IP Library › Granted Patent US 11,319,567
Granted Patent B2
US 11,319,567 · App. 14/722,612 · Granted May 3, 2022

Fucosidase from bacteroides and methods using the same

Inventors: Chi-Huey Wong (Rancho Santa Fe, CA); Tsung-I Tsai (Kaohsiung, TW)
Assignee: ACADEMIA SINICA
C12P19/14A61K39/3955A61K39/42A61K45/06C07K16/00C07K16/1018C07K16/18C07K16/241C07K16/2887C07K16/2896C07K16/30C07K16/32C12N9/14C12N9/24A61K2039/505C07K2317/24C07K2317/41C07K2317/72C07K2317/732C07K2317/734C07K2317/92C12Y302/01C12Y302/01051Y02A50/30
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Quick Facts
Patent No.
US 11,319,567
App. No.
14/722,612
Granted
May 3, 2022
Kind
B2
Abstract

The present disclosure relates to an α-fucosidase having α-(1,2), α-(1,3), α-(1,4), and α-(1,6) fucosidase activity. The present disclosure also relates to the compositions comprising the α-fucosidase, and the methods of producing and using the α-fucosidase in cleaving α-(1,2), α-(1,3), α-(1,4), and/or α-(1,6)-linked fucoses in the glycoconjugates.

Claims (38)

1. A composition comprising an α-fucosidase, wherein the composition comprises:

(a) an α-fucosidase polypeptide having the sequence of SEQ ID NO: 1;

(b) at least one glycosidase selected from the group consisting of Endo-beta-N-acetylglucosaminidases (NAG), EndoA, EndoF1, EndoF2, EndoF3, EndoH, EndoM, EndoS, and variants thereof; and

(c) a glycoprotein comprising an N-linked glycan, wherein the glycoprotein is selected from the group consisting of an immunoglobulin G, an Fc-fusion protein, erythropoietin, interferon and influenza hemagglutinin.

2. The composition of claim 1 , wherein the α-fucosidase is an isolated polypeptide.

3. The composition of claim 1 , wherein the α-fucosidase is a recombinant Bacteroides α-L-fucosidase.

4. The composition of claim 1 , wherein the α-fucosidase can hydrolyze α-(1,2), α-(1,3), α-(1,4), and α-(1,6)-linked fucoses present in N- and/or O-linked glycans in a glycoconjugate.

5. The composition of claim 1 , wherein the α-fucosidase has a pH optimum from about pH 7.0 to about pH 7.5.

6. The composition of claim 1 , wherein the immunoglobulin G comprises an anti-CD20 antibody or an anti-TNFα antibody.

7. The composition of claim 6 , wherein the anti-CD20 antibody is a chimeric IgG1.

8. The composition of claim 7 , wherein the anti-CD20 antibody is rituximab.

9. The composition of claim 6 , wherein the anti-TNFα antibody is adalimumab.

10. A composition comprising an α-fucosidase wherein the composition comprises:

(a) an α-fucosidase polypeptide having the amino acid sequence of SEQ ID NO: 1;

(b) at least one glycosidase selected from the group consisting of Endo-beta-N-acetylglucosaminidases (NAG), EndoA, EndoF1, EndoF2, EndoF3, EndoH, EndoM, EndoS, and variants thereof; and

(c) a glycoprotein selected from the group consisting of an immunoglobulin G, a Fc-fusion protein, erythropoietin, interferon and influenza hemagglutinin.

11. The composition of claim 10 , wherein α-fucosidase is a recombinant Bacteroides α-L-fucosidase.

12. The composition of claim 10 , wherein the α-fucosidase can hydrolyze α-(1,2), α-(1,3), α-(1,4), and α-(1,6)-linked fucoses present in N- and/or O-linked glycans in a glycoconjugate.

13. A composition comprising an α-fucosidase wherein the composition comprises:

(a) an α-fucosidase polypeptide having the sequence of SEQ ID NO: 1;

(b) at least one glycosidase selected from the group consisting of Endo-beta-N-acetylglucosaminidases (NAG), EndoA, EndoF1, EndoF2, EndoF3, EndoH, EndoM, EndoS, and variants thereof; and

(c) a glycoprotein comprising an N-linked glycan, wherein the glycoprotein is selected from the group consisting of an immunoglobulin G, an Fc-fusion protein, erythropoietin, interferon and influenza hemagglutinin; and wherein the pH of the composition is between about 7.0 to about 8.0.

14. A composition comprising an α-fucosidase wherein the composition comprises:

(a) an α-fucosidase polypeptide having the sequence of SEQ ID NO: 1;

(b) at least one glycosidase selected from the group consisting of Endo-beta-N-acetylglucosaminidases (NAG), EndoA, EndoF1, EndoF2, EndoF3, EndoH, EndoM, EndoS, and variants thereof; and

(c) a glycoprotein comprising an N-linked glycan, wherein the glycoprotein is selected from the group consisting of an immunoglobulin G, an Fc-fusion protein, erythropoietin, interferon and influenza hemagglutinin; and wherein the composition excludes a divalent cation selected from the group consisting of Zn 2+ , Cu 2+ and Ni 2+ .

15. A composition comprising an α-fucosidase, wherein the composition comprises:

(a) an α-fucosidase polypeptide having the sequence of SEQ ID NO: 1;

(b) at least one glycosidase selected from the group consisting of EndoF1, EndoF2, EndoF3, EndoH, EndoS, and variants thereof; and

(c) a glycoprotein comprising an N-linked glycan, wherein the glycoprotein is selected from the group consisting of an immunoglobulin G, an Fc-fusion protein, erythropoietin, interferon and influenza hemagglutinin.

16. A composition comprising an α-fucosidase, wherein the composition comprises:

(a) an α-fucosidase polypeptide having the sequence of SEQ ID NO: 1; and

(b) (i) Endo S and optionally at least one glycosidase selected from the group consisting of EndoF1, EndoF2, EndoF3, EndoH, EndoS, and variants thereof; or (ii) a glycosidase cocktail comprising Endo F1, Endo F2, Endo F3, and Endo H; and

(c) an immunoglobulin G or an Fc-fusion protein comprising an N-linked glycan.

17. A composition made by a process comprising:

contacting a glycoprotein with an α-fucosidase to remove one or more fucoses in the glycoprotein,

wherein the composition comprises an α-fucosidase polypeptide having the sequence of SEQ ID NO: 1 and a glycosidase cocktail comprising EndoF1, EndoF2, EndoF3, EndoH and EndoM,

wherein the glycoprotein comprises an N-linked glycan and is selected from the group consisting of an immunoglobulin G, an Fc-fusion protein, erythropoietin, interferon and influenza hemagglutinin.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2022
From: WONG, CHI-HUEY; TSAI, TSUNG-I
To: ACADEMIA SINICA
Reel/Frame 059234/0505 →
Continuity (6)
Provisional Application 62003136 · May 27, 2014
Provisional Application 62003104 · May 27, 2014
Provisional Application 62003908 · May 28, 2014
Provisional Application 62020199 · Jul 2, 2014
Provisional Application 62110338 · Jan 30, 2015
Related Publication 20160017390A1 · Jan 21, 2016