HRP20231433T1 - Inzulin-fc fuzijski proteini ultradugog djelovanja i načini uporabe - Google Patents
Inzulin-fc fuzijski proteini ultradugog djelovanja i načini uporabe Download PDFInfo
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- HRP20231433T1 HRP20231433T1 HRP20231433TT HRP20231433T HRP20231433T1 HR P20231433 T1 HRP20231433 T1 HR P20231433T1 HR P20231433T T HRP20231433T T HR P20231433TT HR P20231433 T HRP20231433 T HR P20231433T HR P20231433 T1 HRP20231433 T1 HR P20231433T1
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- fusion protein
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- 108020001507 fusion proteins Proteins 0.000 title claims 30
- 102000037865 fusion proteins Human genes 0.000 title claims 30
- 102000018071 Immunoglobulin Fc Fragments Human genes 0.000 claims 5
- 108010091135 Immunoglobulin Fc Fragments Proteins 0.000 claims 5
- 102000004877 Insulin Human genes 0.000 claims 5
- 108090001061 Insulin Proteins 0.000 claims 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims 4
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 3
- 239000002299 complementary DNA Substances 0.000 claims 3
- 150000007523 nucleic acids Chemical group 0.000 claims 3
- 210000004027 cell Anatomy 0.000 claims 2
- 239000000710 homodimer Substances 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 102000003746 Insulin Receptor Human genes 0.000 claims 1
- 108010001127 Insulin Receptor Proteins 0.000 claims 1
- 239000011324 bead Substances 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 229940125396 insulin Drugs 0.000 claims 1
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Substances N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 1
- 108010068617 neonatal Fc receptor Proteins 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 102000005962 receptors Human genes 0.000 claims 1
- 108020003175 receptors Proteins 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- 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
- C07K14/575—Hormones
- C07K14/62—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- 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
- C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
- C12N15/62—DNA sequences coding for fusion proteins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Genetics & Genomics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Endocrinology (AREA)
- Biomedical Technology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Biotechnology (AREA)
- Wood Science & Technology (AREA)
- General Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Obesity (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Toxicology (AREA)
- Epidemiology (AREA)
- Plant Pathology (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Dermatology (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (18)
1. Fuzijski protein koji se sastoji od inzulinskog polipeptida i Fc fragmenta, naznačen time što su inzulinski polipeptid i Fc fragment povezani poveznicom, koja sadrži domene u sljedećoj orijentaciji od N- do C- kraja: (N-kraj)-inzulin polipeptid-veznik-Fc fragment-(C-kraj),
pri čemu je Fc fragment ljudskog porijekla i sastoji se od sljedeće sekvence:
[image]
gdje X1 je S ili R;
pri čemu inzulinski polipeptid sadrži sljedeću sekvencu:
[image]
i
pri čemu poveznica sadrži sljedeću sekvencu:
GGGGGAGGGGAGGGGAGGGGG (SEQ ID NO: 67);
GGGGGQGGGGQGGGGQGGGGGQGGGG (SEQ ID NO: 99); ili
GGGGGQGGGGQGGGGQGGGGG (SEQ ID NO: 13).
2. Fuzijski protein prema zahtjevu 1 koji sadrži inzulinski polipeptid i Fc fragment, naznačen time što su inzulinski polipeptid i Fc fragment povezani poveznicom, pri čemu fuzijski protein sadrži sljedeću sekvencu:
[image]
3. Fuzijski protein prema zahtjevu 1, naznačen time što fuzijski protein sadrži sljedeću sekvencu:
[image]
4. Fuzijski protein prema zahtjevu 1, naznačen time što fuzijski protein sadrži sljedeću sekvencu:
[image]
5. Fuzijski protein prema zahtjevu 1, naznačen time što fuzijski protein sadrži sljedeću sekvencu:
[image]
6. Fuzijski protein prema bilo kojem od prethodnih zahtjeva, naznačen time što je fuzijski protein homodimer i pri čemu je postotak homodimera fuzijskog proteina veći od 90%.
