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Last Updated: April 26, 2024

Claims for Patent: 9,616,105

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Summary for Patent: 9,616,105

Title:	Agent for the treatment and/or prophylaxis of an autoimmune disease and for the formation of regulatory T cells
Abstract:	The present invention relates to an agent for the treatment and/or prophylaxis of an autoimmune disease, an agent for the formation of regulatory T cells (T.sub.Reg) in an organism and various methods in which the agents according to the invention are used.
Inventor(s):	Paulsen; Daniela (Wuppertal, DE), Brunner; Nina (Essen, DE), Bray; Dorothy (Buckinghamshire, GB)
Assignee:	AiCuris GmbH & Co. KG (Wuppertal, DE)
Application Number:	14/752,726
Patent Claims:	1. A method for the treatment and/or prevention of the worsening of an autoimmune disease in an organism, the method comprising: (a) administering a mutein of human interleukin-2 (hIL-2 mutein) to the organism, wherein said hIL-2 mutein has an amino acid substitution in at least one of the positions 20, 88 or 126, numbered in accordance with the hIL-2 wild type sequence as set forth in SEQ ID NO: 1; and (b) if necessary, repeating step (a), wherein the autoimmune disease is type I diabetes, multiple sclerosis, or systemic lupus erythematosus, and wherein the administration induces regulatory T cells in the organism. 2. The method according to claim 1, wherein through the substitution at position 88 an asparagine is exchanged for an amino acid which is selected from the group consisting of: arginine (hIL-2-N88R), glycine (hIL-2-N88G), or isoleucine (hIL-2-N88I). 3. The method according to claim 1, wherein through the substitution at position 20 an aspartic acid is exchanged for an amino acid which is selected from the group consisting of: histidine (hIL-2-D20H), isoleucine (hIL-2-D20I), or tyrosine (hIL-2-D20Y). 4. The method according to claim 1, wherein through the substitution at position 126, a glutamine is exchanged for a leucine (hIL-2-Q126L). 5. The method according to claim 1, wherein the method further comprises administering to the organism an immunosuppressant. 6. The method according to claim 5, wherein the immunosuppressant is selected from the group consisting of: glucocorticoid, including decortin, prednisol; azathioprine; cyclosporin A; tacrolimus; an anti-T lymphocyte globulin; an anti-CD3 antibody; muromonab; an anti-CD25 antibody; basiliximab; daclizumab; an anti-TNF-.alpha. antibody; infliximab; adalimumab; azathioprine; methotrexate; cyclosporin; sirolimus; everolimus; fingolimod; CELLCEPT.RTM. (mycophenolate mofetil); myfortic; and cyclophosphamide. 7. The method according to claim 1, wherein the autoimmune disease is type I diabetes. 8. The method according to claim 1, wherein the autoimmune disease is multiple sclerosis. 9. The method according to claim 1, wherein the autoimmune disease is systemic lupus erythematosus (SLE). 10. A method for the treatment and/or prevention of the worsening of an autoimmune disease in an organism, the method comprising: (a) administering a mutein of human interleukin-2 (hIL-2 mutein) to the organism, wherein said hIL-2 mutein has an amino acid substitution in at least one of the positions 20, 88 or 126, numbered in accordance with the hIL-2 wild type sequence as set forth in SEQ ID NO: 1; and (b) if necessary, repeating step (a), wherein the autoimmune disease is type I diabetes or multiple sclerosis. 11. The method according to claim 10, wherein through the substitution at position 88 an asparagine is exchanged for an amino acid which is selected from the group consisting of: arginine (hIL-2-N88R), glycine (hIL-2-N88G), or isoleucine (hIL-2-N88I). 12. The method according to claim 10, wherein through the substitution at position 20 an aspartic acid is exchanged for an amino acid which is selected from the group consisting of: histidine (hIL-2-D20H), isoleucine (hIL-2-D20I), or tyrosine (hIL-2-D20Y). 13. The method according to claim 10, wherein through the substitution at position 126, a glutamine is exchanged for a leucine (hIL-2-Q126L). 14. The method according to claim 10, wherein the method further comprises administering to the organism an immunosuppressant. 15. The method according to claim 14, wherein the immunosuppressant is selected from the group consisting of: glucocorticoid; decortin; prednisol; azathioprine; cyclosporin A; tacrolimus; an anti-T lymphocyte globulin; an anti-CD3 antibody; muromonab; an anti-CD25 antibody; basiliximab; daclizumab; an anti-TNF-.alpha. antibody; infliximab; adalimumab; azathioprine; methotrexate; cyclosporin; sirolimus; everolimus; fingolimod; CELLCEPT.RTM. (mycophenolate mofetil); myfortic; and cyclophosphamide.

Details for Patent 9,616,105

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997	⤷ Try a Trial	2028-05-08
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	05/12/1998	⤷ Try a Trial	2028-05-08
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	01/02/2003	⤷ Try a Trial	2028-05-08
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998	⤷ Try a Trial	2028-05-08
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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