JPWO2019238882A5 - - Google Patents

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JPWO2019238882A5
JPWO2019238882A5 JP2020568955A JP2020568955A JPWO2019238882A5 JP WO2019238882 A5 JPWO2019238882 A5 JP WO2019238882A5 JP 2020568955 A JP2020568955 A JP 2020568955A JP 2020568955 A JP2020568955 A JP 2020568955A JP WO2019238882 A5 JPWO2019238882 A5 JP WO2019238882A5
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amino acid
acid sequence
seq
antigen
binding molecule
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JP2021535733A (en
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Priority claimed from GBGB1809699.0A external-priority patent/GB201809699D0/en
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Priority to JP2024076402A priority Critical patent/JP2024105466A/en
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Claims (27)

ＩＬ－１１に結合することが可能であり、
（ｉ）以下のＣＤＲ：
配列番号３７のアミノ酸配列を有するＨＣ－ＣＤＲ１
配列番号３８のアミノ酸配列を有するＨＣ－ＣＤＲ２
配列番号４０のアミノ酸配列を有するＨＣ－ＣＤＲ３
を組み込んだ重鎖可変（ＶＨ）領域；および
（ｉｉ）以下のＣＤＲ：
配列番号４２のアミノ酸配列を有するＬＣ－ＣＤＲ１
配列番号４５のアミノ酸配列を有するＬＣ－ＣＤＲ２
配列番号８１のアミノ酸配列を有するＬＣ－ＣＤＲ３
を組み込んだ軽鎖可変（ＶＬ）領域
を含む抗原結合性分子。 It is possible to bind to IL-11 and
(I) The following CDR:
HC-CDR1 having the amino acid sequence of SEQ ID NO: 37
HC-CDR2 having the amino acid sequence of SEQ ID NO: 38
HC-CDR3 having the amino acid sequence of SEQ ID NO: 40
Heavy chain variable (VH) region incorporating the; and (ii) CDRs below:
LC-CDR1 having the amino acid sequence of SEQ ID NO: 42
LC-CDR2 having the amino acid sequence of SEQ ID NO: 45
LC-CDR3 having the amino acid sequence of SEQ ID NO: 81
An antigen-binding molecule containing a light chain variable (VL) region incorporating. （ｉ）以下のＣＤＲ：
配列番号３７のアミノ酸配列を有するＨＣ－ＣＤＲ１
配列番号３８のアミノ酸配列を有するＨＣ－ＣＤＲ２
配列番号４０のアミノ酸配列を有するＨＣ－ＣＤＲ３
を組み込んだ重鎖可変（ＶＨ）領域；および
（ｉｉ）以下のＣＤＲ：
配列番号４２のアミノ酸配列を有するＬＣ－ＣＤＲ１
配列番号４５のアミノ酸配列を有するＬＣ－ＣＤＲ２
配列番号５７のアミノ酸配列を有するＬＣ－ＣＤＲ３
を組み込んだ軽鎖可変（ＶＬ）領域
を含む、請求項１に記載の抗原結合性分子。 (I) The following CDR:
HC-CDR1 having the amino acid sequence of SEQ ID NO: 37
HC-CDR2 having the amino acid sequence of SEQ ID NO: 38
HC-CDR3 having the amino acid sequence of SEQ ID NO: 40
Heavy chain variable (VH) region incorporating the; and (ii) CDRs below:
LC-CDR1 having the amino acid sequence of SEQ ID NO: 42
LC-CDR2 having the amino acid sequence of SEQ ID NO: 45
LC-CDR3 having the amino acid sequence of SEQ ID NO: 57
The antigen-binding molecule according to claim 1, which comprises a light chain variable (VL) region incorporating the above. 配列番号８のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＨ領域；および
配列番号８３のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＬ領域
を含む、請求項１または請求項２に記載の抗原結合性分子。 A VH region containing an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 8; and an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 83. The antigen-binding molecule according to claim 1 or 2, which comprises a VL region. 配列番号８のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＨ領域；および
配列番号２０のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＬ領域
を含む、請求項３に記載の抗原結合性分子。 A VH region containing an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 8; and an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 20. The antigen-binding molecule according to claim 3, which comprises a VL region. ＩＬ－１１に結合することが可能であり、
（ｉ）以下のＣＤＲ：
配列番号９５のアミノ酸配列を有するＨＣ－ＣＤＲ１
配列番号９６のアミノ酸配列を有するＨＣ－ＣＤＲ２
配列番号９７のアミノ酸配列を有するＨＣ－ＣＤＲ３、または
ＨＣ－ＣＤＲ１、ＨＣ－ＣＤＲ２、ＨＣ－ＣＤＲ３のうちの１つ以上において、１つ、２つもしくは３つのアミノ酸が別のアミノ酸で置換された前記ＣＤＲの変異体
を組み込んだ重鎖可変（ＶＨ）領域；および
（ｉｉ）以下のＣＤＲ：
配列番号１０１のアミノ酸配列を有するＬＣ－ＣＤＲ１
配列番号１０２のアミノ酸配列を有するＬＣ－ＣＤＲ２
配列番号１０３のアミノ酸配列を有するＬＣ－ＣＤＲ３、または
ＬＣ－ＣＤＲ１、ＬＣ－ＣＤＲ２、ＬＣ－ＣＤＲ３のうちの１つ以上において、１つ、２つもしくは３つのアミノ酸が別のアミノ酸で置換された前記ＣＤＲの変異体
を組み込んだ軽鎖可変（ＶＬ）領域
を含む抗原結合性分子。 It is possible to bind to IL-11 and
(I) The following CDR:
HC-CDR1 having the amino acid sequence of SEQ ID NO: 95
HC-CDR2 having the amino acid sequence of SEQ ID NO: 96
HC-CDR3 having the amino acid sequence of SEQ ID NO: 97 , or
A variant of the CDR in which one, two or three amino acids are replaced with another amino acid in one or more of HC-CDR1, HC-CDR2 and HC-CDR3.