7. Fuzijski protein prema zahtjevu 6, naznačen time što je fuzijski protein napravljen uporabom jedne od HEK293 stanica ili CHO stanica, i rezultirajući titar homodimera nakon pročišćavanja uporabom kuglica proteina A ili kolone proteina A veći je od 150 mg/L.
8. Fuzijski protein prema zahtjevu 6, naznačen time što je IC50 inzulinskog receptora za fuzijski protein manji ili jednak 5000 nM.
9. Fuzijski protein prema patentnom zahtjevu 6, naznačen time što je ljudski FcRn receptor EC50 za fuzijski protein manji ili jednak 1000 ng/mL.
10. Fuzijski protein prema zahtjevu 6, naznačen time što je omjer testa OD450 ljudskog Fc(gama)RI receptora pri koncentraciji biotiniliranog-Fc(gama)RI od 3000 ng/mL fuzijskog proteina manji ili jednak 0.50.
11. Fuzijski protein prema zahtjevu 6, naznačen time što je ljudski C1q omjer testa OD450 pri koncentraciji biotiniliranog-C1q od 1000 ng/mL manji ili jednak 0.35.
12. Fuzijski protein prema zahtjevu 6, naznačen time što je fuzijski protein formuliran kao farmaceutski pripravak i pri čemu je fuzijski protein prisutan u farmaceutskom pripravku u koncentraciji od oko 3 mg/mL ili većoj.
13. Farmaceutski pripravak prema zahtjevu 12, naznačen time što je pripravak prikladan za supkutanu primjenu.
14. Fuzijski protein prema zahtjevu 6 ili njegov farmaceutski pripravak za uporabu kao lijek za snižavanje razine glukoze u krvi pacijenta.
15. Stanica konstruirana za ekspresiju fuzijskog proteina prema bilo kojem od prethodnih zahtjeva.
16. cDNA koja kodira fuzijski protein SEQ ID NO: 87 koja sadrži sljedeću sekvencu nukleinske kiseline:
[image]
[image]
17. cDNA koja kodira fuzijski protein SEQ ID NO: 78 koja sadrži sljedeću sekvencu nukleinske kiseline:
[image]
18. cDNA koja kodira fuzijski protein SEQ ID NO: 84 koja sadrži sljedeću sekvencu nukleinske kiseline:
[image]
[image]
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962950803P | 2019-12-19 | 2019-12-19 | |
| US202062988441P | 2020-03-12 | 2020-03-12 | |
| EP20830444.4A EP4073098B1 (en) | 2019-12-19 | 2020-12-07 | Ultra-long acting insulin-fc fusion proteins and methods of use |
| PCT/US2020/063673 WO2021126584A1 (en) | 2019-12-19 | 2020-12-07 | Ultra-long acting insulin-fc fusion proteins and methods of use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231433T1 true HRP20231433T1 (hr) | 2024-03-29 |
Family
ID=74104207
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231433TT HRP20231433T1 (hr) | 2019-12-19 | 2020-12-07 | Inzulin-fc fuzijski proteini ultradugog djelovanja i načini uporabe |
Country Status (17)
| Country | Link |
|---|---|
| US (3) | US11352407B2 (hr) |
| EP (2) | EP4282473A3 (hr) |
| JP (1) | JP7405486B2 (hr) |
| KR (1) | KR20220115975A (hr) |
| CN (1) | CN114846025A (hr) |
| AU (1) | AU2020407365B2 (hr) |
| BR (1) | BR112022012071A2 (hr) |
| CA (1) | CA3159486A1 (hr) |
| DK (1) | DK4073098T5 (hr) |
| FI (1) | FI4073098T3 (hr) |
| HR (1) | HRP20231433T1 (hr) |
| HU (1) | HUE064376T2 (hr) |
| IL (1) | IL294051A (hr) |
| LT (1) | LT4073098T (hr) |
| SI (1) | SI4073098T1 (hr) |
