RU2017135754A - Антитела со встроенным в легкие цепи гистидином и генетически модифицированные отличные от человека животные для их получения - Google Patents
Антитела со встроенным в легкие цепи гистидином и генетически модифицированные отличные от человека животные для их получения Download PDFInfo
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- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 title claims 6
- 241001465754 Metazoa Species 0.000 title 1
- 238000000034 method Methods 0.000 claims 8
- 108020004705 Codon Proteins 0.000 claims 7
- 239000000427 antigen Substances 0.000 claims 4
- 108091007433 antigens Proteins 0.000 claims 4
- 102000036639 antigens Human genes 0.000 claims 4
- 108060003951 Immunoglobulin Proteins 0.000 claims 3
- 102000013463 Immunoglobulin Light Chains Human genes 0.000 claims 3
- 108010065825 Immunoglobulin Light Chains Proteins 0.000 claims 3
- 230000002378 acidificating effect Effects 0.000 claims 3
- 102000018358 immunoglobulin Human genes 0.000 claims 3
- 238000012986 modification Methods 0.000 claims 3
- 230000004048 modification Effects 0.000 claims 3
- 108090000623 proteins and genes Proteins 0.000 claims 3
- 102000006496 Immunoglobulin Heavy Chains Human genes 0.000 claims 2
- 108010019476 Immunoglobulin Heavy Chains Proteins 0.000 claims 2
- 210000004027 cell Anatomy 0.000 claims 2
- 238000010494 dissociation reaction Methods 0.000 claims 2
- 230000005593 dissociations Effects 0.000 claims 2
- 210000004602 germ cell Anatomy 0.000 claims 2
- 230000007935 neutral effect Effects 0.000 claims 2
- 101001008255 Homo sapiens Immunoglobulin kappa variable 1D-8 Proteins 0.000 claims 1
- 101001047628 Homo sapiens Immunoglobulin kappa variable 2-29 Proteins 0.000 claims 1
- 101001008321 Homo sapiens Immunoglobulin kappa variable 2D-26 Proteins 0.000 claims 1
- 101001047619 Homo sapiens Immunoglobulin kappa variable 3-20 Proteins 0.000 claims 1
- 101001008263 Homo sapiens Immunoglobulin kappa variable 3D-15 Proteins 0.000 claims 1
- 102100022949 Immunoglobulin kappa variable 2-29 Human genes 0.000 claims 1
- 230000001419 dependent effect Effects 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K67/00—Rearing or breeding animals, not otherwise provided for; New or modified breeds of animals
- A01K67/027—New or modified breeds of vertebrates
- A01K67/0275—Genetically modified vertebrates, e.g. transgenic
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K67/00—Rearing or breeding animals, not otherwise provided for; New or modified breeds of animals
- A01K67/027—New or modified breeds of vertebrates
- A01K67/0275—Genetically modified vertebrates, e.g. transgenic
- A01K67/0278—Knock-in vertebrates, e.g. humanised vertebrates
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
- C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
- C12N15/8509—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells for producing genetically modified animals, e.g. transgenic
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K2207/00—Modified animals
- A01K2207/15—Humanized animals
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K2217/00—Genetically modified animals
- A01K2217/07—Animals genetically altered by homologous recombination
- A01K2217/072—Animals genetically altered by homologous recombination maintaining or altering function, i.e. knock in
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K2217/00—Genetically modified animals
- A01K2217/07—Animals genetically altered by homologous recombination
- A01K2217/075—Animals genetically altered by homologous recombination inducing loss of function, i.e. knock out
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K2217/00—Genetically modified animals
- A01K2217/15—Animals comprising multiple alterations of the genome, by transgenesis or homologous recombination, e.g. obtained by cross-breeding
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K2227/00—Animals characterised by species
- A01K2227/10—Mammal
- A01K2227/105—Murine
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A01K2267/00—Animals characterised by purpose
- A01K2267/01—Animal expressing industrially exogenous proteins
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- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/515—Complete light chain, i.e. VL + CL
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2800/00—Nucleic acids vectors
- C12N2800/20—Pseudochromosomes, minichrosomosomes
- C12N2800/204—Pseudochromosomes, minichrosomosomes of bacterial origin, e.g. BAC
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Claims (12)
1. Способ получения антитела, которое проявляет зависимое от pH связывание с представляющим интерес антигеном, предусматривающий:
получение от отличного от человека животного, содержащего в своей зародышевой линии локус легкой цепи иммуноглобулина, который содержит единственную реаранжированную генную последовательность вариабельной области легкой цепи иммуноглобулина человека, содержащую последовательности сегментов VL и JL человека первого антитела, которое связывается с представляющим интерес антигеном с требуемой аффинностью,
модификацию последовательностей сегментов VL и JL человека единственной реаранжированной генной последовательности вариабельной области легкой цепи иммуноглобулина человека для включения по меньшей мере одного гистидинового кодона, который не кодируется соответствующими последовательностями сегментов VL и JL зародышевой линии человека,
экспрессию тяжелой цепи иммуноглобулина первого антитела и модифицированной легкой цепи иммуноглобулина в клетке и
выбор второго антитела, экспрессируемого в клетке, которое сохраняет требуемое сродство к представляющему интерес антигену при нейтральном значении pH и отображает сниженное связывание с представляющим интерес антигеном при кислом значении pH.
