DK3024484T3 - Stabiliserede antistofsammensætninger - Google Patents
Stabiliserede antistofsammensætninger Download PDFInfo
- Publication number
- DK3024484T3 DK3024484T3 DK14742509.4T DK14742509T DK3024484T3 DK 3024484 T3 DK3024484 T3 DK 3024484T3 DK 14742509 T DK14742509 T DK 14742509T DK 3024484 T3 DK3024484 T3 DK 3024484T3
- Authority
- DK
- Denmark
- Prior art keywords
- antibody
- antigen
- protein
- composition
- binding polypeptide
- Prior art date
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Classifications
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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
-
- 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
-
- 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
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- 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
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
-
- 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
- C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
-
- 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)
-
- 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
-
- 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
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Peptides Or Proteins (AREA)
Claims (14)
- STABILISEREDE ANTISTOFSAMMENSÆTNINGER1. Sammensætning, der omfatter et antigenbindende polypeptid eller protein, som er valgt blandt et monoklonalt antistof, polyklonalt antistof, et antistoffragment, et fusionsprotein, der omfatter et antistoffragment, et antistof-lægemiddel-konjugat og en hvilken som helst kombination deraf og et flydende vehikel bestående af en semifluoreret alkan med formlen RFRH hvor RF er et ligekædet perfluoreret hydrocarbonsegment med 4 til 12 carbonatomer, og hvor RFI er en ligekædet alkylgruppe med 4 til 8 carbonatomer; hvor det antigenbindende polypeptid eller protein er inkorporeret i sammensætningen såsom til dannelse af en dispersion eller suspension, og hvor sammensætningen valgfrit omfatter en ikke-fluoreret organisk væske, hvor sammensætningen bibeholder mindst 85 % af sin initiale antigenbindende aktivitet under opbevaring i 6 måneder ved en temperatur på mellem stuetemperatur og 40 °C.
- 2. Sammensætning ifølge krav 1, hvor antistoffragmentet er et antigenbindende fragment (Fab), et enkeltkædet variabelt fragment (scFv), et enkeltdomæne-antistof, et miniantistof eller et diabody.
- 3. Sammensætning ifølge krav 1, hvor det monoklonale antistof er et kimært, humaniseret eller humant antistof.
- 4. Sammensætning ifølge et hvilket som helst foregående krav, hvor det antigenbindende polypeptid eller protein har en molekylvægt på mindst 90 kDa.
- 5. Sammensætning ifølge et hvilket som helst foregående krav, hvor den semifluorerede alkan er valgt blandt F4H5, F4H6, F4H8, F6H4, F6H6, F6H8 og F6H10.
- 6. Sammensætning ifølge et hvilket som helst foregående krav, som reelt er fri forvand.
- 7. Sammensætning ifølge et hvilket som helst foregående krav, hvor det antigenbindende polypeptid eller protein er i en koncentration på mindst 0,5 mg/ml.
- 8. Sammensætning ifølge et hvilket som helst foregående krav til anvendelse som en medicin.
- 9. Sammensætning ifølge krav 8 til anvendelse som en medicin, hvor medicinen er til parenteral administration ved subkutan, dermal, intramuskulær eller lokoregional injektion.
- 10. Fremgangsmåde til stabilisering af et antigenbindende polypeptid eller protein, hvor det antigenbindende polypeptid eller protein er et monoklonalt antistof, et polyklonalt antistof, et antistoffragment, et fusionsprotein, der omfatter et antistoffragment, et antistof-lægemiddel-konjugat eller en hvilken som helst kombination deraf, hvilken fremgangsmåde omfatter det trin, at det antigenbindende polypeptid eller protein blandes med et flydende vehikel, der omfatter en semifluoreret alkan med formlen RFRH hvor RF er et ligekædet perfluoreret hydrocarbonsegment med 4 til 12 carbonatomer, og hvor RH er en ligekædet alkylgruppe med 4 til 8 carbonatomer, såsom til dannelse af en suspension eller en dispersion.
- 11. Fremgangsmåde ifølge krav 10, hvor det antigenbindende polypeptid eller protein bibeholder mindst 85 % af den initiale antigenbindende aktivitet under opbevaring i 6 måneder ved en temperatur mellem stuetemperatur og 40 °C.
- 12. Fremgangsmåde ifølge krav 10, der først omfatter et trin til fremstilling af det antigenbindende polypeptid eller protein ved lyofilisering eller spraytørring.
- 13. Sammensætning ifølge krav 8 til anvendelse som en medicin, hvor medicinen er til behandling af cancer, og hvor det antigenbindende polypeptid eller protein er et monoklonalt antistof eller antistoffragment, som er valgt blandt alemtuzumab, bevacizumab, cetuximab, gemtuzumab, ipilimumab, ibritumomab, nimotuzumab, ofatumumab, panitumumab, rituximab, tositumomab og trastuzumab.
