JPWO2019175359A5 - - Google Patents

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JPWO2019175359A5
JPWO2019175359A5 JP2020543213A JP2020543213A JPWO2019175359A5 JP WO2019175359 A5 JPWO2019175359 A5 JP WO2019175359A5 JP 2020543213 A JP2020543213 A JP 2020543213A JP 2020543213 A JP2020543213 A JP 2020543213A JP WO2019175359 A5 JPWO2019175359 A5 JP WO2019175359A5
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抗ＥＲＢＢ３抗体又はその抗原結合部分であって、当該抗体は、重鎖可変（ＶＨ）領域及び軽鎖可変（ＶＬ）領域を含有し、
（ａ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＳＭＳ（配列番号２４）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＴＹＴＹＹＰＤＳＶＫＧ（配列番号２５）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＦ（配列番号１５）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＥＩＳＴＹＬＳ（配列番号２６１）のＬＣＤＲ１、ＡＡＳＴＬＱＳ（配列番号２６）のＬＣＤＲ２、及びＬＱＹＤＳＳＰＬＴ（配列番号２６２）のＬＣＤＲ３を含有する、
（ｂ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＳＭＳ（配列番号２４）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＴＹＴＹＹＰＤＳＶＫＧ（配列番号２５）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＦ（配列番号１５）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＥＩＳＳＹＬＳ（配列番号２１）のＬＣＤＲ１、ＡＡＳＳＬＤＴ（配列番号２６３）のＬＣＤＲ２、及び配列番号２２４のアミノ酸８９から９７のＬＣＤＲ３を含有する、
（ｃ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＳＭＳ（配列番号２４）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＴＹＴＹＹＰＤＳＶＫＧ（配列番号２５）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＦ（配列番号１５）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＥＩＳＳＹＬＳ（配列番号２１）のＬＣＤＲ１、ＡＡＳＳＬＤＴ（配列番号２６３）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＹＴ（配列番号２３）のＬＣＤＲ３を含有する、
（ｄ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＧＭＳ（配列番号１３）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＳＹＴＹＹＰＤＳＶＫＧ（配列番号１９）のＨＣＤＲ２、及びＥＬＧＤＹＤＧＦＤＹ（配列番号２０）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＥＩＳＳＹＬＳ（配列番号２１）のＬＣＤＲ１、ＡＡＳＳＬＤＳ（配列番号２２）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＹＴ（配列番号２３）のＬＣＤＲ３を含有する、
（ｅ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＳＭＳ（配列番号２４）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＴＹＴＹＹＰＤＳＶＫＧ（配列番号２５）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＦ（配列番号１５）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＥＩＳＳＹＬＳ（配列番号２１）のＬＣＤＲ１、ＡＡＳＴＬＱＳ（配列番号２６）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＬＴ（配列番号１８）のＬＣＤＲ３を含有する、
（ｆ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＧＭＳ（配列番号１３）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＳＹＩＹＹＡＤＳＶＫＧ（配列番号１４）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＦ（配列番号１５）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＳＩＳＳＹＬＳ（配列番号１６）のＬＣＤＲ１、ＡＡＳＳＬＱＳ（配列番号１７）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＬＴ（配列番号１８）のＬＣＤＲ３を含有する、
