Removab: which tox species, and why?

“A number of common laboratory animal species, including the three monkeys marmoset (Callitrix sp.), cynomolgus (Macaca fascicularis) and rhesus (Macaca mulatta) were tested histologically for catumaxomab binding, but none showed a binding pattern similar to that of human tissues, and were consequently considered non-relevant.”

“The non-clinical programme was adapted to the fact that catumaxomab is a protein, and its binding properties are essentially specific for humans.”

“A surrogate antibody (BiLu), which is of equivalent structure to catumaxomab and has the same principal target specificity but binds to mouse CD3 instead of human CD3, was used for pharmacology, pharmacokinetic and toxicology studies in mouse models.”

“The most notable consequence of the inability to find a relevant species is that the present application does not contain repeated dose toxicology studies of catumaxomab.”

“Reproductive and developmental toxicity studies have not been submitted.”

“Carcinogenicity studies have not been submitted.”

“A surrogate antibody (BiLu), which is of equivalent structure to catumaxomab and has the same principal target specificity but binds to mouse CD3 instead of human CD3, was used for pharmacology, pharmacokinetic and toxicology studies in mouse models.”