JPWO2020223702A5 - - Google Patents

Claims (29)

A pharmaceutical composition for use in a method for treating cancer in a subject , comprising an antibody that binds to human galectin-9 (anti-galectin-9 antibody ) , wherein the anti-galectin-9 antibody is represented by SEQ ID NO: 1 Light chain complementarity determining region 1 (CDR1) shown, light chain complementarity determining region 2 (CDR2) shown as SEQ ID NO:2, and light chain complementarity determining region 3 (CDR3) shown as SEQ ID NO:3 and/or a heavy chain complementarity determining region 1 (CDR1) shown as SEQ ID NO:4, a heavy chain complementarity determining region 2 (CDR2) shown as SEQ ID NO:5, and a heavy chain complementarity determining region 2 (CDR2) shown as SEQ ID NO:6 A pharmaceutical composition comprising a heavy chain complementarity determining region 3 (CDR3), wherein the anti-galectin-9 antibody in the pharmaceutical composition is 1 mg to 32 mg per kg body weight of the subject. 2. The pharmaceutical composition of claim 1, wherein said cancer is a solid tumor. 3. The pharmaceutical composition of claim 2, wherein the solid tumor is pancreatic cancer, colorectal cancer (CRC), hepatocellular carcinoma (HCC), or cholangiocarcinoma (CCA). 4. The pharmaceutical composition according to claim 2 or claim 3, wherein said solid tumor is a metastatic tumor. 5. The pharmaceutical composition of any one of claims 1-4, wherein the pharmaceutical composition comprising the anti-galectin-9 antibody is administered to the subject once every two weeks. 6. The pharmaceutical composition of any one of claims 1-5, wherein the anti-galectin-9 antibody in the pharmaceutical composition is between 1 mg and 16 mg per kg body weight of the subject. The anti-galectin-9 antibody in the pharmaceutical composition is 1 mg/kg, 2 mg/kg , 4 mg/kg , 6 mg/kg , 8 mg/kg , 10 mg/kg , 12 mg/kg, or 16 mg 7. The pharmaceutical composition according to any one of claims 1 to 6, administered at a dose of /kg. 8. The pharmaceutical composition of any one of claims 1-7, wherein the pharmaceutical composition comprising the anti-galectin-9 antibody is administered to the subject by intravenous infusion. 9. The pharmaceutical composition of any one of claims 1-8, wherein the subject does not receive any other anti-cancer therapy in combination with treatment with the anti-galectin-9 antibody. 10. The pharmaceutical composition of any one of claims 1-9, wherein the subject is further administered an immune checkpoint inhibitor. 11. The pharmaceutical composition of claim 10, wherein said immune checkpoint inhibitor is an antibody that binds to PD-1. 12. The pharmaceutical composition of claim 11, wherein said PD-1 binding antibody is selected from the group consisting of pembrolizumab, nivolumab, tislelizumab, or cemiplimab. said antibody that binds to PD-1 is nivolumab, said nivolumab being administered to said subject at a dose of 240 mg once every two weeks, or
Claim 11 or claim 12, wherein the antibody that binds to PD-1 is tislelizumab, and said tislelizumab is administered at a dose of 200 mg once every three weeks or at a dose of 480 mg once every four weeks. The pharmaceutical composition according to . 14. The pharmaceutical composition of any one of claims 10-13 , wherein the immune checkpoint inhibitor is administered by intravenous infusion. 15. The pharmaceutical composition of any one of claims 1-14 , wherein the anti-galectin-9 antibody comprises a light chain variable domain of SEQ ID NO:8 and a heavy chain variable domain of SEQ ID NO:7. 16. The pharmaceutical composition of any one of claims 1-15 , wherein the anti-galectin-9 antibody is a full-length antibody. 17. The pharmaceutical composition according to any one of claims 1 to 16 , wherein said anti-galectin-9 antibody is an IgG1 molecule or an IgG4 molecule. 18. The pharmaceutical composition of claim 17 , wherein said anti-galectin-9 antibody is an IgG4 molecule having a modified Fc region of human IgG4. 19. The pharmaceutical composition of claim 18 , wherein said modified Fc region of human IgG4 comprises the amino acid sequence of SEQ ID NO:14. 20. The pharmaceutical composition of any one of claims 1-19, wherein the anti-galectin-9 antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 19 and a light chain comprising the amino acid sequence of SEQ ID NO:15. 21. The pharmaceutical composition of any one of claims 1-20 , wherein the subject is receiving one or more previous anti-cancer therapies. 22. The pharmaceutical composition of claim 21 , wherein the one or more previous anti-cancer therapies comprise chemotherapy, immunotherapy, radiation therapy, therapy with biological agents, or combinations thereof. 23. The subject of claim 21 or claim 22, wherein said subject has progressed disease through said one or more prior anti-cancer therapies or is resistant to said one or more prior therapies. Pharmaceutical composition as described. 24. The pharmaceutical composition of any one of claims 1-23 , wherein the subject is a human patient with elevated levels of galectin-9 compared to control values. 25. The pharmaceutical composition of claim 24 , wherein said human patient has elevated serum or plasma levels of galectin-9 compared to said control value. the human patient has cancer cells expressing galectin-9, and/or
26. The pharmaceutical composition of claim 25 , wherein said human patient has immune cells expressing galectin-9 . said cancer cells are within a tumor organoid derived from said human patient; and/or
27. The pharmaceutical composition of claim 26 , wherein said immune cells are within tumor organoids derived from said human patient . 28. The pharmaceutical composition of any one of claims 1-27 , wherein the method further comprises monitoring the occurrence of adverse effects in the subject. 29. The pharmaceutical composition of claim 28 , wherein said method further comprises reducing said dose of said anti-galectin-9 antibody , said dose of said checkpoint inhibitor, or both.