TEM1, also named endosialin is a transmembrane protein widely expressed on the surface of cells of mesenchymal origin, including pericytes and activated fibroblasts which are thought to play a key role in the development of tumor neovascular networks and stromal interaction. Although TEM1 expression is dramatically reduced during adult life, it may be upregulated during malignancy such as sarcoma and neuroblastoma. Therefore, TEM1 is an ideal target for an ADC approach.
An Italian SME specialized in drug discovery and located in Central Italy has developed and patented an anti-TEM1 monoclonal antibody which has been used to generate a TEM1 targeting ADC. Compared with the naked antibody, the ADC has shown high in vivo activity against osteosarcoma xenografts in mice. The ADC has a good safety profile in treated animals.
The product is in pre-clinical stage of development. In order to submit the application for phase 1 trial, the following steps have to be performed: (i) generation of a stable antibody producing cell line and a master cell bank (ii) production of drug substance batch and performing a toxicology study (iii) production of clinical drug substance batches.
Pharmaceutical companies or investors for financial or license agreement to further develop the product in clinical trials are sought. The company is also interested in a research cooperation agreement.