Marketing approval of mogamulizumab: A triumph for glyco-engineering
Volume 4, Issue 4
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Pages 419 - 425http://dx.doi.org/10.4161/mabs.20996
: ADCC, CDC, Glycosylation, antibody, biobetters, biosimilars, follow-on biologicals, fucose, galactose, glyco-engineering, mannose, sialic acid
Authors: Alain Beck and Janice M. Reichert View affiliations
Therapeutic properties of antibodies strongly depend on the composition of their glycans. Most of the currently approved antibodies are produced in mammalian cell lines, which yield mixtures of different glycoforms that are close to those of humans, but not fully identical. Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of mAbs. The recent approval in Japan of mogamulizumab (POTELIGEO®), the first glyco-engineered antibody to reach the market, is a landmark in the field of therapeutic antibodies. Mogamulizumab is a humanized mAb derived from Kyowa Hakko Kirin’s POTELLIGENT® technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. The approval was granted April 30, 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.
Received: May 15, 2012; Accepted: May 15, 2012