| WO (1) | WO2021126584A1 (hr) |
| ZA (1) | ZA202206047B (hr) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HRP20221418T1 (hr) | 2018-06-29 | 2023-01-06 | Akston Biosciences Corporation | Inzulin-fc fuzijski proteini ultra-dugog djelovanja i postupci uporabe |
| DK4073098T5 (da) | 2019-12-19 | 2024-07-22 | Akston Biosciences Corp | Ultralangtidsvirkende insulin-Fc-fusionsproteiner og fremgangsmåder til anvendelse |
| US11186623B2 (en) | 2019-12-24 | 2021-11-30 | Akston Bioscience Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
| US11192930B2 (en) | 2020-04-10 | 2021-12-07 | Askton Bioscences Corporation | Ultra-long acting insulin-Fc fusion protein and methods of use |
| CA3146464C (en) | 2020-04-10 | 2024-03-12 | Todd C. Zion | Antigen specific immunotherapy employing covid-19 fusion proteins and methods of use |
| EP4373861A2 (en) | 2021-07-23 | 2024-05-29 | Akston Biosciences Corporation | Insulin-fc fusion proteins and methods of use to treat cancer |
| TW202339790A (zh) | 2021-11-15 | 2023-10-16 | 美商美國禮來大藥廠 | 可保存之調配物 |
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| US11186623B2 (en) | 2019-12-24 | 2021-11-30 | Akston Bioscience Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
| US11192930B2 (en) | 2020-04-10 | 2021-12-07 | Askton Bioscences Corporation | Ultra-long acting insulin-Fc fusion protein and methods of use |
| US11198719B2 (en) | 2020-04-29 | 2021-12-14 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion protein and methods of use |
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2020
- 2020-12-07 DK DK20830444.4T patent/DK4073098T5/da active
- 2020-12-07 HU HUE20830444A patent/HUE064376T2/hu unknown
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- 2020-12-07 WO PCT/US2020/063673 patent/WO2021126584A1/en active Application Filing
- 2020-12-07 FI FIEP20830444.4T patent/FI4073098T3/fi active
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- 2020-12-07 AU AU2020407365A patent/AU2020407365B2/en active Active
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| Publication number | Publication date |
|---|---|
| AU2020407365B2 (en) | 2023-09-21 |
| JP2023507376A (ja) | 2023-02-22 |
| CN114846025A (zh) | 2022-08-02 |
| HUE064376T2 (hu) | 2024-03-28 |
| JP7405486B2 (ja) | 2023-12-26 |
| US20210309709A1 (en) | 2021-10-07 |
| SI4073098T1 (sl) | 2023-12-29 |
| LT4073098T (lt) | 2023-12-11 |
| ZA202206047B (en) | 2023-08-30 |
| US11352407B2 (en) | 2022-06-07 |
| EP4282473A3 (en) | 2024-02-21 |
| WO2021126584A1 (en) | 2021-06-24 |
| IL294051A (en) | 2022-08-01 |
| US11555058B2 (en) | 2023-01-17 |
| DK4073098T3 (da) | 2023-11-20 |
| CA3159486A1 (en) | 2021-06-24 |
| KR20220115975A (ko) | 2022-08-19 |
| BR112022012071A2 (pt) | 2022-08-30 |
| EP4073098B1 (en) | 2023-09-27 |
| EP4073098A1 (en) | 2022-10-19 |
| DK4073098T5 (da) | 2024-07-22 |
| US20230250148A1 (en) | 2023-08-10 |
| US20220064251A1 (en) | 2022-03-03 |
| AU2020407365A1 (en) | 2022-06-09 |
| EP4282473A2 (en) | 2023-11-29 |
| FI4073098T3 (fi) | 2023-11-15 |
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