ANTI-GALECTIN-9 ANTIBODIES AND THERAPEUTIC USES THEREOF

1 . A method for treating a solid tumor, the method comprising administering to a subject in need thereof

(a) an effective amount of an antibody that binds human Galectin-9 (anti-Galectin-9 antibody) and

(b) an effective amount of tislelizumab,

wherein the anti-Galectin-9 antibody comprises:

(i) a light chain variable region (V L ) comprising a light chain complementarity determining region 1 (CDR1) set forth as SEQ ID NO: 1, a light chain complementarity determining region 2 (CDR2) set forth as SEQ ID NO: 2, and a light chain complementarity determining region 3 (CDR3) set forth as SEQ ID NO: 3, and

(ii) a heavy chain variable region comprising a heavy chain complementarity determining region 1 (CDR1) set forth as SEQ ID NO: 4, a heavy chain complementarity determining region 2 (CDR2) set forth as SEQ ID NO: 5, and a heavy chain complementarity determining region 3 (CDR3) set forth as SEQ ID NO: 6 and

wherein the anti-Galectin-9 antibody is administered to the subject at a dose of about 0.2 mg/kg to about 18 mg/kg.

2 . The method of claim 1 , wherein the solid tumor is head and neck cancer, urothelial cancer, gastric esophageal cancer, or non-small cell lung cancer.

3 . The method of claim 1 , wherein the solid tumor is a metastatic tumor.

4 . The method of claim 1 , wherein the anti-Galectin-9 antibody is administered to the subject at a dose of about 4 mg/kg to about 18 mg/kg.

5 . The method of claim 4 , wherein the anti-Galectin-9 antibody is administered to the subject at a dose of about 4 mg/kg, about 6.3 mg/kg, about 10 mg/kg, about 12 mg/kg, about 14 mg/kg, about 16 mg/kg, or about 18 mg/kg, optionally wherein the dose of the anti-Galecti-9 antibody is about 6.3 mg/kg, about 10 mg/kg, or about 16 mg/kg.

6 . The method of claim 1 , wherein the anti-Galectin-9 antibody is administered to the subject once a week.

7 . The method of claim 6 , wherein the anti-Galectin-9 antibody is administered to the subject at a dose of about 6.3 mg/kg, about 10 mg/kg once a week, or about 16 mg/kg.

8 . The method of claim 1 , wherein the anti-Galectin-9 antibody is administered to the subject by intravenous infusion.

9 . The method of claim 1 , wherein the tislelizumab is administered to the subject at a dose of about 200 mg once every 3 weeks, at a dose of about 300 mg every 4 weeks, or at a dose of about 400 mg every six weeks.

10 . The method of claim 9 , wherein the tislelizumab is administered to the subject at a dose of about 300 mg every 4 weeks.

11 . The method of claim 9 , wherein the tislelizumab is administered to the subject by intravenous infusion.

12 . The method of claim 1 , wherein the anti-Galectin-9 antibody is administered to the subject at about 6.3 mg/kg once a week by intravenous infusion and the tislelizumab is administered to the subject at a dose of about 300 mg every 4 weeks by intravenous infusion.

13 . The method of claim 1 , wherein the anti-Galectin-9 antibody is administered to the subject at about 10 mg/kg once a week by intravenous infusion and the tislelizumab is administered to the subject at a dose of about 300 mg every 4 weeks by intravenous infusion.

14 . The method of claim 1 , wherein the anti-Galectin-9 antibody is administered to the subject at about 16 mg/kg once a week by intravenous infusion and the tislelizumab is administered to the subject at a dose of about 300 mg every 4 weeks by intravenous infusion.

15 . The method of claim 1 , wherein the tislelizumab is administered to the subject on a day when the subject receives the anti-Galectin 9 antibody or wherein the administration of tislelizumab and the administration of the anti-Galectin 9 antibody are on two consecutive days.

16 . The method of claim 1 , wherein the administration of tislelizumab is performed prior to the administration of the anti-Galectin 9 antibody.

17 . The method of claim 1 , wherein the subject is a human patient having the solid tumor.

18 . The method of claim 1 , wherein the V L of the anti-Galectin-9 antibody comprises the amino acid sequence of SEQ ID NO: 8, and wherein the V H of the anti-Galectin-9 antibody comprises the amino acid sequence of SEQ ID NO: 7.

19 . The method of claim 18 , wherein the anti-Galectin-9 antibody is an IgG1 or IgG4 molecule.

20 . The method of claim 19 , wherein the anti-Galectin-9 antibody is an IgG4 molecule having a modified Fc region of human IgG4.

21 . The method of claim 20 , wherein the modified Fc region of human IgG4 comprises the amino acid sequence of SEQ ID NO: 14.

22 . The method of claim 1 , 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.

23 . The method of claim 1 , wherein the subject has undergone one or more prior anti-cancer therapies.

24 . The method of claim 23 , wherein the one or more prior anti-cancer therapies comprise chemotherapy, immunotherapy, radiation therapy, a therapy involving a biologic agent, or a combination thereof.

25 . The method of claim 23 , wherein the subject has progressed disease through the one or more prior anti-cancer therapies, or is resistant to the one or more prior therapies.

26 . The method of claim 1 , wherein the subject is a human patient having an elevated level of Galectin-9 relative to a control value.

27 . The method of claim 26 , wherein the human patient has an elevated serum or plasma level of Galectin-9 relative to the control value.

28 . The method of claim 1 , wherein the human patient has cancer cells expressing Galectin-9, immune cells expressing Galectin-9, or both.

29 . The method of claim 1 , further comprising monitoring occurrence of adverse effects in the subject.

30 . The method of claim 29 , further comprising reducing the dose of the anti-Galectin-9 antibody, the dose of tislelizumab, or both, when an adverse effect occurs.