JPWO2020076970A5 - - Google Patents
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- JPWO2020076970A5 JPWO2020076970A5 JP2021520197A JP2021520197A JPWO2020076970A5 JP WO2020076970 A5 JPWO2020076970 A5 JP WO2020076970A5 JP 2021520197 A JP2021520197 A JP 2021520197A JP 2021520197 A JP2021520197 A JP 2021520197A JP WO2020076970 A5 JPWO2020076970 A5 JP WO2020076970A5
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- 125000003275 alpha amino acid group Chemical group 0.000 claims description 53
- 102100019456 CD276 Human genes 0.000 claims 87
- 101700015421 CD276 Proteins 0.000 claims 87
- 229920001184 polypeptide Polymers 0.000 claims 44
- 102000004965 antibodies Human genes 0.000 claims 22
- 108090001123 antibodies Proteins 0.000 claims 22
- 150000001413 amino acids Chemical class 0.000 claims 19
- 239000000427 antigen Substances 0.000 claims 10
- 102000038129 antigens Human genes 0.000 claims 10
- 108091007172 antigens Proteins 0.000 claims 10
- 230000001747 exhibiting Effects 0.000 claims 9
- 210000002865 immune cell Anatomy 0.000 claims 7
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 6
- 102000005962 receptors Human genes 0.000 claims 6
- 108020003175 receptors Proteins 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 5
- 229920000023 polynucleotide Polymers 0.000 claims 5
- 239000002157 polynucleotide Substances 0.000 claims 5
- 210000004027 cells Anatomy 0.000 claims 4
- 239000000203 mixture Substances 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 3
- 230000000139 costimulatory Effects 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 230000028993 immune response Effects 0.000 claims 2
- 230000001939 inductive effect Effects 0.000 claims 2
- 230000002401 inhibitory effect Effects 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 230000004936 stimulating Effects 0.000 claims 2
- 108010019670 Chimeric Antigen Receptors Proteins 0.000 claims 1
- 102100015541 FCGR3A Human genes 0.000 claims 1
- 101710044656 FCGR3A Proteins 0.000 claims 1
- 101710044657 FCGR3B Proteins 0.000 claims 1
- 102000018358 Immunoglobulins Human genes 0.000 claims 1
- 108060003951 Immunoglobulins Proteins 0.000 claims 1
- 210000001744 T-Lymphocytes Anatomy 0.000 claims 1
- 230000003213 activating Effects 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 102000003675 cytokine receptors Human genes 0.000 claims 1
- 108010057085 cytokine receptors Proteins 0.000 claims 1
- 150000002019 disulfides Chemical class 0.000 claims 1
- 230000004068 intracellular signaling Effects 0.000 claims 1
- 230000002147 killing Effects 0.000 claims 1
- 230000004048 modification Effects 0.000 claims 1
- 238000006011 modification reaction Methods 0.000 claims 1
- 230000035772 mutation Effects 0.000 claims 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 claims 1
- 230000002285 radioactive Effects 0.000 claims 1
- 101700073818 CDR1 Proteins 0.000 description 2
- 102100002977 CDR1 Human genes 0.000 description 2
- 108060001277 CDR2 Proteins 0.000 description 2
- 102100008744 CDR2 Human genes 0.000 description 2
- 101700027814 CDR3 Proteins 0.000 description 2
Description
いくつかの態様において、抗CD3ε結合ドメインは、
少なくともアミノ酸配列GFTFNTYAMN(SEQ ID NO:471)を含むVH CDR1配列;
少なくともアミノ酸配列RIRSKYNNYATY(SEQ ID NO:472)を含むVH CDR2配列;
少なくともアミノ酸配列HGNFGNSYVSWFAY (SEQ ID NO: 221)を含むVH CDR3配列;
少なくともアミノ酸配列RSSTGAVTTSNYAN (SEQ ID NO: 222)を含むVL CDR1配列;
少なくともアミノ酸配列GTNKRAP(SEQ ID NO:223)を含むVL CDR2配列;および
少なくともアミノ酸配列ALWYSNLWV(SEQ ID NO:224)を含むVL CDR3配列
を含む。
In some embodiments, the anti-CD3ε binding domain comprises
a VH CDR1 sequence comprising at least the amino acid sequence GFTNTYAMN (SEQ ID NO: 471);
a VH CDR2 sequence comprising at least the amino acid sequence RIRSKYNNYATY (SEQ ID NO: 472);
a VH CDR3 sequence comprising at least the amino acid sequence HGNFGNSYVSWFAY (SEQ ID NO: 221);
a VL CDR1 sequence comprising at least the amino acid sequence RSSTGAVTTSNYAN (SEQ ID NO: 222 );
a VL CDR2 sequence comprising at least the amino acid sequence GTNKRAP (SEQ ID NO: 223 ); and a VL CDR3 sequence comprising at least the amino acid sequence ALWYSNLWV (SEQ ID NO: 224 ).
