Treatment method

Patent metadata

Field	Value
Publication number	US-2026053917-A1
Application number	US-202519228960-A
Country	US
Kind code	A1
Filing date	Jun 5, 2025
Priority date	Dec 9, 2015
Publication date	Feb 26, 2026
Grant date	—

Abstract

The present invention relates to methods of treating a disease, and methods for reduction of the formation of anti-drug antibodies (ADAs) in response to the administration of a therapeutic agent. The invention further relates to methods of treating a disease, particularly a B-cell proliferative disorder, and methods for reduction of adverse effects in response to the administration of a therapeutic agent, particularly a T-cell activating therapeutic agent.

First claim

1 . A Type II anti-CD20 antibody for use in a method of treating a disease in a subject, the method comprising a treatment regimen comprising
(i) administration to the subject of the Type II anti-CD20 antibody, and consecutively after a period of time (ii) administration to the subject of a therapeutic agent, wherein the period of time between the administration of the Type II anti-CD20 antibody and the administration of the therapeutic agent is sufficient for reduction of the number of B-cells in the subject in response to the administration of the Type II anti-CD20 antibody.

2 . The Type II anti-CD20 antibody of claim 1 , wherein the treatment regimen effectively reduces the formation of anti-drug antibodies (ADAs) in the subject in response to the administration of the therapeutic agent as compared to a corresponding treatment regimen without the administration of the anti-CD20 antibody.

3 . The Type II anti-CD20 antibody of claim 1 , er 2, wherein the treatment regimen effectively reduces cytokine release associated with the administration of the therapeutic agent in the subject as compared to a corresponding treatment regimen without the administration of the Type II anti-CD20 antibody.

4 . The Type II anti-CD20 antibody of claim 3 , wherein the therapeutic agent is a T cell activating therapeutic agent.

5 . A Type II anti-CD20 antibody for use in a method for (i) reducing the formation of anti-drug antibodies (ADAs) against a therapeutic agent in a subject and/or (ii) reducing cytokine release associated with the administration a therapeutic agent, particularly a T-cell activating therapeutic agent, in a subject, comprising administration of the Type II anti-CD20 antibody to the subject prior to administration of the therapeutic agent.

6 . The Type II anti-CD20 antibody of claim 5 , wherein the period of time between the administration of the Type II anti-CD20 antibody and administration of the therapeutic agent is sufficient for reduction of the number of B-cells in the subject in response to the administration of the Type II anti-CD20 antibody.

7 . The Type II anti-CD20 antibody of claim 1 , wherein the anti-CD20 antibody comprises a heavy chain variable region comprising the heavy chain CDR (HCDR) 1 of SEQ ID NO: 4, the HCDR2 of SEQ ID NO: 5, and the HCDR3 of SEQ ID NO: 6; and a light chain variable region comprising the light chain CDR (LCDR) 1 of SEQ ID NO: 7, the LCDR2 of SEQ ID NO: 8 and the LCDR3 of SEQ ID NO: 9.

8 . The Type II anti-CD20 antibody of claim 1 , wherein the anti-CD20 antibody comprises the heavy chain variable region sequence of SEQ ID NO: 10 and the light chain variable region sequence of SEQ ID NO: 11.

9 . The Type II anti-CD20 antibody of claim 1 , wherein the anti-CD20 antibody is an IgG antibody, particularly an IgG 1 antibody, and wherein at least about 40% of the N-linked oligosaccharides in the Fc region of the anti-CD20 antibody are non-fucosylated.

10 . The Type II anti-CD20 antibody of claim 1 , wherein the anti-CD20 antibody is obinutuzumab.

11 . The Type II anti-CD20 antibody of claim 1 , wherein the therapeutic agent comprises a polypeptide.

12 . The Type II anti-CD20 antibody of claim 1 , wherein the therapeutic agent comprises an antibody.

13 . The Type II anti-CD20 antibody of claim 12 , wherein the antibody comprised in the therapeutic agent specifically binds to carcinoembryonic antigen (CEA).

14 . The Type II anti-CD20 antibody of claim 13 , wherein the antibody comprised in the therapeutic agent comprises
(i) a heavy chain variable region comprising the heavy chain CDR (HCDR) 1 of SEQ ID NO: 14, the HCDR2 of SEQ ID NO: 15, and the HCDR3 of SEQ ID NO: 16; and a light chain variable region comprising the light chain CDR (LCDR) 1 of SEQ ID NO: 17, the LCDR2 of SEQ ID NO: 18 and the LCDR3 of SEQ ID NO: 19; or (ii) a heavy chain variable region sequence of SEQ ID NO: 20 and a light chain variable region sequence of SEQ ID NO: 21.

15 . The Type II anti-CD20 antibody of claim 12 , wherein the antibody comprised in the therapeutic agent specifically binds to CD3, particularly CD3E.

16 . The Type II anti-CD20 antibody of claim 15 , wherein the antibody comprised in the therapeutic agent comprises
(i) a heavy chain variable region comprising the heavy chain CDR (HCDR) 1 of SEQ ID NO: 32, the HCDR2 of SEQ ID NO: 33, and the HCDR3 of SEQ ID NO: 34; and a light chain variable region comprising the light chain CDR (LCDR) 1 of SEQ ID NO: 35, the LCDR2 of SEQ ID NO: 36 and the LCDR3 of SEQ ID NO: 37; or (ii) a heavy chain variable region sequence of SEQ ID NO: 38 and a light chain variable region sequence of SEQ ID NO: 39.

17 . The Type II anti-CD20 antibody of claim 12 , wherein the antibody comprised in the therapeutic agent specifically binds to CD20.

18 . The Type II anti-CD20 antibody of claim 15 , wherein the antibody comprised in the therapeutic agent comprises
(i) a heavy chain variable region comprising the heavy chain CDR (HCDR) 1 of SEQ ID NO: 4, the HCDR2 of SEQ ID NO: 5, and the HCDR3 of SEQ ID NO: 6; and a light chain variable region comprising the light chain CDR (LCDR) 1 of SEQ ID NO: 7, the LCDR2 of SEQ ID NO: 8 and the LCDR3 of SEQ ID NO: 9; or (ii) a heavy chain variable region sequence of SEQ ID NO: 10 and a light chain variable region sequence of SEQ ID NO: 11.

19 . The Type II anti-CD20 antibody of claim 1 , wherein the therapeutic agent comprises a cytokine, particularly interleukin-2.

20 . The Type II anti-CD20 antibody of claim 19 , wherein the cytokine is a mutant human IL-2 polypeptide comprising the amino acid substitutions F42A, Y45A and L72G (numbering relative to the human IL-2 sequence SEQ ID NO: 12).

21 - 23 . (canceled)

Assignees

• Hoffmann La Roche

Inventors

• Bacac Marina
• Evers Stefan
• Klein Christian
• Pisa Pavel
• Rossmann Eva
• Saro Jose
• Umana Pablo

Classifications

• A61K39/39583

  against materials not provided for elsewhere, e.g. haptens, coenzymes · CPC title

• C07K16/2887 Primary

  against CD20 · CPC title

• A61K2039/507

  Comprising a combination of two or more separate antibodies · CPC title

• C07K16/2809 Primary

  against the T-cell receptor (TcR)-CD3 complex · CPC title

• C07K2319/00

  Fusion polypeptide · CPC title