DK2748201T3 - Bispecifikke t-celleaktiverende antigenbindende molekyler - Google Patents
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- DK2748201T3 DK2748201T3 DK12750364.7T DK12750364T DK2748201T3 DK 2748201 T3 DK2748201 T3 DK 2748201T3 DK 12750364 T DK12750364 T DK 12750364T DK 2748201 T3 DK2748201 T3 DK 2748201T3
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- C—CHEMISTRY; METALLURGY
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- C07K16/00—Immunoglobulins [IG], 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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- 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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- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IG], 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
- C07K16/2809—Immunoglobulins [IG], 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 the T-cell receptor (TcR)-CD3 complex
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IG], 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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3007—Carcino-embryonic Antigens
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3053—Skin, nerves, brain
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/40—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against enzymes
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- 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
- C07K2317/626—Diabody or triabody
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/66—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a swap of domains, e.g. CH3-CH2, VH-CL or VL-CH1
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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- C—CHEMISTRY; METALLURGY
- 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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- C—CHEMISTRY; METALLURGY
- 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
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
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Claims (13)
1. T-celleaktiverende bispecifikt antigenbindende molekyle, der omfatter en første og en anden antigenbindende del, hvoraf den ene er et Fab-molekyle, som er i stand til specifikt at binde til et aktiverende T-celleantigen, og hvoraf den anden er et Fab-molekyle, som er i stand til specifikt at binde til et målcelleantigen, og et Fc-domæne bestående af en første og en anden underenhed, som er i stand til stabil association; hvor den første antigenbindende del er et crossover-Fab-molekyle, hvor enten de variable eller de konstante regioner i Fab-letkæden og Fab-tungkæden er udskiftet; hvor den første og den anden antigenbindende del er forenet med hinanden, eventuelt via en peptidlinker; og hvor det T-celleaktiverende bispecifikke antigenbindende molekyle omfatter højst en antigenbindende del, som er i stand til specifikt at binde til et aktiverende T-cellea ntigen.
2. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge krav 1, hvor den anden antigenbindende del er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af Fab-tungkæden af den første antigenbindende del, hvor eventuelt i) Fab-letkæden af den første antigenbindende del og Fab-letkæden af den anden antigenbindende del er forenet med hinanden, eventuelt via en peptidlinker; og/eller ii) den første antigenbindende del er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af den første eller anden underenhed af Fc-domænet.
3. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge krav 1, hvor den første antigenbindende del er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af Fab-tungkæden af den anden antigenbindende del, hvor eventuelt i) Fab-letkæden af den første antigenbindende del og Fab-letkæden af den anden antigenbindende del er forenet med hinanden, eventuelt via en peptidlinker; og/eller ii) hvor den anden antigenbindende del er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af den første eller den anden underenhed af Fc-domænet.
4. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge krav 1, hvor den anden antigenbindende del er forenet i den C-terminale ende af Fab-letkæden med den N-terminale ende af Fab-letkænden af den første antigenbindende del, og hvor den anden antigenbindende del eventuelt er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af den første eller den anden underenhed af Fc-domænet.
5. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge et hvilket som helst af kravene 1 til 4, hvilket molekyle omfatter en tredje antigenbindende del, som er et Fab-molekyle, der er i stand til specifikt at binde til et målcelleantigen, hvor den tredje antigenbindende del eventuelt er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af den første eller anden underenhed af Fc-domænet, og hvor eventuelt i) den anden og den tredje antigenbindende del hver er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af en af underenhederne af Fc-domænet, og den første antigenbindende del er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af Fab-tungkæden af den anden antigenbindende del; eller ii) den første og den tredje antigenbindende del hver er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af en af underenhederne af Fc-domænet, og den anden antigenbindende del er forenet i den C-terminale ende af Fab-tungkæden med den N-terminale ende af Fab-tungkæden af den første antigenbindende del.
6. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge et hvilket som helst af de foregående krav, hvor i) det T-celleaktiverende bispecifikke antigenbindende molekyle er defineret i krav 5(i), og hvor den anden og den tredje antigenbindende del og Fc-domænet er del af et immunoglobulinmolekyle, især et immunoglobulin af klasse IgG; ii) Fc-domænet er et IgG-, specifikt et IgGi- eller IgG4-Fc-domæne; iii) Fc-domænet er et humant Fc-domæne; og/eller iv) Fc-domænet omfatter en modifikation, der fremmer associationen af den første og den anden underenhed af Fc-domænet, hvor en aminosyrerest i CH3-domænet af den første underenhed af Fc-domænet eventuelt er erstattet med en aminosyrerest med et større sidekædevolumen, hvorved der dannes et fremspring i CH3-domænet af den første underenhed, som kan placeres i en forsænkning i CH3-domænet af den anden underenhed, og en aminosyrerest i CH3-domændet af den anden underenhed af Fc-domænet er erstattet med en aminosyrerest med et mindre sidekædevolumen, hvorved der dannes en forsænkning i CH3-domænet af den anden underenhed, i hvilken fremspringet i CH3-domænet af den første underenhed er placerebart.
7. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge et hvilket som helst af de foregående krav, hvor i) Fc-domænet udviser reduceret bindingsaffinitet med en Fc-receptor og/eller reduceret effektorfunktion sammenlignet med et nativt IgGl-Fc-domæne; ii) Fc-domænet omfatter en eller flere aminosyreudskiftninger, som reducerer bindingen til en Fc-receptor og/eller effektorfunktion; iii) Fc-domænet omfatter en eller flere aminosyreudskiftninger, som reducerer bindingen til en Fc-receptor og/eller effektorfunktion, hvor den ene eller flere aminosyreudskiftning er i en eller flere positioner valgt fra gruppen af L234, L235 og P329 (EU-nummerering); og/eller iv) hver underenhed af Fc-domænet omfatter tre aminosyreudskiftninger, som reducerer bindingen til en aktiverende Fc-receptor og/eller effektorfunktion, hvor aminosyreudskiftningerne er L234A, L235A og P329G (EU-nummerering).
8. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge krav 7, hvor i) Fc-receptoren er en Fcy-receptor; eller ii) effektorfunktionen er antistofafhængig cellemedieret cytotoksicitet (ADCC).
9. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge et hvilket som helst af de foregående krav, hvor i) det aktiverende T-celleantigen er CD3; og/eller ii) målcelleantigenet er valgt fra gruppen bestående af: melanom-associeret chondroitinsulfatproteoglycan (MCSP), epidermal vækstfaktorreceptor (EGFR), CD19, CD20, CD33, carcinoembryonisk antigen (CEA) og fibroblastaktiveringsprotein (FAP).
10. Isoleret polynukleotid, der koder for det T-celleaktiverende bispecifikke antigenbindende molekyle ifølge et hvilket som helst af kravene 1 til 9.
11. Fremgangsmåde til fremstilling af det T-celleaktiverende bispecifikke antigenbindende molekyle ifølge et hvilket som helst af kravene 1 til 9, hvilken fremgangsmåde omfatter trinnene, der går ud på a) at dyrke en værtscelle, som omfatter det isolerede polynukleotid ifølge krav 10, eller en vektor, som omfatter det isolerede polynukleotid ifølge krav 10, ved betingelser, der er egnede for ekspression af det T-celleaktiverende bispecifikke antigenbindende molekyle, og b) at indvinde det T-celleaktiverende bispecifikke antigenbindende molekyle.
12. Farmaceutisk sammensætning, der omfatter det T-celleaktiverende bispecifikke antigenbindende molekyle ifølge et hvilket som helst af kravene 1 til 9 og en farmaceutisk acceptabel bærer.