Claims (50)
SEQ ID NO:146、147、148、149、150、151、152、153、154、155、156、157、158、159、160、161、162、163、164、165、166、および167からなる群より選択されるアミノ酸配列を含む相補性決定領域2(CDR2);ならびに
SEQ ID NO:168、169、170、171、172、173、174、175、176、177、178、179、180、181、182、183、184、185、186、187、188、189、および483~488からなる群より選択されるアミノ酸配列を含む相補性決定領域3(CDR3)
を含む少なくとも1つの重鎖のみの可変ドメイン(B7H3 VHHドメイン)
を含む、B7H3結合ポリペプチド構築物。 SEQ ID NOs: 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, complementarity determining region 1 (CDR1) comprising an amino acid sequence selected from the group consisting of 138, 139, 140, 141, 142, 143, 144, and 145;
SEQ ID NO: 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, and 167 a complementarity determining region 2 (CDR2) comprising an amino acid sequence selected from the group; and
SEQ ID NOs: 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, and 483 a complementarity determining region 3 (CDR3) comprising an amino acid sequence selected from the group consisting of -488
at least one heavy chain-only variable domain (B7H3 VHH domain) containing
A B7H3-binding polypeptide construct comprising:
SEQ ID NO:115、116、117、118、119、120、121、および122からなる群より選択されるアミノ酸配列を含むCDR1;
SEQ ID NO:146、147、148、149、150、および151からなる群より選択されるアミノ酸配列を含むCDR2;ならびに
SEQ ID NO:168および169からなる群より選択されるアミノ酸配列を含むCDR3
を含む、かつ/または
(b)前記少なくとも1つのB7H3 VHHドメインが、
それぞれSEQ ID NO:115、146、および168;
それぞれSEQ ID NO:115、147、および168;
それぞれSEQ ID NO:115、148、および168;
それぞれSEQ ID NO:115、149、および168;
それぞれSEQ ID NO:115、150、および168;
それぞれSEQ ID NO:116、146、および168;
それぞれSEQ ID NO:117、146、および168;
それぞれSEQ ID NO:118、146、および168;
それぞれSEQ ID NO:115、146、および169;
それぞれSEQ ID NO:119、146、および168;
それぞれSEQ ID NO:120、146、および168;
それぞれSEQ ID NO:115、151、および168;
それぞれSEQ ID NO:116、147、および168;
それぞれSEQ ID NO:118、147、および168;
それぞれSEQ ID NO:119、147、および168;
それぞれSEQ ID NO:116、151、および168;
それぞれSEQ ID NO:115、146、および168;
それぞれSEQ ID NO:121、147、および168;
それぞれSEQ ID NO:115、146、および168;
それぞれSEQ ID NO:119、149、および168;もしくは
それぞれSEQ ID NO:122、151、および168
に示されるCDR1、CDR2、およびCDR3を含む、
請求項1~13のいずれか一項記載のB7H3結合ポリペプチド構築物。 (a) said at least one B7H3 VHH domain is
a CDR1 comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 115, 116, 117, 118, 119, 120 , 121 , and 122 ;
a CDR2 comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 146, 147, 148, 149, 150, and 151; and
SEQ ID NO: CDR3 comprising an amino acid sequence selected from the group consisting of 168 and 169
and/or
(b) said at least one B7H3 VHH domain is
SEQ ID NOs: 115, 146, and 168, respectively;
SEQ ID NOs: 115, 147, and 168, respectively;
SEQ ID NOs: 115, 148, and 168, respectively;
SEQ ID NOs: 115, 149, and 168, respectively;
SEQ ID NOs: 115, 150, and 168, respectively;
SEQ ID NOs: 116, 146, and 168, respectively;
SEQ ID NOs: 117, 146, and 168, respectively;
SEQ ID NOs: 118, 146, and 168, respectively;
SEQ ID NOs: 115, 146, and 169, respectively;
SEQ ID NOs: 119, 146, and 168, respectively;
SEQ ID NOs: 120, 146, and 168, respectively;
SEQ ID NOs: 115, 151, and 168, respectively;
SEQ ID NOs: 116, 147, and 168, respectively;
SEQ ID NOs: 118, 147, and 168, respectively;
SEQ ID NOs: 119, 147, and 168, respectively;
SEQ ID NOs: 116, 151, and 168, respectively;
SEQ ID NOs: 115, 146, and 168, respectively;
SEQ ID NOs: 121, 147, and 168, respectively;
SEQ ID NOs: 115, 146, and 168, respectively;
SEQ ID NOs: 119, 149, and 168, respectively; or
SEQ ID NOs: 122, 151, and 168, respectively
including CDR1, CDR2, and CDR3 shown in
A B7H3 binding polypeptide construct according to any one of claims 1-13 .