（ｇ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＧＭＳ（配列番号１３）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＳＹＩＹＹＡＤＳＶＫＧ（配列番号１４）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＨ（配列番号２７）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＥＩＳＳＹＬＳ（配列番号２１）のＬＣＤＲ１、ＡＡＳＳＬＱＳ（配列番号１７）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＬＴ（配列番号１８）のＬＣＤＲ３を含有する、
（ｈ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＧＭＳ（配列番号１３）のＨＣＤＲ１、ＶＳＴＩＳＤＧＧＳＹＴＹＹＡＤＳＶＫＧ（配列番号２８）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＥ（配列番号２９）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＳＩＳＧＹＬＳ（配列番号３０）のＬＣＤＲ１、ＡＡＳＴＬＱＳ（配列番号２６）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＹＴ（配列番号２３）のＬＣＤＲ３を含有する、
（ｉ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＧＭＳ（配列番号１３）のＨＣＤＲ１、ＶＳＴＩＳＤＧＧＳＹＴＹＹＡＤＮＶＫＧ（配列番号３１）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＦ（配列番号１５）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＳＩＳＳＹＬＳ（配列番号１６）のＬＣＤＲ１、ＡＡＳＴＬＱＳ（配列番号２６）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＬＴ（配列番号１８）のＬＣＤＲ３を含有する、又は
（ｊ）ＶＨ領域のアミノ酸配列が、ＧＦＴＦＳＤＹＧＭＳ（配列番号１３）のＨＣＤＲ１、ＶＳＴＩＳＤＳＧＳＹＩＹＹＡＤＳＶＫＧ（配列番号１４）のＨＣＤＲ２、及びＥＷＧＤＹＤＧＦＤＥ（配列番号２９）のＨＣＤＲ３を含有し、ＶＬ領域のアミノ酸配列が、ＲＡＳＱＳＩＳＳＹＬＳ（配列番号１６）のＬＣＤＲ１、ＡＡＳＳＬＱＳ（配列番号１７）のＬＣＤＲ２、及びＬＱＹＤＳＴＰＬＴ（配列番号１８）のＬＣＤＲ３を含有する、
抗ＥＲＢＢ３抗体又はその抗原結合部分。 An anti-ERBB3 antibody or antigen-binding portion thereof, the antibody containing a heavy chain variable (VH) region and a light chain variable (VL) region.
(A) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYSMS (SEQ ID NO: 24), HCDR2 of VSTISDSGTYTYYPDSVKG (SEQ ID NO: 25), and HCDR3 of EWGDYDGFDF (SEQ ID NO: 15), and the amino acid sequence of the VL region is RASQEASTYLS (SEQ ID NO: 25). Containing LCDR1 of SEQ ID NO: 261), LCDR2 of AASTLQS (SEQ ID NO: 26), and LCDR3 of LQYDSSPLT (SEQ ID NO: 262).
(B) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYSMS (SEQ ID NO: 24), HCDR2 of VSTISDSGTYTYYPDSVKG (SEQ ID NO: 25), and HCDR3 of EWGDYDGFDF (SEQ ID NO: 15), and the amino acid sequence of the VL region is RASQEISSSYLS (SEQ ID NO: 25). Containing LCDR1 of SEQ ID NO: 21), LCDR2 of AASSLDT (SEQ ID NO: 263), and LCDR3 of amino acids 89-97 of SEQ ID NO: 224.
( C ) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYSMS (SEQ ID NO: 24), HCDR2 of VSTISDSGTYTYYPDSVKG (SEQ ID NO: 25), and HCDR3 of EWGDYDGFDF (SEQ ID NO: 15), and the amino acid sequence of the VL region is RASQEISSYLS (SEQ ID NO: 15). Containing LCDR1 of SEQ ID NO: 21), LCDR2 of AASSLDT (SEQ ID NO: 263), and LCDR3 of LQYDSTPYT (SEQ ID NO: 23).
( D ) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYGMS (SEQ ID NO: 13), HCDR2 of VSTISDSGSYTYYPDSVKG (SEQ ID NO: 19), and HCDR3 of ELGDYDGDY (SEQ ID NO: 20), and the amino acid sequence of the VL region is RASQEISSYLS (SEQ ID NO: 20). Containing LCDR1 of SEQ ID NO: 21), LCDR2 of AASSLDS (SEQ ID NO: 22), and LCDR3 of LQYDSTPYT (SEQ ID NO: 23).