Heavy chain variable (VH) region incorporating the; and (ii) CDRs below:
LC-CDR1 having the amino acid sequence of SEQ ID NO: 101
LC-CDR2 having the amino acid sequence of SEQ ID NO: 102
LC-CDR3 having the amino acid sequence of SEQ ID NO: 103 , or
A variant of the CDR in which one, two or three amino acids are replaced with another amino acid in one or more of LC-CDR1, LC-CDR2 and LC-CDR3.
An antigen-binding molecule containing a light chain variable (VL) region incorporating. （ｉ）以下のＣＤＲ：(I) The following CDR:
配列番号９５のアミノ酸配列を有するＨＣ－ＣＤＲ１HC-CDR1 having the amino acid sequence of SEQ ID NO: 95
配列番号９６のアミノ酸配列を有するＨＣ－ＣＤＲ２HC-CDR2 having the amino acid sequence of SEQ ID NO: 96
配列番号９７のアミノ酸配列を有するＨＣ－ＣＤＲ３HC-CDR3 having the amino acid sequence of SEQ ID NO: 97
を組み込んだＶＨ領域；およびVH region incorporating; and
（ｉｉ）以下のＣＤＲ：(Ii) The following CDR:
配列番号１０１のアミノ酸配列を有するＬＣ－ＣＤＲ１LC-CDR1 having the amino acid sequence of SEQ ID NO: 101
配列番号１０２のアミノ酸配列を有するＬＣ－ＣＤＲ２LC-CDR2 having the amino acid sequence of SEQ ID NO: 102
配列番号１０３のアミノ酸配列を有するＬＣ－ＣＤＲ３LC-CDR3 having the amino acid sequence of SEQ ID NO: 103
を組み込んだＶＬ領域VL area incorporating
を含む、請求項５に記載の抗原結合性分子。5. The antigen-binding molecule according to claim 5. 配列番号９２、１１６、１１７、１１８、１１９、または１２０のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＨ領域；および
配列番号９４、１２１、１２２、１２３、１２４、１２５、１２６、１２７、または１２８のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＬ領域
を含む、請求項５または６に記載の抗原結合性分子。 A VH region comprising an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 92, 116, 117, 118, 119, or 120; and SEQ ID NOs: 94, 121, 122, 123, 124, The antigen-binding molecule of claim 5 or 6 , comprising a VL region comprising an amino acid sequence having at least 70% sequence identity to the amino acid sequence of 125, 126, 127, or 128. 配列番号９２、１１６、１１７、１１８、１１９、または１２０のアミノ酸配列に対して少なくとも９０％の配列同一性を有するアミノ酸配列を含むＶＨ領域；およびA VH region comprising an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 92, 116, 117, 118, 119, or 120; and
配列番号９４、１２１、１２２、１２３、１２４、１２５、１２６、１２７、または１２８のアミノ酸配列に対して少なくとも９０％の配列同一性を有するアミノ酸配列を含むＶＬ領域A VL region containing an amino acid sequence having at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 94, 121, 122, 123, 124, 125, 126, 127, or 128.
