US2012082662A1PendingUtilityA1

Anti-cmet antagonists

Individually held — no corporate assignee on recordPriority: Aug 5, 2004Filed: Jul 28, 2011Published: Apr 5, 2012
Est. expiryAug 5, 2024(expired)· nominal 20-yr term from priority
A61P 43/00C07K 2317/73C07K 16/2863C07K 2317/55C07K 16/005C07K 16/32A61K 2039/505C07K 2317/24C07K 2317/92C07K 2319/30A61P 35/00C07K 16/46A61K 39/395C07K 16/00
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Claims

Abstract

The invention provides therapeutic anti-c-met antibodies, and compositions comprising and methods of using these antibodies.

Claims

exact text as granted — not AI-modified
1 . An anti-c-met antibody comprising:
 (a) at least one HVR sequence selected from the group consisting of:
 (i) HVR-L1 comprising sequence A1-A17, wherein A1-A17 is KSSQSLLYTSSQKNYLA (SEQ ID NO:1) 
 (ii) HVR-L2 comprising sequence B1-B7, wherein B1-B7 is WASTRES (SEQ ID NO:2) 
 (iii) HVR-L3 comprising sequence C1-C9, wherein C1-C9 is QQYYAYPWT (SEQ ID NO:3) 
 (iv) HVR-H1 comprising sequence D1-D10, wherein D1-D10 is GYTFTSYWLH (SEQ ID NO:4) 
 (v) HVR-H2 comprising sequence E1-E18, wherein E1-E18 is GMIDPSNSDTRFNPNFKD (SEQ ID NO:5) 
 (vi) HVR-H3 comprising sequence F1-F 11, wherein F1-F11 is XYGSYVSPLDY (SEQ ID NO:6) and X is not R; and 
   (b) at least one variant HVR, wherein the variant HVR comprises modification of at least one residue of the sequence depicted in SEQ ID NO: 1, 2, 3, 4, 5 or 6.   
     
     
         2 . The antibody of  claim 1 , wherein Fl in a variant HVR-H3 is T or S, F3 is R or S and F7 is T. 
     
     
         3 . The antibody of  claim 1 , wherein the antibody is humanized. 
     
     
         4 . The antibody of  claim 1 , wherein at least a portion of the framework sequence is a human consensus framework sequence. 
     
     
         5 . The antibody of  claim 1 , wherein said modification is substitution, insertion or deletion. 
     
     
         6 . The antibody of  claim 1 , wherein a HVR-L2 variant comprises 1-5 (1, 2, 3, 4 or 5) substitutions in any combination of the following positions: B1 (M or L), B2 (P, T, G or S), B3 (N, G, R or T), B4 (I, N or F), B5 (P, I, L or G), B6 (A, D, T or V) and B7 (R, I, M or G). 
     
     
         7 . The antibody of  claim 1 , wherein a HVR-H1 variant comprises 1-5 (1, 2, 3, 4 or 5) substitutions in any combination of the following positions: D3 (N, P, L, S, A, I), D5 (I, S or Y), D6 (G, D, T, K, R), D7 (F, H, R, S, T or V) and D9 (M or V). 
     
     
         8 . The antibody of  claim 1 , wherein a HVR-H2 variant comprises 1-4 (1, 2, 3 or 4) substitutions in any combination of the following positions: E7 (Y), E9 (I), E10 (I), E14 (T or Q), E15 (D, K, S, T or V), E16 (L), E17 (E, H, N or D) and E18 (Y, E or H). 
     
     
         9 . The antibody of  claim 1 , wherein a HVR-H3 variant comprises 1-5 (1, 2, 3, 4 or 5) substitutions in any combination of the following positions: F1 (T, S), F3 (R, S, H, T, A, K), F4 (G), F6 (R, F, M, T, E, K, A, L, W), F7 (L, I, T, R, K, V), F8 (S, A), F10 (Y, N) and F11 (Q, S, H, F). 
     
     
         10 . The antibody of  claim 1  comprising an HVR-L1 having the sequence of SEQ ID NO:1. 
     
     
         11 . The antibody of  claim 1  comprising an HVR-L3 having the sequence of SEQ ID NO:3. 
     
     
         12 . The antibody of  claim 1 , wherein F1 in a variant HVR-H3 is T. 
     
     
         13 . The antibody of  claim 1 , wherein F3 in a variant HVR-H3 is R or S. 
     
     
         14 . The antibody of  claim 1 , wherein F7 in a variant HVR-H3 is T. 
     
     
         15 . A humanized anti-c-met antibody wherein monovalent affinity of the antibody to human c-met is substantially the same as monovalent affinity of a murine antibody comprising a light chain and heavy chain variable sequence as depicted in  FIG. 7  (SEQ ID NO: 9 and 10). 
     
     
         16 . A humanized anti-c-met antibody wherein monovalent affinity of the antibody to human c-met is at least 3-fold greater than monovalent affinity of a murine antibody comprising a light chain and heavy chain variable sequence as depicted in  FIG. 7  (SEQ ID NO: 9 and 10). 
     
     
         17 . The humanized antibody of  claim 15  or  16  wherein the murine antibody is produced by hybridoma cell line deposited under American Type Culture Collection Accession Number ATCC with designation HB-11894 (hybridoma 1A3.3.13) or HB-11895 (hybridoma 5D5.11.6). 
     
     
         18 . The antibody of any of  claims 15 - 17  wherein the binding affinity is expressed as a Kd value. 
     
     
         19 . The antibody of any of  claim 15 - 18  wherein the binding affinity is measured by Biacore or radioimmunoassay. 
     
     
         20 . The antibody of  claim 1  comprising human subgroup 1 consensus framework sequence. 
     
     
         21 . The antibody of  claim 1  comprising heavy chain human subgroup III consensus framework sequence. 
     
     
         22 . The antibody of  claim 21  wherein the framework sequence comprises a substitution at position 71, 73 and/or 78. 
     
     
         23 . The antibody of  claim 22  wherein said substitution is R71A, N73T and/or N78A. 
     
     
         24 . A humanized anti-c-met antibody wherein the humanized antibody inhibits binding human hepatocyte growth factor to its receptor better than a reference antibody comprising a chimeric anti-c-met antibody comprising a light chain and heavy chain variable sequence as depicted in  FIG. 7  (SEQ ID NO: 9 and 10). 
     
     
         25 . The antibody of  claim 24 , wherein the humanized antibody inhibits binding with an IC50 value that is less than half that of the chimeric antibody. 
     
     
         26 . The antibody of  claim 25 , wherein the IC50 is determined across an antibody concentration range from about 0.01 nM to around 1000 nM. 
     
     
         27 . A humanized anti-c-met antibody wherein the humanized antibody inhibits human hepatocyte growth factor (HGF) receptor activation better than a reference antibody comprising a chimeric anti-c-met antibody comprising a light chain and heavy chain variable sequence as depicted in  FIG. 7  (SEQ ID NO: 9 and 10). 
     
     
         28 . The antibody of  claim 27 , wherein the humanized antibody inhibits receptor activation with an IC50 value that is less than half that of the chimeric antibody. 
     
     
         29 . The antibody of  claim 28 , wherein the IC50 is determined across an antibody concentration range from about 0.1 nM to about 100 nM. 
     
     
         30 . A humanized anti-c-met antibody wherein the humanized antibody inhibits c-met-dependent cell proliferation better than a reference antibody comprising a chimeric anti-c-met antibody comprising a light chain and heavy chain variable sequence as depicted in  FIG. 7  (SEQ ID NO: 9 and 10). 
     
     
         31 . The antibody of  claim 30 , wherein the humanized antibody inhibits cell proliferation with an IC50 value that is less than half that of the chimeric antibody. 
     
     
         32 . The antibody of  claim 31 , wherein the IC50 is determined across an antibody concentration range from about 0.01 nM to about 100 nM. 
     
     
         33 . The antibody of the preceding claims, wherein both the humanized antibody and chimeric antibody are monovalent. 
     
     
         34 . The antibody of the preceding claims, wherein both the humanized antibody and chimeric antibody comprise a single Fab region linked to an Fc region. 
     
     
         35 . An antibody comprising a heavy chain variable domain comprising HVR1-HC, HVR2-HC and/or HVR3-HC sequence depicted in  FIG. 13  (SEQ ID NO: 191-193). 
     
     
         36 . The antibody of  claim 35 , wherein the variable domain comprises FR1-HC, FR2-HC, FR3-HC and/or FR4-HC sequence depicted in  FIG. 13  (SEQ ID NO: 187-190). 
     
     
         37 . The antibody of  claim 35  or  36 , wherein the antibody comprises CH1 and/or Fc sequence depicted in  FIG. 13  (SEQ ID NO: 194 and/or 195). 
     
     
         38 . An antibody comprising a light chain variable domain comprising HVR1-LC, HVR2-LC and/or HVR3-LC sequence depicted in  FIG. 13  (SEQ ID NO: 183-185). 
     
     
         39 . The antibody of  claim 38 , wherein the variable domain comprises FR1-LC, FR2-LC, FR3-LC and/or FR4-LC sequence depicted in  FIG. 13  (SEQ ID NO: 179-182). 
     
     
         40 . The antibody of  claim 38  or  39 , wherein the antibody comprises CL1 sequence depicted in  FIG. 13  (SEQ ID NO: 186). 
     
     
         41 . An antibody comprising a heavy chain variable domain of any of  claims 35 - 37  and a light chain variable domain of any of  claims 38 - 40 . 
     
     
         42 . The antibody of  claim 41 , wherein the antibody is monovalent and comprises an Fc region. 
     
     
         43 . The antibody of  claim 42 , wherein the Fc region comprises a first and a second polypeptide, wherein the first and second polypeptide each comprises one or more mutations with respect to wild type human Fc. 
     
     
         44 . The antibody of  claim 43 , wherein the first polypeptide comprises the Fc sequence depicted in  FIG. 13  (SEQ ID NO: 195) and the second polypeptide comprises the sequence depicted in  FIG. 14  (SEQ ID NO: 196). 
     
     
         45 . A method of inhibiting c-met activated cell proliferation, said method comprising contacting a cell or tissue with an effective amount of an antibody of any of the preceding claims. 
     
     
         46 . A method of modulating a disease associated with dysregulation of the HGF/c-met signaling axis, said method comprising administering to a subject an effective amount of an antibody of any of the preceding claims. 
     
     
         47 . A method of treating a subject having cancer, said method comprising administering to the subject an effective amount of an antibody of any of the preceding claims. 
     
     
         48 . The method of  claim 47 , wherein the cancer is lung cancer, brain cancer, kidney cancer, gastric cancer, colorectal cancer and/or pancreatic cancer. 
     
     
         49 . A method of treating a proliferative disorder in a subject, said method comprising administering to the subject an effective amount of an antibody of any of the preceding claims. 
     
     
         50 . The method of  claim 49 , wherein the proliferative disorder is cancer. 
     
     
         51 . A nucleic acid encoding the antibody of any of  claims 1 - 44 . 
     
     
         52 . A host cell comprising the nucleic acid of  claim 51 . 
     
     
         53 . A composition comprising the antibody of any of  claims 1 - 44 . 
     
     
         54 . The composition of  claim 53 , wherein the composition comprises a carrier.

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