( E ) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYSMS (SEQ ID NO: 24), HCDR2 of VSTISDSGTYTYYPDSVKG (SEQ ID NO: 25), and HCDR3 of EWGDYDGFDF (SEQ ID NO: 15), and the amino acid sequence of the VL region is RASQEISSYLS (SEQ ID NO: 15). Containing LCDR1 of SEQ ID NO: 21), LCDR2 of AASTLQS (SEQ ID NO: 26), and LCDR3 of LQYDSTPLT (SEQ ID NO: 18).
( F ) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYGMS (SEQ ID NO: 13), HCDR2 of VSTISDSGSYIYYADSVKG (SEQ ID NO: 14), and HCDR3 of EWGDYDGFDF (SEQ ID NO: 15), and the amino acid sequence of the VL region is RASQSISSYLS (SEQ ID NO: 15). Containing LCDR1 of SEQ ID NO: 16), LCDR2 of AASSLQS (SEQ ID NO: 17), and LCDR3 of LQYDSTPLT (SEQ ID NO: 18).
( G ) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYGMS (SEQ ID NO: 13), HCDR2 of VSTISDSGSYIYYADSVKG (SEQ ID NO: 14), and HCDR3 of EWGDYDGFDH (SEQ ID NO: 27), and the amino acid sequence of the VL region is RASQEISSYLS (SEQ ID NO: 27). Contains LCDR1 of SEQ ID NO: 21), LCDR2 of AASSLQS (SEQ ID NO: 17), and LCDR3 of LQYDSTPLT (SEQ ID NO: 18).
( H ) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYGMS (SEQ ID NO: 13), HCDR2 of VSTISDGGSYTYYADSVKG (SEQ ID NO: 28), and HCDR3 of EWGDYDGFDE (SEQ ID NO: 29), and the amino acid sequence of the VL region is RASQSSGYLS (SEQ ID NO: 29). Contains LCDR1 of SEQ ID NO: 30), LCDR2 of AASTLQS (SEQ ID NO: 26), and LCDR3 of LQYDSTPYT (SEQ ID NO: 23).
( I ) The amino acid sequence of the VH region contains HCDR1 of GFTFSDYGMS (SEQ ID NO: 13), HCDR2 of VSTISDGGSYTYYADNVKG (SEQ ID NO: 31), and HCDR3 of EWGDYDGFDF (SEQ ID NO: 15), and the amino acid sequence of the VL region is RASQSISSYLS (SEQ ID NO: 15). Contains LCDR1 of SEQ ID NO: 16), LCDR2 of AASTLQS (SEQ ID NO: 26), and LCDR3 of LQYDSTPLT (SEQ ID NO: 18), or
The amino acid sequence of the ( j ) VH region contains HCDR1 of GFTFSDYGMS (SEQ ID NO: 13), HCDR2 of VSTISDSGSYIYYADSVKG (SEQ ID NO: 14), and HCDR3 of EWGDYDGFDE (SEQ ID NO: 29), and the amino acid sequence of the VL region is RASQSISSYLS (SEQ ID NO: 29). Containing LCDR1 of SEQ ID NO: 16), LCDR2 of AASSLQS (SEQ ID NO: 17), and LCDR3 of LQYDSTPLT (SEQ ID NO: 18).
Anti-ERBB3 antibody or antigen-binding portion thereof. （ａ）前記ＶＨ領域のアミノ酸配列が配列番号２３６を含み、前記ＶＬ領域のアミノ酸配列が配列番号２２５を含む、
（ｂ）前記ＶＨ領域のアミノ酸配列が配列番号２３５を含み、前記ＶＬ領域のアミノ酸配列が配列番号２２４を含む、
（ｃ）前記ＶＨ領域のアミノ酸配列が配列番号２３２を含み、前記ＶＬ領域のアミノ酸配列が配列番号２２１を含む、
（ｄ）前記ＶＨ領域のアミノ酸配列が配列番号２５３を含み、前記ＶＬ領域のアミノ酸配列が配列番号２５４を含む、又は
（ｅ）前記ＶＨ領域のアミノ酸配列が配列番号２５５を含み、前記ＶＬ領域のアミノ酸配列が配列番号２５６を含む、
請求項１記載の抗体又はその抗原結合部分。 (A) The amino acid sequence of the VH region comprises SEQ ID NO: 236, and the amino acid sequence of the VL region comprises SEQ ID NO: 225.
