Claims for Patent: 10,086,046

Summary for Patent: 10,086,046

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:	15/439,845
Patent Claims:	1. A method for the treatment of an autoimmune disease in an organism, the method comprising: (a) contacting peripheral mononuclear blood cells (PBMCs) derived from a first organism with a mutein of human interleukin-2 (hIL-2 mutein), 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, to obtain a cell population which comprises regulatory T cells, and (b) introducing the cell population into a second organism for the treatment of the autoimmune disease in the second organism, wherein the autoimmune disease is selected from the group consisting of type I diabetes, multiple sclerosis, and systemic lupus erythematosus (SLE). 2. The method of claim 1, wherein the first and the second organisms are the same individual or are individuals of the same species. 3. The method of claim 1, wherein in said hIL-2 mutein, 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). 4. The method of claim 1, wherein said hIL-2 mutein has at least one further amino acid substitution in any position except the positions 20, 88, or 126, and wherein the at least one further substitution is a conservative amino acid substitution. 5. The method of claim 1, wherein in said hIL-2 mutein, 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-D200, or tyrosine (hIL-2-D20Y). 6. The method of claim 1, wherein in said hIL-2 mutein, through the substitution at position 126, a glutamine is exchanged for a leucine (hIL-2-Q126L). 7. The method of claim 1, wherein the method further comprises administering to the second organism an immunosuppressant. 8. The method of claim 7, 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.

Details for Patent 10,086,046

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	05/12/1998		2028-05-08
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	01/02/2003		2028-05-08
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2028-05-08