COMPOSITIONS AND METHODS RELATING TO UNIVERSAL GLYCOFORMS FOR ENHANCED ANTIBODY EFFICACY

摘要

The present disclosure relates to glycoproteins, particularly monoclonal antibodies, comprising a glycoengineered Fc region, wherein said Fc region comprises an optimized N-glycan having the structure of Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2. The glycoengineered Fc region binds FcγRIIA or FcγRIIIA with a greater affinity, relative to comparable monoclonal antibodies comprising the wild-type Fc region. The monoclonal antibodies of the invention are particularly useful in preventing, treating, or ameliorating one or more symptoms associated with a disease, disorder, or infection where an enhanced efficacy of effector cell function (e.g., ADCC) mediated by FcγR is desired, e.g., cancer, autoimmune, infectious disease, and in enhancing the therapeutic efficacy of therapeutic antibodies the effect of which is mediated by ADCC.

主权项

1. A composition comprising a homogeneous population of monoclonal antibodies or antigen binding fragment thereof, wherein each glycoantibody or antigen binding fragment molecule comprising a single, uniform N-glycan on the Fc region, wherein the N-glycan has the structure of Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2, and wherein the N-glycan is optimized for improving effector cell function.