(B) The amino acid sequence of the VH region comprises SEQ ID NO: 235, and the amino acid sequence of the VL region comprises SEQ ID NO: 224.
( C ) The amino acid sequence of the VH region comprises SEQ ID NO: 232 and the amino acid sequence of the VL region comprises SEQ ID NO: 221.
( D ) The amino acid sequence of the VH region comprises SEQ ID NO: 253, and the amino acid sequence of the VL region comprises SEQ ID NO: 254, or
( E ) The amino acid sequence of the VH region comprises SEQ ID NO: 255, and the amino acid sequence of the VL region comprises SEQ ID NO: 256.
The antibody according to claim 1 or an antigen-binding portion thereof. 前記抗体が、ヒト化抗体又はキメラ抗体である、請求項１又は２に記載の抗体又は抗原結合部分。 The antibody or antigen-binding moiety according to claim 1 or 2 , wherein the antibody is a humanized antibody or a chimeric antibody. 前記ＶＨ領域、前記ＶＬ領域、又は前記ＶＨ領域と前記ＶＬ領域との両方が、１つ又は複数のヒトフレームワーク領域のアミノ酸配列を含有する、請求項１から３のいずれか一項に記載の抗体又は抗原結合部分。 The one according to any one of claims 1 to 3 , wherein the VH region, the VL region, or both the VH region and the VL region contain an amino acid sequence of one or more human framework regions. An antibody or antigen binding moiety. 前記ＶＨ領域、前記ＶＬ領域、又は前記ＶＨ領域と前記ＶＬ領域との両方が、前記ＣＤＲが挿入されたヒト可変領域フレームワークスキャホールドのアミノ酸配列を含有する、請求項１から４のいずれか一項に記載の抗体又は抗原結合部分。 One of claims 1 to 4 , wherein the VH region, the VL region, or both the VH region and the VL region contain the amino acid sequence of the human variable region framework scaffold into which the CDR is inserted. The antibody or antigen binding moiety according to the section. 前記ＶＨ領域が、前記ＨＣＤＲ１、ＨＣＤＲ２、及びＨＣＤＲ３のアミノ酸配列が挿入されたＩＧＨＶ３－１１ヒト生殖細胞系列スキャホールドのアミノ酸配列を含有する、請求項１に記載の抗体又は抗原結合部分。 The antibody or antigen binding moiety according to claim 1, wherein the VH region contains the amino acid sequence of the IGHV3-11 human germline scaffold into which the amino acid sequences of HCDR1, HCDR2, and HCDR3 have been inserted. 前記ＶＬ領域が、前記ＬＣＤＲ１、ＬＣＤＲ２、及びＬＣＤＲ３のアミノ酸配列が挿入されたＩＧＫＶ１－３９ヒト生殖細胞系列スキャホールドのアミノ酸配列を含有する、請求項１又は６に記載の抗体又は抗原結合部分。 The antibody or antigen binding moiety according to claim 1 or 6 , wherein the VL region contains the amino acid sequence of IGKV1-39 human germline scaffold into which the amino acid sequences of LCDR1, LCDR2, and LCDR3 are inserted. 前記抗体が、免疫グロブリン定常領域を含有する、請求項１から７のいずれか一項に記載の抗体又は抗原結合部分。 The antibody or antigen-binding moiety according to any one of claims 1 to 7 , wherein the antibody contains an immunoglobulin constant region. 前記免疫グロブリン定常領域が、ＩｇＧ、ＩｇＥ、ＩｇＭ、ＩｇＤ、ＩｇＡ又はＩｇＹである、請求項８に記載の抗体又は抗原結合部分。 The antibody or antigen binding moiety according to claim 8, wherein the immunoglobulin constant region is IgG, IgE, IgM, IgD, IgA or IgY. 前記免疫グロブリン定常領域が、ＩｇＧ１、ＩｇＧ２、ＩｇＧ３、ＩｇＧ４、ＩｇＡ１又はＩｇＡ２である、請求項９に記載の抗体又は抗原結合部分。 The antibody or antigen binding moiety of claim 9, wherein the immunoglobulin constant region is IgG1, IgG2, IgG3, IgG4, IgA1 or IgA2. 前記免疫グロブリン定常領域が、免疫学的に不活性である、請求項８に記載の抗体又は抗原結合部分。 The antibody or antigen-binding moiety according to claim 8, wherein the immunoglobulin constant region is immunologically inactive. 前記免疫グロブリン定常領域が、野生型ヒトＩｇＧ４定常領域、Ｓ２２８Ｐのアミノ酸置換を含有するヒトＩｇＧ４定常領域、野生型ヒトＩｇＧ１定常領域、Ｌ２３４Ａ、Ｌ２３５Ａ及びＧ２３７Ａのアミノ酸置換を含有するヒトＩｇＧ１定常領域、又は野生型ヒトＩｇＧ２定常領域であり、番号付けは、ＫａｂａｔにあるＥＵインデックスに従う、請求項８に記載の抗体又は抗原結合部分。 The immunoglobulin constant region is a wild-type human IgG4 constant region, a human IgG4 constant region containing an amino acid substitution of S228P, a wild-type human IgG1 constant region, a human IgG1 constant region containing amino acid substitutions of L234A, L235A and G237A, or a human IgG1 constant region. The antibody or antigen binding moiety of claim 8, which is a wild-type human IgG2 constant region, numbered according to the EU index in Kabat . 前記免疫グロブリン定常領域が、配列番号２３９～２４５のいずれか１つを含有する、請求項８に記載の抗体又は抗原結合部分。 The antibody or antigen-binding moiety according to claim 8, wherein the immunoglobulin constant region contains any one of SEQ ID NOs: 239 to 245. 前記抗体又は抗原結合部分が、Ｆａｂ、Ｆａｂ'、Ｆ（ａｂ'）2、Ｆｖ、ｓｃＦｖ、マキシボディ、ミニボディ、ダイアボディ、トリアボディ、テトラボディ、又はｂｉｓ－ｓｃＦｖである、請求項１から１３のいずれか一項に記載の抗体又は抗原結合部分。 From claim 1, the antibody or antigen-binding moiety is Fab, Fab', F (ab') 2 , Fv, scFv, maxibody, minibody, diabody, triabody, tetrabody, or bis-scFv. 13. The antibody or antigen-binding moiety according to any one of 13. 前記抗体がモノクローナルである、請求項１から１４のいずれか一項に記載の抗体又は抗原結合部分。 The antibody or antigen-binding moiety according to any one of claims 1 to 14 , wherein the antibody is monoclonal. 前記抗体が、四量体抗体、四価抗体、又は多特異性抗体である、請求項１から１５のいずれか一項に記載の抗体又は抗原結合部分。 The antibody or antigen-binding moiety according to any one of claims 1 to 15 , wherein the antibody is a tetramer antibody, a tetravalent antibody, or a polyspecific antibody. 前記抗体が、第一の抗原及び第二の抗原に特異的に結合する二特異性抗体であり、前記第一の抗原はＥＲＢＢ３であり、前記第二の抗原はＥＲＢＢ３ではない、請求項１から１６のいずれか一項に記載の抗体又は抗原結合部分。 The antibody is a bispecific antibody that specifically binds to the first antigen and the second antigen, the first antigen is ERBB3, and the second antigen is not ERBB3, according to claim 1. 