DK2822592T3 - Tgf-1-specifikke antistoffer og fremgangsmåder samt anvendelser deraf - Google Patents
Tgf-1-specifikke antistoffer og fremgangsmåder samt anvendelser deraf Download PDFInfo
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- DK2822592T3 DK2822592T3 DK13758033.8T DK13758033T DK2822592T3 DK 2822592 T3 DK2822592 T3 DK 2822592T3 DK 13758033 T DK13758033 T DK 13758033T DK 2822592 T3 DK2822592 T3 DK 2822592T3
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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
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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
- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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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
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- 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
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/475—Assays involving growth factors
- G01N2333/495—Transforming growth factor [TGF]
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
- G01N33/57488—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds identifable in body fluids
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
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- Molecular Biology (AREA)
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- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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- Engineering & Computer Science (AREA)
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- Animal Behavior & Ethology (AREA)
- Microbiology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Mycology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cell Biology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Biotechnology (AREA)
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Claims (15)
1. Isoleret antistofmolekyle eller fragment deraf, som genkender human og murin transformerende vækstfaktor beta 1 (TGF-βΙ), ikke reagerer med TGF-32 eller TGF-33 og neutraliserer aktivitet af TGF-βΙ; og som omfatter en tung kædes variable region, der omfatter CDR-domæne-sekvenserne CDR1 GYTFTNYW (SEQ ID NO: 11) eller GYTFTNYWMH (SEQ ID NO: 3), CDR2 IYPGNSDT (SEQ ID NO: 12) eller TIYPGNSDTN (SEQ ID NO: 4) og CDR3 EDSRSLYYNGWDYFDY (SEQ ID NO: 5), og en let kædes variable region, der omfatter CDR-domæne-sekvenserne CDR1 ESVDNYGISF (SEQ ID NO: 6), CDR2 YAAS (SEQ ID NO: 7) og CDR3 QQSKEVPRT (SEQ ID NO: 8).
2. Isoleret antistof eller fragment ifølge krav 1, som er et antistof eller antistoffragment, der omfatter en tung kædes variable region, der omfatter CDR-domæne-sekvenserne CDR1 GYTFTNYW (SEQ ID NO: 11), CDR2 IYPGNSDT (SEQ ID NO: 12) og CDR3 EDSRSLYYNGWDYFDY (SEQ ID NO: 5) eller CDR1 GYTFTNYWMH (SEQ ID NO: 3), CDR2 TIYPGNSDTN (SEQ ID NO: 4) og CDR3 EDSRSLYYNGWDYFDY (SEQ ID NO: 5), og en let kædes variable region, der omfatter CDR-domæne-sekvenserne CDR1 ESVDNYGISF (SEQ ID NO: 6), CDR2 YAAS (SEQ ID NO: 7) og CDR3 QQSKEVPRT (SEQ ID NO: 8).
3. Isoleret antistof eller fragment ifølge krav 1 eller krav 2, som er et antistof eller antistoffragment, der omfatter en aminosyresekvens for en tung kædes variable region valgt blandt aminosyresekvensen SEQ ID NO: 1 angivet i figur 1 eller varianter deraf med mindst 90 % aminosyreidentitet med SEQ ID NO:1, eller som omfatter 1 til 3 aminosyresubstitutioner i én eller flere tungkæde-CDR-regioner i figur 1, hvor varianterne bevarer TGF-βΙ-reaktivitet og neutralisering og mangler TGF^2- og TGF^3-reaktivitet.
4. Isoleret antistof ifølge krav 3, der endvidere omfatter en let kædes variable region, der omfatter en aminosyresekvens, som er valgt blandt aminosyresekvensen som angivet i SEQ ID NO: 2 eller varianter deraf med mindst 90 % aminosyreidentitet med SEQ ID NO:2, eller som omfatter 1 til 3 aminosyresubstitutioner i én eller flere letkæde-CDR-regioner i figur 1, hvor varianterne bevarer TGF-βΙ-reaktivitet og neutralisering og mangler TGF^2- og TGF^3-reaktivitet.
5. Isoleret antistof eller fragment ifølge et hvilket som helst af kravene 1 til 4, der er et antistof eller fragment deraf, hvor det isolerede antistof er i form af et antistof-F(ab')2-, -scFv-fragment, et domæneantistof, et miniantistof, et diabody, et triabody eller et tetrabody.
6. Isoleret antistof eller fragment ifølge et hvilket som helst af kravene 1 til 4, der endvidere omfatter et detekterbart eller funktionelt mærke.
7. Isoleret antistof ifølge krav 6, hvor det detekterbare eller funktionelle mærke er et kovalent bundet lægemiddel, eller er et radioaktivt mærke.
8. Isoleret nukleinsyre, der omfatter en sekvens, som koder for et antistof eller fragment ifølge et hvilket som helst af kravene 1 til 5.
9. Fremgangsmåde til fremstilling af et antistof eller fragment som defineret i et hvilket som helst af kravene 1 til 5, hvilken fremgangsmåde omfatter ekspression af nukleinsyren ifølge krav 8 i celler in vitro under betingelser, der skal frembringe ekspression af antistoffet eller fragmentet, og isolering af antistoffet eller fragmentet.
