Anti-TNF-alpha glycoantibodies and uses thereof
AssigneeAcademia Sinica
InventorsChi-Huey Wong, Chung-Yi Wu
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Abstract
The present disclosure relates to a novel class of anti-TNFα monoclonal antibodies or antigen binding fragments comprising a homogeneous population of anti-TNFα IgG molecules having the same N-glycan on each of Fc. The antibodies of the invention can be produced from anti-TNFα monoclonal antibodies by Fc glycoengineering. The glycoantibodies of the invention may have improved therapeutic values compared to the corresponding monoclonal antibodies that have not been glycoengineered.
Claims8
A pharmaceutical formulation comprising a composition of glycoengineered anti-TNFα glycoantibodies comprising an essentially pure population of anti-TNFα IgG molecules having the same N-glycan on the Fe region of each anti-TNFα IgG molecule and a pharmaceutically acceptable carrier, wherein the essentially pure population of anti-TNFα IgG molecules comprises at least about 90% by weight of protein, wherein the anti-TNFα IgG molecule comprises a heavy chain having the amino acid sequence of SEQ ID NO:
- 1, and a light chain having the amino acid sequence of SEQ ID NO:
- 2, and wherein the N-glycan is Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2 or Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2(F).
A pharmaceutical formulation comprising a fusion protein comprising a TNFα receptor sequence and an IgG1 Fc sequence, wherein the formulation comprises a homogeneous population of fusion protein molecules, wherein the IgG1 Fc has the same N-glycan on the Fc region of each fusion protein molecule, and a pharmaceutically acceptable carrier, wherein the N-glycan is Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2 or Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2(F).
A prelyophilized pharmaceutical formulation comprising a composition of glycoengineered anti-TNFα glycoantibodies comprising an essentially pure population of anti-TNFα IgG molecules having the same N-glycan on the Fc region of each anti-TNFα IgG molecule, wherein the essentially pure population of anti-TNFα IgG molecules comprises at least about 90% by weight of protein, and a lyoprotectant, wherein the anti-TNFα IgG molecule comprises a heavy chain having the amino acid sequence of SEQ ID NO:
- 1, and a light chain having the amino acid sequence of SEQ ID NO:
- 2, and wherein the N-glycan is Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2 or Sia2(α2-6)Gal2GlcNAc2Man3GlcNAc2(F).
Dependencies are inferred from the claim text.