DAC HYP compositions and methods

Patent metadata

Field	Value
Publication number	US-9676860-B2
Application number	US-201514601909-A
Country	US
Kind code	B2
Filing date	Jan 21, 2015
Priority date	May 27, 2011
Publication date	Jun 13, 2017
Grant date	Jun 13, 2017

Abstract

The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof.

First claim

What is claimed is:

1. A method of treating a patient suffering from multiple sclerosis, comprising administering to the patient an amount of a daclizumab composition sufficient to provide therapeutic benefit, wherein the daclizumab has two or more of the following:
(a) an N-terminal isoform with one pyroglutamate residue and one glutamine residue that comprises 3%-17% of the total daclizumab:
(b) an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is GO-GlcNAc glycoform present in about 5% to about 20% of the AUC, the other main peak is GO glycoform present in about 70% to about 99.2% of the AUC, and the minor peak is G1 glycoform present in 1% to 9% of the AUC when determined according to the method described in Section 7.6.14,
(c) <3% aggregates when formulated at a concentration of about 150 mg/mL.

2. The method of claim 1 in which the daclizumab composition is administered:
(a) subcutaneously;
(b) in an amount corresponding to about 1 mg/kg daclizumab, once every two weeks or in an amount corresponding to about 2 mg/kg daclizumab, once every month;
(c) for a total of about 24 weeks; or
(d) according to any combination of (a)-(c).

3. The method of claim 2 , in which the daclizumab composition is administered in an amount corresponding to 75 mg to 300 mg daclizumab, or 150 mg, or 300 mg.

4. The method of claim 3 wherein the daclizumab composition is administered subcutaneously in an amount corresponding to 150 mg daclizumab once every month.

5. The method of claim 3 in which the daclizumab is administered as monotherapy, in which the patient has either failed to respond to prior treatment with interferon-beta or has discontinued prior treatment with interferon-beta.

6. The method of claim 3 in which the daclizumab is administered adjunctively to interferon-beta.

7. The method of claim 1 in which the daclizumab has an N-linked glycosylation profile determined according to the method described in Section 7.6.14, in which the total AUC of the peaks in the profile corresponding to non-fucosylated mannose glycosyls is less than about 6% of the total AUC of all peaks in the profile.

8. The method of claim 4 which is administered for a total of at least 48 weeks.

Assignees

• Abbvie Biotherapeutics Inc

Inventors

• Hartman Taymar E
• Sauer Paul W
• Burky John E
• Wesson Mark C
• Huang Ping Y
• Robinson Thomas J
• Partridge Braeden D
• Tso J Yun

Classifications

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A61P37/02

  Immunomodulators · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P27/02

  Ophthalmic agents · 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