Claims for Patent: 9,358,282

Summary for Patent: 9,358,282

Title:	Re-directed immunotherapy
Abstract:	The invention provides an agent for preventing or treating a condition characterized by the presence of unwanted cells, the agent comprising: (i) a targeting moiety that is capable of targeting to the unwanted cells; and (ii) a T cell antigen, wherein the T cell antigen can be released from the targeting moiety by selective cleavage of a cleavage site in the agent in the vicinity of the unwanted cells.
Inventor(s):	Cobbold; Mark (Birmingham, GB), Millar; David (Birmingham, GB)
Assignee:	The University of Birmingham (Birmingham, GB)
Application Number:	14/660,137
Patent Claims:	1. An agent for retargeting T cells to cancer cells, the agent comprising: (i) a targeting moiety that is capable of targeting to the cancer cells, wherein the targeting moiety is Rituximab or Cetuximab; (ii) a T cell epitope capable of eliciting a T cell response in a subject, wherein the T cell epitope is NLVPMVATV (SEQ ID NO: 21), and (iii) a peptide linker comprising a peptide cleavage site cleavable by a tumor associated protease and wherein the linker can be selectively cleaved by the tumor associated protease to release the T cell epitope in the vicinity of, and outside of, the cancer cell. 2. The agent according to claim 1, wherein selective cleavage of the cleavage site enables release of the T cell epitope at or near to the cell surface of the cancer cells. 3. The agent according to claim 1, wherein the cancer cells are a tumour, and the T cell epitope is released by selective cleavage of a protease cleavage site. 4. A method of retargeting cytomegalovirus (CMV) specific T cells to cancer cells, the method comprising administering the agent of claim 1 to a subject. 5. The method according to claim 4, further comprising determining any one of (i) the MHC alleles of the subject, (ii) the cytotoxic T cell response of the subject to a T cell epitope (iii) the expression profile of the cancer cell in the subject. 6. A composition comprising (i) an agent according to claim 1 and (ii) a therapeutic agent. 7. The agent of claim 1, wherein the cleavage site in the agent is between the targeting moiety and T cell epitope. 8. The agent according to claim 1, wherein the antibody is Rituximab. 9. The agent according to claim 8, wherein the tumor associated protease is Cathepsin B, Cathepsin L, Cathepsin S, Cathepsin D, Cathepsin E, Cathepsin A, Cathepsin G, Thrombin, Plasmin, Urokinase, Tissue Plasminogen Activator, any one of Metalloproteinase 1 (MMP1), MMP2, MMP3, MMP4, MMP7, MMP8, MMP9, MMP10, MMP11, MMP12, MMP13, MMP14, MMP15, MMP16, MMP17, MMP20, MMP21, MMP23, MMP24, MMP25, MMP26, MMP28, ADAM, ADAMTS, CD10 (CALLA), or prostate specific antigen. 10. The agent according to claim 8, wherein the tumor associated protease is a metalloprotease or a cathepsin. 11. The agent according to claim 8, wherein the tumor associated protease is MMP2, ADAM28, or Cathepsin B. 12. The agent according to claim 8, wherein the tumor associated protease is ADAM28. 13. The agent according to claim 8, wherein the T cell epitope and the cleavage site are conjugated to the targeting moiety by a maleimide conjugation. 14. The agent according to claim 12, wherein the T cell epitope and the cleavage site are conjugated to the targeting moiety by a maleimide conjugation. 15. The agent according to claim 1, wherein the antibody is Cetuximab. 16. The agent according to claim 15, wherein the tumor associated protease is Cathepsin B, Cathepsin L, Cathepsin S, Cathepsin D, Cathepsin E, Cathepsin A, Cathepsin G, Thrombin, Plasmin, Urokinase, Tissue Plasminogen Activator, any one of Metalloproteinase 1 (MMP1), MMP2, MMP3, MMP4, MMP7, MMP8, MMP9, MMP10, MMP11, MMP12, MMP13, MMP14, MMP15, MMP16, MMP17, MMP20, MMP21, MMP23, MMP24, MMP25, MMP26, MMP28, ADAM, ADAMTS, CD10 (CALLA), or prostate specific antigen. 17. The agent according to claim 15, wherein the tumor associated protease is a metalloprotease or a cathepsin. 18. The agent according to claim 15, wherein the tumor associated protease is MMP2, ADAM28, or Cathepsin B. 19. The agent according to claim 15, wherein the tumor associated protease is ADAM28. 20. The agent according to claim 15, wherein the T cell epitope and the cleavage site are conjugated to the targeting moiety by a maleimide linkage. 21. The agent according to claim 19, wherein the T cell epitope and the cleavage site are conjugated to the targeting moiety by a maleimide linkage. 22. A method of treating a condition characterised by the of cancer cells expressing CD20, the method comprising administering the agent of claim 8 to a subject. 23. A method of treating a condition characterised by the of cancer cells expressing CD20, the method comprising administering the agent of claim 14 to a subject. 24. A method of treating a condition characterised by the of cancer cells expressing EGFR, the method comprising administering the agent of claim 15 to a subject. 25. A method of treating a condition characterised by the of cancer cells expressing EGFR, the method comprising administering the agent of claim 21 to a subject. 26. The method of claim 4, wherein the method further comprises administering a therapeutic agent suitable for treating cancer.

Details for Patent 9,358,282

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Microbix Biosystems Inc.	KINLYTIC	urokinase	For Injection	021846	01/16/1978		2031-03-17
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2031-03-17
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2031-03-17