IP Library › Granted Patent US 12693298

Granted Patent B1

US 12693298 · App. 18/148,109 · Granted Jul 28, 2026

Anti-vedolizumab antibodies and uses thereof

Inventors: Julius Juarez (Lexington, MA); Brandi Lynn Bailey (Lexington, MA)

Assignee: Takeda Pharmaceutical Company Limited

G01N33/686 C07K16/2839 C07K16/4241 G01N33/532 A61K2039/505 A61K2039/545 C07K2317/24 C07K2317/565

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Quick Facts

Patent No.: US 12693298
App. No.: 18/148,109
Granted: Jul 28, 2026
Kind: B1

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Abstract

The invention provides methods and compositions related to anti-idiotypic antibodies that specifically bind to vedolizumab, and uses thereof.

Claims (68)

1 . A method of treating a human patient having an inflammatory bowel disease (IBD), the method comprising

(i) administering a dose of vedolizumab to the human patient having IBD,

(ii) contacting a biological sample comprising a population of cells from the human patient 1 to 2 weeks after administration of vedolizumab with an anti-idiotypic antibody, or an antigen-binding fragment thereof, with binding specificity to vedolizumab, under conditions in which the anti-idiotypic antibody, or antigen-binding fragment thereof, binds to vedolizumab,

(iii) measuring a level of vedolizumab bound to immune cells in the biological sample with the anti-idiotypic antibody, or antigen-binding fragment thereof, and

(iv) administering one or more doses of vedolizumab to the human patient, wherein the level of vedolizumab bound to immune cells in the biological sample is increased relative to a reference level, wherein the reference level is a baseline sample obtained from the human patient prior to treatment with vedolizumab,

thereby treating the human patient having IBD,

wherein the anti-idiotypic antibody or antigen-binding fragment thereof, comprises:

(i) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 1, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 2, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 3; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 4, a CDR2 domain comprising the amino acid sequence of RMS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 6;

(ii) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 11, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 12, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 13; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 14, a CDR2 domain comprising the amino acid sequence of RTS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 16;

(iii) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 21, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 22, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 23; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 24, a CDR2 domain comprising the amino acid sequence of RAS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 26;

(iv) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 31, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 22, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 32; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 33, a CDR2 domain comprising the amino acid sequence of RAS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 26;

(v) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 38, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 39, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 40; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 41, a CDR2 domain comprising the amino acid sequence of LVS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 43;

(vi) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 48, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 49, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 50; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 51, a CDR2 domain comprising the amino acid sequence of SGS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 53;

(vii) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 31 a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 22, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 58; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 24, a CDR2 domain comprising the amino acid sequence of RAS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 26;

(viii) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 63 a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 22, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 58; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 24, a CDR2 domain comprising the amino acid sequence of RAS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 26; or

(ix) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 68 a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 69, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 70; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 71, a CDR2 domain comprising the amino acid sequence of YAS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 73.

2 . The method of claim 1 , wherein the method comprises administering to the human patient a dose of vedolizumab and a dose of an additional therapeutic agent, wherein the level of vedolizumab bound to immune cells in the biological sample is increased relative to a reference level.

3 . A method of treating a human patient having an inflammatory bowel disease (IBD), the method comprising

administering a dose of vedolizumab to the patient at an initial time point,

measuring the amount of vedolizumab-bound immune cells in a biological sample obtained from the human patient about two weeks after the initial time point with an anti-idiotypic antibody, or an antigen-binding fragment thereof, with binding specificity to vedolizumab; and

administering one or more doses of vedolizumab to the human patient, wherein if the level of vedolizumab-bound immune cells in the biological sample is increased relative to a reference level, wherein the reference level is a baseline sample obtained from the human patient prior to treatment with vedolizumab,

thereby treating the human patient having IBD

wherein the anti-idiotypic antibody or antigen-binding fragment thereof, comprises:

(v) a heavy chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO:38, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 39, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 40; and a light chain variable region comprising a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 41, a CDR2 domain comprising the amino acid sequence of LVS, and a CDR3 domain comprising the amino acid sequence of SEQ ID NO: 43;

4 . The method of claim 1 , wherein the immune cells are T cells, B cells, NK cells, monocytes, dendritic cells, plasma cells, and/or eosinophils.

5 . The method of claim 3 , wherein the immune cells are T cells, B cells, NK cells, monocytes, dendritic cells, plasma cells, and/or eosinophils.

6 . The method of claim 1 , wherein the anti-idiotypic antibody, or antigen-binding fragment thereof, comprises a detectable label.

7 . The method of claim 3 , wherein the anti-idiotypic antibody, or antigen-binding fragment thereof, comprises a detectable label.

8 . The method of claim 6 , wherein the anti-idiotypic antibody, or antigen-binding fragment thereof, is detected by flow cytometry, mass spectrometry, immunohistochemistry, Cellular Indexing of Transcriptomes and Epitopes by Sequencing (CITE-Seq), or oligonucleotide sequencing.

9 . The method of claim 7 , wherein the anti-idiotypic antibody, or antigen-binding fragment thereof, is detected by flow cytometry, mass spectrometry, immunohistochemistry, Cellular Indexing of Transcriptomes and Epitopes by Sequencing (CITE-Seq), or oligonucleotide sequencing.

10 . The method of claim 1 , wherein the inflammatory bowel disease is Crohn's disease, pouchitis, or ulcerative colitis.

11 . The method of claim 3 , herein the inflammatory bowel disease is Crohn's disease, pouchitis, or ulcerative colitis.

12 . The method of claim 1 , wherein the method further comprises measuring the level of α4β1, αLβ2, αEβ7, α6β1, or α6β4 in the biological sample.

13 . The method of claim 6 , wherein the method further comprises measuring the level of α4β1, αLβ2, αEβ7, α6β1, or α6β4 in the biological sample.

14 . The method of claim 1 , wherein the method further comprises measuring the fecal calprotectin, C-reactive protein (CRP), and/or albumin concentration in the biological sample.

15 . The method of claim 3 , wherein the method further comprises measuring the fecal calprotectin, C-reactive protein (CRP), and/or albumin concentration in the biological sample.

16 . The method of claim 1 , wherein the anti-idiotypic antibody, or antigen-binding fragment thereof, comprises:

(i) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 7, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 8;

(ii) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 17, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 18;

(iii) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 27, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 28;

(iv) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 34, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 35;

(v) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 44, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 45;

(vi) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 54, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 55;

(vii) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 59, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 60;

(viii) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 64, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 65; or

(ix) a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 74, and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 75.

17 . The method of claim 3 , wherein the anti-idiotypic antibody, or antigen-binding fragment thereof, comprises: