Claims for Patent: 10,428,143

Summary for Patent: 10,428,143

Title:	Modulation of stimulatory and non-stimulatory myeloid cells
Abstract:	Provided herein are methods and compositions for enhancing an immune response and/or for the treatment of an immune-related condition in an individual, e.g., cancer, comprising killing, disabling, or depleting non-stimulatory myeloid cells using an antigen binding protein such as an antibody or antigen binding fragment thereof.
Inventor(s):	Krummel; Matthew (San Francisco, CA), Broz; Miranda (San Francisco, CA), Wolf; Denise (San Francisco, CA), Pollack; Joshua (San Francisco, CA), Biennewies; Mikhail (San Francisco, CA)
Assignee:	The Regents of the University of California (Oakland, CA)
Application Number:	15/514,471
Patent Claims:	1. A method of killing, disabling, or depleting Triggering Receptor Expressed on Myeloid Cells 2 (TREM2+) myeloid cells present in a cancer tissue of a subject, comprising: contacting the TREM2+ myeloid cells present in the cancer tissue of the subject with an antibody or antigen-binding fragment thereof comprising a human Fc domain, wherein the antibody or antigen-binding fragment thereof binds to the extracellular domain of TREM2; wherein the antibody or antigen-binding fragment thereof is present in an amount effective to kill, disable, or deplete the TREM2+ myeloid cells via antibody-dependent cell-mediated cytotoxicity activity, antibody-dependent phagocytosis activity, complement-dependent cytotoxicity activity, or antibody-mediated phagocytosis activity. 2. The method of claim 1, wherein the TREM2+ myeloid cells are CD45+, HLA-DR+, CD11c+, CD14+, and BDCA3-, wherein the TREM2+ myeloid cells are present in a population of immune cells comprising myeloid cells that are CD45+, HLA-DR+, CD14-, CD11c+, BDCA1-, and BDCA3+ and the TREM2+ myeloid cells, and wherein the killing, disabling, or depleting of the TREM2+ myeloid cells treats the cancer by enhancing an immune response to the cancer tissue. 3. The method of claim 1 wherein the TREM2+ myeloid cells present in the cancer tissue of the subject comprise at least one of: tumor-associated macrophages; tumor-associated dendritic cells; CD45+, HLA-DR+, CD11c+, CD14+, and BDCA3- cells; CD45+, HLA-DR+, and CD14+ cells; CD45+, HLA-DR+, CD14+, BDCA3-, CD11b+, and CD11c+ cells; CD45+, HLA-DR+, CD14-, CD11c+, and BDCA1+ cells; and wherein the TREM2+ myeloid cells are not BDCA3+ cells, as determined by flow cytometry or an equivalent assay. 4. The method of claim 1, wherein the antibody is at least one of a monoclonal antibody, an IgG1 antibody, an IgG4 antibody, an afucosylated antibody, a human antibody, a humanized antibody, a chimeric antibody, and a full length antibody. 5. The method of claim 1, wherein the contacting induces at least one of: death of the TREM2+ myeloid cells, apoptosis of the TREM2+ myeloid cells, lysis of the TREM2+ myeloid cells, phagocytosis of the TREM2+ myeloid cells, and growth arrest in the TREM2+ myeloid cells. 6. The method of claim 1, wherein the cancer tissue is a solid cancer or a liquid cancer. 7. The method of claim 6, wherein the cancer is selected from the group consisting of: melanoma, kidney cancer, hepatobiliary cancer, head-neck squamous carcinoma, pancreatic cancer, colon cancer, bladder cancer, glioblastoma, prostate cancer, lung cancer, and breast cancer. 8. The method of claim 1, wherein the subject has previously received an immunotherapy. 9. The method of claim 8, wherein the immunotherapy comprises the administration to the subject of at least one of: pembromizulab, nivolumab, and ipilimumab. 10. The method of claim 1, further comprising administering an immunotherapy to the subject concurrently with the antibody or antigen-binding fragment thereof, wherein the immunotherapy comprises at least one of pembromizulab, nivolumab, or ipilimumab. 