IP Library › Granted Patent US 9,687,531
Granted Patent B2
US 9,687,531 · App. 14/463,955 · Granted Jun 27, 2017

Methods for introducing mannose 6 phosphate and other oligosaccharides onto glycoproteins and applications thereof

Inventor: Yunxiang Zhu (Wayland, MA)
Assignee: Genzyme Corporation
A61K38/47A61K31/7024A61K38/1709A61K47/26C07H11/04C07K14/47C12N9/2465C12P21/005C07K1/1077C12Y302/01045C12Y302/01052
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Quick Facts
Patent No.
US 9,687,531
App. No.
14/463,955
Granted
Jun 27, 2017
Kind
B2
Abstract

Methods to introduce highly phosphorylated mannopyranosyl oligosaccharide derivatives containing mannose-6-phosphate (M6P), or other oligosaccharides bearing other terminal hexoses, to carbonyl groups on oxidized glycans of glycoproteins while retaining their biological activity are described. The methods are useful for modifying glycoproteins, including those produced by recombinant protein expression systems, to increase uptake by cell surface receptor-mediated mechanisms, thus improving their therapeutic efficacy in a variety of applications.

Claims (31)

1. A method of coupling a beta-glucocerebrosidase to an oligosaccharide that comprises a phosphorylated mannose, comprising:

(a) derivatizing an oligosaccharide comprising a phosphorylated mannose with a compound containing a carbonyl-reactive group;

(b) oxidizing a beta-glucocerebrosidase having at least one oligosaccharide to generate at least one carbonyl group on the at least one oligosaccharide of the beta-glucocerebrosidase; and

(c) reacting the derivatized oligosaccharide with the oxidized beta-glucocerebrosidase, thereby coupling the oligosaccharide to the beta-glucocerebrosidase.

2. The method of claim 1 , wherein the oligosaccharide is a biantennary mannopyranosyl oligosaccharide.

3. The method of claim 2 , wherein the biantennary mannopyranosyl oligosaccharide comprises bis-mannose 6 phosphate (M6P).

4. The method of claim 1 , wherein the carbonyl-reactive group is a hydrazine, a hydrazide, an aminooxy, or a semicarbazide.

5. The method of claim 1 , wherein periodate or galactose oxidase is used to oxidize the beta-glucocerebrosidase.

6. The method of claim 5 , wherein less than or equal to about 10mM periodate is used to oxidize one or more sialic acid residues on the beta-glucocerebrosidase.

7. A conjugate comprising a beta-glucocerebrosidase coupled to an oligosaccharide comprising a phosphorylated mannose, prepared by the method of claim 1 .

8. A method of treating Gaucher disease, comprising administering to a subject in need thereof the conjugate of claim 7 .

9. The method of claim 8 , wherein the oligosaccharide is a biantennary mannopyranosyl oligosaccharide.

10. The method according to claim 9 , wherein the biantennary mannopyranosyl oligosaccharide comprises bis-M6P.

11. The method of claim 8 , wherein the oxidizing is by contact with periodate or galactose oxidase.

12. The method of claim 8 , wherein the carbonyl-reactive group is a hydrazine, a hydrazide, an aminooxy, or a semicarbazide.

13. A method of coupling a beta-N-acetyl-hexosaminidase to an oligosaccharide that comprises a phosphorylated mannose, comprising:

(a) derivatizing an oligosaccharide comprising a phosphorylated mannose with a compound containing a carbonyl-reactive group;

(b) oxidizing a beta-N-acetyl-hexosaminidase having at least one oligosaccharide to generate at least one carbonyl group on the at least one oligosaccharide of the beta-N-acetyl-hexosaminidase; and

(c) reacting the derivatized oligosaccharide with the oxidized beta-N-acetyl-hexosaminidase,

thereby coupling the oligosaccharide to the beta-N-acetyl-hexosaminidase.

14. The method of claim 13 , wherein the oligosaccharide is a biantennary mannopyranosyl oligosaccharide.

15. The method of claim 14 , wherein the biantennary mannopyranosyl oligosaccharide comprises bis-mannose 6 phosphate (M6P).

16. The method of claim 13 , wherein the carbonyl-reactive group is a hydrazine, a hydrazide, an aminooxy, or a semicarbazide.

17. The method of claim 13 , wherein periodate or galactose oxidase is used to oxidize the beta-N-acetyl-hexosaminidase.

18. The method of claim 17 , wherein less than or equal to about 10 mM periodate is used to oxidize one or more sialic acid residues on the beta-N-acetyl-hexosaminidase.

19. A conjugate comprising a beta-N-acetyl-hexosaminidase coupled to an oligosaccharide comprising a phosphorylated mannose, prepared by the method of claim 13 .

20. A method of treating Tay-Sachs disease, comprising administering to a subject in need thereof the conjugate of claim 19 .

21. The method of claim 20 , wherein the oligosaccharide is a biantennary mannopyranosyl oligosaccharide.

22. The method according to claim 21 , wherein the biantennary mannopyranosyl oligosaccharide comprises bis-M6P.

23. The method of claim 20 , wherein the oxidizing is by contact with periodate or galactose oxidase.

24. The method of claim 20 , wherein the carbonyl-reactive group is a hydrazine, a hydrazide, an aminooxy, or a semicarbazide.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2015
From: ZHU, YUNXIANG
To: GENZYME CORPORATION
Reel/Frame 035606/0385 →
Continuity (6)
Continuation 13768266 · Feb 15, 2013
Continuation 12642383 · Dec 18, 2009
Continuation 10943893 · Sep 20, 2004
Continuation In Part 10051711 · Jan 17, 2002
Provisional Application 60263078 · Jan 18, 2001
Related Publication 20150202270A1 · Jul 23, 2015