13. T-celleaktiverende bispecifikt antigenbindende molekyle ifølge et hvilket som helst af kravene 1 til 9 eller farmaceutisk sammensætning ifølge krav 12 i) til anvendelse som et lægemiddel; ii) til anvendelse ved behandling af en sygdom hos et individ, der har behov derfor; iii) til anvendelse ved behandling af en sygdom hos et individ, der har behov derfor, hvor sygdommen er cancer; eller iv) til anvendelse i en fremgangsmåde til at inducere lysis af en målcelle hos et individ, hvilken fremgangsmåde omfatter at bringe en målcelle i kontakt med det T-celleaktiverende bispecifikke antigenbindende molekyle i nærvær af en T-celle, hvor målcellen er en tumorcelle.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11178370 | 2011-08-23 | ||
| EP12168192 | 2012-05-16 | ||
| PCT/EP2012/066215 WO2013026833A1 (en) | 2011-08-23 | 2012-08-21 | Bispecific t cell activating antigen binding molecules |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2748201T3 true DK2748201T3 (da) | 2018-02-12 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK12750364.7T DK2748201T3 (da) | 2011-08-23 | 2012-08-21 | Bispecifikke t-celleaktiverende antigenbindende molekyler |
Country Status (34)
| Country | Link |
|---|---|
| US (5) | US20130078249A1 (da) |
| EP (3) | EP3321286B1 (da) |
| JP (4) | JP6339015B2 (da) |
| KR (1) | KR101963923B1 (da) |
| CN (1) | CN103748114B (da) |
| AR (1) | AR087608A1 (da) |
| AU (1) | AU2012298537B2 (da) |
| BR (1) | BR112014003769B1 (da) |
| CA (1) | CA2837975C (da) |
| CL (1) | CL2014000126A1 (da) |
| CO (1) | CO6811817A2 (da) |
| CR (1) | CR20130669A (da) |
| DK (1) | DK2748201T3 (da) |
| EA (1) | EA030147B1 (da) |
| EC (1) | ECSP14013220A (da) |
| ES (2) | ES2659764T3 (da) |
| HR (1) | HRP20180243T1 (da) |
| HU (1) | HUE038225T2 (da) |
| IL (2) | IL229765B (da) |
| LT (1) | LT2748201T (da) |
| MA (1) | MA35448B1 (da) |
| MX (1) | MX352101B (da) |
| MY (1) | MY169358A (da) |
| NO (1) | NO2748201T3 (da) |
| PE (1) | PE20141521A1 (da) |
| PH (1) | PH12013502531A1 (da) |
| PL (2) | PL3321286T3 (da) |
| PT (1) | PT2748201T (da) |
| RS (1) | RS56879B1 (da) |
| SI (1) | SI2748201T1 (da) |
| TW (1) | TWI633121B (da) |
| UA (1) | UA116192C2 (da) |
| WO (1) | WO2013026833A1 (da) |
| ZA (1) | ZA201309742B (da) |
Families Citing this family (363)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090162359A1 (en) | 2007-12-21 | 2009-06-25 | Christian Klein | Bivalent, bispecific antibodies |
| US9266967B2 (en) | 2007-12-21 | 2016-02-23 | Hoffmann-La Roche, Inc. | Bivalent, bispecific antibodies |
| CA2756244A1 (en) | 2009-04-02 | 2010-10-07 | Roche Glycart Ag | Multispecific antibodies comprising full length antibodies and single chain fab fragments |
| SG175077A1 (en) | 2009-04-07 | 2011-11-28 | Roche Glycart Ag | Trivalent, bispecific antibodies |
| US9676845B2 (en) | 2009-06-16 | 2017-06-13 | Hoffmann-La Roche, Inc. | Bispecific antigen binding proteins |
| US8703132B2 (en) * | 2009-06-18 | 2014-04-22 | Hoffmann-La Roche, Inc. | Bispecific, tetravalent antigen binding proteins |