前記少なくとも1つのB7H3 VHHドメインが、SEQ ID NO:8~34、467、489~490、および492~497のいずれか1つに示されるアミノ酸の配列を含む、
請求項1~14のいずれか一項記載のB7H3結合ポリペプチド構築物。 said at least one B7H3 VHH domain is a sequence of amino acids set forth in any one of SEQ ID NOs: 8-34, 467, 489-490, and 492-497, or SEQ ID NOs: 8-34, 467; at least 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95% for any one of 489-490 and 492-497, comprises a sequence of amino acids exhibiting 96%, 97%, 98% or 99% sequence identity and binds to B7H3; and/or
said at least one B7H3 VHH domain comprises a sequence of amino acids set forth in any one of SEQ ID NOs: 8-34, 467, 489-490, and 492-497;
A B7H3 binding polypeptide construct according to any one of claims 1-14 .
SEQ ID NO:123に示されるアミノ酸配列を含むCDR1;
SEQ ID NO:152および153からなる群より選択されるアミノ酸配列を含むCDR2;ならびに
SEQ ID NO:170および171からなる群より選択されるアミノ酸配列を含むCDR3
を含む、かつ/または
(b)前記少なくとも1つのB7H3 VHHドメインが、
それぞれSEQ ID NO:123、152、および170;
それぞれSEQ ID NO:123、152、および171;
それぞれSEQ ID NO:123、153、および170;もしくは
それぞれSEQ ID NO:123、153、および171
に示されるCDR1、CDR2、およびCDR3を含む、
請求項1~12および16のいずれか一項記載のB7H3結合ポリペプチド構築物。 (a) said at least one B7H3 VHH domain is
a CDR1 comprising the amino acid sequence shown in SEQ ID NO:123;
a CDR2 comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 152 and 153; and
SEQ ID NO: CDR3 comprising an amino acid sequence selected from the group consisting of 170 and 171
and/or
(b) said at least one B7H3 VHH domain is
SEQ ID NOs: 123, 152, and 170, respectively;
SEQ ID NOs: 123, 152, and 171, respectively;
SEQ ID NOs: 123, 153, and 170, respectively; or
SEQ ID NOs: 123, 153, and 171, respectively
including CDR1, CDR2, and CDR3 shown in
A B7H3 binding polypeptide construct according to any one of claims 1-12 and 16 .
SEQ ID NO:124、125、126、127、128、129、130、131、132、および133からなる群より選択されるアミノ酸配列を含むCDR1;
SEQ ID NO:154に示されるアミノ酸配列を含むCDR2;ならびに
SEQ ID NO:172、173、174、175、176、177、178、179、180、181、182、および183からなる群より選択されるアミノ酸配列を含むCDR3
を含む、かつ/または
(b)前記少なくとも1つのB7H3 VHHドメインが、
それぞれSEQ ID NO:124、154、および172;
それぞれSEQ ID NO:124、154、および173;
それぞれSEQ ID NO:124、154、および174;
それぞれSEQ ID NO:124、154、および175;
それぞれSEQ ID NO:125、154、および173;
それぞれSEQ ID NO:126、154、および173;
それぞれSEQ ID NO:127、154、および173;
それぞれSEQ ID NO:128、154、および173;
それぞれSEQ ID NO:129、154、および173;
それぞれSEQ ID NO:130、154、および173;
それぞれSEQ ID NO:131、154、および173;
それぞれSEQ ID NO:124、154、および176;
それぞれSEQ ID NO:124、154、および177;
それぞれSEQ ID NO:124、154、および178;
それぞれSEQ ID NO:124、154、および179;
それぞれSEQ ID NO:124、154、および180;
それぞれSEQ ID NO:124、154、および181;
それぞれSEQ ID NO:124、154、および182;
それぞれSEQ ID NO:124、154、および183;
それぞれSEQ ID NO:126、154、および176;
それぞれSEQ ID NO:124、154、および179;
それぞれSEQ ID NO:124、154、および182;
それぞれSEQ ID NO:132、154、および176;もしくは
それぞれSEQ ID NO:133、154、および173
に示されるCDR1、CDR2、およびCDR3を含む、
請求項1~12および19のいずれか一項記載のB7H3結合ポリペプチド構築物。 (a) said at least one B7H3 VHH domain is
a CDR1 comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 124, 125, 126, 127, 128, 129, 130, 131, 132, and 133;
a CDR2 comprising the amino acid sequence shown in SEQ ID NO:154; and
a CDR3 comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, and 183
and/or
(b) said at least one B7H3 VHH domain is
SEQ ID NOs: 124, 154, and 172, respectively;
SEQ ID NOs: 124, 154, and 173, respectively;
SEQ ID NOs: 124, 154, and 174, respectively;
SEQ ID NOs: 124, 154, and 175, respectively;
SEQ ID NOs: 125, 154, and 173, respectively;
SEQ ID NOs: 126, 154, and 173, respectively;
SEQ ID NOs: 127, 154, and 173, respectively;
SEQ ID NOs: 128, 154, and 173, respectively;
SEQ ID NOs: 129, 154, and 173, respectively;
SEQ ID NOs: 130, 154, and 173, respectively;
SEQ ID NOs: 131, 154, and 173, respectively;
SEQ ID NOs: 124, 154, and 176, respectively;
SEQ ID NOs: 124, 154, and 177, respectively;
SEQ ID NOs: 124, 154, and 178, respectively;
SEQ ID NOs: 124, 154, and 179, respectively;
SEQ ID NOs: 124, 154, and 180, respectively;
SEQ ID NOs: 124, 154, and 181, respectively;
SEQ ID NOs: 124, 154, and 182, respectively;
SEQ ID NOs: 124, 154, and 183, respectively;
SEQ ID NOs: 126, 154, and 176, respectively;
SEQ ID NOs: 124, 154, and 179, respectively;
SEQ ID NOs: 124, 154, and 182, respectively;
SEQ ID NOs: 132, 154, and 176, respectively; or
SEQ ID NOs: 133, 154, and 173, respectively
including CDR1, CDR2, and CDR3 shown in
A B7H3 binding polypeptide construct according to any one of claims 1-12 and 19 .
