US2023159656A1PendingUtilityA1

Anti-steap1 antigen-binding protein

Assignee: AMGEN INCPriority: Jul 2, 2018Filed: Nov 10, 2022Published: May 25, 2023
Est. expiryJul 2, 2038(~11.9 yrs left)· nominal 20-yr term from priority
A61K 40/4274A61K 40/11A61K 2239/31A61K 2239/38A61K 2039/5158C07K 2317/92C07K 2317/73C07K 2317/31A61P 13/08C07K 16/3069C07K 16/2818C07K 16/2809C07K 2317/622A61P 35/00C07K 2317/33C07K 2317/24A61K 2039/505A61K 2039/6056C07K 2317/32C07K 2317/565C07K 2317/34C07K 16/18
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Claims

Abstract

The disclosure provides novel antigen-binding proteins that bind STEAP1 and methods of use.

Claims

exact text as granted — not AI-modified
1 . An antigen-binding protein that binds STEAP1 of SEQ ID NO: 2 and comprises:
 (a) heavy chain CDRs comprising amino acid sequences set forth in vhCDR1 SEQ ID NO: 14, vhCDR2 SEQ ID NO: 15 or vhCDR2 SEQ ID NO: 21, and vhCDR3 SEQ ID NO: 16 and   (b) light chain CDRs comprising amino acid sequences set forth in i) vlCDR1 SEQ ID NO: 11, vlCDR2 SEQ ID NO: 12, and vlCDR3 SEQ ID NO: 13.   
     
     
         2 . An antigen-binding protein that binds STEAP1 of SEQ ID NO: 2 and comprises CDR sequences
 a) vlCDR1 comprising SEQ ID NO: 30, vlCDR2 comprising SEQ ID NO: 31, and vlCDR3 comprising SEQ ID NO: 32, and   b) vhCDR1 comprising SEQ ID NO:33, vhCDR2 comprising SEQ ID NO: 34, and vhCDR3 comprising SEQ ID NO: 35.   
     
     
         3 . The antigen-binding protein of  claim 1 , comprising vhCDR1 comprising SEQ ID NO: 14,
 vhCDR2 comprising SEQ ID NO: 15,   vhCDR3 comprising SEQ ID NO: 16,   vlCDR1 comprising SEQ ID NO: 11,   vlCDR2 comprising SEQ ID NO: 12, and   vlCDR3 comprising SEQ ID NO: 13.   
     
     
         4 . The antigen-binding protein of  claim 1 , comprising
 vhCDR1 comprising SEQ ID NO: 14,   vhCDR2 comprising SEQ ID NO: 21,   vhCDR3 comprising SEQ ID NO: 16,   vlCDR1 comprising SEQ ID NO: 11,   vlCDR2 comprising SEQ ID NO: 12, and   vlCDR3 comprising SEQ ID NO: 13.   
     
     
         5 . (canceled) 
     
     
         6 . The antigen-binding protein of  claim 3 , comprising a variable heavy domain comprising an amino acid sequence at least 90% identical to SEQ ID NO: 182. 
     
     
         7 . The antigen-binding protein of  claim 3 , comprising a variable light domain comprising an amino acid sequence at least 90% identical SEQ ID NO: 183. 
     
     
         8 . The antigen-binding protein of  claim 3 , comprising a variable heavy domain comprising an amino acid sequence at least 90% identical SEQ ID NO: 182 and a variable light domain comprising an amino acid sequence at least 90% identical SEQ ID NO: 183. 
     
     
         9 . The antigen-binding protein of  claim 3 , comprising a variable heavy domain comprising SEQ ID NO: 182 and a variable light domain comprising SEQ ID NO: 183. 
     
     
         10 . The antigen-binding protein of  claim 4 , which comprises a variable heavy domain comprising an amino acid sequence at least 90% identical to SEQ ID NO: 184. 
     
     
         11 . The antigen-binding protein of  claim 4 , comprising a variable light domain comprising an amino acid sequence at least 90% identical SEQ ID NO: 183. 
     
