JP2015517505A - 抗BLyS抗体 - Google Patents
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Abstract
Description
現在の多くの科学者の見解によればSLEの病因は、細胞レベルにおいて、自己反応性のB細胞が抹消組織にとても長く留まることによる。かかるB細胞はヒト自己抗原を生じ、自己免疫を引き起こす。このため、初期のB細胞の成長と増殖を阻害できれば、SLEの治療も可能性が開ける。
かかる特異性があるためBLySはB細胞抗体による自己免疫疾患及びリンパ腫の標的として非常に好適である。
a:SEQ ID NO.(配列番号)31及びSEQ ID NO. 32で表されるアミノ酸配列又はこれらの機能性変異体;
b:SEQ ID NO. 33及びSEQ ID NO. 34で表されるアミノ酸配列又はこれらの機能性変異体;
c:SEQ ID NO. 35及びSEQ ID NO. 36で表されるアミノ酸配列又はこれらの機能性変異体;
d:SEQ ID NO. 37及びSEQ ID NO. 38で表されるアミノ酸配列又はこれらの機能性変異体;
e:SEQ ID NO. 39及びSEQ ID NO. 40で表されるアミノ酸配列又はこれらの機能性変異体。
I:SEQ ID NO. 41及びSEQ ID NO. 42で表されるアミノ酸配列又はこれらの機能性変異体;
II:SEQ ID NO. 43及びSEQ ID NO. 44で表されるアミノ酸配列又はこれらの機能性変異体;
III:SEQ ID NO. 45及びSEQ ID NO. 46で表されるアミノ酸配列又はこれらの機能性変異体;
IV:SEQ ID NO. 47及びSEQ ID NO. 48で表されるアミノ酸配列又はこれらの機能性変異体。
I:SEQ ID NO. 41及びSEQ ID NO. 42で表されるアミノ酸配列又はこれらの機能性変異体;
II:SEQ ID NO. 43及びSEQ ID NO. 44で表されるアミノ酸配列又はこれらの機能性変異体;
III:SEQ ID NO. 45及びSEQ ID NO. 46で表されるアミノ酸配列又はこれらの機能性変異体;
IV:SEQ ID NO. 47及びSEQ ID NO. 48で表されるアミノ酸配列又はこれらの機能性変異体。
好ましい態様において、本発明のBLyS抗体はさらにヒトの軽鎖定常領域及び重鎖定常領域、並びに軽鎖定常領域及び重鎖定常領域にそれぞれ結合する軽鎖可変領域及び重鎖可変領域を含む。一態様において、かかるヒト化抗BLyS抗体は完全長の軽鎖及び完全長の重鎖を有する。かかる完全長の軽鎖は抗BLyS抗体に含まれる軽鎖可変領域をヒト軽鎖定常領域に結合することで形成する。かかる完全長の重鎖は抗BLyS抗体に含まれる重鎖可変領域をヒト重鎖定常領域に結合することで形成する。
5xRT buffer (with 25mM Mg2+) 4μL
dNTP (10 mM each) 2μL
RNase Inhibitor (10 U/μL) 0.5μL
Oligo (dT) 20 (10 μmol/L) 1μL
鋳型全RNA 2μL
ReverTra Ace 1μL
dNTP (5 mM) 4μL
上流プライマー(100 ng/μL) 1μL
下流プライマー(100 ng/μL) 1μL
鋳型(5-50 ng/μL) 1μL
Taq酵素(2 U/μL) 0.5μL
94℃ 45秒の変性
55℃ 45秒のアニーリング
72℃ 45秒の伸長
変性、アニーリング及び伸長を32サイクル
72℃ 200秒の伸長
dNTP (5 mM) 1μL
重鎖のプライマー混合液又は軽鎖のプライマー混合液(各プライマーは100 ng/μL)
1μL
cDNA (5-50 ng/μL) 1μL
Taq enzyme (2 U/μL) 1μL
94℃ 1分の変性
55℃ 1分のアニーリング
72℃ 115秒の伸長
変性、アニーリング及び伸長を30サイクル
72℃ 10分の伸長
個々のハイブリドーマ細胞から分泌される抗体の遺伝子配列中の個々の重要なアミノ酸であってBLySと相互作用し特別なフレームワークを維持することができるものを分析する。かかるアミノ酸を選択されたヒト胚系の遺伝子の読み枠に移入する。以上により4種のヒト化抗BLyS抗体を得た。それらの軽鎖可変領域及び重鎖可変領域の配列を表5に表す。
Claims (15)
- 前記抗BLyS抗体の軽鎖可変領域のアミノ酸配列及び重鎖可変領域のアミノ酸配列として、以下の各組中から一組選択される、請求項1に記載の抗BLyS抗体:
a:SEQ ID NO. 31及びSEQ ID NO. 32で表されるアミノ酸配列又はこれらの機能性変異体;
b:SEQ ID NO. 33及びSEQ ID NO. 34で表されるアミノ酸配列又はこれらの機能性変異体;
