Claims for Patent: 9,724,395

Summary for Patent: 9,724,395

Title:	Treatment of cancer with immune stimulators
Abstract:	The present invention provides compositions and methods for treating cancer or a metastasis thereof in a subject. In some embodiments, the methods involve administering a composition comprising therapeutically effective amount of at least one immune stimulator to the subject. In some embodiments, a combination of at least two immune stimulators is used for the treatment. In some embodiments, the combination includes an alpha thymosin peptide and an additional immune stimulator, and/or optionally one or more additional anti-cancer agents.
Inventor(s):	King; Robert S. (Fremont, CA), Tuthill; Cynthia W. (Hercules, CA), Blobel; Friedhelm (Foster City, CA)
Assignee:	SciClone Pharmaceuticals, Inc. (Foster City, CA)
Application Number:	14/918,675
Patent Claims:	1. A method of treating cancer or a metastasis thereof in a subject comprising administering a composition comprising therapeutically effective amount of a first immune stimulator and a second immune stimulator, wherein the first immune stimulator is an alpha thymosin peptide, and the second immune stimulator is a programmed cell death-1 (PD-1) inhibitor. 2. The method of claim 1, wherein the subject is a human. 3. The method of claim 1, wherein the second immune stimulator is administered to said subject at a dosage of about 0.01-1000 mg/day. 4. The method of claim 1, wherein the alpha thymosin peptide is administered to the subject during at least a portion of the treatment at a dosage within a range of about 0.5-10 mg/day. 5. The method of claim 4, wherein said dosage of the alpha thymosin peptide is within a range of about 0.1-10 mg/day. 6. The method of claim 1, wherein the alpha thymosin peptide is thymosin alpha 1 (TA1). 7. The method of claim 6, comprising administration of TA1 daily for a period of about 1-10 days, followed by about 1-5 days of non-administration of TA1. 8. The method of claim 7, wherein TA1 is administered daily for about 3-5 days, followed by about 2-4 days of non-administration of TA1. 9. The method of claim 8, wherein TA1 is administered daily for about 4 days, followed by about 3 days non-administration of TA1. 10. The method of claim 1, wherein the combination further comprises a kinase inhibitor. 11. The method of claim 10, wherein said kinase inhibitor comprises sorafenib. 12. The method of claim 10, wherein said kinase inhibitor is administered to said patient at a dosage within a range of about 10-200 mg/day. 13. The method of claim 1, wherein the composition further comprises an antineoplastic heat shock apoptosis activator (HSAA). 14. The method of claim 13, wherein said HSAA comprises STA-4783 (elesclomol). 15. The method of claim 13, wherein said HSAA is administered to said patient at a dosage within a range of about 0.01-100 mg/kg/day. 16. The method of claim 1, wherein said combination further includes administration of an antibody against cytotoxic T lymphocyte-associated antigen 4 (CTLA4). 17. The method of claim 16, wherein said CTLA4 antibody comprises 9H10, MDC010, 1F4, BNI3, Q01, A01, M08, 1B8, WKH203, ab9984, ab13486, ipilimumab, ticilimumab or a combination thereof. 18. The method of claim 16, wherein said CTLA4 antibody is administered to said patient at a dosage within a range of about 0.001-50 mg/kg/day. 19. The method of claim 1, wherein said combination further includes administration of an alkylating antineoplastic agent (AlkAA). 20. The method of claim 19, wherein the alkylating antineoplastic agent (AlkAA) comprises dacarbazine (DTIC). 21. The method of claim 19, wherein the alkylating antineoplastic agent (AlkAA) is administered to said patient at a dosage within a range of about 700-1300 mg/kg/day. 22. The method of claim 1, wherein the method further comprising administering a chemotherapeutic agent to the subject. 23. The method of claim 22, wherein the chemotherapeutic agent is dacarbazine (DTIC) or cisplatin. 24. The method of claim 1, wherein the cancer is melanoma. 25. The method of claim 24, wherein the composition further comprises an additional anti-melanoma agent.

Details for Patent 9,724,395

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	03/25/2011		2034-10-21