Claims for Patent: 10,377,809

Summary for Patent: 10,377,809

Title:	Modified glycoproteins
Abstract:	Sulfated glycoproteins, and methods of making and using such sulfated glycoproteins, are described.
Inventor(s):	Bulik; Dorota A. (Malden, MA), Bosques; Carlos J. (Arlington, MA), Collins; Brian Edward (Arlington, MA), Hains; Maurice Gaston (Brockton, MA), Washburn; Nathaniel J. (Littleton, MA), Meador; James (Framingham, MA), Smith; Sean (Littleton, MA), Bhatnagar; Naveen (Framingham, MA)
Assignee:	Momenta Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	15/483,545
Patent Claims:	1. A preparation of abatacept, wherein at least 5% of the abatacept of the preparation comprises an Fc region comprising a sulfated glycan. 2. The preparation of claim 1, wherein the sulfated glycan is linked to a CH2 domain of an IgG heavy chain. 3. The preparation of claim 2, wherein the sulfated glycan is linked to Asn297 of the IgG heavy chain. 4. The preparation of claim 1, wherein the sulfated glycan comprises a branched glycan. 5. The preparation of claim 2, wherein the sulfated glycan comprises one or more of a sulfated N-acetylglucosamine, a sulfated galactose, or a sulfated N-acetylgalactosamine. 6. The preparation of claim 1, wherein at least 10% of the abatacept of the preparation comprises an Fc region comprising a sulfated glycan. 7. The preparation of claim 1, wherein the glycan is singly sulfated. 8. The preparation of claim 1, wherein the glycan is doubly sulfated. 9. The preparation of claim 1, wherein the abatacept comprising an Fc region comprising a sulfated glycan has a different Fc receptor affinity, Fc receptor specificity, complement activation activity, signaling activity, targeting activity, effector function, half-life, clearance, pro-inflammatory activity, anti-inflammatory activity, or transcytosis activity than a corresponding abatacept comprising an Fc region that does not comprise a sulfated Fc glycan. 10. The preparation of claim 9, wherein the effector function is antibody dependent cellular cytotoxicity, complement dependent cytotoxicity, programmed cell death, or cellular phagocytosis. 11. The preparation of claim 9, wherein the Fc receptor is an Fc.gamma.RI, Fc.gamma.RIIA, Fc.gamma.RIIB, Fc.gamma.RIIIA, Fc.gamma.RIIIB, Fc.gamma.RIV, or FcRn receptor. 12. The preparation of claim 11, wherein the abatacept comprising an Fc region comprising a sulfated glycan binds to a macrophage, neutrophil, dendritic cell, B cell, natural killer cell, or eosinophil. 13. A method of modifying activity of a preparation of abatacept, the method comprising: providing a preparation of abatacept comprising an immunoglobulin Fc region comprising a glycan; and sulfating the glycan of at least 5% of the abatacept of the preparation, the abatacept comprising the sulfated glycan having a different Fc receptor affinity, Fc receptor specificity, complement activation activity, signaling activity, targeting activity, effector function, half-life, clearance, pro-inflammatory activity, anti-inflammatory activity, or transcytosis activity than a corresponding abatacept that does not comprise a sulfated glycan.

Details for Patent 10,377,809

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118	12/23/2005		2031-05-20
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	07/29/2011		2031-05-20
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	06/07/2016		2031-05-20
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	03/30/2017		2031-05-20