Claims for Patent: 10,342,815

Summary for Patent: 10,342,815

Title:	GLA monotherapy for use in cancer treatment
Abstract:	The present disclosure relates generally to compositions and methods for treating cancer with a glucopyranosyl lipid A (GLA) in the absence of antigen.
Inventor(s):	Paya Cuenca; Carlos V. (San Francisco, CA), Ter Meulen; Jan Henrik (Mercer Island, WA)
Assignee:	IMMUNE DESIGN CORP. (Seattle, WA)
Application Number:	14/836,115
Patent Claims:	1. A method of treating cancer in a mammal, comprising administering by intratumoral injection an effective amount of a composition comprising GLA, said composition comprising: (a) GLA of the formula: ##STR00009## or a pharmaceutically acceptable salt thereof, wherein: L.sub.1, L.sub.3, L.sub.5 and L.sub.6 are O; L.sub.2 and L.sub.4 are NH; L.sub.7, L.sub.8, L.sub.9 and L.sub.10 are C(.dbd.O); Y.sub.1 is phosphate; Y.sub.2, Y.sub.3 and Y.sub.4 are OH; R.sub.1, R.sub.3, R.sub.5 and R.sub.6 are C11 alkyl; and R.sub.2 and R.sub.4 are C9 alkyl, and (b) a pharmaceutically acceptable carrier or excipient; wherein the composition does not comprise antigen. 2. The method of claim 1 wherein the mammal is human. 3. The method of claim 1 wherein the composition is an aqueous formulation. 4. The method of claim 1 wherein the composition is in the form of an oil-in-water emulsion, a water-in-oil emulsion, liposome, micellar formulation, or a microparticle. 5. The method of claim 1 wherein the cancer comprises a solid tumor. 6. The method of claim 5 wherein the solid tumor is a carcinoma, a sarcoma or a lymphoma. 7. The method of claim 5 wherein the solid tumor is a primary solid tumor. 8. The method of claim 5 wherein the solid tumor is a secondary solid tumor. 9. The method of claim 1 wherein the cancer is selected from the group consisting of, melanoma, Merkel cell carcinoma, lung cancer, cervical cancer, ovarian cancer, uterine cancer, breast cancer, liver cancer, gastric cancer, prostate cancer, colon cancer, kidney cancer, bladder cancer, brain cancer, and pancreatic cancer. 10. The method of claim 1 wherein the composition is administered in conjunction with one or more additional therapeutic agents or treatments. 11. The method of claim 10 wherein the therapeutic agents is an immune checkpoint inhibitor. 12. The method of claim 10 wherein the therapeutic agent is an antibody that activates a co-stimulatory pathway. 13. The method of claim 12 wherein the antibody is an anti-CD40 antibody. 14. The method of claim 10 wherein the therapeutic agent is a cancer therapeutic agent. 15. The method of claim 14 wherein the cancer therapeutic agent is selected from the group consisting of taxotere, carboplatin, trastuzumab, epirubicin, cyclophosphamide, cisplatin, docetaxel, doxorubicin, etoposide, 5-FU, gemcitabine, methotrexate, and paclitaxel, mitoxantrone, epothilone B, epidermal-growth factor receptor (EGFR)-targeting monoclonal antibody 7A7.27, vorinostat, romidepsin, docosahexaenoic acid, bortezomib, shikonin and an oncolytic virus. 16. The method of claim 10 wherein the one or more additional therapeutic treatments is radiation therapy. 17. A method of reducing the size of a tumor in a mammal, comprising administering by intratumoral injection an effective amount of a composition comprising GLA, said composition comprising: (a) GLA of the formula: ##STR00010## or a pharmaceutically acceptable salt thereof, wherein: L.sub.1, L.sub.3, L.sub.5 and L.sub.6 are O; L.sub.2 and L.sub.4 are NH; L.sub.7, L.sub.8, L.sub.9 and L.sub.10 are C(.dbd.O); Y.sub.1 is phosphate; Y.sub.2, Y.sub.3 and Y.sub.4 are OH; R.sub.1, R.sub.3, R.sub.5 and R.sub.6 are C11 alkyl; and R.sub.2 and R.sub.4 are C9alkyl, and (b) a pharmaceutically acceptable carrier or excipient; wherein the composition does not comprise antigen.

Details for Patent 10,342,815

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2039-07-20
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2039-07-20
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2039-07-20