Methods for the treatment of neurodegeneration

Patent metadata

Field	Value
Publication number	US-11352415-B2
Application number	US-201916671595-A
Country	US
Kind code	B2
Filing date	Nov 1, 2019
Priority date	May 13, 2013
Publication date	Jun 7, 2022
Grant date	Jun 7, 2022

Abstract

The invention encompasses the discovery that Fc-containing polypeptides that include branched glycans and that are sialylated on the branched glycan (e.g., on an α 1,3 and/or α 1,6 arm in the Fc region's N-linked glycosylation site), with, e.g., a NeuA-α 2,6-Gal or NeuAc-α 2,3-Gal terminal linkage, are useful in treating neurodegeneration, e.g., in the treatment of neurodegenerative diseases such as Alzheimer's Disease. The present disclosure provides, in pert, methods for treating neurodegeneration or neurodegenerative diseases by administering compositions containing such Fc-containing polypeptides as well as methods for evaluating, identifying, and/or producing (e.g., manufacturing) such polypeptides for the treatment of neurodegeneration.

First claim

What is claimed is:

1. A method for treating chronic inflammatory demyelinating polyneuropathy or myasthenia gravis, the method comprising administering to a subject in need thereof a preparation comprising an effective amount of sialylated pooled polyvalent IgG, wherein at least 87% of branched glycans on the Fc region of the pooled polyvalent IgG in the preparation are sialylated on both the α 1,3 arm and the α 1,6 arm of the branched glycan via a NeuAc-α 2,6-Gal terminal linkage.

2. The method of claim 1 , wherein the sialylated pooled polyvalent IgG is enzymatically sialylated by a process comprising providing an a preparation of pooled polyvalent IgG;
combining the IgG preparation with galactosyltransferase and a galactose donor to provide a galactosylation reaction mixture;
incubating the galactosylation reaction mixture to allow galactosylation of branched
glycans;
adding an ST6-Gal1 sialyltransferase and a sialic acid donor to the galactosylation reaction mixture to provide a sialylation reaction mixture; and
incubating the sialylation reaction mixture for a sufficient period of time to allow at least 87% of the branched glycans in the IgG preparation to be sialylated on both the alpha1,3 arm and on the alpha1,6 arm of the branched glycan via a NeuAc-α 2,6-Gal terminal linkage, wherein additional sialic acid donor is added to the reaction mixture during the incubation of the sialylation reaction mixture.

3. The method of claim 1 , wherein the neurodegeneration associated with chronic inflammatory demyelinating polyneuropathy is treated.

4. The method of claim 1 , wherein the neurodegeneration is associated with or myasthenia gravis treated.

5. The method of claim 1 , wherein the sialylated pooled polyvalent IgG is sialylated IVIG.

Assignees

• Momenta Pharmaceuticals Inc

Inventors

• Prod'Homme Thomas E
• Ling Leona E
• Bosques Carlos J
• Manning Anthony
• Kaundinya Ganesh

Classifications

• C07K16/06 Primary

  from serum · CPC title

• Y02A50/30

  Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change · CPC title

• A61K2039/54

  characterised by the route of administration · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• A61P25/28

  for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia · CPC title