HaemaLogiX initiates collaboration with TPL Path Labs
7 May 2019
In May 2019, HaemaLogiX employed TPL Path Labs in Freiburg, Germany to perform a series of tissue cross reactivity studies using frozen normal human tissues and two of our human anti-myeloma antibodies.
The two therapeutic antibodies in development target lambda myeloma antigen (LMA) and they bind to a unique conformational epitope that has been identified on lambda light chains (λ LC) and myeloma cells.
These studies are being conducted to address preclinical regulatory requirements from FDA/CDER and EMA to demonstrate that non-target tissue binding (i.e., binding to non-tumor or healthy tissues) of the antibodies is not occurring. Such binding “may have serious consequences in a human, particularly when pharmacologically active antibodies or cytotoxic immunoconjugates are used”.