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Last Updated: April 24, 2024

Claims for Patent: 9,763,985

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Summary for Patent: 9,763,985

Title:	Antigen-specific central-memory T cell preparations having high CD4+ fraction
Abstract:	The invention relates to a method for generation of T cell preparations that are specific for at least one target antigen, comprising the steps of expanding lymphoid cells in vitro in the presence of a target antigen or peptide fragments thereof in an expansion step, isolating cells that secrete interferon gamma and culturing, the cells in the presence of interleukin 2 and interleukin 7 and either an inhibitor of the mTOR Complex 1, or in the presence of an inhibitor of IL-2/IL-2R interaction. The invention further relates to preparations obtained by the method of the invention.
Inventor(s):	Volk; Hans-dieter (Berlin, DE), Schmuck; Michael (Berlin, DE), Reinke; Petra (Berlin, DE)
Assignee:
Application Number:	14/125,101
Patent Claims:	1. A method for generation of a mixed CD4+ and CD8+ central memory T cell preparation that is specific for at least one target antigen, comprising the steps of: expanding lymphoid cells in vitro in the presence of a target antigen or peptide fragments thereof in an expansion step, yielding a first T cell preparation, wherein the lymphoid cells are isolated from whole blood peripheral mononuclear cells obtained from a human patient; isolating responding cells from the first T cell preparation in an isolation step, yielding a second T cell preparation; culturing, in a culturing step, the cells obtained as second T cell preparation in the presence of a cytokine, preferably interleukin 2 and/or interleukin 7, and i. an inhibitor of the mTOR Complex 1, preferably rapamycin or a rapamycin analogue, wherein the concentration of the inhibitor of the mTOR complex 1 is between 2 nmol/l and 20 nmol/l, or ii. an inhibitor of interleukin 2 (IL-2)--interleukin-2-receptor (IL-2R) interaction thereby generating a mixed CD4+ and CD8+ central memory T cell preparation that is specific for at least one target antigen. 2. The method according to claim 1, wherein the concentration of inhibitor of IL-2-IL-2R interaction is between 2 to 20 .mu.g/ml. 3. The method according to claim 1, wherein the inhibitor of IL-2-IL-2R interaction is a monoclonal antibody targeting CD25, particularly Daclizumab or Basiliximab. 4. The method according to claim 1, wherein the culturing step lasts between 10 and 25 days, between 15 and 21 days, or about 18 days. 5. A method for generation of a mixed CD4+ and CD8+ central memory T cell preparation that is specific for at least one target antigen, comprising the steps of: expanding lymphoid cells in vitro in the presence of a target antigen or peptide fragments thereof in an expansion step, yielding a first T cell preparation, wherein the lymphoid cells are isolated from whole blood peripheral mononuclear cells obtained from a human patient; isolating responding cells from the first T cell preparation in an isolation step, yielding a second T cell preparation; culturing, in a culturing step, the cells obtained as second T cell preparation in the presence of a cytokine, preferably interleukin 2 and/or interleukin 7, and an inhibitor of interleukin 2 (IL-2)--interleukin-2-receptor (IL-2R) interaction thereby generating a mixed CD4+ and CD8+ central memory T cell preparation that is specific for at least one target antigen. 6. The method according to claim 1, wherein the concentration of the inhibitor of IL-2-IL-2R interaction is between 2 to 20 .mu.g/ml. 7. The method according to claim 1, wherein the inhibitor of IL-2-IL-2R interaction is a monoclonal antibody targeting CD25, particularly Daclizumab or Basiliximab. 8. The method according to claim 1, wherein the culturing step lasts between 10 and 25 days, between 15 and 21 days, or about 18 days.

Details for Patent 9,763,985

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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	2031-06-11
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	05/12/1998	⤷ Try a Trial	2031-06-11
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	01/02/2003	⤷ Try a Trial	2031-06-11
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016	⤷ Try a Trial	2031-06-11
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017	⤷ Try a Trial	2031-06-11
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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