JP7011078B2 - 抗-tigit抗体及びその用途 - Google Patents
抗-tigit抗体及びその用途 Download PDFInfo
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Description
本発明による抗-TIGIT抗体、又は抗原結合断片は、
配列番号1又は2のアミノ酸配列を含む重鎖(heavy chain)CDR(complementarity determining region、相補性決定領域)1、
配列番号3又は4のアミノ酸配列を含む重鎖CDR2、及び
配列番号5又は6のアミノ酸配列を含む重鎖CDR3、を含む重鎖可変領域と、
配列番号7又は8のアミノ酸配列を含む軽鎖(light chain)CDR1、
配列番号9又は10のアミノ酸配列を含む軽鎖CDR2、及び
配列番号11又は12のアミノ酸配列を含む軽鎖CDR3、を含む軽鎖可変領域とを含むことを特徴とする。
配列番号1又は2のアミノ酸配列を含む重鎖CDR1、
配列番号3又は4のアミノ酸配列を含む重鎖CDR2、及び
配列番号5又は6のアミノ酸配列を含む重鎖CDR3、を含む重鎖可変領域と、
配列番号7又は8のアミノ酸配列を含む軽鎖CDR1、
配列番号9又は10のアミノ酸配列を含む軽鎖CDR2、及び
配列番号11又は12のアミノ酸配列を含む軽鎖CDR3、を含む軽鎖可変領域とを含むことを特徴とする。
(1)配列番号1のアミノ酸配列を含む重鎖CDR1、配列番号3のアミノ酸配列を含む重鎖CDR2、及び配列番号5のアミノ酸配列を含む重鎖CDR3、を含む重鎖可変領域、及び
配列番号7のアミノ酸配列を含む軽鎖CDR1、配列番号9のアミノ酸配列を含む軽鎖CDR2、及び配列番号11のアミノ酸配列を含む軽鎖CDR3、を含む軽鎖可変領域と、
(2)配列番号2のアミノ酸配列を含む重鎖CDR1、配列番号4のアミノ酸配列を含む重鎖CDR2、及び配列番号6のアミノ酸配列を含む重鎖CDR3、を含む重鎖可変領域、及び
配列番号8のアミノ酸配列を含む軽鎖CDR1、配列番号10のアミノ酸配列を含む軽鎖CDR2、及び配列番号12のアミノ酸配列を含む軽鎖CDR3、を含む軽鎖可変領域と、
(3)配列番号13のアミノ酸配列を含む重鎖可変領域、及び
配列番号15のアミノ酸配列を含む軽鎖可変領域と、
(4)配列番号14のアミノ酸配列を含む重鎖可変領域、及び
配列番号16のアミノ酸配列を含む軽鎖可変領域と、
を含むことを特徴とする。
配列番号13又は14のアミノ酸配列を含む重鎖可変領域と80%以上の配列相同性、好ましくは90%以上の配列相同性、より好ましくは99%の配列相同性を有する配列を含み、本発明によるTIGITと同じ特性を有する抗体又はその抗原結合断片も本発明による抗-TIGIT抗体又はその抗原結合断片の権利範囲に含まれる。
配列番号15又は16のアミノ酸配列を含む軽鎖可変領域と80%以上の配列相同性、好ましくは90%以上の配列相同性、より好ましくは99%の配列相同性を有する配列を含む軽鎖可変領域を含み、本発明によるTIGITと同じ特性を有する抗体又はその抗原結合断片も本発明による抗-TIGIT抗体又はその抗原結合断片の権利範囲に含まれる。
1.1抗-TIGITヒト抗体scFvとFabクローン選別
2.1F04及びS64抗体の最適化
TGI rate(%)=100×(1-ΔT/ΔC)
ΔT=終了日に測定した試験物質投与群の平均腫瘍容積-投与開示日に測定した試験物質投与群の平均腫瘍容積
ΔC=終了日に測定した陰性対照物質投与群の平均腫瘍体-積投与開日に測定した陰性対照物質投与群の平均腫瘍容積
TGI rate(%)=100×(1-ΔT/ΔC)
ΔT=終了日に測定した試験物質投与群の平均腫瘍容積-投与開始日に測定した試験物質投与群の平均腫瘍容積
ΔC=終了日に測定した陰性対照物質投与群の平均腫瘍容積-投与開始日に測定した陰性対照物質投与群の平均腫瘍容積
Claims (17)
- (1)配列番号1のアミノ酸配列を含む重鎖(heavy chain)CDR1、
配列番号3のアミノ酸配列を含む重鎖CDR2、及び
配列番号5のアミノ酸配列を含む重鎖CDR3、を含む重鎖可変領域と、
配列番号7のアミノ酸配列を含む軽鎖(light chain)CDR1、
配列番号9のアミノ酸配列を含む軽鎖CDR2、及び
配列番号11のアミノ酸配列を含む軽鎖CDR3、を含む軽鎖可変領域と、
を含むか、又は
(2)配列番号2のアミノ酸配列を含む重鎖(heavy chain)CDR1、
配列番号4のアミノ酸配列を含む重鎖CDR2、及び
配列番号6のアミノ酸配列を含む重鎖CDR3、を含む重鎖可変領域と、
配列番号8のアミノ酸配列を含む軽鎖(light chain)CDR1、
配列番号10のアミノ酸配列を含む軽鎖CDR2、及び
配列番号12のアミノ酸配列を含む軽鎖CDR3、を含む軽鎖可変領域と
を含む、抗-TIGIT抗体又はその抗原結合断片。 - 配列番号13又は14のアミノ酸配列を含む重鎖可変領域と、配列番号15又は16の軽鎖可変領域とを含む、請求項1に記載の抗-TIGIT抗体又はその抗原結合断片。
- 単クローン抗体であることを特徴とする、請求項1又は2に記載の抗-TIGIT抗体又はその抗原結合断片。