11. The method of claim 1, further comprising administering an immunotherapy to the subject subsequently to the antibody or antigen-binding fragment thereof, wherein the immunotherapy comprises at least one of pembromizulab, nivolumab, or ipilimumab. 12. A method of treating a cancer in a subject, comprising administering to the subject an antibody or antigen-binding fragment thereof comprising a human Fc domain, wherein the antibody or antigen-binding fragment thereof binds to the extracellular domain Triggering Receptor Expressed on Myeloid Cells 2 (TREM2+), wherein TREM2+ myeloid cells are present in the cancer and the antibody or antigen-binding fragment thereof is present in an amount effective to kill, disable, or deplete the TREM2+ myeloid cells via antibody-dependent cell-mediated cytotoxicity activity, antibody-dependent phagocytosis activity, complement-dependent cytotoxicity activity, or antibody-mediated phagocytosis activity. 13. The method of claim 12, wherein the TREM2+ myeloid cells are CD45+, HLA-DR+, CD11c+, CD14+, and BDCA3-, wherein the TREM2+ myeloid cells are present in a population of immune cells comprising myeloid cells that are CD45+, HLA-DR+, CD14-, CD11c+, BDCA1-, and BDCA3+ and the TREM2+ myeloid cells, and wherein the killing, disabling, or depleting of the TREM2+ myeloid cells treats the cancer. 14. The method of claim 12, wherein the TREM2+ myeloid cells present in the cancer tissue of the subject comprise at least one of: tumor-associated macrophages; tumor-associated dendritic cells; CD45+, HLA-DR+, CD11c+, CD14+, and BDCA3- cells; CD45+, HLA-DR+, and CD14+ cells; CD45+, HLA-DR+, CD14+, BDCA3-, CD11b+, and CD11c+ cells; CD45+, HLA-DR+, CD14-, CD11c+, and BDCA1+ cells; and wherein the TREM2+ myeloid cells are not BDCA3+ cells, as determined by flow cytometry or an equivalent assay. 15. The method of claim 12, wherein the antibody is at least one of a monoclonal antibody, an IgG1 antibody, an IgG4 antibody, an afucosylated antibody, a human antibody, a humanized antibody, a chimeric antibody, and a full length antibody. 16. The method of claim 12, wherein the administering induces at least one of death of the TREM2+ myeloid cells, apoptosis of the TREM2+ myeloid cells, lysis of the TREM2+ myeloid cells, phagocytosis of the TREM2+ myeloid cells, and growth arrest in the TREM2+ myeloid cells. 17. The method of claim 12, wherein the cancer is a solid cancer or a liquid cancer. 18. The method of claim 17, wherein the cancer is selected from the group consisting of: melanoma, kidney cancer, hepatobiliary cancer, head-neck squamous carcinoma, pancreatic cancer, colon cancer, bladder cancer, glioblastoma, prostate cancer, lung cancer, and breast cancer. 19. The method of claim 12, wherein the subject has previously received an immunotherapy. 20. The method of claim 19, wherein the immunotherapy comprises the administration to the subject of at least one of: pembromizulab, nivolumab, and ipilimumab. 21. The method of claim 12, further comprising administering an immunotherapy to the subject concurrently with the antibody or antigen-binding fragment thereof, wherein the immunotherapy comprises at least one of pembromizulab, nivolumab, or ipilimumab. 22. The method of claim 12, further comprising administering an immunotherapy to the subject subsequently to the antibody or antigen-binding fragment thereof, wherein the immunotherapy comprises at least one of pembromizulab, nivolumab, or ipilimumab.

Details for Patent 10,428,143

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	03/25/2011		2034-09-28
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	12/22/2014		2034-09-28
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	10/04/2017		2034-09-28
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	08/27/2021		2034-09-28