c:SEQ ID NO. 35及びSEQ ID NO. 36で表されるアミノ酸配列又はこれらの機能性変異体;
d:SEQ ID NO. 37及びSEQ ID NO. 38で表されるアミノ酸配列又はこれらの機能性変異体;
e:SEQ ID NO. 39及びSEQ ID NO. 40で表されるアミノ酸配列又はこれらの機能性変異体。 - ヒト化されている、請求項1又は2に記載の抗BLyS抗体。
- 前記抗BLyS抗体の軽鎖可変領域のアミノ酸配列及び重鎖可変領域のアミノ酸配列は以下の各組中から一組選択される、請求項1−3のいずれかに記載の抗BLyS抗体:
I:SEQ ID NO. 41及びSEQ ID NO. 42で表されるアミノ酸配列又はこれらの機能性変異体;
II:SEQ ID NO. 43及びSEQ ID NO. 44で表されるアミノ酸配列又はこれらの機能性変異体;
III:SEQ ID NO. 45及びSEQ ID NO. 46で表されるアミノ酸配列又はこれらの機能性変異体;
IV:SEQ ID NO. 47及びSEQ ID NO. 48で表されるアミノ酸配列又はこれらの機能性変異体。 - さらにヒト軽鎖定常領域及びヒト重鎖定常領域、並びに前記ヒト軽鎖定常領域及び前記ヒト重鎖定常領域にそれぞれ結合する軽鎖可変領域及び重鎖可変領域を含むことを特徴とする、請求項3又は4に記載の抗BLyS抗体。
- 前記ヒト軽鎖定常領域はヒト軽鎖κ定常領域である、請求項5に記載の抗BLyS抗体。
- 前記ヒト重鎖定常領域はヒト重鎖Fcフラグメントである、請求項6に記載の抗BLyS抗体。
- 請求項1−7のいずれかに記載の抗BLyS抗体をコードするDNA分子。
- SEQ ID NO. 49-58から選択される核酸配列を有する、請求項8に記載のDNA分子。
- 請求項8又は9に記載のDNA分子を含むことを特徴とする組み換えDNAベクター。
- 請求項10に記載の組み換えDNAベクターを含むことを特徴とする宿主細胞。
- B細胞の過剰な増殖によって引き起こされる疾病を予防及び/又は治療するための方法であって、請求項1から7のいずれかに記載の抗BLyS抗体を有効量投与することを含む方法。
- 前記B細胞の過剰な増殖によって引き起こされる疾病は全身性エリテマトーデス、関節リウマチ、強直性関節炎、及びB細胞リンパ腫から選ばれることを特徴とする、請求項12記載の方法。
- 請求項1から7のいずれかに記載の抗体であって有効量の抗体及び薬学的に許容される担体を含有することを特徴とする、医薬組成物。
- 抗BLyS抗体を調製する方法であって、請求項11に記載の宿主細胞を培養すること、及び抗体を得ることを含む方法。
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CN201210160474.3 | 2012-05-22 | ||
CN201210160474.3A CN103421113B (zh) | 2012-05-22 | 2012-05-22 | 抗BLyS抗体 |
PCT/CN2013/076074 WO2013174264A1 (zh) | 2012-05-22 | 2013-05-22 | 抗BLyS抗体 |
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JP2015517505A true JP2015517505A (ja) | 2015-06-22 |
JP6006404B2 JP6006404B2 (ja) | 2016-10-12 |
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US (1) | US9828423B2 (ja) |
EP (2) | EP3792280A3 (ja) |
JP (1) | JP6006404B2 (ja) |
CN (1) | CN103421113B (ja) |
IN (1) | IN2014MN02367A (ja) |
RU (1) | RU2613422C2 (ja) |
WO (1) | WO2013174264A1 (ja) |
ZA (1) | ZA201408955B (ja) |
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KR102312856B1 (ko) | 2012-08-24 | 2021-10-13 | 더 리젠츠 오브 더 유니버시티 오브 캘리포니아 | Ror1 암을 치료하고 전이를 저해하는데 이용을 위한 항체와 백신 |
CN104045713B (zh) * | 2013-03-13 | 2019-02-12 | 江苏诺迈博生物医药科技有限公司 | 一种抗Blys的单克隆抗体及含有该抗体的药物组合物 |