SEQ ID NO:145に示されるアミノ酸配列を含むCDR1;
SEQ ID NO:167に示されるアミノ酸配列を含むCDR2;ならびに
SEQ ID NO:488に示されるアミノ酸配列を含むCDR3
を含む、請求項1~12および22のいずれか一項記載のB7H3結合ポリペプチド構築物。 said at least one B7H3 VHH domain is
a CDR1 comprising the amino acid sequence shown in SEQ ID NO:145;
a CDR2 comprising the amino acid sequence shown in SEQ ID NO:167; and
CDR3 comprising the amino acid sequence shown in SEQ ID NO:488
The B7H3-binding polypeptide construct of any one of claims 1-12 and 22 , comprising:
SEQ ID NO:139に示されるアミノ酸配列を含むCDR1;
SEQ ID NO:161に示されるアミノ酸配列を含むCDR2;ならびに
SEQ ID NO:189に示されるアミノ酸配列を含むCDR3
を含む、請求項1~12および25のいずれか一項記載のB7H3結合ポリペプチド構築物。 said at least one B7H3 VHH domain is
a CDR1 comprising the amino acid sequence shown in SEQ ID NO:139;
a CDR2 comprising the amino acid sequence shown in SEQ ID NO:161; and
CDR3 comprising the amino acid sequence shown in SEQ ID NO:189
The B7H3-binding polypeptide construct of any one of claims 1-12 and 25 , comprising:
を含み、
抗CD3抗体または抗原結合断片を構成するVHおよびVLが、ヘテロ二量体Fcの相対するポリペプチドに連結されており;
第1および第2の構成要素が、リンカーによってカップリングされ、へテロ二量体Fc領域が、抗CD3抗体または抗原結合断片のアミノ末端に位置づけられ;かつ
第1および第2の構成要素の一方または両方が、前記少なくとも1つのB7H3 VHHドメインを含む、
請求項1~27のいずれか一項記載のB7H3結合ポリペプチド構築物。 (a) a first component comprising a heterodimeric Fc region comprising a first Fc polypeptide and a second Fc polypeptide, and (b) a variable heavy chain region (VH) and a variable light chain region a second component comprising an anti- CD3 antibody or antigen-binding fragment comprising (VL) and
the VH and VL that make up the anti-CD3 antibody or antigen-binding fragment are linked to opposing polypeptides of the heterodimeric Fc;
the first and second components are coupled by a linker and the heterodimeric Fc region is positioned at the amino terminus of the anti-CD3 antibody or antigen-binding fragment ; and one of the first and second components or both comprise said at least one B7H3 VHH domain ,