10. Antistof eller fragment ifølge et hvilket som helst af kravene 1 til 7 til anvendelse i en fremgangsmåde til behandling af cancer eller forebyggelse af tilbagefald eller metastase af cancer hos et pattedyr, til anvendelse ved stimulering eller forøgelse af en immunrespons på en cancervaccine eller et antigen, til anvendelse som et immunmodulerende middel hos et pattedyr, til anvendelse ved blokering af Treg-medieret immunsuppression hos et pattedyr eller til anvendelse i en fremgangsmåde til diagnose af cancer hos et pattedyr.
11. Kit til in y/fro-diagnose eller -prognose af cancer, hvor TGF-βΙ-antigen udtrykkes, hvilket kit omfatter et antistof eller fragment ifølge et hvilket som helst af kravene 1 til 7, valgfrit med reagenser og/eller en brugsanvisning.
12. Farmaceutisk sammensætning eller immunologisk sammensætning, der omfatter et antistof eller fragment som defineret i et hvilket som af kravene 1 til 7 og et farmaceutisk acceptabelt vehikel, en farmaceutisk acceptabel bærer eller diluent, der valgfrit omfatter en adjuvans og/eller ét eller flere antigener, et immunregulatorisk antistof eller en småmolekyleinhibitor til en immunmodulator.
13. Farmaceutisk doseringsform af den farmaceutiske sammensætning eller den immunologiske sammensætning ifølge krav 12 til anvendelse i et kit til behandling af en tumor hos en human patient, hvilken doseringsform endvidere omfatter en separat farmaceutisk doseringsform, der omfatter et yderligere anticancermiddel, som er valgt fra gruppen bestående af cancer- eller tumorantigen(-er), kemoterapeutiske midler, radioimmunterapeutiske midler og kombinationer deraf.
14. In v'/fro-fremgangsmåde til detektering af forekomsten af cancer eller bestemmelse af prognosen for cancer hos et pattedyr, hvor canceren måles, eller prognosen bestemmes ved at bestemme forekomsten og/eller mængden af TGF-βΙ, hvilken fremgangsmåde omfatter, at: A. en biologisk prøve fra et pattedyr, hvor der er mistanke om forekomst af cancer, bringes i kontakt med antistoffet eller fragmentet ifølge et hvilket som helst af kravene 1 til 7 under betingelser, der tillader, at der optræder binding af TGF-βΙ til antistoffet; og B. det detekteres, hvorvidt der er sket binding mellem TGF-βΙ fra prøven og antistoffet, eller omfanget af binding, der er sket for TGF-βΙ fra prøven og antistoffet, bestemmes; hvor detektion af binding viser forekomsten af cancer i prøven, og omfanget af binding viser prognosen for cancer i prøven.
15. Antistof eller fragment til anvendelse ifølge krav 10 i en fremgangsmåde til behandling af cancer eller forebyggelse af tilbagefald eller metastase af cancer hos et pattedyr, til stimulering eller forøgelse afen immunrespons på en cancervaccine eller et antigen eller til diagnose af cancer hos et pattedyr eller en fremgangsmåde ifølge krav 14, hvor canceren er valgt blandt melanom, tyktarmscancer, brystcancer, lungecancer, prostatacancer og fibrosarkom.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261608393P | 2012-03-08 | 2012-03-08 | |
| PCT/US2013/029334 WO2013134365A1 (en) | 2012-03-08 | 2013-03-06 | TGF-β1 SPECIFIC ANTIBODIES AND METHODS AND USES THEREOF |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2822592T3 true DK2822592T3 (da) | 2018-10-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13758033.8T DK2822592T3 (da) | 2012-03-08 | 2013-03-06 | Tgf-1-specifikke antistoffer og fremgangsmåder samt anvendelser deraf |
Country Status (5)
| Country | Link |
|---|---|
| US (3) | US9518112B2 (da) |
| EP (1) | EP2822592B1 (da) |
| DK (1) | DK2822592T3 (da) |
| ES (1) | ES2694203T3 (da) |
| WO (1) | WO2013134365A1 (da) |
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| EA201891909A1 (ru) * | 2016-03-11 | 2019-02-28 | Сколар Рок, Инк. | TGFβ1-СВЯЗЫВАЮЩИЕ ИММУНОГЛОБУЛИНЫ И ИХ ПРИМЕНЕНИЕ |
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2013
- 2013-03-06 US US14/383,602 patent/US9518112B2/en active Active
- 2013-03-06 DK DK13758033.8T patent/DK2822592T3/da active
- 2013-03-06 ES ES13758033.8T patent/ES2694203T3/es active Active
- 2013-03-06 EP EP13758033.8A patent/EP2822592B1/en active Active
- 2013-03-06 WO PCT/US2013/029334 patent/WO2013134365A1/en active Application Filing
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2016
- 2016-11-02 US US15/341,077 patent/US10035851B2/en active Active
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2018
- 2018-07-26 US US16/046,025 patent/US10947303B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US10035851B2 (en) | 2018-07-31 |
| EP2822592B1 (en) | 2018-08-15 |
| EP2822592A4 (en) | 2016-01-06 |
| EP2822592A1 (en) | 2015-01-14 |
| WO2013134365A1 (en) | 2013-09-12 |
| US9518112B2 (en) | 2016-12-13 |
| ES2694203T3 (es) | 2018-12-19 |
| US20190092847A1 (en) | 2019-03-28 |
| US20170137507A1 (en) | 2017-05-18 |
| US10947303B2 (en) | 2021-03-16 |
| US20150132319A1 (en) | 2015-05-14 |
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