を含む、請求項５～７のいずれか一項に記載の抗原結合性分子。The antigen-binding molecule according to any one of claims 5 to 7, wherein the antigen-binding molecule comprises. 配列番号１１７のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＨ領域；および
配列番号１２２のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＬ領域
を含む、請求項５～７のいずれか一項に記載の抗原結合性分子。 A VH region containing an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 117; and an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 122. The antigen-binding molecule according to any one of claims 5 to 7 , which comprises a VL region. 配列番号１１７のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＨ領域；および
配列番号１２１のアミノ酸配列に対して少なくとも７０％の配列同一性を有するアミノ酸配列を含むＶＬ領域
を含む、請求項５～７のいずれか一項に記載の抗原結合性分子。 A VH region containing an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 117; and an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 121. The antigen-binding molecule according to any one of claims 5 to 7 , which comprises a VL region. ＩＬ－１１媒介性シグナル伝達を阻害することが可能である、請求項１～１０のいずれか一項に記載の抗原結合性分子。 The antigen-binding molecule according to any one of claims 1 to 10 , which is capable of inhibiting IL-11-mediated signal transduction. （ｉ）請求項１～１１のいずれか一項に記載の抗原結合性分子、および（ｉｉ）ＩＬ－１１以外の抗原に結合することが可能な抗原結合性分子を含む抗原結合性分子。 (I) An antigen-binding molecule comprising the antigen-binding molecule according to any one of claims 1 to 11 and (ii) an antigen-binding molecule capable of binding to an antigen other than IL-11 . ＩＬ－１１またはＩＬ－１１を含む複合体と、ＩＬ－１１受容体との相互作用を阻害することが可能である、請求項１～１２のいずれか一項に記載の抗原結合性分子。 The antigen-binding molecule according to any one of claims 1 to 12 , which is capable of inhibiting the interaction between the complex containing IL-11 or IL-11 and the IL-11 receptor. 請求項１～１３のいずれか一項に記載の抗原結合性分子を含むキメラ抗原受容体（ＣＡＲ）。 A chimeric antigen receptor (CAR) comprising the antigen-binding molecule according to any one of claims 1 to 13 . 請求項１～１３のいずれか一項に記載の抗原結合性分子または請求項１４に記載のＣＡＲをコードする１つの核酸または複数の核酸。 One nucleic acid or a plurality of nucleic acids encoding the antigen-binding molecule according to any one of claims 1 to 13 or the CAR according to claim 14 . 請求項１５に記載の１つの核酸または複数の核酸を含む１つの発現ベクターまたは複数の発現ベクター。 A single expression vector or a plurality of expression vectors comprising the one nucleic acid or the plurality of nucleic acids according to claim 15 . 請求項１～１３のいずれか一項に記載の抗原結合性分子、請求項１４に記載のＣＡＲ、請求項１５に記載の１つの核酸もしくは複数の核酸、または請求項１６に記載の１つの発現ベクターもしくは複数の発現ベクターを含む細胞。 The antigen-binding molecule according to any one of claims 1 to 13 , the CAR according to claim 14 , one nucleic acid or a plurality of nucleic acids according to claim 15 , or one expression according to claim 16 . A cell containing a vector or multiple expression vectors. 請求項１５に記載の１つの核酸もしくは複数の核酸または請求項１６に記載の１つの発現ベクターもしくは複数の発現ベクターを含む細胞を、該核酸または該発現ベクターから該抗原結合性分子または該ＣＡＲを発現させるのに適した条件下で培養するステップを含む方法。 A cell containing one nucleic acid or a plurality of nucleic acids according to claim 15 or one expression vector or a plurality of expression vectors according to claim 16 can be subjected to the antigen-binding property from the nucleic acid or the expression vector. A method comprising culturing under conditions suitable for expressing the molecule or said CAR . 請求項１～１３のいずれか一項に記載の抗原結合性分子、請求項１４に記載のＣＡＲ、請求項１５に記載の１つの核酸もしくは複数の核酸、請求項１６に記載の１つの発現ベクターもしくは複数の発現ベクター、または請求項１７に記載の細胞を含む組成物。 The antigen-binding molecule according to any one of claims 1 to 13 , the CAR according to claim 14 , one nucleic acid or a plurality of nucleic acids according to claim 15 , and one expression vector according to claim 16 . Alternatively, a composition comprising a plurality of expression vectors or the cells according to claim 17 . 医学的処置または予防の方法における使用のための医薬組成物であって、請求項１～１３のいずれか一項に記載の抗原結合性分子、請求項１４に記載のＣＡＲ、請求項１５に記載の１つの核酸もしくは複数の核酸、請求項１６に記載の１つの発現ベクターもしくは複数の発現ベクター、請求項１７に記載の細胞または請求項１９に記載の組成物を含む医薬組成物。 