16. The antibody or antigen-binding moiety according to any one of 16. 前記抗体又は抗原結合部分が、（ａ）ヒトＥＲＢＢ３に特異的に結合する、又は（ｂ）ヒトＥＲＢＢ３及びアカゲザルＥＲＢＢ３に特異的に結合する、請求項１から１７のいずれか一項に記載の抗体又は抗原結合部分。 The antibody according to any one of claims 1 to 17 , wherein the antibody or antigen-binding moiety specifically binds to (a) human ERBB3 or (b) human ERBB3 and rhesus monkey ERBB3. Or the antigen binding part. 治療剤に結合された請求項１から１８のいずれか一項に記載の抗体又は抗原結合部分を含有する免疫結合体。 The immunoconjugate containing the antibody or antigen-binding moiety according to any one of claims 1 to 18 , which is bound to a therapeutic agent. 前記治療剤が、細胞毒素、放射性同位体、化学療法剤、免疫調節剤、細胞増殖抑制酵素、細胞溶解性酵素、治療用核酸、抗血管新生剤、抗増殖剤、又はアポトーシス促進剤である、請求項１９に記載の免疫結合体。 The therapeutic agent is a cytotoxin, a radioisotope, a chemotherapeutic agent, an immunomodulator, a cell growth inhibitor, a cytolytic enzyme, a therapeutic nucleic acid, an antiangiogenic agent, an antiproliferative agent, or an antiproliferative agent. The immune conjugate according to claim 19 . 請求項１から１８のいずれか一項に記載の抗体又は抗原結合部分、又は請求項１９又は２０に記載の免疫結合体と、薬学的に許容可能な担体、希釈剤又は賦形剤と、を含有する医薬組成物。 The antibody or antigen-binding moiety according to any one of claims 1 to 18 , or the immunoconjugate according to claim 19 or 20 , and a pharmaceutically acceptable carrier, diluent or excipient . The pharmaceutical composition contained. 核酸分子であって、請求項１から１８のいずれか一項に記載の抗体又は抗原結合部分の
（ａ）ＶＨ領域のアミノ酸配列、
（ｂ）ＶＬ領域のアミノ酸配列、又は
（ｃ）ＶＨ領域及びＶＬ領域の両方のアミノ酸配列、
をコードする核酸分子。 (A) Amino acid sequence of the VH region of the antibody or antigen-binding portion according to any one of claims 1 to 18 , which is a nucleic acid molecule.
(B) Amino acid sequence of VL region or
(C) Amino acid sequences of both VH and VL regions,
Nucleic acid molecule encoding. 請求項２２に記載の核酸分子を含有する発現ベクター。 An expression vector containing the nucleic acid molecule according to claim 22 . 請求項２２に記載の核酸分子、又は請求項２３に記載の発現ベクターを含有する組換え宿主細胞。 A recombinant host cell containing the nucleic acid molecule of claim 22 or the expression vector of claim 23 . 抗ＥＲＢＢ３抗体又はその抗原結合部分を作製する方法であって、
核酸分子が発現される条件下で、請求項２３に記載の発現ベクターを含有する組換え宿主細胞を培養し、それにより抗体又は抗原結合部分を作製することと、
前記宿主細胞又は培養物から、前記抗体又は抗原結合部分を単離することと、
を含む、方法。 A method for producing an anti-ERBB3 antibody or an antigen-binding portion thereof.
Culturing a recombinant host cell containing the expression vector according to claim 23 under conditions in which a nucleic acid molecule is expressed , thereby producing an antibody or antigen-binding moiety.
