Trion Pharma GmbH announced that the European Commission has approved its trifunctional antibody Removab (catumaxomab) for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas. The Marketing Authorisation Application was filed by Trion's partner Fresenius Biotech in December 2007. Removab will be marketed by Fresenius Biotech and produced by Trion Pharma, the inventor of the compound and the underlying Triomab technology.
Removab is worldwide first approved treatment of malignant ascites. It is the only approved antibody targeting EpCAM, an antigen expressed on almost all carcinomas. It is the first approved bispecific, trifunctional antibody. The first approved therapeutic antibody invented, developed and produced in Germany.
"It has been a long-standing vision of physicians and scientists to create a bispecific antibody that would be able to direct T cells, the body's most potent immune effector cells, against cancer. Removab is the first approved antibody to achieve this goal," said Horst Lindhofer, CEO of Trion Pharma.
Traditional, monospecific antibodies can only recruit effector cells from the innate immune defense. TRION's bispecific, trifunctional Triomab antibodies, however, additionally bind and activate the particularly potent group of killer T cells. As a result, they destroy tumour cells at least 1,000fold more effectively than conventional antibodies do. Whereas these are applied in doses of milligrams or grams, Triomab antibodies work in the range of micrograms and can thus be produced in much smaller facilities.
Triomab development dates back to the 1990s with the pioneering work of Trion founder Horst Lindhofer and his team at the Helmholtz Zentrum Munich, Germany. In 1998, he established TRION as a spin-out from the institution in order to exploit the potential of his invention for cancer therapy. "After all these years of intense research and development, it is extremely satisfying to see the first representative of our Triomab family reach the market. This success not only demonstrates the innovative potential of public research in Germany, but also provides new hope to patients. The targeted stimulation of an orchestrated immune response by Triomab antibodies holds strong potential for the treatment of a broad range of diseases."