28. The B7H3 binding polypeptide construct of any one of claims 1-27 .
アミノ酸配列TYAMN(SEQ ID NO:219)を含むVH CDR1;
アミノ酸配列RIRSKYNNYATYYADSVKD (SEQ ID NO: 220)を含むVH CDR2;
アミノ酸配列HGNFGNSYVSWFAY (SEQ ID NO: 221)を含むVH CDR3、
アミノ酸配列RSSTGAVTTSNYAN (SEQ ID NO: 222)を含むVL CDR1;
アミノ酸配列GTNKRAP(SEQ ID NO:223)を含むVL CDR2;および
アミノ酸配列ALWYSNLWV(SEQ ID NO:224)を含むVL CDR3
を含む、
(b)前記抗CD3抗体もしくは抗原結合断片が、
アミノ酸配列GFTFNTYAMN(SEQ ID NO:471)を含むVH CDR1;
アミノ酸配列RIRSKYNNYATY(SEQ ID NO:472)を含むVH CDR2;
アミノ酸配列HGNFGNSYVSWFAY (SEQ ID NO: 221)を含むVH CDR3、
アミノ酸配列RSSTGAVTTSNYAN (SEQ ID NO: 222)を含むVL CDR1;
アミノ酸配列GTNKRAP(SEQ ID NO:223)を含むVL CDR2;および
アミノ酸配列ALWYSNLWV(SEQ ID NO:224)を含むVL CDR3
を含む、
(c)前記抗CD3抗体もしくは抗原結合断片が、
アミノ酸配列GFTFNTYAMN(SEQ ID NO:471)を含むVH CDR1;
アミノ酸配列RIRSKYNNYATY(SEQ ID NO:472)を含むVH CDR2;
アミノ酸配列HGNFGNSYVSWFAY (SEQ ID NO: 221)を含むVH CDR3、
アミノ酸配列GSSTGAVTTSNYAN (SEQ ID NO: 478)を含むVL CDR1;
アミノ酸配列GTNKRAP(SEQ ID NO:223)を含むVL CDR2;および
アミノ酸配列ALWYSNHWV(SEQ ID NO:474)を含むVL CDR3
を含む、
(d)前記抗CD3抗体もしくは抗原結合断片が、
アミノ酸配列GFTFSTYAMN(SEQ ID NO:476)を含むVH CDR1;
アミノ酸配列RIRSKYNNYATY(SEQ ID NO:477)を含むVH CDR2;
アミノ酸配列HGNFGDSYVSWFAY (SEQ ID NO: 473)を含むVH CDR3、
アミノ酸配列GSSTGAVTTSNYAN (SEQ ID NO: 478)を含むVL CDR1;
アミノ酸配列GTNKRAP(SEQ ID NO:223)を含むVL CDR2;および
アミノ酸配列ALWYSNHWV(SEQ ID NO:474)を含むVL CDR3
を含む、かつ/または
(e)抗CD3抗体もしくは抗原結合断片が、
SEQ ID NO:225~255、480、460、もしくは462のいずれかのアミノ酸配列、もしくはSEQ ID NO:225~255、480、460、もしくは462のいずれかに対して少なくとも90%、91%、92%、93%、94%、95%、96%、97%、98%、もしくは99%の配列同一性を示す配列を有し、かつCD3に結合するVH;および、
SEQ ID NO:256~274、417、459、もしくは461のいずれかのアミノ酸配列、またはSEQ ID NO:256~274、417、459、もしくは461のいずれかに対して少なくとも90%、91%、92%、93%、94%、95%、96%、97%、98%、もしくは99%の配列同一性を示す配列を有し、かつCD3に結合するVL
を含む、
請求項28~31のいずれか一項記載のB7H3結合ポリペプチド構築物。 (a) the anti-CD3 antibody or antigen-binding fragment is
VH CDR1 comprising the amino acid sequence TYAMN (SEQ ID NO: 219);
VH CDR2 comprising the amino acid sequence RIRSKYNNYATYYADSVKD (SEQ ID NO: 220);
a VH CDR3 comprising the amino acid sequence HGNFGNSYVSWFAY (SEQ ID NO: 221);
VL CDR1 comprising the amino acid sequence RSSTGAVTTSNYAN (SEQ ID NO: 222);
VL CDR2 comprising the amino acid sequence GTNKRAP (SEQ ID NO:223); and VL CDR3 comprising the amino acid sequence ALWYSNLWV (SEQ ID NO:224).
including,
(b) the anti-CD3 antibody or antigen-binding fragment is
VH CDR1 comprising the amino acid sequence GFTNTYAMN (SEQ ID NO: 471);
VH CDR2 comprising the amino acid sequence RIRSKYNNYATY (SEQ ID NO: 472);
a VH CDR3 comprising the amino acid sequence HGNFGNSYVSWFAY (SEQ ID NO: 221);
VL CDR1 comprising the amino acid sequence RSSTGAVTTSNYAN (SEQ ID NO: 222);
VL CDR2 comprising the amino acid sequence GTNKRAP (SEQ ID NO: 223); and
VL CDR3 containing the amino acid sequence ALWYSNLWV (SEQ ID NO: 224)
including,
(c) the anti-CD3 antibody or antigen-binding fragment is
VH CDR1 comprising the amino acid sequence GFTNTYAMN (SEQ ID NO: 471);
VH CDR2 comprising the amino acid sequence RIRSKYNNYATY (SEQ ID NO: 472);
a VH CDR3 comprising the amino acid sequence HGNFGNSYVSWFAY (SEQ ID NO: 221);
VL CDR1 comprising the amino acid sequence GSSTGAVTTSNYAN (SEQ ID NO: 478);
VL CDR2 comprising the amino acid sequence GTNKRAP (SEQ ID NO: 223); and
VL CDR3 containing the amino acid sequence ALWYSNHWV (SEQ ID NO: 474)
including,
(d) the anti-CD3 antibody or antigen-binding fragment is
VH CDR1 comprising the amino acid sequence GFTFSTYAMN (SEQ ID NO: 476);
VH CDR2 comprising the amino acid sequence RIRSKYNNYATY (SEQ ID NO: 477);
a VH CDR3 comprising the amino acid sequence HGNFGDSYVSWFAY (SEQ ID NO: 473);
VL CDR1 comprising the amino acid sequence GSSTGAVTTSNYAN (SEQ ID NO: 478);