| WO2011028952A1 (en) | 2009-09-02 | 2011-03-10 | Xencor, Inc. | Compositions and methods for simultaneous bivalent and monovalent co-engagement of antigens |
| EP2478013B1 (en) | 2009-09-16 | 2018-10-24 | F.Hoffmann-La Roche Ag | Coiled coil and/or tether containing protein complexes and uses thereof |
| TW201138821A (en) | 2010-03-26 | 2011-11-16 | Roche Glycart Ag | Bispecific antibodies |
| AU2011283694B2 (en) | 2010-07-29 | 2017-04-13 | Xencor, Inc. | Antibodies with modified isoelectric points |
| CN103068846B9 (zh) | 2010-08-24 | 2016-09-28 | 弗·哈夫曼-拉罗切有限公司 | 包含二硫键稳定性Fv片段的双特异性抗体 |
| ES2758994T3 (es) | 2010-11-05 | 2020-05-07 | Zymeworks Inc | Diseño anticuerpo heterodimérico estable con mutaciones en el dominio Fc |
| PT3434767T (pt) | 2010-11-30 | 2026-01-23 | Chugai Pharmaceutical Co Ltd | Agente terapêutico indutor de citotoxicidade |
| SG191153A1 (en) | 2010-12-23 | 2013-07-31 | Hoffmann La Roche | Polypeptide-polynucleotide-complex and its use in targeted effector moiety delivery |
| MX342034B (es) | 2011-02-28 | 2016-09-12 | Hoffmann La Roche | Proteinas monovalentes que se unen a antigenos. |
| AR085404A1 (es) | 2011-02-28 | 2013-09-25 | Hoffmann La Roche | Proteinas de union a antigeno |
| AU2012222833B2 (en) | 2011-03-03 | 2017-03-16 | Zymeworks Inc. | Multivalent heteromultimer scaffold design and constructs |
| EP2699596A4 (en) | 2011-04-22 | 2015-01-14 | Emergent Product Dev Seattle | PROSTATE-SPECIFIC MEMBRANE-BINDING PROTEINS AND COMPOSITIONS AND METHOD THEREFOR |
| EA201892619A1 (ru) | 2011-04-29 | 2019-04-30 | Роше Гликарт Аг | Иммуноконъюгаты, содержащие мутантные полипептиды интерлейкина-2 |
| NO2748201T3 (da) * | 2011-08-23 | 2018-05-12 | ||
| WO2013026839A1 (en) | 2011-08-23 | 2013-02-28 | Roche Glycart Ag | Bispecific antibodies specific for t-cell activating antigens and a tumor antigen and methods of use |
| RU2014109038A (ru) | 2011-08-23 | 2015-09-27 | Рош Гликарт Аг | Антитела к хондроитинсульфат протеогликану меланомы |
| US10851178B2 (en) | 2011-10-10 | 2020-12-01 | Xencor, Inc. | Heterodimeric human IgG1 polypeptides with isoelectric point modifications |
| US12466897B2 (en) | 2011-10-10 | 2025-11-11 | Xencor, Inc. | Heterodimeric human IgG1 polypeptides with isoelectric point modifications |
| BR112014010580B1 (pt) | 2011-11-04 | 2021-01-12 | Zymeworks, Inc. | constructo de fc heteromultimérico isolado, composição, uso de um constructo de fc heteromultimérico isolado, composição de ácido nucléico e método para expressar o constructo de fc heteromultimérico isolado |
| TWI679212B (zh) | 2011-11-15 | 2019-12-11 | 美商安進股份有限公司 | 針對ｂｃｍａ之e3以及ｃｄ３的結合分子 |
| CA2861124A1 (en) | 2012-02-10 | 2013-08-15 | Genentech, Inc. | Single-chain antibodies and other heteromultimers |
| JP6628966B2 (ja) | 2012-06-14 | 2020-01-15 | 中外製薬株式会社 | 改変されたＦｃ領域を含む抗原結合分子 |
| US9499634B2 (en) | 2012-06-25 | 2016-11-22 | Zymeworks Inc. | Process and methods for efficient manufacturing of highly pure asymmetric antibodies in mammalian cells |
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