JPWO2019140229A5 - - Google Patents

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JPWO2019140229A5
JPWO2019140229A5 JP2020538616A JP2020538616A JPWO2019140229A5 JP WO2019140229 A5 JPWO2019140229 A5 JP WO2019140229A5 JP 2020538616 A JP2020538616 A JP 2020538616A JP 2020538616 A JP2020538616 A JP 2020538616A JP WO2019140229 A5 JPWO2019140229 A5 JP WO2019140229A5
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  1. ヒトＴ細胞免疫グロブリンおよびムチンドメイン含有３(ＴＩＭ３)に結合し、重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３および軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３を含み、ここで、
    (ａ)重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号４５、４１３、および４１４をそれぞれ含み、軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号６４、６６、および６９をそれぞれ含む；
    (ｂ)重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号４５、４１５、および４１６をそれぞれ含み、軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号６４、６６、および６８をそれぞれ含む；または
    (ｃ)重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号４５、４１５、および４１６をそれぞれ含み、軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号６４、６６、および４１９をそれぞれ含む、
    単離抗体。
  2. 重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号４５、４１３、および４１４をそれぞれ含み、軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号６４、６６、および６９をそれぞれ含む、請求項１に記載の抗体。
  3. 重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号４５、４１５、および４１６をそれぞれ含み、軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号６４、６６、および６８をそれぞれ含む、請求項１に記載の抗体。
  4. 重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号４５、４１５、および４１６をそれぞれ含み、軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３が配列番号６４、６６、および４１９をそれぞれ含む、請求項１に記載の抗体。
  5. 重鎖可変領域(ＶＨ)および軽鎖可変領域(ＶＬ)を含み、ここで、
    (ａ)ＶＨが配列番号４１０または４１１に示すアミノ酸配列と少なくとも約８０％、少なくとも約８５％、少なくとも約９０％、少なくとも約９５％、少なくとも約９６％、少なくとも約９７％、少なくとも約９８％、少なくとも約９９％または約１００％同一であるアミノ酸配列を含む；または
    (ｂ)ＶＬが配列番号４１７または４１８に示すアミノ酸配列と少なくとも約８０％、少なくとも約８５％、少なくとも約９０％、少なくとも約９５％、少なくとも約９６％、少なくとも約９７％、少なくとも約９８％、少なくとも約９９％または約１００％同一であるアミノ酸配列を含む、
    請求項１に記載の抗体。
  6. 重鎖可変領域(ＶＨ)および軽鎖可変領域(ＶＬ)を含み、ここで、ＶＨが配列番号４１０を含み、ＶＬが配列番号４１７を含む、請求項１、２および５の何れかに記載の抗体。
  7. 重鎖可変領域(ＶＨ)および軽鎖可変領域(ＶＬ)を含み、ここで、ＶＨが配列番号４１１を含み、ＶＬが配列番号４１８を含むか、またはＶＨが配列番号４１２を含み、ＶＬが配列番号６０を含む、請求項１および３～５の何れかに記載の抗体。
  8. 重鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３および軽鎖ＣＤＲ１、ＣＤＲ２およびＣＤＲ３を含む、ヒトＴＩＭ３に結合する単離抗体であって、ここで
    (ａ)重鎖ＣＤＲ１は配列番号４６９を含み、重鎖ＣＤＲ２は配列番号４７０を含み、そして重鎖ＣＤＲ３は配列番号４７１を含み、軽鎖ＣＤＲ１は配列番号４７２を含み、軽鎖ＣＤＲ２は配列番号４７３を含み、そして軽鎖ＣＤＲ３は配列番号４７４を含む；