VL CDR2 comprising the amino acid sequence GTNKRAP (SEQ ID NO: 223); and
VL CDR3 containing the amino acid sequence ALWYSNHWV (SEQ ID NO: 474)
and/or
(e) an anti-CD3 antibody or antigen-binding fragment,
amino acid sequence of any of SEQ ID NOs: 225-255, 480, 460, or 462 or at least 90%, 91%, 92 of any of SEQ ID NOs: 225-255, 480, 460, or 462 VHs having sequences exhibiting %, 93%, 94%, 95%, 96%, 97%, 98%, or 99% sequence identity and that bind to CD3; and
amino acid sequence of any of SEQ ID NOs: 256-274, 417, 459, or 461 or at least 90%, 91%, 92 of any of SEQ ID NOs: 256-274, 417, 459, or 461 VL having a sequence exhibiting %, 93%, 94%, 95%, 96%, 97%, 98% or 99% sequence identity and that binds to CD3
including,
32. The B7H3 binding polypeptide construct of any one of claims 28-31 .
前記第1および前記第2の構成要素の一方または両方が、抑制性受容体に結合する少なくとも1つの抑制性受容体結合領域(IRBR)を含む、
請求項28~34のいずれか一項記載のB7H3結合ポリペプチド構築物。 one or both of said first and said second components comprise at least one costimulatory receptor binding region (CRBR) that binds to a costimulatory receptor; and/or
one or both of said first and said second components comprises at least one inhibitory receptor binding region (IRBR) that binds to an inhibitory receptor;
A B7H3 binding polypeptide construct according to any one of claims 28-34 .
SEQ ID NO:146、147、148、149、150、151、152、153、154、155、156、157、158、159、160、161、162、163、164、165、166、および167からなる群より選択されるアミノ酸配列を含む相補性決定領域2(CDR2);ならびに
SEQ ID NO:168、169、170、171、172、173、174、175、176、177、178、179、180、181、182、183、184、185、186、187、188、189、および483~488からなる群より選択されるアミノ酸配列を含む相補性決定領域3(CDR3)
を含む、B7H3に結合する単離されたシングルドメイン抗体(sdAb)。 SEQ ID NOs: 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, complementarity determining region 1 (CDR1) comprising an amino acid sequence selected from the group consisting of 138, 139, 140, 141, 142, 143, 144, and 145;
SEQ ID NO: 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, and 167 a complementarity determining region 2 (CDR2) comprising an amino acid sequence selected from the group; and
SEQ ID NOs: 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, and 483 a complementarity determining region 3 (CDR3) comprising an amino acid sequence selected from the group consisting of -488
An isolated single domain antibody (sdAb) that binds to B7H3, comprising:
それぞれSEQ ID NO:115、146、および168;
それぞれSEQ ID NO:115、147、および168;
それぞれSEQ ID NO:115、148、および168;
それぞれSEQ ID NO:115、149、および168;
それぞれSEQ ID NO:115、150、および168;
それぞれSEQ ID NO:116、146、および168;
それぞれSEQ ID NO:117、146、および168;
それぞれSEQ ID NO:118、146、および168;
それぞれSEQ ID NO:115、146、および169;
それぞれSEQ ID NO:119、146、および168;
それぞれSEQ ID NO:120、146、および168;
それぞれSEQ ID NO:115、151、および168;
それぞれSEQ ID NO:116、147、および168;
それぞれSEQ ID NO:118、147、および168;
それぞれSEQ ID NO:119、147、および168;
それぞれSEQ ID NO:116、151、および168;
それぞれSEQ ID NO:115、146、および168;
それぞれSEQ ID NO:121、147、および168;
それぞれSEQ ID NO:115、146、および168;
それぞれSEQ ID NO:119、149、および168;
それぞれSEQ ID NO:122、151、および168;
それぞれSEQ ID NO:123、152、および170;
それぞれSEQ ID NO:123、152、および171;
それぞれSEQ ID NO:123、153、および170;
それぞれSEQ ID NO:123、153、および171;
それぞれSEQ ID NO:124、154、および172;
それぞれSEQ ID NO:124、154、および173;
それぞれSEQ ID NO:124、154、および174;
それぞれSEQ ID NO:124、154、および175;
それぞれSEQ ID NO:125、154、および173;
それぞれSEQ ID NO:126、154、および173;
それぞれSEQ ID NO:127、154、および173;
それぞれSEQ ID NO:128、154、および173;
それぞれSEQ ID NO:129、154、および173;
それぞれSEQ ID NO:130、154、および173;
それぞれSEQ ID NO:131、154、および173;
それぞれSEQ ID NO:124、154、および176;
それぞれSEQ ID NO:124、154、および177;
それぞれSEQ ID NO:124、154、および178;