Isolating the antibody or antigen-binding moiety from the host cell or culture and
Including, how. 対象において、免疫反応を強化する使用のための、請求項１から１８のいずれか一項に記載の抗体又は抗原結合部分、請求項１９又は２０に記載の免疫結合体、又は請求項２１に記載の医薬組成物。 21. The antibody or antigen binding moiety of any one of claims 1-18, the immune conjugate of claim 19 or 20 , or claim 21 for use in a subject to enhance an immune response. Pharmaceutical composition. 癌、自己免疫性疾患、炎症性疾患、心血管疾患、又は線維症の治療における使用のための請求項１から１８のいずれか一項に記載の抗体又は抗原結合部分、請求項１９又は２０に記載の免疫結合体、又は請求項２１に記載の医薬組成物。 The antibody or antigen-binding moiety according to any one of claims 1 to 18 , claim 19 or 20 , for use in the treatment of cancer, autoimmune disease, inflammatory disease, cardiovascular disease, or fibrosis. The immunoconjugate according to claim 21 or the pharmaceutical composition according to claim 21. 前記癌が、消化管間質癌（ＧＩＳＴ）、膵臓癌、メラノーマ、乳癌、肺癌、気管支癌、結腸直腸癌、前立腺癌、胃癌、卵巣癌、膀胱癌、脳腫瘍又は中枢神経系の癌、末梢神経系の癌、食道癌、子宮頸癌、子宮癌又は子宮内膜癌、口腔又は咽頭の癌、肝癌、腎癌、精巣癌、胆管癌、小腸癌又は虫垂癌、唾液腺癌、甲状腺癌、副腎癌、骨肉腫、軟骨肉腫、又は血液組織の癌である、請求項２７に記載の使用のための抗体又は抗原結合部分、免疫結合体、又は医薬組成物。 The cancers are gastrointestinal stromal cancer (GIST), pancreatic cancer, melanoma, breast cancer, lung cancer, bronchial cancer, colorectal cancer, prostate cancer, gastric cancer, ovarian cancer, bladder cancer, brain cancer or central nervous system cancer, peripheral nerve. System cancer, esophageal cancer, cervical cancer, uterine cancer or endometrial cancer, oral or pharyngeal cancer, liver cancer, renal cancer, testis cancer, bile duct cancer, small intestinal cancer or pituitary cancer, salivary adenocarcinoma, thyroid cancer, adrenal cancer The antibody or antigen binding moiety, immune conjugate, or pharmaceutical composition for use according to claim 27 , which is an osteosarcoma, chondrosarcoma, or cancer of blood tissue. 前記自己免疫性疾患又は前記炎症性疾患が、関節炎、喘息、多発性硬化症、乾癬、クローン病、炎症性腸疾患、ループス（ｌｕｐｕｓ）、グレーブス病、橋本甲状腺炎、又は強直性脊椎炎である、請求項２７に記載の使用のための抗体又は抗原結合部分、免疫結合体、又は医薬組成物。 The autoimmune disease or the inflammatory disease is arthritis, asthma, multiple sclerosis, psoriasis, Crohn's disease, inflammatory bowel disease, lupus, Graves' disease, Hashimoto thyroiditis, or tonic spondylitis. 27. The antibody or antigen binding moiety, immune conjugate, or pharmaceutical composition for use according to claim 27 . 前記心血管疾患が、冠動脈心疾患又はアテローム性動脈硬化症である、請求項２７に記載の使用のための抗体又は抗原結合部分、免疫結合体、又は医薬組成物。 The antibody or antigen binding moiety, immune conjugate, or pharmaceutical composition for use according to claim 27 , wherein the cardiovascular disease is coronary heart disease or atherosclerosis. 前記線維症が、心筋梗塞、狭心症、変形性関節症、肺線維症、嚢胞性線維症、気管支炎又は喘息である、請求項２７に記載の使用のための抗体又は抗原結合部分、免疫結合体、又は医薬組成物。 23. The antibody or antigen binding moiety, immunity for use according to claim 27, wherein the fibrosis is myocardial infarction, angina, osteoarthritis, pulmonary fibrosis, cystic fibrosis, bronchitis or asthma. Bounds, or pharmaceutical compositions. 医薬品としての使用のための、請求項１から１８のいずれか一項に記載の抗体又は抗原結合部分、請求項１９又は２０に記載の免疫結合体、又は請求項２１に記載の医薬組成物。 The antibody or antigen-binding moiety according to any one of claims 1 to 18 , the immunoconjugate according to claim 19 or 20 , or the pharmaceutical composition according to claim 21 for use as a pharmaceutical product.
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