2. Способ по п. 1, при котором первое антитело, полученное от отличного от человека животного, содержит последовательность тяжелой цепи иммуноглобулина, полученную из репертуара сегментов VH, DH и JH человека.
3. Способ по п. 1, при котором единственную реаранжированную последовательность вариабельной области легкой цепи иммуноглобулина человека выбирают из генной последовательности Vκ1-39/Jκ5 и Vκ3-20/Jκ1.
4. Способ по п. 3, при котором единственная реаранжированная последовательность вариабельной области легкой цепи иммуноглобулина человека представляет собой Vκ1-39/Jκ5, и модификация содержит замену по меньшей мере одного негистидинового кодона на гистидиновый кодон в кодоне CDR3 в положении, выбранном из 105, 106, 108, 111 и их комбинации.
5. Способ по п. 3, при котором единственная реаранжированная последовательность вариабельной области легкой цепи иммуноглобулина человека представляет собой Vκ3-20/Jκ1, и модификация содержит замену по меньшей мере одного негистидинового кодона на гистидиновый кодон в кодоне CDR3 в положении, выбранном из 105, 106, 107, 109 и их комбинации.
6. Способ по п. 1, при котором антитело демонстрирует снижение в диссоциационном периоде полувыведения (t1/2) при кислом значении pH, по сравнению с нейтральным значением pH, по меньшей мере приблизительно в 2 раза, по меньшей мере приблизительно в 3 раза, по меньшей мере приблизительно 4 раза, по меньшей мере приблизительно в 5 раз, по меньшей мере приблизительно в 10 раз, по меньшей мере приблизительно в 15 раз, по меньшей мере приблизительно в 20 раз, по меньшей мере приблизительно в 25 раз или по меньшей мере приблизительно в 30 раз.
7. Способ по п. 1, при котором антитело проявляет диссоциационный период полувыведения (t1/2) при кислом значении pH и 37°С равный приблизительно 2 минутам или менее.
8. Способ по п. 1, при котором отличное от человека животное представляет собой мышь.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261611950P | 2012-03-16 | 2012-03-16 | |
US61/611,950 | 2012-03-16 | ||
US201261736930P | 2012-12-13 | 2012-12-13 | |
US61/736,930 | 2012-12-13 |
Related Parent Applications (1)
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RU2014141537A Division RU2644684C2 (ru) | 2012-03-16 | 2013-03-15 | Антитела со встроенным в легкие цепи гистидином и генетически модифицированные отличные от человека животные для их получения |
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RU2017135754A true RU2017135754A (ru) | 2019-02-08 |
RU2017135754A3 RU2017135754A3 (ru) | 2021-01-27 |
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RU2017135754A RU2017135754A (ru) | 2012-03-16 | 2013-03-15 | Антитела со встроенным в легкие цепи гистидином и генетически модифицированные отличные от человека животные для их получения |
RU2014141537A RU2644684C2 (ru) | 2012-03-16 | 2013-03-15 | Антитела со встроенным в легкие цепи гистидином и генетически модифицированные отличные от человека животные для их получения |
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RU2014141537A RU2644684C2 (ru) | 2012-03-16 | 2013-03-15 | Антитела со встроенным в легкие цепи гистидином и генетически модифицированные отличные от человека животные для их получения |
Country Status (26)
Country | Link |
---|---|
US (3) | US9334334B2 (ru) |
EP (4) | EP3348140B1 (ru) |
JP (5) | JP6185978B2 (ru) |
KR (1) | KR102228296B1 (ru) |
CN (3) | CN104302169B (ru) |
AU (3) | AU2013204579B2 (ru) |
BR (1) | BR112014022850A2 (ru) |
CA (1) | CA2865643A1 (ru) |
CY (2) | CY1120599T1 (ru) |
DK (2) | DK2825036T3 (ru) |
ES (3) | ES2665793T3 (ru) |
HK (2) | HK1200273A1 (ru) |