それぞれSEQ ID NO:124、154、および179;
それぞれSEQ ID NO:124、154、および180;
それぞれSEQ ID NO:124、154、および181;
それぞれSEQ ID NO:124、154、および182;
それぞれSEQ ID NO:124、154、および183;
それぞれSEQ ID NO:126、154、および176;
それぞれSEQ ID NO:124、154、および179;
それぞれSEQ ID NO:124、154、および182;
それぞれSEQ ID NO:132、154、および176;
それぞれSEQ ID NO:133、154、および173;
それぞれSEQ ID NO:145、167、および488;
それぞれSEQ ID NO:139、161、および189;
それぞれSEQ ID NO:134、155、および184;
それぞれSEQ ID NO:135、156、および168;
それぞれSEQ ID NO:136、157、および185;
それぞれSEQ ID NO:137、158、および186;
それぞれSEQ ID NO:138、159、および187;
それぞれSEQ ID NO:138、160、および188;
それぞれSEQ ID NO:139、161、および189;
それぞれSEQ ID NO:140、162、および483;
それぞれSEQ ID NO:141、163、および484;
それぞれSEQ ID NO:139、161、および189;
それぞれSEQ ID NO:142、164、および485;
それぞれSEQ ID NO:143、165、および486;または
それぞれSEQ ID NO:144、166、および487
に示されるCDR1、CDR2、およびCDR3
を含む、請求項37記載の単離されたシングルドメイン抗体。 said sdAb is
SEQ ID NOs: 115, 146, and 168, respectively;
SEQ ID NOs: 115, 147, and 168, respectively;
SEQ ID NOs: 115, 148, and 168, respectively;
SEQ ID NOs: 115, 149, and 168, respectively;
SEQ ID NOs: 115, 150, and 168, respectively;
SEQ ID NOs: 116, 146, and 168, respectively;
SEQ ID NOs: 117, 146, and 168, respectively;
SEQ ID NOs: 118, 146, and 168, respectively;
SEQ ID NOs: 115, 146, and 169, respectively;
SEQ ID NOs: 119, 146, and 168, respectively;
SEQ ID NOs: 120, 146, and 168, respectively;
SEQ ID NOs: 115, 151, and 168, respectively;
SEQ ID NOs: 116, 147, and 168, respectively;
SEQ ID NOs: 118, 147, and 168, respectively;
SEQ ID NOs: 119, 147, and 168, respectively;
SEQ ID NOs: 116, 151, and 168, respectively;
SEQ ID NOs: 115, 146, and 168, respectively;
SEQ ID NOs: 121, 147, and 168, respectively;
SEQ ID NOs: 115, 146, and 168, respectively;
SEQ ID NOs: 119, 149, and 168, respectively;
SEQ ID NOs: 122, 151, and 168, respectively ;
SEQ ID NOs: 123, 152, and 170, respectively;
SEQ ID NOs: 123, 152, and 171, respectively;
SEQ ID NOs: 123, 153, and 170, respectively;
SEQ ID NOs: 123, 153, and 171, respectively;
SEQ ID NOs: 124, 154, and 172, respectively;
SEQ ID NOs: 124, 154, and 173, respectively;
SEQ ID NOs: 124, 154, and 174, respectively;
SEQ ID NOs: 124, 154, and 175, respectively;
SEQ ID NOs: 125, 154, and 173, respectively;
SEQ ID NOs: 126, 154, and 173, respectively;
SEQ ID NOs: 127, 154, and 173, respectively;
SEQ ID NOs: 128, 154, and 173, respectively;
SEQ ID NOs: 129, 154, and 173, respectively;
SEQ ID NOs: 130, 154, and 173, respectively;
SEQ ID NOs: 131, 154, and 173, respectively;
SEQ ID NOs: 124, 154, and 176, respectively;
SEQ ID NOs: 124, 154, and 177, respectively;
SEQ ID NOs: 124, 154, and 178, respectively;
SEQ ID NOs: 124, 154, and 179, respectively;
SEQ ID NOs: 124, 154, and 180, respectively;
SEQ ID NOs: 124, 154, and 181, respectively;
SEQ ID NOs: 124, 154, and 182, respectively;
SEQ ID NOs: 124, 154, and 183, respectively;
SEQ ID NOs: 126, 154, and 176, respectively;
SEQ ID NOs: 124, 154, and 179, respectively;
SEQ ID NOs: 124, 154, and 182, respectively;
SEQ ID NOs: 132, 154, and 176, respectively;
SEQ ID NOs: 133, 154, and 173, respectively;
SEQ ID NOs: 145, 167, and 488, respectively;
SEQ ID NOs: 139, 161, and 189, respectively;
SEQ ID NOs: 134, 155, and 184, respectively;
SEQ ID NOs: 135, 156, and 168, respectively;
SEQ ID NOs: 136, 157, and 185, respectively;
SEQ ID NOs: 137, 158, and 186, respectively;
SEQ ID NOs: 138, 159, and 187, respectively;
SEQ ID NOs: 138, 160, and 188, respectively;
SEQ ID NOs: 139, 161, and 189, respectively;
SEQ ID NOs: 140, 162, and 483, respectively;
SEQ ID NOs: 141, 163, and 484, respectively;