    (ｂ)重鎖ＣＤＲ１は配列番号４５を含み、重鎖ＣＤＲ２は配列番号４１５を含み、そして重鎖ＣＤＲ３は配列番号４１６を含み、軽鎖ＣＤＲ１は配列番号６４を含み、軽鎖ＣＤＲ２は配列番号６６を含み、そして軽鎖ＣＤＲ３は配列番号６８を含む；または
    (ｃ)重鎖ＣＤＲ１は配列番号４５を含み、重鎖ＣＤＲ２は配列番号４１３を含み、そして重鎖ＣＤＲ３は配列番号４１４を含み、軽鎖ＣＤＲ１は配列番号６４を含み、軽鎖ＣＤＲ２は配列番号６６を含み、そして軽鎖ＣＤＲ３は配列番号６９を含む
    単離抗体。
  9. 抗体がＩｇＧ１、ＩｇＧ２、ＩｇＧ３、ＩｇＧ４およびそのバリアントからなる群から選択される、請求項１～８の何れかに記載の抗体。
  10. エフェクターレスＩｇＧ１ Ｆｃを含む、請求項９に記載の抗体。
  11. (ａ１)それぞれ配列番号３８６(または３８７)および４０８を含む重鎖および軽鎖配列；
    (ａ２)それぞれ配列番号３８８(または３８９)および４０８を含む重鎖および軽鎖配列；
    (ａ３)それぞれ配列番号３９０(または３９１)および４０８を含む重鎖および軽鎖配列；
    (ａ４)それぞれ配列番号３９２(または３９３)および４０８を含む重鎖および軽鎖配列；
    (ｂ１)それぞれ配列番号３９４(または３９５)および２９を含む重鎖および軽鎖配列；
    (ｂ２)それぞれ配列番号３９４(または３９５)および４０９を含む重鎖および軽鎖配列；
    (ｂ３)それぞれ配列番号３９６(または３９７)および２９を含む重鎖および軽鎖配列；
    (ｂ４)それぞれ配列番号３９８(または３９９)および２９を含む重鎖および軽鎖配列；
    (ｂ５)それぞれ配列番号４００(または４０１)および２９を含む重鎖および軽鎖配列；
    (ｂ６)それぞれ配列番号４０２(または４０３)および２９を含む重鎖および軽鎖配列；
    (ｂ７)それぞれ配列番号４０４(または４０５)および２９を含む重鎖および軽鎖配列；
    (ｂ８)それぞれ配列番号４０６(または４０７)および２９を含む重鎖および軽鎖配列；
    (ｃ１)それぞれ配列番号４５１(または４６１)および４５３を含む重鎖および軽鎖配列；
    (ｃ２)それぞれ配列番号４５２(または４６２)および４５３を含む重鎖および軽鎖配列；
    (ｄ１)それぞれ配列番号４５７(または４６５)および４５３を含む重鎖および軽鎖配列；または
    (ｄ２)それぞれ配列番号４５８(または４６６)および４５３を含む重鎖および軽鎖配列
    を含む、請求項１および８～１０の何れかに記載の抗体。
  12. 次の性質の１以上を有する、請求項１～１１の何れかに記載の抗体：
    (１)例えば、フローサイトメトリーで測定して膜結合ヒトＴＩＭ３に、例えば、１μg／mL以下(例えば、０.０１μg／mL～０.０５μg／mL)のＥＣ５０で結合する；
    (２)例えば、フローサイトメトリーで測定して、膜結合カニクイザルＴＩＭ３に結合する；
    (３)実施例２２に記載の方法で測定して、ｈＴＩＭ３－ＩｇＶに５×１０－8Ｍ、２×１０－8Ｍ、１０－8Ｍまたは５×１０－9Ｍ以下のＫＤで結合する；
    (４)実施例２２に記載の方法で測定して、ｈＴＩＭ３－ＩｇＶに１０－7Ｍ、２×１０－8Ｍまたは１０－8Ｍ以下のＫＤで結合する；
    (５)実施例２２に記載の方法で測定して、カニクイザルＴＩＭ３－ＥＣＤに５×１０－7Ｍ、２×１０－8Ｍまたは１０－8Ｍ以下のＫＤで結合する；
    (６)実施例２２に記載の方法で測定して、ｈＴＩＭ３－ＥＣＤに８×１０－8Ｍ、５×１０－8Ｍまたは１０－8Ｍ以下のＫＤで結合する；および／または
    (７)ＴＩＭ３発現Ｔ細胞(例えば、Ｔｈ１細胞またはＴＩＬ)の増殖増大により証明されるとおり、Ｔ細胞活性化(例えば、ＴＩＭ３の阻害効果の遮断または低減により)を誘導または増強する。
  13. 第二の結合特異性を有する分子に結合している、請求項１～１２の何れかに記載の抗体を含む二重特異性分子。
  14. 請求項１～１２の何れかに記載の抗体のＶＨおよび／またはＶＬをコードする、核酸。
  15. 請求項１４に記載の核酸を含む発現ベクターでトランスフォームされた、細胞。
  16. 薬剤に結合した請求項１～１２の何れかに記載の抗体を含む、イムノコンジュゲート。
  17. 対象における癌を処置するための、請求項１～１２の何れかに記載の抗体、請求項１３に記載の二重特異性分子、請求項１４に記載の核酸、請求項１５に記載の細胞または請求項１６に記載のイムノコンジュゲートを含む、医薬組成物。
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CN113214396B (zh) * 2020-07-31 2022-04-19 北京市神经外科研究所 抗tim3的单链抗体及其在制备治疗肿瘤的药物中的用途
EP4083065A1 (en) 2021-01-28 2022-11-02 NantBio, Inc. Anti-tim3 monoclonal antibodies and chimeric antigen receptors
CN112961239B (zh) * 2021-02-24 2021-09-10 北京昭衍生物技术有限公司 Tim抑制剂及其应用

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