HR (2) | HRP20180682T1 (ru) |
HU (3) | HUE053310T2 (ru) |
IL (5) | IL234355B (ru) |
LT (3) | LT2883449T (ru) |
MX (1) | MX355732B (ru) |
MY (1) | MY172730A (ru) |
NZ (1) | NZ629639A (ru) |
PL (2) | PL2883449T3 (ru) |
PT (3) | PT2825036T (ru) |
RS (2) | RS57118B1 (ru) |
RU (2) | RU2017135754A (ru) |
SG (2) | SG10201607689PA (ru) |
SI (3) | SI2883449T1 (ru) |
WO (1) | WO2013138680A1 (ru) |
Families Citing this family (47)
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EP2006381B1 (en) | 2006-03-31 | 2016-02-03 | Chugai Seiyaku Kabushiki Kaisha | Method for controlling blood pharmacokinetics of antibodies |
PL2202245T3 (pl) | 2007-09-26 | 2017-02-28 | Chugai Seiyaku Kabushiki Kaisha | Sposób modyfikowania punktu izoelektrycznego przeciwciała poprzez podstawienie aminokwasu w cdr |
ES2563483T3 (es) | 2008-04-11 | 2016-03-15 | Chugai Seiyaku Kabushiki Kaisha | Molécula de unión a antígeno capaz de unirse repetidamente a dos o más moléculas de antígeno |
US20140234340A1 (en) | 2010-11-30 | 2014-08-21 | Chugai Seiyaku Kabushiki Kaisha | Antigen-binding molecule capable of binding to plurality of antigen molecules repeatedly |
SG10201609665PA (en) | 2011-02-25 | 2017-01-27 | Chugai Pharmaceutical Co Ltd | FcɣRIIb-SPECIFIC Fc ANTIBODY |
JP6322411B2 (ja) | 2011-09-30 | 2018-05-09 | 中外製薬株式会社 | 複数の生理活性を有する抗原の消失を促進する抗原結合分子 |
HUE057680T2 (hu) | 2011-10-17 | 2022-06-28 | Regeneron Pharma | Korlátozott immunglobulin-nehézlánccal rendelkezõ egerek |
CA3233142A1 (en) | 2011-11-30 | 2013-06-06 | Chugai Seiyaku Kabushiki Kaisha | Drug containing carrier into cell for forming immune complex |
KR102459666B1 (ko) | 2012-03-16 | 2022-10-27 | 리제너론 파마슈티칼스 인코포레이티드 | pH-민감성 면역글로불린 서열을 발현하는 비-사람 동물 |
US20140013456A1 (en) | 2012-03-16 | 2014-01-09 | Regeneron Pharmaceuticals, Inc. | Histidine Engineered Light Chain Antibodies and Genetically Modified Non-Human Animals for Generating the Same |
PL3597037T3 (pl) | 2012-06-12 | 2021-10-25 | Regeneron Pharmaceuticals, Inc. | Humanizowane zwierzęta inne niż ludzie z ograniczonymi loci łańcucha ciężkiego immunoglobuliny |
CA2882272C (en) | 2012-08-24 | 2023-08-29 | Chugai Seiyaku Kabushiki Kaisha | Fc.gamma.riib-specific fc region variant |
WO2014030750A1 (ja) | 2012-08-24 | 2014-02-27 | 中外製薬株式会社 | マウスFcγRII特異的Fc抗体 |
US10766960B2 (en) | 2012-12-27 | 2020-09-08 | Chugai Seiyaku Kabushiki Kaisha | Heterodimerized polypeptide |
MY178882A (en) | 2013-02-20 | 2020-10-21 | Regeneron Pharma | Non-human animals with modified immunoglobulin heavy chain sequences |
EP2982689B1 (en) | 2013-04-02 | 2020-08-26 | Chugai Seiyaku Kabushiki Kaisha | Fc region variant |
MY172430A (en) | 2013-04-29 | 2019-11-25 | Hoffmann La Roche | Human fcrn-binding modified antibodies and methods of use |
RU2698969C2 (ru) | 2014-01-15 | 2019-09-02 | Ф.Хоффманн-Ля Рош Аг | Варианты fc-области с улучшенной способностью связываться с белком а |
TWI681969B (zh) * | 2014-01-23 | 2020-01-11 | 美商再生元醫藥公司 | 針對pd-1的人類抗體 |
TWI680138B (zh) | 2014-01-23 | 2019-12-21 | 美商再生元醫藥公司 | 抗pd-l1之人類抗體 |
EP3160996B1 (en) * | 2014-06-30 | 2022-06-08 | Merck Patent GmbH | Anti-tnfa antibodies with ph-dependent antigen binding |
KR20230044338A (ko) * | 2014-12-19 | 2023-04-03 | 추가이 세이야쿠 가부시키가이샤 | 항-c5 항체 및 그의 사용 방법 |
SG11201700841QA (en) | 2014-12-19 | 2017-03-30 | Chugai Pharmaceutical Co Ltd | Anti-myostatin antibodies, polypeptides containing variant fc regions, and methods of use |
US20180016327A1 (en) * | 2015-01-22 | 2018-01-18 | Chugai Seiyaku Kabushiki Kaisha | A Combination of Two or More Anti-C5 Antibodies and Methods of Use |
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