15. A pharmaceutical composition for use in a method of medical treatment or prevention, wherein the antigen-binding molecule according to any one of claims 1 to 13 , CAR according to claim 14 , and claim 15 . A pharmaceutical composition comprising one nucleic acid or a plurality of nucleic acids, one expression vector or a plurality of expression vectors according to claim 16 , the cell according to claim 17 , or the composition according to claim 19 . 線維症、線維症により特徴付けられる疾患、がん、炎症、炎症により特徴付けられる疾患、肝毒性、肝毒性により特徴付けられる疾患、代謝性疾患、消耗性障害、腎損傷または腎毒性を治療または予防する方法における使用のための医薬組成物であって、請求項１～１３のいずれか一項に記載の抗原結合性分子、請求項１４に記載のＣＡＲ、請求項１５に記載の１つの核酸もしくは複数の核酸、請求項１６に記載の１つの発現ベクターもしくは複数の発現ベクター、請求項１７に記載の細胞または請求項１９に記載の組成物を含む医薬組成物。 Treat or treat fibrosis, diseases characterized by fibrosis, cancer, inflammation, diseases characterized by inflammation, hepatic toxicity, diseases characterized by hepatic toxicity, metabolic disorders, wasting disorders, renal damage or renal toxicity A pharmaceutical composition for use in a prophylactic method, wherein the antigen-binding molecule according to any one of claims 1 to 13 , CAR according to claim 14 , and one nucleic acid according to claim 15 . Alternatively , a pharmaceutical composition comprising a plurality of nucleic acids, one expression vector according to claim 16 , or a plurality of expression vectors, the cell according to claim 17 , or the composition according to claim 19 . ＩＬ－１１媒介性シグナル伝達を阻害する方法であって、ＩＬ－１１発現細胞をｉｎ ｖｉｔｒｏにおいて請求項１～１３のいずれか一項に記載の抗原結合性分子と接触させるステップを含む方法。 A method of inhibiting IL-11-mediated signal transduction, comprising contacting IL-11 expressing cells in vitro with the antigen-binding molecule of any one of claims 1-13 . ＩＬ－１１またはＩＬ－１１を含む複合体に結合した請求項１～１３のいずれか一項に記載の抗原結合性分子を含むｉｎ ｖｉｔｒｏ複合体。 The in vitro complex comprising the antigen-binding molecule according to any one of claims 1 to 13 , which is bound to a complex containing IL-11 or IL-11 . ＩＬ－１１またはＩＬ－１１を含む複合体を含有するか、またはこれを含有することが疑われる試料を、ｉｎ ｖｉｔｒｏにおいて、請求項１～１３のいずれか一項に記載の抗原結合性分子と接触させるステップと、ＩＬ－１１またはＩＬ－１１を含む複合体と前記抗原結合性分子との複合体の形成を検出するステップとを含む方法。 A sample containing or suspected of containing IL-11 or a complex containing IL-11 is used in vitro with the antigen-binding molecule according to any one of claims 1 to 13 . A method comprising contacting and detecting the formation of a complex of the complex comprising IL-11 or IL-11 with the antigen-binding molecule . 対象を、ＩＬ－１１ターゲティング剤による処置のために選択または層別化する方法であって、ｉｎ ｖｉｔｒｏにおいて、対象に由来する試料を、請求項１～１３のいずれか一項に記載の抗原結合性分子と接触させるステップと、ＩＬ－１１またはＩＬ－１１を含む複合体と前記抗原結合性分子との複合体の形成を検出するステップとを含む方法。 The antigen binding according to any one of claims 1 to 13 , wherein the subject is selected or stratified for treatment with an IL-11 targeting agent, wherein the sample derived from the subject is subjected to in vitro. A method comprising contacting with a sex molecule and detecting the formation of a complex of the complex comprising IL-11 or IL-11 with the antigen-binding molecule . 請求項１～１３のいずれか一項に記載の抗原結合性分子を含む、ｉｎ ｖｉｔｒｏまたはｉｎ ｖｉｖｏにおいてＩＬ－１１を検出するための薬剤。 An agent for detecting IL-11 in vitro or in vivo, which comprises the antigen-binding molecule according to any one of claims 1 to 13 . 所定数量の、請求項１～１３のいずれか一項に記載の抗原結合性分子、請求項１４に記載のＣＡＲ、請求項１５に記載の１つの核酸もしくは複数の核酸、請求項１６に記載の１つの発現ベクターもしくは複数の発現ベクター、請求項１７に記載の細胞、または請求項１９に記載の組成物を含むキットオブパーツ。 The antigen-binding molecule according to any one of claims 1 to 13 , the CAR according to claim 14 , one nucleic acid or a plurality of nucleic acids according to claim 15 , according to claim 16 . A kit of parts comprising one expression vector or multiple expression vectors, the cell of claim 17 , or the composition of claim 19 .
JP2020568955A 2018-06-13 2019-06-13 IL-11 antibody Pending JP2021535733A (en)

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