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Last Updated: April 26, 2024

Claims for Patent: 9,464,137


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Summary for Patent: 9,464,137
Title:Glycoprotein
Abstract: The invention relates to a composition comprising a glycoprotein comprising the Fc domain of an antibody, or a fragment thereof, comprising an Asn (asparagine) residue and an oligosaccharide structure attached thereto, wherein said oligosaccharide structure has a structure according to formula I; and wherein at least 20% of the oligosaccharide structures attached to glycoprotein in the composition consist of oligosaccharide structures according to formula (I).
Inventor(s): Satomaa; Tero (Helsinki, FI), Saarinen; Juhani (Helsinki, FI), Natunen; Jari (Vantaa, FI), Vilkman; Anja (Klaukkala, FI), Virtanen; Heidi (Helsinki, FI), Hiltunen; Jukka (Helsinki, FI)
Assignee: Glykos Finland Oy (Helsinki, FI)
Application Number:14/365,022
Patent Claims:1. A pharmaceutical composition comprising a glycoprotein comprising the Fc domain of an antibody, or a fragment thereof, comprising an Asn residue and an oligosaccharide structure attached thereto and a pharmaceutically acceptable carrier, wherein the oligosaccharide structure consists of the structure according to formula I ##STR00005## wherein (.beta.-N-Asn)=.beta.-N linkage to Asn; wherein at least 50% of the oligosaccharide structures attached to glycoprotein in the composition consist of oligosaccharide structures according to formula I.

2. The pharmaceutical composition according to claim 1, wherein at least 66.7% at least 90%, at least 95%, or at least 99% of the oligosaccharide structures attached to the glycoprotein in the composition consist of oligosaccharide structures according to formula I.

3. The pharmaceutical composition according to claim 1, wherein the Asn residue corresponds to Asn297 of human IgG wherein the numbering corresponds to the EU index as in Kabat.

4. The pharmaceutical composition according to claim 1, wherein the Fc domain is a human Fc domain.

5. The pharmaceutical composition according to claim 1, wherein the glycoprotein is a fusion protein comprising an Fc domain.

6. The pharmaceutical composition according to claim 1, wherein the glycoprotein is a human antibody, a humanized antibody or a chimeric antibody comprising a human Fc domain.

7. The pharmaceutical composition according to claim 1, wherein the glycoprotein is an IgG antibody.

8. The pharmaceutical composition according to claim 1, wherein the glycoprotein is an IgG1 antibody.

9. The pharmaceutical composition according to claim 1, wherein the glycoprotein is an antibody directed against human vascular endothelial growth factor (VEGF), epidermal growth factor receptor 1 (EGFR), tumor necrosis factor alpha (TNF-.alpha.), CD20, epidermal growth factor receptor 2 (HER2/neu), CD52, CD33, CD11a, glycoprotein IIb/IIIa, CD25, IgE, interleukin-2 (IL-2) receptor, or respiratory syncytial virus (RSV).

10. The pharmaceutical composition according to claim 1, wherein the glycoprotein is an antibody that is bevacizumab, tositumomab, etanercept, trastuzumab, adalimumab, alemtuzumab, gemtuzumab ozogamicin, efalizumumab, rituximab, infliximab, abciximab, baasiliximab, palivizumab, omalizumab, daclizumab, cetuximab, panitumumab, or ibritumomab tiuxetan.

Details for Patent 9,464,137

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REOPRO abciximab Injection 103575 12/22/1994 ⤷  Try a Trial 2031-12-13
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2031-12-13
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2031-12-13
Hoffmann-la Roche Inc. ZENAPAX daclizumab Injection 103749 12/10/1997 ⤷  Try a Trial 2031-12-13
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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