RU2019100481A - Биспецифические антитела-ингибиторы контрольных точек - Google Patents
Биспецифические антитела-ингибиторы контрольных точек Download PDFInfo
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- 239000003112 inhibitor Substances 0.000 title 1
- 150000007523 nucleic acids Chemical group 0.000 claims 7
- 102000039446 nucleic acids Human genes 0.000 claims 7
- 108020004707 nucleic acids Proteins 0.000 claims 7
- 239000013604 expression vector Substances 0.000 claims 5
- 125000003275 alpha amino acid group Chemical group 0.000 claims 4
- 238000006467 substitution reaction Methods 0.000 claims 4
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 1
- 101100510617 Caenorhabditis elegans sel-8 gene Proteins 0.000 claims 1
- 102100034458 Hepatitis A virus cellular receptor 2 Human genes 0.000 claims 1
- 101710083479 Hepatitis A virus cellular receptor 2 homolog Proteins 0.000 claims 1
- 101000889276 Homo sapiens Cytotoxic T-lymphocyte protein 4 Proteins 0.000 claims 1
- 101000831007 Homo sapiens T-cell immunoreceptor with Ig and ITIM domains Proteins 0.000 claims 1
- 102000037978 Immune checkpoint receptors Human genes 0.000 claims 1
- 108091008028 Immune checkpoint receptors Proteins 0.000 claims 1
- 229940126547 T-cell immunoglobulin mucin-3 Drugs 0.000 claims 1
- 102100024834 T-cell immunoreceptor with Ig and ITIM domains Human genes 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 1
- 102000043321 human CTLA4 Human genes 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000178 monomer Substances 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
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- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/70503—Immunoglobulin superfamily
- C07K14/70535—Fc-receptors, e.g. CD16, CD32, CD64 (CD2314/705F)
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- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
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- 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
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
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- 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
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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
- C12N15/86—Viral vectors
- C12N15/861—Adenoviral vectors
- C12N15/8613—Chimaeric vector systems comprising heterologous sequences for production of another viral vector
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
- A61K2039/572—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 cytotoxic response
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- 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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- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
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- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/524—CH2 domain
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- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/526—CH3 domain
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- C07K2317/53—Hinge
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- C07K2317/55—Fab or Fab'
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- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- 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
- C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
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- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
- C07K2317/622—Single chain antibody (scFv)
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- C07K2317/71—Decreased effector function due to an Fc-modification
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- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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Claims (21)
1. Гетеродимерное антитело, содержащее:
а) первую тяжелую цепь, содержащую:
i) первый вариантный Fc-домен; а также
ii) одноцепочечную Fv-область (scFv), которая связывает первый антиген, причем указанная scFv-область содержит первый вариабельный домен тяжелой цепи, первый вариабельный домен легкой цепи и заряженный линкер scFv, причем указанный заряженный линкер scFv ковалентно присоединяет указанный первый вариабельный домен тяжелой цепи и указанный вариабельный домен легкой цепи; а также
b) вторую тяжелую цепь, содержащую мономер VH-CH1-шарнир-CH2-CH3, причем VH является вторым вариабельным доменом тяжелой цепи, а CH2-CH3 является вторым вариантным Fc-доменом; а также
c) легкую цепь, содержащую второй вариабельный домен легкой цепи и константный домен легкой цепи;
причем указанный второй вариантный Fc-домен содержит аминокислотные замены N208D/Q295E/N384D/Q418E/N241D, причем указанные первый и второй вариантные Fc-домены каждый содержат аминокислотные замены E233P/L234V/L235A/G236del/S267K; причем указанный первый вариантный Fc-домен содержит аминокислотные замены S364K/E357Q, а второй вариантный Fc-домен содержит аминокислотные замены L368D/K370S, причем указанный первый вариабельный домен тяжелой цепи и первый вариабельный домен легкой цепи выбирают из наборов, содержащих SEQ ID NO: 11376 и SEQ ID NO: ID NO: 11377, SEQ ID NO: 22970 и SEQ ID NO: 22971, SEQ ID NO: 11394 и SEQ ID NO: 11395, SEQ ID NO: 11367 и SEQ ID NO: 11368 и SEQ ID NO: 11412 и SEQ ID NO: 11413, при этом нумерация соответствует индексу EU, как у Кабата.
