da
References
- Seimetz D, Lindhofer H, Bokemeyer C: Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010 Oct;36(6):458-67. doi: 10.1016/j.ctrv.2010.03.001. Epub 2010 Mar 27. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- Part of the TCR-CD3 complex present on T-lymphocyte cell surface that plays an essential role in adaptive immune response. When antigen presenting cells (APCs) activate T-cell receptor (TCR), TCR-mediated signals are transmitted across the cell membrane by the CD3 chains CD3D, CD3E, CD3G and CD3Z. All CD3 chains contain immunoreceptor tyrosine-based activation motifs (ITAMs) in their cytoplasmic domain. Upon TCR engagement, these motifs become phosphorylated by Src family protein tyrosine kinases LCK and FYN, resulting in the activation of downstream signaling pathways (PubMed:2470098). In addition of this role of signal transduction in T-cell activation, CD3E plays an essential role in correct T-cell development. Initiates the TCR-CD3 complex assembly by forming the two heterodimers CD3D/CD3E and CD3G/CD3E. Participates also in internalization and cell surface down-regulation of TCR-CD3 complexes via endocytosis sequences present in CD3E cytosolic region (PubMed:10384095, PubMed:26507128)
- Specific Function
- Identical protein binding
- Gene Name
- CD3E
- Uniprot ID
- P07766
- Uniprot Name
- T-cell surface glycoprotein CD3 epsilon chain
- Molecular Weight
- 23147.09 Da
References
- Seimetz D, Lindhofer H, Bokemeyer C: Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010 Oct;36(6):458-67. doi: 10.1016/j.ctrv.2010.03.001. Epub 2010 Mar 27. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- High affinity receptor for the Fc region of immunoglobulins gamma. Functions in both innate and adaptive immune responses. Mediates IgG effector functions on monocytes triggering antibody-dependent cellular cytotoxicity (ADCC) of virus-infected cells
- Specific Function
- High-affinity igg receptor activity
- Gene Name
- FCGR1A
- Uniprot ID
- P12314
- Uniprot Name
- High affinity immunoglobulin gamma Fc receptor I
- Molecular Weight
- 42631.525 Da
References
- Seimetz D, Lindhofer H, Bokemeyer C: Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010 Oct;36(6):458-67. doi: 10.1016/j.ctrv.2010.03.001. Epub 2010 Mar 27. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- No
- Actions
- Ligand
- Curator comments
- Catumaxomab does not exert a pharmacological effect on cancer cells. It only binds to epithelial cell adhesion molecule on the cell's surface to bring T cells and accessory immune cells into close proximity.
- General Function
- May act as a physical homophilic interaction molecule between intestinal epithelial cells (IECs) and intraepithelial lymphocytes (IELs) at the mucosal epithelium for providing immunological barrier as a first line of defense against mucosal infection. Plays a role in embryonic stem cells proliferation and differentiation. Up-regulates the expression of FABP5, MYC and cyclins A and E
- Specific Function
- Cadherin binding involved in cell-cell adhesion
- Gene Name
- EPCAM
- Uniprot ID
- P16422
- Uniprot Name
- Epithelial cell adhesion molecule
- Molecular Weight
- 34932.005 Da
References
- Seimetz D, Lindhofer H, Bokemeyer C: Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer Treat Rev. 2010 Oct;36(6):458-67. doi: 10.1016/j.ctrv.2010.03.001. Epub 2010 Mar 27. [Article]
Drug created at March 19, 2008 16:40 / Updated at September 14, 2024 04:03