IP Library › Patent Application 16768020

Patent Application

App. No. 16/768,020

HUMANIZED ANTI-LIV1 ANTIBODIES FOR THE TREATMENT OF BREAST CANCER

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Patent No.: US None
App. No.: 16/768,020

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Abstract

Methods for using anti-LIV1 antibodies, including dmg conjugated anti-LIV1 antibodies, to inhibit proliferation of a LIV-1-expressing cell, as well as for the treatment of one or more diseases or disorders associated with LIV-1-expressing cells (e.g., a LIV-1-associated breast cancer), are provided.

Claims (111)

1 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is less than about 200 mg of the antibody or antigen-binding fragment thereof per treatment cycle, and

wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region (HCVR) having at least 95% identity to SEQ ID NO: 1, and a light chain variable region (LCVR) having at least 95% identity to SEQ ID NO: 2.

2 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per treatment cycle,

wherein if the dose administered is greater than or equal to about 200 mg of the antibody or antigen-binding fragment thereof per treatment cycle, the method further comprises administering granulocyte colony stimulating factor (GCSF) to the subject.

3 . The method of claim 2 , wherein, if administered, the GCSF is administered prophylactically.

4 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject granulocyte colony stimulating factor (GCSF),

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is greater than or equal to about 200 mg and less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per treatment cycle,

5 . The method of claim 4 , wherein the GCSF is administered prophylactically.

6 . The method of any one of claims 1 - 5 , wherein the LIV-1-associated cancer is a breast cancer.

7 . The method of claim 6 , wherein the breast cancer is a triple negative breast cancer.

8 . The method of claim 6 , wherein the breast cancer is a metastatic breast cancer.

9 . The method of claim 6 , wherein the breast cancer is a triple-negative, metastatic breast cancer.

10 . The method of claim 6 , wherein the breast cancer is a hormone receptor-positive, metastatic breast cancer.

11 . The method of any one of claims 1 - 10 , wherein the treatment cycle is about every three weeks (Q3W).

12 . The method of any one of claims 1 - 11 , wherein the dose is about 2.5 mg/kg of body weight of the subject.

13 . The method of any one of claims 1 - 12 , wherein the antibody or antigen-binding fragment thereof is conjugated to monomethyl auristatin E (MMAE):

14 . The method of any one of claims 1 - 13 , wherein the antibody or antigen-binding fragment thereof is conjugated to valine-citrulline-monomethyl auristatin E (vcMMAE):

15 . The method of claim 14 , wherein a vcMMAE to antibody or antigen-binding fragment thereof ratio is from about 1 to about 8.

16 . The method of claim 15 , wherein the vcMMAE to antibody or antigen-binding fragment thereof ratio is about 4.

17 . The method of any one of claims 1 - 16 , wherein the HCVR has at least 97% sequence identity to SEQ ID NO: 1 and the LCVR has at least 97% sequence identity to SEQ ID NO: 2.

18 . The method of any one of claims 1 - 17 , wherein the HCVR has at least 99% sequence identity to SEQ ID NO: 1 and the LCVR has at least 99% sequence identity to SEQ ID NO: 2.

19 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is less than about 200 mg of the antibody or antigen-binding fragment thereof per treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR having at least 95% identity to SEQ ID NO: 1, and an LCVR having at least 95% identity to SEQ ID NO: 2, and

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

20 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR having at least 95% identity to SEQ ID NO: 1, and an LCVR having at least 95% identity to SEQ ID NO: 2,

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

and

21 . The method of claim 20 , wherein, if administered, the GCSF is administered prophylactically.

22 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject granulocyte colony stimulating factor (GCSF),

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is greater than or equal to about 200 mg and less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR having at least 95% identity to SEQ ID NO: 1, and an LCVR having at least 95% identity to SEQ ID NO: 2, and

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

23 . The method of claim 22 , wherein the GCSF is administered prophylactically.

24 . The method of any one of claims 19 - 23 , wherein the dose is administered at a concentration of about 2.5 mg/kg of body weight of the subject.

25 . The method of any one of claims 19 - 24 , wherein each treatment cycle is administered to the subject Q3W.

26 . The method of any one of claims 19 - 25 , wherein a vcMMAE to antibody or antigen-binding fragment thereof ratio is from about 1 to about 8.

27 . The method of claim 26 , wherein the vcMMAE to antibody or antigen-binding fragment thereof ratio is about 4.

28 . The method of any one of claims 19 - 27 , wherein the LIV-1-associated cancer is a breast cancer.

