JP7095992B2 - 可溶性ユニバーサルadcc増強合成融合遺伝子およびペプチド技術ならびにその使用 - Google Patents
可溶性ユニバーサルadcc増強合成融合遺伝子およびペプチド技術ならびにその使用 Download PDFInfo
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Description
本出願は、2014年12月8日に出願された米国仮特許出願第62/089,097号、および2015年8月3日に出願された同第62/200,557号に対する優先権および利益を主張し、その両方は、その全体が本明細書に参考として援用される。
本発明は、免疫エフェクター細胞、特にT細胞、が抗体依存性細胞傷害性(ADCC)を媒介することを可能とするように使用され得る合成生物学的生成物およびプロセス、ならびにがん、感染性疾患、炎症性および自己免疫疾患ならびに他の疾患の処置および防止においてそれらを使用するための方法に関する。
哺乳動物、特に高等脊椎動物(ヒトを含む)は、複数の機構およびエフェクターを使用して、外来病原体ならびに罹病したかもしくはストレスを受けた自己由来細胞を検出、破壊もしくは少なくとも封じ込める、非常に複雑な免疫系を発達させた。これらの罹病細胞は、ウイルスもしくは細菌によって感染した可能性があるか、またはがんになった可能性がある。
本発明により新たなアプローチがもたらされ、がん、感染および他の疾患に対する免疫系の防御が改善される。本発明は、T細胞の細胞傷害性および増殖ポテンシャルを抗体に基づく治療法に結び付ける、新規の自由に会合する(free-associating)アダプター様ADCCエンハンサーを考案する。
本発明の実施形態において、例えば以下の項目が提供される。
(項目1)
高親和性Fc結合ドメインと、高親和性CD3結合ドメインとを含む融合タンパク質。
(項目2)
前記高親和性Fc結合ドメインが、CD64のエクトドメイン、高親和性CD16改変体およびヒトFcに対し高親和性を有する抗体フラグメントからなる群より選択される、項目1に記載の融合タンパク質。
(項目3)
高親和性CD3結合ドメインが、OKT3モノクローナル抗体のscFvである、項目1に記載の融合タンパク質。
(項目4)
前記OKT3モノクローナル抗体が、dhOKT3である、項目3に記載の融合タンパク質。
(項目5)
項目1~4に記載の融合タンパク質と、薬学的に受容可能な賦形剤とを含む薬学的組成物。
(項目6)
処置の必要性のある被験体を、ある状態について治療的に処置する方法であって、前記被験体に治療上有効な量の項目5に記載の薬学的組成物を投与する工程を含む方法。
(項目7)
前記状態を示す少なくとも1種の細胞表面抗原に対する治療用抗体を投与する工程をさらに含む、項目6に記載の方法。
(項目8)
前記抗体が、ヒトIgG4と実質的に同様のFc領域を含む、項目7に記載の方法。
(項目9)
前記状態が、がん、炎症性疾患、自己免疫性疾患、移植片拒絶および感染からなる群より選択される、項目6に記載の方法。
(項目10)
処置の必要性のある被験体を、ある状態について予防的に処置する方法であって、前記被験体に予防上有効な量の項目5に記載の薬学的組成物を投与する工程を含む方法。
(項目11)
前記状態に対するワクチンを投与する工程をさらに含む、項目10に記載の方法。
(項目12)
前記状態が、がんである、項目10に記載の方法。
(I.定義)
別段示されなければ、技術用語は、従来の使用法に従って使用される。分子生物学における一般用語の定義は、例えば、Benjamin Lewin, Genes VII,Oxford University Pressにより出版,2000 (ISBN
019879276X); Kendrew et al.(編); The Encyclopedia of Molecular Biology,Blackwell
Publishersにより出版,1994 (ISBN 0632021829);およびRobert A. Meyers(編), Molecular Biology and Biotechnology: a Comprehensive Desk Reference,Wiley, John & Sons, Inc.により出版, 1995(ISBN 0471186341);ならびに他の類似の技術的参考文献に見出され得る。
II.組成物
T細胞のためのアダプター
(a)Fc結合ドメイン
(b)CD3結合ドメイン
III.治療薬およびワクチン
(1)T細胞アダプター構築
本発明の様々な実施形態によって、アダプター様ADCCエンハンサー、すなわち、高親和性CD3結合ドメインに連結された高親和性Fc結合ドメインを有する融合タンパク質を開発し、検査した。
(2)発現および精製
(4)細胞傷害性増強
Claims (12)
- Fc結合ドメインと、CD3結合ドメインとを含む融合タンパク質であって、
前記Fc結合ドメインは、CD64のエクトドメインであり、
前記CD3結合ドメインは、抗CD3モノクローナル抗体のscFvである、
融合タンパク質。 - (i)前記抗CD3モノクローナル抗体が、OKT3である、
(ii)前記抗CD3モノクローナル抗体が、dhOKT3である、
(iii)前記抗CD3モノクローナル抗体が、ヒト化TR66である、
請求項1に記載の融合タンパク質。 - 前記融合タンパク質のアミノ酸配列が、配列番号3である、請求項1に記載の融合タンパク質。
- (i)請求項1~3のいずれか1項に記載の融合タンパク質および薬学的に受容可能な賦形剤、または
(ii)請求項1~3のいずれか1項に記載の融合タンパク質をコードするDNAおよび/またはRNA構築物、および薬学的に受容可能な賦形剤
を含む薬学的組成物。 - 薬学的に受容可能な賦形剤とともに、請求項1~3のいずれか1項に記載の融合タンパク質をコードする遺伝子構築物で満たされた1もしくはそれより多くの容器を含む、キット。
- 処置の必要性のある被験体を、ある状態について治療的に処置する方法における使用のための請求項4に記載の薬学的組成物であって、前記方法が、前記被験体に治療上有効な量の前記薬学的組成物を投与する工程を含み、前記状態が、がん、炎症性疾患、自己免疫性疾患、移植片拒絶および感染からなる群より選択される、薬学的組成物。
- 前記方法が、前記状態を示す少なくとも1種の細胞表面抗原に対する治療用抗体を投与する工程をさらに含む、請求項6に記載の使用のための薬学的組成物。
- 前記細胞表面抗原が、CD19、CD20、CD33、EpCAM、HER2/neu、PD-L1、PD-1およびCTLA-4からなる群から選択される、請求項7に記載の使用のための薬学的組成物。
- 前記抗体が、ヒトIgG4と実質的に同様のFc領域を含む、請求項7に記載の使用のための薬学的組成物。
- 前記抗体が、リツキシマブ、トラスツズマブおよびニボルマブからなる群から選択される、請求項7に記載の使用のための薬学的組成物。
