IP Library › Granted Patent US 12,359,178
Granted Patent B2
US 12,359,178 · App. 18/645,049 · Granted Jul 15, 2025

Methods and compositions for treatment of hunter syndrome comprising iduronate-2-sulfatase

Inventor: Dave Nichols (Lexington, MA)
Assignee: Takeda Pharmaceutical Company Limited
C12N9/16A61K38/465C12Y301/06013
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Quick Facts
Patent No.
US 12,359,178
App. No.
18/645,049
Granted
Jul 15, 2025
Kind
B2
Abstract

The present invention provides, among other things, improved methods for purifying I2S protein produced recombinantly for enzyme replacement therapy. The present invention is, in part, based on the surprising discovery that recombinant I2S protein can be purified from unprocessed biological materials, such as, I2S-containing cell culture medium, using a process involving as few as four chromatography columns.

Claims (13)

1. A method of treating Hunter syndrome comprising administering to a subject in need of treatment a composition comprising purified recombinant iduronate-2-sulfatase (I2S) having an amino acid sequence with at least 95% sequence identity to SEQ ID NO: 1 and a carrier, wherein the purified recombinant I2S comprises at least 70% conversion of the cysteine residue corresponding to Cys59 of SEQ ID NO:1 to Cα-formylglycine (FGly), and wherein the purified recombinant I2S contains less than 150 ng Host Cell Protein (HCP)/mg I2S.

2. The method of claim 1 , wherein the purified recombinant I2S comprises at least 75% conversion of the cysteine residue corresponding to Cys59 of SEQ ID NO: 1 to Cα-formylglycine (FG1y).

3. The method of claim 1 , wherein the purified recombinant I2S comprises at least 85% conversion of the cysteine residue corresponding to Cys59 of SEQ ID NO: 1 to Cα-formylglycine (FG1y).

4. The method of claim 1 , wherein the purified recombinant I2S comprises a moiety that binds to a receptor on the surface of target cells.

5. The method of claim 4 , wherein the moiety is fused to the I2S protein at the N-terminus, C-terminus or internally.

6. The method of claim 1 , wherein the composition is administered by intrathecal or intravenous administration.

7. The method of claim 6 , wherein the composition is administered by intrathecal administration.

8. The method of claim 6 , wherein the composition is administered by intravenous administration.

9. The method of claim 1 , wherein the composition is administered once weekly.

10. The method of claim 1 , wherein the composition is administered biweekly.

11. The method of claim 1 , wherein the composition is administered once monthly.

12. The method of claim 1 , wherein administration of the composition results in a reduction of zebra bodies in the patient.

13. The method of claim 1 , wherein administration of the composition results in a reduction in the amount of glycosaminoglycans within lysosomes of the patient.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2024
From: NICHOLS, DAVE
To: SHIRE HUMAN GENETIC THERAPIES, INC.
Reel/Frame 068208/0218 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 7, 2024
From: SHIRE HUMAN GENETIC THERAPIES, INC.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 068339/0322 →
Continuity (8)
Continuation 18052442 · Nov 3, 2022
Continuation 17092034 · Nov 6, 2020
Continuation 16417440 · May 20, 2019
Division 15279018 · Sep 28, 2016
Division 14673607 · Mar 30, 2015
Division 13829706 · Mar 14, 2013
Provisional Application 61666733 · Jun 29, 2012
Related Publication 20240401010A1 · Dec 5, 2024
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