IP Library › Patent Application 18620208

Patent Application

App. No. 18/620,208

ANTI-CLDN6 AND ANTI-CD3 MULTISPECIFIC ANTIBODIES AND METHODS OF USE

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Patent No.: US None
App. No.: 18/620,208

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Abstract

The present disclosure provides for multi-specific antibodies and antigen-binding fragments thereof that bind to human CLDN6 and CD3, a pharmaceutical composition comprising said antibody or antigen-binding fragments thereof, and use of the multi-specific antibody or antigen-binding fragments thereof or the composition for treating a disease, such as cancer.

Claims (188)

1 . A multi-specific antibody or antigen-binding fragment thereof, comprising a first antigen binding domain that specifically binds to human claudin 6 (CLDN6) and a second antigen binding domain that specifically binds to human cluster of differentiation 3 (CD3).

2 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the first antigen binding domain does not bind to other claudin (CLDN) protein family members.

3 . The multi-specific antibody or antigen-binding fragment of claim 2 , wherein the first antigen binding domain does not bind to human claudin 9 (CLDN9).

4 . The multi-specific antibody or antigen-binding fragment of claim 3 , wherein the first antigen binding domain has high selectivity for human CLDN6 over human CLDN9.

5 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the first antigen binding domain that specifically binds to human CLDN6 comprises:

(a) a heavy chain variable region that comprises (i) a heavy chain complementarity-determining region (HCDR)1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3; and a light chain variable region that comprises: (iv) a light chain complementarity-determining region (LCDR)1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6;

(b) a heavy chain variable region that comprises: (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 2, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3; and a light chain variable region that comprises:(iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6;

(c) a heavy chain variable region that comprises: (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 23, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3; and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; or

(d) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 45, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3; and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6.

6 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the first antigen binding domain comprises:

(a) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 43, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 44;

(b) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO:7, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 8;

(c) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 24, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 12;

(d) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 41, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 42;

(e) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 46, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 47; or

(f) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 46, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 42.

7 . The multi-specific antibody or antigen-binding fragment of claim 6 , wherein one, two, three, four, five, six, seven, eight, nine, or ten amino acids of SEQ ID NOS: 7, 8, 12, 24, 41, 42, 43, 44, 46, or 47 have been inserted, deleted or substituted.

8 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the first antigen binding domain comprises:

(a) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 44;

(b) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO:7, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 8;

(c) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 24, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 12;

(d) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 41, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 42;

(e) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 46, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 47; or

(f) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 46, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 42.

9 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the second antigen binding domain that specifically binds to human CD3 comprises:

(a) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 75, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53;

(b) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 49, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53; or

(c) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53.

10 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the second antigen binding domain comprises:

(a) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 76, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 68;

(b) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 54, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 55;

(v) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 58, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 59;

(d) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 62, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 63;

(e) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 62, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 68; or

(f) a heavy chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 72, and a light chain variable region having an amino acid sequence at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% identical to SEQ ID NO: 68.

11 . The multi-specific antibody or antigen-binding fragment of claim 10 , wherein one, two, three, four, five, six, seven, eight, nine, or ten amino acids of SEQ ID NOS: 54, 55, 58, 59, 62, 68, 72 or 76 have been inserted, deleted or substituted.

12 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the second antigen binding domain comprises:

(a) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 76, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 68;

(b) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 54, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 55;

(c) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 58, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 59;

(d) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 63;

(e) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 68; or

(f) a heavy chain variable region having an amino acid sequence that comprises SEQ ID NO: 72, and a light chain variable region having an amino acid sequence that comprises SEQ ID NO: 68.

13 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the second antigen binding domain comprises:

(a) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 77;

(b) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 66;

(d) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 73.

14 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

(a) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 2, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vii) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 49, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53;

(b) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 2, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53; or

(c) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 2, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 75, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53.

15 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

(a) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 23, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 49, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53;

(b) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 23, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53; or

(c) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 23, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 75 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53.

16 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

(a) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 49, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53;

(b) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (f) a LCDR3 having an amino acid sequence of SEQ ID NO: 53; or

(c) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, and (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 75, and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53.

17 . The multi-specific antibody or antigen-binding fragment of claim 16 , wherein: the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vii) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 75 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53.

18 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

(a) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 45, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (ivd) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 49, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53;

(b) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 45, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 50 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53; or

(c) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 45, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 75 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53.

19 . The multi-specific antibody or antigen-binding fragment of claim 18 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 45, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6;

and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 48, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 71, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 75 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 51, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 52, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 53.

20 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises:

a) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 2, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6;

b) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 23, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6;

c) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; or

d) the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 45, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; and

the second antigen binding domain that specifically binds to human CD3 comprises:

a) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 54, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 55;

b) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 58, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 59;

c) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 63;

d) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68;

e) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 72, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68; or

f) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 76, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

21 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises:

a) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; or

and

the second antigen binding domain that specifically binds to human CD3 comprises:

b) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 54, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 55;

c) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 58, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 59;

d) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 63;

e) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68;

f) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 72, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68; or

g) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 76, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

22 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises:

(a) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 23, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 4, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; or

(b) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 39, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6; or

(c) a heavy chain variable region that comprises (i) a HCDR1 having an amino acid sequence of SEQ ID NO: 1, (ii) a HCDR2 having an amino acid sequence of SEQ ID NO: 45, (iii) a HCDR3 having an amino acid sequence of SEQ ID NO: 3 and a light chain variable region that comprises: (iv) a LCDR1 having an amino acid sequence of SEQ ID NO: 40, (v) a LCDR2 having an amino acid sequence of SEQ ID NO: 5, and (vi) a LCDR3 having an amino acid sequence of SEQ ID NO: 6;

and

the second antigen binding domain that specifically binds to human CD3 comprises:

(i) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 66;

(ii) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 69;

(iii) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 73; or

(iv) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 77.

