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 Its market authorization was withdrawn in the EU in June 2017 at the manufacturer's request due to the company's insolvency.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- Approved, Investigational, Withdrawn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.
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- Associated Therapies
- Contraindications & Blackbox Warnings
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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. Ambroxol The risk or severity of methemoglobinemia can be increased when Catumaxomab is combined with Ambroxol. Amivantamab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Anifrolumab. Ansuvimab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Ansuvimab. Anthrax immune globulin human The risk or severity of adverse effects can be increased when Catumaxomab is combined with Anthrax immune globulin human. 
Identify potential medication risksEasily compare up to 40 drugs with our drug interaction checker.Get severity rating, description, and management advice.Learn more - 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 Solution 0.1 mg / mL Intraperitoneal Fresenius Biotech Gmbh Not applicable Not applicable Canada 
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 2017-07-12 EU 
Removab Injection, solution, concentrate 10 microgram Intraperitoneal Neovii Biotech 2020-12-16 2017-07-12 EU
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
Phase Status Purpose Conditions Count 3 Completed Treatment Ascites, Malignant / Cancer / Carcinoma / Neoplasm 1 3 Recruiting Treatment Neoplasm of Stomach 1 2 Completed Treatment Abdominal wall neoplasm / Fallopian Tube Neoplasms / Ovarian Cancer 1 2 Completed Treatment Ascites, Malignant 1 2 Completed Treatment Epithelial Ovarian Cancer / Ovarian Cancer 1 2 Completed Treatment Gastric Adenocarcinoma With Peritoneal Carcinomatosis / Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis / Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis 1 2 Completed Treatment Gastric Adenocarcinoma / Gastric Cancer 2 2 Completed Treatment Malignant Ascites Due to Epithelial Carcinoma 1 2 Completed Treatment Ovarian Cancer 2 2 Completed Treatment Recurrent Epithelial Ovarian Cancer 1
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
- Not Available
- Specific 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 ...
- 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
- Not Available
- Specific Function
- Receptor for the Fc region of IgG. Binds complexed or aggregated IgG and also monomeric IgG. Mediates antibody-dependent cellular cytotoxicity (ADCC) and other antibody-dependent responses, such as...
- 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
- Not Available
- Specific 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...
- Gene Name
- FCGR3B
- Uniprot ID
- O75015
- Uniprot Name
- Low affinity immunoglobulin gamma Fc region receptor III-B
- Molecular Weight
- 26215.64 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
- Transmembrane signaling receptor activity
- Specific Function
- The CD3 complex mediates signal transduction, resulting in T cell activation and proliferation. Required for normal immune responses (PubMed:15546002, PubMed:8490660).
- 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
- Receptor signaling protein activity
- Specific Function
- High affinity receptor for the Fc region of immunoglobulins gamma. Functions in both innate and adaptive immune responses.
- 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
- Protein complex binding
- Specific 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...
- 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 December 01, 2023 08:05