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US 12,693,298 B1Granted
Anti-vedolizumab antibodies and uses thereof
AssigneeTakeda Pharmaceutical Company Limited
InventorsJulius Juarez, Brandi Lynn Bailey
Life of this patent
Estimating the term…
Abstract
The invention provides methods and compositions related to anti-idiotypic antibodies that specifically bind to vedolizumab, and uses thereof.
Claims21
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.
67 more elements
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:
- (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.
66 more elements
Dependencies are inferred from the claim text.