SEQ ID NOs: 139, 161, and 189, respectively;
SEQ ID NOs: 142, 164, and 485, respectively;
SEQ ID NOs: 143, 165, and 486, respectively; or
SEQ ID NOs: 144, 166, and 487, respectively
CDR1, CDR2, and CDR3 shown in
38. The isolated single domain antibody of claim 37 , comprising:
SEQ ID NO:8~34、467、489~490、および492~497のいずれか1つに示されるアミノ酸の配列、もしくはSEQ ID NO:8~34、467、489~490、および492~497のいずれか1つに対して少なくとも85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、もしくは99%の配列同一性を示すアミノ酸の配列を含み、かつB7H3に結合する;
SEQ ID NO:40、41、および498~503のいずれか1つに示されるアミノ酸の配列、もしくはSEQ ID NO:40、41、および498~503のいずれか1つに対して少なくとも85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、もしくは99%の配列同一性を示すアミノ酸の配列を含み、かつB7H3に結合する;
SEQ ID NO:56~91、466、および504~514のいずれか1つに示されるアミノ酸の配列、もしくはSEQ ID NO:56~91、466、および504~514のいずれか1つに対して少なくとも85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、もしくは99%の配列同一性を示すアミノ酸の配列を含み、かつB7H3に結合する;
SEQ ID NO:106~109のいずれか1つに示されるアミノ酸の配列、もしくはSEQ ID NO:106~109のいずれか1つに対して少なくとも85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、もしくは99%の配列同一性を示すアミノ酸の配列を含み、かつB7H3に結合する;かつ/または
SEQ ID NO:515~518のいずれか1つに示されるアミノ酸の配列、またはSEQ ID NO:515~518のいずれか1つに対して少なくとも85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、もしくは99%の配列同一性を示すアミノ酸の配列を含み、かつB7H3に結合する、
請求項37または38記載の単離されたシングルドメイン抗体。 said sdAb is
A sequence of amino acids set forth in any one of SEQ ID NOs: 8-34, 467, 489-490, and 492-497, or a sequence of SEQ ID NOs: 8-34, 467, 489-490, and 492-497 at least 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% of any one; or comprises a sequence of amino acids exhibiting 99% sequence identity and binds to B7H3 ;
A sequence of amino acids set forth in any one of SEQ ID NOs: 40, 41, and 498-503, or at least 85% of any one of SEQ ID NOs: 40, 41, and 498-503, 86 A sequence of amino acids exhibiting %, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% sequence identity and binds to B7H3;
A sequence of amino acids set forth in any one of SEQ ID NOs: 56-91, 466, and 504-514, or at least for any one of SEQ ID NOs: 56-91, 466, and 504-514 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% sequence identity contains the sequence of amino acids shown and binds to B7H3;
A sequence of amino acids set forth in any one of SEQ ID NOs: 106-109 or at least 85%, 86%, 87%, 88%, 89% of any one of SEQ ID NOs: 106-109 , comprising a sequence of amino acids exhibiting 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% sequence identity and binds to B7H3; and /or
A sequence of amino acids set forth in any one of SEQ ID NOs: 515-518 or at least 85%, 86%, 87%, 88%, 89% of any one of SEQ ID NOs: 515-518 , comprising a sequence of amino acids exhibiting 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, or 99% sequence identity and binds to B7H3;
39. The isolated single domain antibody of claim 37 or 38 .
請求項40または41記載の1つもしくは複数のポリヌクレオチド、または請求項42記載の1つもしくは複数のベクターを細胞中に導入する工程、および
B7H3結合ポリペプチド構築物を産生する条件下で該細胞を培養する工程
を含む、前記方法。 A method of producing a polypeptide, comprising:
introducing into a cell one or more polynucleotides according to claim 40 or 41 or one or more vectors according to claim 42 ; and
culturing the cell under conditions that produce the B7H3-binding polypeptide construct .
膜貫通ドメイン;および
細胞内シグナル伝達ドメイン
を含むキメラ抗原受容体を含む、操作された免疫細胞。 an extracellular domain comprising the single domain antibody of any one of claims 37-39 ;
engineered immune cells comprising a chimeric antigen receptor comprising a transmembrane domain; and an intracellular signaling domain.
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