23 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises:

(i) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 24, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 12;

(ii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 41, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42;

(iii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44;

(iv) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 46, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 47; or

(v) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 46, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42;

and

the second antigen binding domain that specifically binds to human CD3 comprises:

(i) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 54, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 55;

(ii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 58, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 59;

(iii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 63;

(iv) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68;

(v) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 72, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68; or

(vi) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 76, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

24 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises:

(i) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 24, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 12;

(ii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 41, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42;

(iii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44;

(v) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 46, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42;

and

the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 72, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

25 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises:

(i) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 24, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 12;

(ii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 41, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42;

(iii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44;

(v) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 46, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42;

and

the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 76, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

26 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44;

and the second antigen binding domain that specifically binds to human CD3 comprises:

(i) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 54, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 55;

(ii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 58, and a light chain variable region (VL) that comprises SEQ ID NO: 59;

(iii) a heavy chain variable region (VH) that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 63;

(iv) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 62, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68;

(vi) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 76, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

27 . The multi-specific antibody or antigen-binding fragment of claim 26 , wherein: the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 72, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

28 . The multi-specific antibody or antigen-binding fragment of claim 26 , wherein: the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44; and the second antigen binding domain that specifically binds to human CD3 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 76, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 68.

29 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

the first antigen binding domain that specifically binds to human CLDN6 comprises:

(i) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 24, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 12;

(ii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 41, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42;

(iii) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44;

(v) a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 46, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 42.

and

the second antigen binding domain that specifically binds to human CD3 comprises:

(i) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 66;

(ii) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 69;

(iii) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 73; or

(iv) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 77.

30 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein:

and the second antigen binding domain that specifically binds to human CD3 comprises:

(a) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 66;

(b) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 69;

(d) a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 77.

31 . The multi-specific antibody or antigen-binding fragment of claim 30 , wherein: the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44; and the second antigen binding domain that specifically binds to human CD3 comprises: a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 66.

32 . The multi-specific antibody or antigen-binding fragment of claim 30 , wherein: the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44; and the second antigen binding domain that specifically binds to human CD3 comprises: a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 69.

33 . The multi-specific antibody or antigen-binding fragment of claim 30 , wherein: the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44; and the second antigen binding domain that specifically binds to human CD3 comprises: a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 73.

34 . The multi-specific antibody or antigen-binding fragment of claim 30 , wherein: the first antigen binding domain that specifically binds to human CLDN6 comprises: a heavy chain variable region (VH) having an amino acid sequence that comprises SEQ ID NO: 43, and a light chain variable region (VL) having an amino acid sequence that comprises SEQ ID NO: 44; and the second antigen binding domain that specifically binds to human CD3 comprises: a single chain variable fragment (scFv) having an amino acid sequence that comprises SEQ ID NO: 77.

35 . The multi-specific antibody or antigen-binding fragment of claim 1 , which is a monoclonal antibody, a chimeric antibody, a humanized antibody, a human engineered antibody, a single chain antibody (scFv), a Fab fragment, a Fab′ fragment, or a F(ab′)2 fragment.

36 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the multi-specific antibody is a bispecific antibody.

37 . The multi-specific antibody or antigen-binding fragment of claim 36 , wherein the bispecific antibody is BG143P.

38 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the antibody or antigen-binding fragment thereof has antibody dependent cellular cytotoxicity (ADCC) or complement dependent cytotoxicity (CDC).

39 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the antibody or antigen-binding fragment thereof has reduced glycosylation or no glycosylation or is hypofucosylated.

40 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the antibody or antigen-binding fragment thereof comprises increased bisecting GlcNac structures.

41 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the antibody or antigen-binding fragment comprises a Fc domain that is an IgG1 with reduced effector function.

42 . The multi-specific antibody or antigen-binding fragment of claim 1 , wherein the antibody or antigen-binding fragment comprises a Fc domain that is an IgG4.

43 . A pharmaceutical composition comprising the multi-specific antibody or antigen-binding fragment of claim 1 and a pharmaceutically acceptable carrier.

44 . The pharmaceutical composition of claim 43 , further comprising a histidine/histidine HCl, a trehalose dihydrate, and/or a polysorbate 20.

45 . A method of treating cancer comprising administering to a patient in need an effective amount of the multi-specific antibody or antigen-binding fragment of claim 1 .

46 - 52 . (canceled)

53 . An isolated nucleic acid that encodes the multi-specific antibody or antigen-binding fragment of claim 1 .

54 . A vector comprising the nucleic acid of claim 53 .

55 . A host cell comprising the vector of claim 54 .

56 . A process for producing a multi-specific antibody or antigen-binding fragment thereof comprising cultivating the host cell of claim 55 in culture and recovering the antibody or antigen-binding fragment from the culture.

57 - 59 . (canceled)

Assignments (2)

CHANGE OF NAME Recorded Sep 23, 2025

From: BEIGENE SWITZERLAND GMBH

To: BEONE MEDICINES I GMBH

Reel/Frame 072872/0076 →

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 10, 2025

From: WAN, ZHITAO; LI, DAN; TANG, XIAOYAN; CHEN, YUN; LEI, MING; SHAO, TING; XUE, LIU; DING, YAO; JI, RUYUE; XU, QIMING; GUO, HUI

To: BEIGENE SWITZERLAND GMBH

Reel/Frame 070455/0539 →