29 . The method of claim 28 , wherein the breast cancer is a triple negative breast cancer.

30 . The method of claim 28 , wherein the breast cancer is a metastatic breast cancer.

31 . The method of claim 28 , wherein the breast cancer is a triple-negative, metastatic breast cancer.

32 . The method of claim 28 , wherein the breast cancer is a hormone receptor-positive, metastatic breast cancer.

33 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein a dose administered is less than about 200 mg of the antibody or antigen-binding fragment thereof per Q3W treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR of SEQ ID NO: 1, and an LCVR of SEQ ID NO: 2, and

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

34 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein a dose administered is less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per Q3W treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR of SEQ ID NO: 1, and an LCVR of SEQ ID NO: 2,

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

and

35 . The method of claim 34 , wherein, if administered, the GCSF is administered prophylactically.

36 . A method of treating a subject having or at risk of having a LIV-1-associated cancer, comprising:

administering to the subject granulocyte colony stimulating factor (GCSF),

administering to the subject a therapeutically effective dose of an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein a dose administered is greater than or equal to about 200 mg and less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per Q3W treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR of SEQ ID NO: 1, and an LCVR of SEQ ID NO: 2, and

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

37 . The method of claim 36 , wherein the GCSF is administered prophylactically.

38 . The method of any one of claims 33 - 37 , wherein the LIV-1-associated cancer is a breast cancer.

39 . The method of claim 38 , wherein the breast cancer is a triple negative breast cancer.

40 . The method of claim 38 , wherein the breast cancer is a metastatic breast cancer.

41 . The method of claim 38 , wherein the breast cancer is a triple-negative, metastatic breast cancer.

42 . The method of claim 38 , wherein the breast cancer is a hormone receptor-positive, metastatic breast cancer.

43 . The method of any one of claims 33 - 42 , wherein a vcMMAE to antibody or antigen-binding fragment thereof ratio is about 4.

44 . The method of any one of claims 33 - 43 , wherein the dose is about 2.5 mg/kg of body weight of the subject.

45 . A method of treating a subject having or at risk of having a LIV-1-associated breast cancer, comprising:

administering to the subject a dose of about 2.5 mg/kg of body weight of the subject an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is less than about 200 mg of the antibody or antigen-binding fragment thereof per Q3W treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR of SEQ ID NO: 1, and an LCVR of SEQ ID NO: 2, and

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

46 . A method of treating a subject having or at risk of having a LIV-1-associated breast cancer, comprising:

administering to the subject a dose of about 2.5 mg/kg of body weight of the subject an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per Q3W treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR of SEQ ID NO: 1, and an LCVR of SEQ ID NO: 2,

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

and

47 . The method of claim 46 , wherein, if administered, the GCSF is administered prophylactically.

48 . A method of treating a subject having or at risk of having a LIV-1-associated breast cancer, comprising:

administering to the subject granulocyte colony stimulating factor (GCSF),

administering to the subject a dose of about 2.5 mg/kg of body weight of the subject an antibody or an antigen-binding fragment thereof that specifically binds human LIV-1,

wherein the dose administered is greater than or equal to about 200 mg and less than or equal to about 250 mg of the antibody or antigen-binding fragment thereof per Q3W treatment cycle,

wherein the antibody or antigen-binding fragment thereof comprises an HCVR of SEQ ID NO: 1, and an LCVR of SEQ ID NO: 2, and

wherein the antibody or antigen-binding fragment thereof is conjugated to vcMMAE:

49 . The method of claim 48 , wherein the GCSF is administered prophylactically.

50 . The method of any one of claims 45 - 49 , wherein the breast cancer is a triple negative breast cancer.

51 . The method of any one of claims 45 - 50 , wherein the breast cancer is a metastatic breast cancer.

52 . The method of claim 51 , wherein the breast cancer is a triple-negative, metastatic breast cancer.

53 . The method of any one of claims 45 - 50 , wherein the breast cancer is a hormone receptor-positive, metastatic breast cancer.

54 . The method of any one of claims 45 - 53 , wherein a vcMMAE to antibody or antigen-binding fragment thereof ratio is about 4.

55 . The method of any one of claims 1 - 54 , wherein the subject is a human.

Assignments (1)

CHANGE OF NAME Recorded Oct 16, 2020

From: SEATTLE GENETICS, INC.

To: SEAGEN INC.

Reel/Frame 054102/0821 →