CN104804090B (zh) * | 2014-01-29 | 2018-03-27 | 普瑞金(深圳)生物技术有限公司 | 一种抗b细胞生长刺激因子的纳米抗体和用途 |
CN104804092B (zh) * | 2014-01-29 | 2018-03-27 | 天津胜发生物技术有限公司 | 一种抗b细胞生长刺激因子的纳米抗体及其用途 |
CN104804091B (zh) * | 2014-01-29 | 2018-03-27 | 普瑞金(深圳)生物技术有限公司 | 一种抗b细胞生长刺激因子的纳米抗体及用途 |
WO2015187521A2 (en) * | 2014-06-03 | 2015-12-10 | Merck Sharp & Dohme Corp. | Anti-blys antibodies |
CN104628856A (zh) * | 2015-01-23 | 2015-05-20 | 中国人民解放军军事医学科学院放射与辐射医学研究所 | 一种抗BLyS单链抗体及其制备方法和用途 |
CN105061596B (zh) * | 2015-08-05 | 2019-01-29 | 江苏诺迈博生物医药科技有限公司 | 人b淋巴细胞刺激因子的单克隆抗体及其应用 |
CN106916224B (zh) * | 2015-12-28 | 2021-03-23 | 中国人民解放军军事医学科学院放射与辐射医学研究所 | 抗b淋巴细胞刺激因子单克隆抗体及其制备方法和用途 |
CN109996544A (zh) | 2016-06-27 | 2019-07-09 | 加利福尼亚大学董事会 | 癌症治疗组合 |
CN107586339B (zh) * | 2016-07-06 | 2023-01-20 | 尚华科创投资管理(江苏)有限公司 | 一种BLyS抗体及其制备方法和应用 |
CA3092434A1 (en) * | 2017-02-27 | 2018-08-30 | Caerus Therapeutics, Inc. | Compositions of a novel anti-human ceacam6 antibody and uses thereof |
JP2022519534A (ja) * | 2019-01-31 | 2022-03-24 | シーメンス・ヘルスケア・ダイアグノスティックス・インコーポレイテッド | 抗ナロキソンおよび抗ナルトレキソンモノクローナル抗体ならびにその作製方法および使用方法 |
CN112111461B (zh) * | 2020-08-17 | 2022-08-30 | 浙江正熙生物医药有限公司 | 一种单细胞分选构建单克隆抗体高产株细胞工作库的方法 |
WO2022223028A1 (zh) * | 2021-04-23 | 2022-10-27 | 上海君实生物医药科技股份有限公司 | 抗BLyS抗体、其药物组合物及其用途 |
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CN101851291B (zh) * | 2010-02-09 | 2011-10-26 | 中国人民解放军第四军医大学 | 一种抗人baff单克隆抗体的重链和轻链可变区 |
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EP2853543A1 (en) | 2015-04-01 |
CN103421113B (zh) | 2018-01-19 |
IN2014MN02367A (ja) | 2015-08-14 |
BR112014025651A2 (pt) | 2017-07-04 |
US9828423B2 (en) | 2017-11-28 |
US20150259409A1 (en) | 2015-09-17 |
EP2853543B1 (en) | 2020-09-02 |
WO2013174264A1 (zh) | 2013-11-28 |
RU2613422C2 (ru) | 2017-03-16 |
CN103421113A (zh) | 2013-12-04 |
EP2853543A4 (en) | 2016-03-30 |
EP3792280A2 (en) | 2021-03-17 |
ZA201408955B (en) | 2015-12-23 |
EP2853543A8 (en) | 2015-05-13 |
RU2014133410A (ru) | 2016-07-10 |
EP3792280A3 (en) | 2021-07-21 |
JP6006404B2 (ja) | 2016-10-12 |
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