- 14. Sammensætning ifølge krav 8 til anvendelse som en medicin, hvor medicinen er til behandling af autoimmune eller inflammatoriske tilstande, og det antigenbindende polypeptid eller protein er et monoklonalt antistof eller antistoffragment, som er valgt blandt adalimumab, alemtuzumab, belimumab, briakinumab, canakinumab, eculizumab, epratuzumab, efalizumab, golimumab, infliximab, mepolizumab, natalizumab, ofatumumab, ocrelizumab, otelixizumab, omalizumab, reslizumab, rituximab, teplizumab, tocilizumab, ustekinumab og vedolizumab.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13177699 | 2013-07-23 | ||
| PCT/EP2014/065840 WO2015011199A1 (en) | 2013-07-23 | 2014-07-23 | Stabilized antibody compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3024484T3 true DK3024484T3 (da) | 2018-10-08 |
Family
ID=48803483
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14742509.4T DK3024484T3 (da) | 2013-07-23 | 2014-07-23 | Stabiliserede antistofsammensætninger |
Country Status (14)
| Country | Link |
|---|---|
| US (3) | US10273298B2 (da) |
| EP (1) | EP3024484B1 (da) |
| JP (1) | JP6503349B2 (da) |
| KR (1) | KR102272568B1 (da) |
| CN (2) | CN105555311B (da) |
| AU (1) | AU2014295052B2 (da) |
| BR (1) | BR112016001522B1 (da) |
| CA (1) | CA2918419C (da) |
| DK (1) | DK3024484T3 (da) |
| ES (1) | ES2687094T3 (da) |
| MX (1) | MX370207B (da) |
| PL (1) | PL3024484T3 (da) |
| PT (1) | PT3024484T (da) |
| WO (1) | WO2015011199A1 (da) |
Families Citing this family (40)
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| ES2564502T3 (es) | 2010-03-17 | 2016-03-23 | Novaliq Gmbh | Composición farmacéutica para el tratamiento de la presión intraocular aumentada |
| EP2444063A1 (en) | 2010-10-20 | 2012-04-25 | Novaliq GmbH | Liquid pharmaceutical compositions for the delivery of active ingredients |
| EP2462921A1 (en) | 2010-11-11 | 2012-06-13 | Novaliq GmbH | Liquid pharmaceutical compositions for the treatment of a posterior eye disease |
| JP6039145B2 (ja) | 2011-05-25 | 2016-12-07 | ノバリック ゲーエムベーハー | 半フッ化アルカンを基礎にした局所薬学的組成物 |
| PT2806886T (pt) | 2012-01-23 | 2017-03-24 | Novaliq Gmbh | Composições de proteínas estabilizadas baseadas em alcanos semifluorados |
| MX363182B (es) | 2012-09-12 | 2019-03-13 | Novaliq Gmbh | Composiciones que comprenden mezclas de alcanos semifluorados. |
| EP2895144B1 (en) | 2012-09-12 | 2017-01-11 | Novaliq GmbH | Semifluorinated alkane compositions |
| UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
| DK3024484T3 (da) | 2013-07-23 | 2018-10-08 | Novaliq Gmbh | Stabiliserede antistofsammensætninger |
| EP2893939A1 (en) * | 2014-01-10 | 2015-07-15 | Netris Pharma | Anti-netrin-1 antibody |
| AR103726A1 (es) * | 2015-02-27 | 2017-05-31 | Merck Sharp & Dohme | Cristales de anticuerpos monoclonales anti-pd-1 humanos |
| US20170087100A1 (en) | 2015-09-30 | 2017-03-30 | Novaliq Gmbh | Semifluorinated compounds and their compositions |
| EP3722274B1 (en) | 2015-09-30 | 2023-06-07 | Novaliq GmbH | 2-perfluorobutyl pentane for ophthalmic administration |
| DK3442480T3 (da) | 2016-06-23 | 2020-01-13 | Novaliq Gmbh | Fremgangsmåde til topisk indgivelse |
| KR102614858B1 (ko) | 2016-09-22 | 2023-12-18 | 노바리크 게엠베하 | 안검염 치료에 사용되는 약제학적 조성물 |
| AU2017329983B2 (en) | 2016-09-23 | 2022-05-05 | Novaliq Gmbh | Ophthalmic compositions comprising ciclosporin |
| MX381639B (es) | 2016-12-23 | 2025-03-13 | Novaliq Gmbh | Composicion oftalmica para el tratamiento de la enfermedad del ojo seco. |
| PL3612228T3 (pl) | 2017-04-21 | 2024-04-08 | Dermaliq Therapeutics, Inc. | Kompozycje jodu |
| CN110913906A (zh) | 2017-05-02 | 2020-03-24 | 默沙东公司 | 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂 |
| JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| US11278503B2 (en) | 2017-05-12 | 2022-03-22 | Novaliq Gmbh | Pharmaceutical compositions comprising semifluorinated alkanes for the treatment of contact lense-related conditions |
| JP7814839B2 (ja) | 2017-09-27 | 2026-02-17 | ノバリック ゲーエムベーハー | 眼疾患の治療に使用するためのラタノプロストを含む眼科用組成物 |
| CN111182893A (zh) | 2017-10-04 | 2020-05-19 | 诺瓦利克有限责任公司 | 包含f6h8的眼用组合物 |
| US11576893B2 (en) | 2018-03-02 | 2023-02-14 | Novaliq Gmbh | Pharmaceutical compositions comprising nebivolol |
| AU2019246035B2 (en) | 2018-03-28 | 2024-07-18 | Novaliq Gmbh | Pharmaceutical composition comprising timolol |
| JP7855312B2 (ja) | 2018-04-27 | 2026-05-08 | ノバリック ゲーエムベーハー | 緑内障の治療のためのタフルプロストを含む眼科用組成物 |
| US11510855B2 (en) | 2018-09-27 | 2022-11-29 | Dermaliq Therapeutics, Inc. | Topical sunscreen formulation |
| WO2020064549A1 (en) | 2018-09-27 | 2020-04-02 | Novaliq Gmbh | Lipid barrier repair |
| CA3112031A1 (en) | 2018-10-12 | 2020-04-16 | Novaliq Gmbh | Ophthalmic composition for treatment of dry eye disease |
| MX2021004356A (es) | 2018-10-18 | 2021-05-31 | Merck Sharp & Dohme Llc | Formulaciones de anticuerpos anti-rsv y metodos de uso de las mismas. |
| MA54089A (fr) | 2018-10-31 | 2022-02-09 | Merck Sharp & Dohme | Anticorps anti-pd-1 humain et procédés d'utilisation associés |
| JP7503056B6 (ja) | 2018-11-07 | 2024-07-16 | メルク・シャープ・アンド・ドーム・エルエルシー | 抗lag3抗体および抗pd-1抗体の共-製剤 |
| EP3923907B1 (en) | 2019-02-13 | 2024-09-25 | Novaliq GmbH | Compositions and methods for the treatment of ocular neovascularization |
| JP7137696B2 (ja) | 2019-05-14 | 2022-09-14 | プロヴェンション・バイオ・インコーポレイテッド | 1型糖尿病を予防するための方法および組成物 |
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-
2014
- 2014-07-23 DK DK14742509.4T patent/DK3024484T3/da active
- 2014-07-23 AU AU2014295052A patent/AU2014295052B2/en active Active
- 2014-07-23 BR BR112016001522-3A patent/BR112016001522B1/pt active IP Right Grant
- 2014-07-23 EP EP14742509.4A patent/EP3024484B1/en active Active
- 2014-07-23 US US14/907,254 patent/US10273298B2/en active Active
- 2014-07-23 JP JP2016528526A patent/JP6503349B2/ja active Active
- 2014-07-23 WO PCT/EP2014/065840 patent/WO2015011199A1/en not_active Ceased
- 2014-07-23 CN CN201480040002.1A patent/CN105555311B/zh active Active
- 2014-07-23 ES ES14742509.4T patent/ES2687094T3/es active Active
- 2014-07-23 PL PL14742509T patent/PL3024484T3/pl unknown
- 2014-07-23 PT PT14742509T patent/PT3024484T/pt unknown
- 2014-07-23 MX MX2016001018A patent/MX370207B/es active IP Right Grant
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- 2014-07-23 KR KR1020167001802A patent/KR102272568B1/ko active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| US20210340248A1 (en) | 2021-11-04 |
| PL3024484T3 (pl) | 2018-11-30 |
| CA2918419C (en) | 2022-05-03 |
| AU2014295052A1 (en) | 2016-02-11 |
| EP3024484B1 (en) | 2018-06-20 |
| US10273298B2 (en) | 2019-04-30 |
| MX370207B (es) | 2019-12-05 |
| KR102272568B1 (ko) | 2021-07-05 |
| JP2016525139A (ja) | 2016-08-22 |
| KR20160034307A (ko) | 2016-03-29 |
| US20160159902A1 (en) | 2016-06-09 |
| CN114028560A (zh) | 2022-02-11 |
| CA2918419A1 (en) | 2015-01-29 |
| CN105555311A (zh) | 2016-05-04 |
| WO2015011199A1 (en) | 2015-01-29 |
| JP6503349B2 (ja) | 2019-04-17 |
| US20190256591A1 (en) | 2019-08-22 |
| HK1224218A1 (zh) | 2017-08-18 |
| BR112016001522B1 (pt) | 2019-10-01 |
| ES2687094T3 (es) | 2018-10-23 |
| AU2014295052B2 (en) | 2018-08-30 |
| US11987623B2 (en) | 2024-05-21 |
| MX2016001018A (es) | 2016-09-06 |
| CN105555311B (zh) | 2021-10-08 |
| EP3024484A1 (en) | 2016-06-01 |
| PT3024484T (pt) | 2018-10-24 |
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