2. Гетеродимерное антитело по п. 1, отличающееся тем, что компонент CH1-шарнир-CH2-CH3 второй тяжелой цепи имеет SEQ ID NO: 37725, указанный первый вариантный Fc-домен имеет SEQ ID NO: 37726, и указанный константный домен легкой цепи имеет SEQ ID NO: 37727.
3. Гетеродимерное антитело по п. 1 или 2, отличающееся тем, что указанный второй вариабельный домен тяжелой цепи и указанный второй вариабельный домен легкой цепи образуют антигенсвязывающий домен, который связывает рецептор контрольной точки человека из группы, состоящей из CTLA-4 человека, LAG-3 человека, TIM-3 человека и TIGIT человека.
4. Гетеродимерное антитело по п. 1, 2 или 3, отличающееся тем, что указанный первый вариабельный домен тяжелой цепи имеет SEQ ID NO: 11394, а первый вариабельный домен легкой цепи имеет SEQ ID NO: 11395.
5. Гетеродимерное антитело по п. 1, 2, 3 или 4, отличающееся тем, что указанная первая тяжелая цепь имеет SEQ ID NO: 23581, указанная вторая тяжелая цепь имеет SEQ ID NO: 23576, а указанная легкая цепь имеет SEQ ID NO: 23591.
6. Композиция нуклеиновых кислот, содержащая:
а) первую нуклеиновую кислоту, кодирующую указанную первую тяжелую цепь по пп. 1-5;
b) вторую нуклеиновую кислоту, кодирующую указанную вторую тяжелую цепь по пп. 1-5; и
c) третью нуклеиновую кислоту, кодирующую указанную легкую цепь по пп. 1-5, соответственно.
7. Композиция экспрессионных векторов, содержащая:
а) первый экспрессионный вектор, содержащий указанную первую нуклеиновую кислоту по п. 6;
b) второй экспрессионный вектор, содержащий указанную вторую нуклеиновую кислоту по п. 6; и
c) третий экспрессионный вектор, содержащий указанную третью нуклеиновую кислоту по п. 6.
8. Клетка-хозяин, содержащая указанную композицию экспрессионных векторов по п. 7.
9. Способ получения гетеродимерного антитела по пп. 1-5, включающий культивирование указанной клетки-хозяина по п. 8 в условиях, в которых указанное антитело экспрессируется, и выделение указанного антитела.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662350145P | 2016-06-14 | 2016-06-14 | |
| US62/350,145 | 2016-06-14 | ||
| US201662353511P | 2016-06-22 | 2016-06-22 | |
| US62/353,511 | 2016-06-22 | ||
| US201662420500P | 2016-11-10 | 2016-11-10 | |
| US62/420,500 | 2016-11-10 | ||
| PCT/US2017/037555 WO2017218707A2 (en) | 2016-06-14 | 2017-06-14 | Bispecific checkpoint inhibitor antibodies |
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| RU2022104399A Division RU2022104399A (ru) | 2016-06-14 | 2017-06-14 | Биспецифические антитела-ингибиторы контрольных точек |
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| RU2019100481A true RU2019100481A (ru) | 2020-07-14 |
| RU2019100481A3 RU2019100481A3 (ru) | 2020-10-08 |
| RU2767357C2 RU2767357C2 (ru) | 2022-03-17 |
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| RU2019100481A RU2767357C2 (ru) | 2016-06-14 | 2017-06-14 | Биспецифические антитела-ингибиторы контрольных точек |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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