     
         12 . (canceled) 
     
     
         13 . The antigen-binding protein of  claim 4 , comprising a variable heavy domain comprising an amino acid sequence at least 90% identical SEQ ID NO: 184 and a variable light domain comprising an amino acid sequence at least 90% identical SEQ ID NO: 183. 
     
     
         14 . The antigen-binding protein of  claim 4 , comprising a variable heavy domain comprising SEQ ID NO: 184 and a variable light domain comprising SEQ ID NO: 183. 
     
     
         15 . The antigen-binding protein of  claim 1 , wherein the antigen-binding protein is an antibody. 
     
     
         16 . The antigen-binding protein of  claim 15 , which is a monoclonal antibody, a chimeric antibody, or a humanized antibody. 
     
     
         17 . The antigen-binding protein of  claim 1 , wherein the antigen-binding protein is an antigen-binding antibody fragment. 
     
     
         18 . The antigen-binding protein of  claim 1 , comprising a single chain antibody. 
     
     
         19 . A pharmaceutical composition comprising the antigen-binding protein of  claim 1  and a physiologically acceptable carrier. 
     
     
         20 . (canceled) 
     
     
         21 . A method of treating cancer, the method comprising administering to a subject in need thereof the antigen-binding protein of  claim 1 . 
     
     
         22 . The method of  claim 21 , further comprising administering to the subject an anti-PD-1 antigen-binding protein. 
     
     
         23 .- 26 . (canceled) 
     
     
         27 . The method of  claim 22 , wherein the anti-PD: 1 antigen-binding protein comprises a vhCDR1 comprising the amino acid sequence set forth in SEQ ID NO: 189 a vhCDR2 comprising the amino acid sequence set forth in SEQ ID NO: 190, a vhCDR3 comprising the amino acid sequence set forth in SEQ ID NO: 191, a vlCDR1 comprising the amino acid sequence set forth in SEQ ID NO: 192, a vhCDR2 comprising the amino acid sequence set forth in SEQ ID NO: 193, and a vl CDR3 comprising the amino acid sequence set forth in SEQ ID NO: 194. 
     
     
         28 . The method of  claim 27 , wherein the anti-PD: 1 antigen-binding protein comprises a heavy chain variable domain comprising an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 195 and a light chain variable domain comprising an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 196. 
     
     
         29 . The method of  claim 28 , wherein the anti-PD-1 antigen-binding protein comprises a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO: 195 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO: 196. 
     
     
         30 . The method of  claim 27 , wherein the anti-PD-1 antigen-binding protein is an antigen-binding antibody fragment. 
     
     
         31 . The method of  claim 27 , wherein the anti-PD-1 antigen-binding protein is an antibody. 
     
     
         32 . The method of  claim 27 , wherein the anti-PD-1 antigen-binding protein is a monoclonal antibody, a chimeric antibody, or a humanized antibody. 
     
     
         33 . The method of  claim 27 , wherein the anti-PD-1 antigen-binding protein comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 197 and a light chain comprising the amino acid sequence of SEQ ID NO: 198. 
     
     
         34 . The method of  claim 21 , wherein the cancer is prostate cancer. 
     
     
         35 . The method of  claim 21 , wherein the cancer is Ewing sarcoma. 
     
     
         36 . A polynucleotide comprising a nucleic acid sequence encoding the light chain variable domain and/or heavy chain variable domain of the antigen-binding protein of  claim 14 . 
     
     
         37 . An expression vector comprising the polynucleotide of  claim 36 . 
     
     
         38 . A composition comprising a polynucleotide comprising a nucleic acid sequence encoding the light chain variable domain of the antigen-binding protein of  claim 14  and a polynucleotide comprising a nucleic acid sequence encoding the heavy chain variable domain of the antigen-binding protein of  claim 14 . 
     
     
         39 . A method of making an antigen-binding protein, the method comprising contacting a host cell with the composition of  claim 38  under conditions that allow expression of the light chain variable domain and the heavy chain variable domain. 
     
     
         40 .- 79 . (canceled) 
     
     
         80 . The antigen-binding protein of  claim 1 , which is a Fab antibody fragment. 
     