- 前記抗原結合断片は、前記抗-TIGIT抗体のscFv、(scFv)2、scFv-Fc、Fab、Fab’及びF(ab’)2からなる群から選択されることを特徴とする、請求項1~3のいずれか一項に記載の抗-TIGIT抗体又はその抗原結合断片。
- 請求項1~4のいずれか一項に記載の抗-TIGIT抗体又はその抗原結合断片を有効成分として含む、癌又は腫瘍治療用医薬組成物。
- 前記癌又は腫瘍は、皮膚癌、肝臓癌、肝細胞癌、胃癌、乳房癌、肺癌、卵巣癌、気管支癌、鼻咽腔癌、喉頭癌、膵膓癌、膀胱癌、大膓癌、結腸癌、子宮頸癌、脳癌、前立腺癌、骨癌、甲状腺癌、副甲状線癌、腎臓癌、食道癌、胆管癌、精巣癌、直膓癌、頭頸部癌、頸椎癌、尿管癌、骨肉腫、神経芽細胞腫、線維肉腫、横紋筋肉腫、星状細胞腫、神経芽細胞腫及び神経膠腫からなる群から選択されることを特徴とする、請求項5に記載の医薬組成物。
- 請求項1~4のいずれか一項に記載の抗-TIGIT抗体又はその抗原結合断片及び他の癌治療剤を含む癌又は腫瘍治療用併用投与組成物。
- 前記癌治療剤は免疫チェックポイント抑制剤であることを特徴とする、請求項7に記載の組成物。
- 前記免疫チェックポイント抑制剤は、抗-CTLA-4抗体、抗-PD-1抗体又は抗-PD-L1抗体であることを特徴とする、請求項8に記載の組成物。
- 請求項1~4のいずれか一項に記載の抗-TIGIT抗体又はその抗原結合断片を含む、抗体-薬物接合体(antibody-drug conjugate)。
- 請求項10に記載の抗体-薬物接合体を含む、癌又は腫瘍治療用組成物。
- 請求項1~4のいずれか一項に記載の抗-TIGIT抗体又はその抗原結合断片をコードする、核酸。
- 請求項12に記載の核酸を含む、組み換え発現ベクター。
- 請求項13に記載の組み換え発現ベクターで形質転換された、宿主細胞。
- 動物細胞、植物細胞、酵母、大膓菌及び昆虫細胞からなる群から選択されることを特徴とする、請求項14に記載の宿主細胞。
- サル腎臓細胞7(COS7:monkey kidney cells)細胞、NSO細胞、SP2/0細胞、チャイニーズハムスター卵巣(CHO:chinese hamster ovary)細胞、W138、ベビーハムスター腎臓(BHK:baby hamster kidney)細胞、MDCK、骨髄腫細胞株、HuT78細胞、HEK293細胞、大膓菌、バシラス・サブチリス(Bacillus subtilis)、ストレプトミセス属(Streptomyces sp.)、シュードモナス属(Pseudomonas sp.)、プロテウス・ミラビリス(Proteus mirabilis)又はスタフィロコッカス属(Staphylococcus sp.)、アスペルギルス属(Aspergillus sp.)、ピチア・パストリス(Pichia pastoris)、サッカロマイセス・セレヴィシエ(Saccharomyces cerevisiae)、シゾサッカロミセス属(Schizosaccharomyces sp.)及びニューロスポラ・クラッサ(Neurospora crassa)から選択されることを特徴とする、請求項15に記載の宿主細胞。
- 請求項14~16のいずれか一項に記載の宿主細胞を培養する段階を含む、抗-TIGIT抗体又はその抗原結合断片の製造方法。
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KR20180024822 | 2018-02-28 | ||
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PCT/KR2019/002440 WO2019168382A1 (en) | 2018-02-28 | 2019-02-28 | Anti-tigit antibodies and uses thereof |
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EP3618863B1 (en) | 2017-05-01 | 2023-07-26 | Agenus Inc. | Anti-tigit antibodies and methods of use thereof |
US20230071889A1 (en) | 2018-12-21 | 2023-03-09 | Ose Immunotherapeutics | Bifunctional anti-pd-1/il-7 molecule |
WO2020165374A1 (en) | 2019-02-14 | 2020-08-20 | Ose Immunotherapeutics | Bifunctional molecule comprising il-15ra |
WO2021113831A1 (en) | 2019-12-05 | 2021-06-10 | Compugen Ltd. | Anti-pvrig and anti-tigit antibodies for enhanced nk-cell based tumor killing |
WO2021122866A1 (en) | 2019-12-17 | 2021-06-24 | Ose Immunotherapeutics | Bifunctional molecules comprising an il-7 variant |
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