DK2046382T3 - scFv-Antistoffer, som passerer igennem epithele og/eller endothele lag - Google Patents
scFv-Antistoffer, som passerer igennem epithele og/eller endothele lag Download PDFInfo
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- DK2046382T3 DK2046382T3 DK07763939.1T DK07763939T DK2046382T3 DK 2046382 T3 DK2046382 T3 DK 2046382T3 DK 07763939 T DK07763939 T DK 07763939T DK 2046382 T3 DK2046382 T3 DK 2046382T3
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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
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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
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/04—Artificial tears; Irrigation solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/06—Antiglaucoma agents or miotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/14—Decongestants or antiallergics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- 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
-
- 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
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- 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
-
- 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
- C07K2317/622—Single chain antibody (scFv)
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Ophthalmology & Optometry (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Microbiology (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Pain & Pain Management (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Claims (27)
1. Farmaceutisk sammensætning formuleret til lokal påføring på en overflade af en epithelvævsbarriere, hvilken sammensætning omfatter et opløseligt antigen-bindende polypeptid og et farmaceutisk acceptabelt bærestof, fortyndingsmiddel eller hjælpestof, hvor det antigen-bindende polypeptid er i stand til at krydse en intakt pattedyrshornhinde på mindre 8 timer under fraværet af et penetrationsfremmende middel, og hvor det antigen-bindende polypeptid er et enkeltkædeantistof (scFv) og omfatter: (a) en let kæde variabel domæne (VL) ramme med i det mindste 85% lighed med en VL ramme valgt fra gruppen bestående af SEQ ID NO: 1,2, 3, 4, 5, 6 og 7; og en tung kæde variabel domæne (VH) ramme med i det mindste 85% lighed med en VH ramme valgt fra gruppen omfattende SEQ ID NO: 8, 9, 10 og 11; eller (b) sekvensen ifølge SEQ ID NO: 13.
2. Farmaceutisk sammensætning ifølge krav 1, som er til topisk påføring på et øje.
3. Farmaceutisk sammensætning ifølge krav 2, som er formuleret til at opnå en intraokulær koncentration af det antigen-bindende polypeptid på i det mindste 100 ng/ml.
4. Farmaceutisk sammensætning ifølge krav 2 eller 3, hvor det antigen-bindende polypeptid er formuleret til topisk påføring på øjet og er i stand til at passere igennem hornhinden og ind i et intraokulært rum under fraværet af penetrationsfremmer.
5. Farmaceutisk sammensætning ifølge ethvert af kravene 2 til 4, hvor sammensætningen foreligger i form af øjendråber.
6. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor sammensætningen har en pH på mindre end 8.
7. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor poly-peptidet er tilstrækkeligt opløseligt til at overskride det ene eller flere epithele lag på mindre end 4 timer.
8. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor sammensætningen yderligere omfatter ét eller flere penetreringsfremmende midler.
9. Farmaceutisk sammensætning ifølge krav 8, hvor det penetreringsfremmende middel er valgt fra gruppen bestående af azon, benzalkoniumchlorid (BzC1), BL-7, BL-
9. Brij 35, Brij 78, Brij 98, Brij 99, polyoxyethylen-polyoxypropylen 1800, natriumcaprat, caprylsyre, cetylpyridiniumchlorid, chlorhexidin, cholat, ricinusolie, majsolie, cremophor-EL, DMSO, decamethoniumbromid, deoxycholat, dextransulfat, EDTA, dinatrium EDETATE, ethanol, fusidat, glycocholat, laurylsulfat, L-alysophosphatidyl-cholin, N-lauroylsarcosin, NMP, oleinsyre, phospholipider, poly 20 oxyethylen-9-laurylether, saponin, Tween 20, Tween 40, Tween 60, Tween 80, taurocholeat og taurodeoxycholat, især natriumcaprat.
10. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor polypeptidet har en bindingsaffinitet for et målantigen af en KD på i det mindste 10E-6 M eller mindre.
11. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, som omfatter det antigen-bindende polypeptid i en koncentration på mere end 2 mg/ml, eller mere end 2,5 mg/ml, fortrinsvis mere end 5 mg/ml, mere foretrukkent mere end 10 mg/ml.
12. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor det antigen-bindende polypeptid opnår en intraokulær koncentration på mere end 100 ng/ml.
13. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor det antigen-bindende polypeptid er stabilt ved en temperatur fra -80°C til 37°C.
14. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor det antigen-bindende polypeptid forbliver stabilt i i det mindste otte uger.
15. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor det antigen-bindende polypeptid forbliver stabilt i i det mindste seks uger ved 4°C.
16. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor det antigen-bindende polypeptid forbliver stabilt i én måned, fortrinsvis i det mindste to måneder, mest foretrukkent i det mindste seks måneder ved 20°C til 40°C, fortrinsvis ved 27°C i PBS.
17. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor det antigen-bindende polypeptid er stabilt under reducerende betingelser som målt i en gærinteraktionsassay kaldt "Quality control".
18. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor poly-peptidet forbliver på monomer form under fysiologiske betingelser.
19. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor poly-peptidet er opløseligt ved omgivelsestemperatur i PBS ved koncentrationer på mere end 1 mg/ml, fortrinsvis mere end 4 mg/ml, mere foretrukkent mere end 10 mg/ml, endnu mere foretrukkent mere end 25 mg/ml, eller mest foretrukkent mere end 50 mg/ml.
20. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor poly-peptidet afslører en midtpunktsovergang i guanidiniumhydrochloridtitrering på i det mindste 1,5 M, fortrinsvis i det mindste 1,75 M, mere foretrukkent i det mindste 1,9 M eller mest foretrukkent i det mindste 2 M.
21. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor opløseligheden eller transitkinetikken for det antigen-bindende polypeptid måles ved et assay valgt blandt et standard Caco-2 epithelcellemonolagsassay, et standardintracellulært én hybrid eller to hybrid-opløselighedsassay, og et standardmusejejunumpermeabili-tetassay.
22. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor opløselighed måles ved et standard PEG præcipitationsassay eller selv-interaktionschroma-tografi (SIC) assay.
23. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor (a) den lette kæde variable domæne (VL) ramme har i det mindste 85% lighed med SEQ ID NO: 2 og den tunge kæde variable domæne (VH) ramme er i det mindste 85% lignende SEQ ID NO: 8; (b) den lette kæde variable domæne (VL) ramme har i det mindste 85% lighed med SEQ ID NO: 4 og den tunge kæde variable domæne (VH) ramme er i det mindste 85% lignende SEQ ID NO: 10; eller (c) den lette kæde variable domæne (VL) ramme har i det mindste 95% sekvenslighed med SEQ ID NO: 7 og den tunge kæde variable domæne (VH) ramme har i det mindste 95% sekvenslighed med SEQ ID NO: 8.
24. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor affiniteten for antistoffet for dets antigen er kendetegnet ved en dissociationskonstant KD på mindre end 100 nM.
25. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor antistoffet har en specificitet for humant TNFa.
26. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor antistoffet er kemisk modificeret.
27. Farmaceutisk sammensætning ifølge ethvert af de foregående krav, hvor hjælpestoffet vælges fra gruppen omfattende benzalkoniumchlorid, Tween 20, Tween 40, Tween 60, Tween 80 og chlorhexidin.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US81937806P | 2006-07-10 | 2006-07-10 | |
US89990707P | 2007-02-06 | 2007-02-06 | |
PCT/CH2007/000334 WO2008006235A2 (en) | 2006-07-10 | 2007-07-10 | Scfv antibodies which pass epithelial and/or endothelial layers |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2046382T3 true DK2046382T3 (da) | 2016-12-12 |
Family
ID=38792084
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK07763939.1T DK2046382T3 (da) | 2006-07-10 | 2007-07-10 | scFv-Antistoffer, som passerer igennem epithele og/eller endothele lag |
Country Status (16)
Country | Link |
---|---|
US (2) | US8936785B2 (da) |
EP (2) | EP3093026B1 (da) |
JP (6) | JP2009542232A (da) |
CN (2) | CN103251947B (da) |
AU (1) | AU2007272224B2 (da) |
CA (1) | CA2658241C (da) |
DK (1) | DK2046382T3 (da) |
ES (2) | ES2603399T3 (da) |
HU (1) | HUE032654T2 (da) |
LT (1) | LT2046382T (da) |
NZ (2) | NZ700275A (da) |
PL (1) | PL2046382T3 (da) |
PT (1) | PT2046382T (da) |
RU (3) | RU2438708C2 (da) |
SI (1) | SI2046382T1 (da) |
WO (1) | WO2008006235A2 (da) |
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2007
- 2007-07-10 JP JP2009518698A patent/JP2009542232A/ja not_active Withdrawn
- 2007-07-10 WO PCT/CH2007/000334 patent/WO2008006235A2/en active Application Filing
- 2007-07-10 NZ NZ700275A patent/NZ700275A/en not_active IP Right Cessation
- 2007-07-10 ES ES07763939.1T patent/ES2603399T3/es active Active
- 2007-07-10 AU AU2007272224A patent/AU2007272224B2/en active Active
- 2007-07-10 NZ NZ574308A patent/NZ574308A/en not_active IP Right Cessation
- 2007-07-10 ES ES16175728T patent/ES2820837T3/es active Active
- 2007-07-10 CN CN201310159387.0A patent/CN103251947B/zh active Active
- 2007-07-10 EP EP16175728.1A patent/EP3093026B1/en active Active
- 2007-07-10 HU HUE07763939A patent/HUE032654T2/en unknown
- 2007-07-10 LT LTEP07763939.1T patent/LT2046382T/lt unknown
- 2007-07-10 RU RU2009104318/15A patent/RU2438708C2/ru active
- 2007-07-10 PL PL07763939T patent/PL2046382T3/pl unknown
- 2007-07-10 PT PT77639391T patent/PT2046382T/pt unknown
- 2007-07-10 CA CA2658241A patent/CA2658241C/en active Active
- 2007-07-10 DK DK07763939.1T patent/DK2046382T3/da active
- 2007-07-10 CN CN2007800314717A patent/CN101505794B/zh active Active
- 2007-07-10 SI SI200731858A patent/SI2046382T1/sl unknown
- 2007-07-10 US US12/307,875 patent/US8936785B2/en active Active
- 2007-07-10 EP EP07763939.1A patent/EP2046382B1/en active Active
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2011
- 2011-06-24 RU RU2011126239/15A patent/RU2565399C2/ru active
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2014
- 2014-04-30 US US14/266,444 patent/US20140234315A1/en not_active Abandoned
- 2014-06-16 JP JP2014123202A patent/JP6226824B2/ja active Active
- 2014-06-16 JP JP2014123201A patent/JP6230195B2/ja active Active
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2015
- 2015-07-21 RU RU2015130221A patent/RU2015130221A/ru not_active Application Discontinuation
- 2015-12-21 JP JP2015248371A patent/JP2016041758A/ja active Pending
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2017
- 2017-09-01 JP JP2017168662A patent/JP2017209114A/ja active Pending
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2019
- 2019-02-04 JP JP2019017744A patent/JP2019089809A/ja not_active Withdrawn
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