Catumaxomab

Medical use

In the European Union, catumaxomab is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy. Ascites is an accumulation of fluid in the peritoneal cavity.

Adverse effects

Common adverse effects include fever, nausea and vomiting. Fever and pain should be controlled by giving NSAIDs, analgetics or antipyretics before application of catumaxomab. All side effects were fully reversible in studies. Most are caused by the liberation of cytokines.

Mechanism of action

Many types of cancer cells carry EpCAM (epithelial cell adhesion molecule) on their surface. By binding to such a cell via one arm, to a T lymphocyte via the other arm and to an antigen-presenting cell like a macrophage, a natural killer cell or a dendritic cell via the heavy chains, an immunological reaction against the cancer cell is triggered. Removing cancer cells from the abdominal cavity reduces the tumour burden which is seen as the cause for ascites in people with cancer.

Chemical structure

Catumaxomab consists of one "half" (one heavy chain and one light chain) of an anti-EpCAM antibody and one half of an anti-CD3 antibody, so that each molecule of catumaxomab can bind both EpCAM and CD3. In addition, the Fc-region can bind to an Fc receptor on accessory cells like other antibodies, which has led to calling the drug a trifunctional antibody.

History

Catumaxomab was developed by Trion Pharma, based on preliminary work by the Helmholtz Zentrum München. Dr. Horst Lindhofer is listed at the primary inventor of the patent. Fresenius Biotech conducted clinical trials and filed the drug for approval with the European Medicines Agency (EMA). It was approved in Europe on 20 April 2009. In 2013, catumaxomab was voluntarily withdrawn from the US market and in 2017 in the EU market for commercial reasons. The product has not been marketed in the EU since 2014.

Society and culture

Legal status

In October 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Korjuny, intended for the intraperitoneal treatment of malignant ascites. The applicant for this medicinal product is Lindis Biotech GmbH. Catumaxomab was approved for medical use in the European Union in February 2025.

References

References

1. (2010). "Catumaxomab: clinical development and future directions". mAbs.
2. (March 2009). "European Public Assessment Report for March 2009". European Medicines Agency.
3. (November 2010). "The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial". International Journal of Cancer.
4. (November 2010). "Review of catumaxomab in the treatment of malignant ascites". Cancer Management and Research.
5. (May 2010). "Palliative treatment of malignant ascites: profile of catumaxomab". Biologics: Targets and Therapy.
6. (September 2008). "The evolving role of catumaxomab in gastric cancer". Expert Opinion on Biological Therapy.
7. (2009). "Neue Arzneimittel".
8. "Capital Market Day Fresenius Biotech: Fresenius concentrates biotechnology activities on antibody and innovative cell therapies". Fresenius SE.
9. (August 2007). "Characterisation of the new EpCAM-specific antibody HO-3: implications for trifunctional antibody immunotherapy of cancer". British Journal of Cancer.
10. "Use of Trifunctional Bispecific and Trispecific Antibodies for the Treatment of Malignant Ascites".
11. "TRION Pharma: Trifunctional Antibody Catumaxomab Kills Cancer Stem Cells".
12. (26 July 2017). "Neovii completes marketing authorisation withdrawal of Removab in the European Union". Neovii Biotech GmbH.
13. (10 July 2017). "Removab: Withdrawal of the marketing authorisation in the European Union". European Medicines Agency.
14. (17 October 2024). "Korjuny EPAR".
15. (18 October 2024). "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024".
16. (12 February 2025). "Korjuny PI".