Claims for Patent: 10,179,135

Summary for Patent: 10,179,135

Title:	Apilimod compositions and methods for using same
Abstract:	The present invention relates to methods for treating cancer with apilimod and related compositions and methods.
Inventor(s):	Lichenstein; Henri (Guilford, CT), Rothberg; Jonathan M. (Guilford, CT), Gayle; Sophia (East Haven, CT), Beeharry; Neil (Guilford, CT), Beckett; Paul (Yorktown Heights, NY), Landrette; Sean (Meriden, CT), Conrad; Chris (Mount Vernon, NY), Dyer; Matt (Heber City, UT), Xu; Tian (Guilford, CT)
Assignee:	LAM Therapeutics, Inc. (Guilford, CT)
Application Number:	15/113,154
Patent Claims:	1. A method for treating a refractory or recurrent non-Hodgkin's B cell lymphoma in a humor subject in need thereof, the method comprising administering a pharmaceutical composition comprising apilimod dimesylate to the subject in a therapeutically effective amount of from 200-300 mg/day. 2. The method of claim 1, wherein the pharmaceutical composition is an oral dosage form. 3. The method of claim 1, wherein the non-Hodgkin's B cell lymphoma is selected from diffuse large B cell lymphoma (DLBCL), Burkitt's lymphoma, mediastinal B cell lymphoma, and mantle cell lymphoma. 4. The method of claim 3, wherein the non-Hodgkins B cell lymphoma is DLBCL. 5. The method of claim 4, wherein the DLBCL is DLBCL-GCB. 6. The method of claim 1, wherein the method comprises administering apilimod in combination with at least one additional active agent. 7. The method of claim 6, wherein the at least one additional active agent is a therapeutic agent or a non-therapeutic agent, or combinations thereof. 8. The method of claim 6, wherein the at least one additional active agent is administered in the same dosage form as the apilimod, or in a separate dosage form. 9. The method of claim 7, wherein the at least one additional active agent is selected from the group consisting of an alkylating agent, an intercalating agent, a tubulin binding agent, a corticosteroid, and combinations thereof. 10. The method of claim 7, wherein the at least one additional active agent is a therapeutic agent selected from the group consisting of ibrutinib, rituximab, doxorubicin, prednisolone vincristine, velcade, and everolimus, and combinations thereof. 11. The method of claim 7, wherein the at least one additional active agent is a therapeutic agent selected from cyclophosphamide, hydroxydaunorubicin (also referred to as doxorubicin or Adriamycin.TM.), vincristine (also referred to as Oncovin.TM.), prednisone, prednisolone, and combinations thereof. 12. The method of claim 7, wherein the at least one additional active agent is a non-therapeutic agent selected to ameliorate one or more side effects of the apilimod composition. 13. The method of claim 12, wherein the non-therapeutic agent is selected from the group consisting of ondansetron, granisetron, dolasetron and palonosetron. 14. The method of claim 12, wherein the non-therapeutic agent is selected from the group consisting of pindolol and risperidone. 15. The method of claim 10, wherein the therapeutic agent is rituximab. 16. The method of claim 10, wherein the therapeutic agent is ibrutinib. 17. The method of claim 1, wherein the non-Hodgkin's B cell lymphoma is a follicular lymphoma. 18. The method of claim 1, wherein the amount is 200 mg/day, 225 mg/day, 250 mg/day, or 275 mg/day.

Details for Patent 10,179,135

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-02-26
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	06/22/2017		2039-02-26