- 処置の必要性のある被験体を、ある状態について予防的に処置する方法における使用のための請求項4に記載の薬学的組成物であって、前記方法が、前記被験体に予防上有効な量の前記薬学的組成物を投与する工程を含み、前記状態が、がんである、薬学的組成物。
- 前記方法が、前記状態に対するワクチンを投与する工程をさらに含む、請求項11に記載の使用のための薬学的組成物。
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US201462089097P | 2014-12-08 | 2014-12-08 | |
US62/089,097 | 2014-12-08 | ||
US201562200557P | 2015-08-03 | 2015-08-03 | |
US62/200,557 | 2015-08-03 | ||
PCT/US2015/064572 WO2016094456A1 (en) | 2014-12-08 | 2015-12-08 | Soluble universal adcc-enhancing synthetic fusion gene and peptide technology and its use thereof |
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JP2006526414A (ja) | 2003-06-02 | 2006-11-24 | アレクシオン ファーマシューティカルズ, インコーポレイテッド | 脱免疫化抗cd3抗体 |
US20080003225A1 (en) | 2006-06-29 | 2008-01-03 | Henri Vie | Method for enhancing the antibody-dependent cellular cytotoxicity (ADCC) and uses of T cells expressing CD16 receptors |
US20120294857A1 (en) | 2010-01-11 | 2012-11-22 | Trustees Of Dartmouth College | Monomeric Bi-Specific Fusion Protein |
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ES2388893T3 (es) * | 1998-08-11 | 2012-10-19 | Biogen Idec Inc. | Terapias de combinación para linfomas de células B que comprenden la administración de anticuerpos anti-CD20 |
BR0116024A (pt) * | 2000-12-07 | 2005-12-13 | Lilly Co Eli | Proteìna de fusão heteróloga e uso da mesma |
JP4619651B2 (ja) * | 2001-06-01 | 2011-01-26 | コーネル・リサーチ・ファンデーション・インコーポレイテッド | 前立腺特異的膜抗原に対する修飾抗体およびその使用 |
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ES2358427T3 (es) * | 2003-10-16 | 2011-05-10 | Micromet Ag | Elementos de unión a cd-3 desinmunizados multiespecíficos. |
DE602005022830D1 (de) * | 2004-02-16 | 2010-09-23 | Micromet Ag | Weniger immunogene bindungsmoleküle |
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US20150037334A1 (en) * | 2012-03-01 | 2015-02-05 | Amgen Research (Munich) Gmbh | Long life polypeptide binding molecules |
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US20080003225A1 (en) | 2006-06-29 | 2008-01-03 | Henri Vie | Method for enhancing the antibody-dependent cellular cytotoxicity (ADCC) and uses of T cells expressing CD16 receptors |
US20120294857A1 (en) | 2010-01-11 | 2012-11-22 | Trustees Of Dartmouth College | Monomeric Bi-Specific Fusion Protein |
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KR20170089003A (ko) | 2017-08-02 |
NZ732073A (en) | 2019-04-26 |
US20170362299A1 (en) | 2017-12-21 |
WO2016094456A1 (en) | 2016-06-16 |
SG11201704124YA (en) | 2017-06-29 |
CN107108718B (zh) | 2022-07-22 |
AU2015360642B2 (en) | 2019-04-04 |
JP2021035994A (ja) | 2021-03-04 |
RU2017124141A (ru) | 2019-01-10 |
EP3230311A4 (en) | 2018-05-30 |
CN107108718A (zh) | 2017-08-29 |
EP3230311A1 (en) | 2017-10-18 |
JP2018502068A (ja) | 2018-01-25 |
EP3230311B1 (en) | 2022-01-26 |
US20220235115A1 (en) | 2022-07-28 |
AU2015360642A1 (en) | 2017-06-08 |
RU2017124141A3 (ja) | 2019-06-19 |
KR102654033B1 (ko) | 2024-04-02 |
RU2725807C2 (ru) | 2020-07-06 |
CA2968987C (en) | 2022-05-10 |
CA2968987A1 (en) | 2016-06-16 |
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