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On August 8, the US Food & Drug Administration (FDA) approved Poteligeo (mogamulizumab) for the treatment of two types of cutaneous T cell lymphoma. The monoclonal antibody is the first biological agent targeting CC chemokine receptor 4 (CCR4) available in the US. But another, largely unnoticed, aspect of the drug, made by Kyowa Hakko Kirin in Tokyo, has wider implications. Poteligeo is an IgG1 that's engineered to lack the fucose sugar normally attached to the antibody's Fc (fragment crystallizable) portion. The absence of this fucose greatly enhances a mechanism of cell-mediated immune defense known as antibody-dependent cellular cytotoxicity (ADCC). This makes Poteligeo a much more potent cell killer than the normally glycosylated antibody. Poteligeo is the third afucosylated antibody approved, but it is the second in the past year, and at least 15 other such antibodies are in active clinical development (Table 1). “Defucosylation is very hot right now,” says Dimiter Dimitrov, founder of the Center for Antibody Therapeutics at the University of Pittsburgh.
It has taken afucosylated antibodies 15 years to finally take off. The technology followed a predictable course, says Bill Strohl, owner of BiStro Biotech Consulting in Bridgewater, New Jersey. It normally takes “anywhere between 12 and 14 years for any technology to go from discovery to market,” says Strohl. Poteligeo, first approved in Japan in 2012, was slightly ahead of schedule. After the first approval, “what happens then is usually there's a bit of a gap, and you have a few follow-ons after that, and then all of a sudden everybody picks up on it,” says Strohl.