     
         81 . The antigen-binding protein of  claim 3 , which is a Fab antibody fragment. 
     
     
         82 . The antigen-binding protein of  claim 81 , which is attached to a detectable label. 
     
     
         83 . The antigen-binding protein of  claim 82 , wherein the label is radioactive. 
     
     
         84 . The antigen-binding protein of  claim 4 , which is a Fab antibody fragment. 
     
     
         85 . The antigen-binding protein of  claim 84 , which is attached to a detectable label. 
     
     
         86 . The antigen-binding protein of  claim 85 , wherein the label is radioactive. 
     
     
         87 . The antigen-binding protein of  claim 8 , which is a Fab antibody fragment. 
     
     
         88 . The antigen-binding protein of  claim 87 , which is attached to a detectable label. 
     
     
         89 . The antigen-binding protein of  claim 88 , wherein the label is radioactive. 
     
     
         90 . The antigen-binding protein of  claim 9 , which is a Fab antibody fragment. 
     
     
         91 . The antigen-binding protein of  claim 90 , which is attached to a detectable label. 
     
     
         92 . The antigen-binding protein of  claim 91 , wherein the label is radioactive. 
     
     
         93 . The antigen-binding protein of  claim 13 , which is a Fab antibody fragment. 
     
     
         94 . The antigen-binding protein of  claim 93 , which is attached to a detectable label. 
     
     
         95 . The antigen-binding protein of  claim 94 , wherein the label is radioactive. 
     
     
         96 . The antigen-binding protein of  claim 14 , which is a Fab antibody fragment. 
     
     
         97 . The antigen-binding protein of  claim 96 , which is attached to a detectable label. 
     
     
         98 . The antigen-binding protein of  claim 97 , wherein the label is radioactive. 
     
     
         99 . A method for detecting STEAP1 in a subject, wherein the method comprises administering to the subject the antigen-binding protein of  claim 82  and detecting the label. 
     
     
         100 . The method of  claim 99 , wherein the detection of the label is by positron emission tomography. 
     
     
         101 . A method for detecting STEAP1 in a subject, wherein the method comprises administering to the subject the antigen-binding protein of  claim 85  and detecting the label. 
     
     
         102 . The method of  claim 101 , wherein the detection of the label is by positron emission tomography. 
     
     
         103 . A method for detecting STEAP1 in a subject, wherein the method comprises administering to the subject the antigen-binding protein of  claim 88  and detecting the label. 
     
     
         104 . The method of  claim 103 , wherein the detection of the label is by positron emission tomography. 
     
     
         105 . A method for detecting STEAP1 in a subject, wherein the method comprises administering to the subject the antigen-binding protein of  claim 91  and detecting the label. 
     
     
         106 . The method of  claim 105 , wherein the detection of the label is by positron emission tomography. 
     
     
         107 . A method for detecting STEAP1 in a subject, wherein the method comprises administering to the subject the antigen-binding protein of  claim 94  and detecting the label. 
     
     
         108 . The method of  claim 107 , wherein the detection of the label is by positron emission tomography. 
     
     
         109 . A method for detecting STEAP1 in a subject, wherein the method comprises administering to the subject the antigen-binding protein of  claim 97  and detecting the label. 
     
     
         110 . The method of  claim 109 , wherein the detection of the label is by positron emission tomography. 
     
     
         111 . The antigen-binding protein of  claim 1 , which is a F(ab′)2 fragment. 
     
     
         112 . The antigen-binding protein of  claim 3 , which is a F(ab′)2 fragment. 
     
     
         113 . The antigen-binding protein of  claim 4 , which is a F(ab′)2 fragment. 
     
     
         114 . The antigen-binding protein of  claim 8 , which is a F(ab′)2 fragment. 
     
     
         115 . The antigen-binding protein of  claim 9 , which is a F(ab′)2 fragment. 
     
     
         116 . The antigen-binding protein of  claim 13 , which is a F(ab′)2 fragment. 
     
     
         117 . The antigen-binding protein of  claim 14 , which is a F(ab′)2 fragment.

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