HRP20230991T1 - Inzulin-fc fuzijski proteini ultradugog djelovanja i metode uporabe - Google Patents
Inzulin-fc fuzijski proteini ultradugog djelovanja i metode uporabe Download PDFInfo
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- HRP20230991T1 HRP20230991T1 HRP20230991TT HRP20230991T HRP20230991T1 HR P20230991 T1 HRP20230991 T1 HR P20230991T1 HR P20230991T T HRP20230991T T HR P20230991TT HR P20230991 T HRP20230991 T HR P20230991T HR P20230991 T1 HRP20230991 T1 HR P20230991T1
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- fusion protein
- cell culture
- nucleic acid
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- 238000000034 method Methods 0.000 title claims 9
- 102000037865 fusion proteins Human genes 0.000 title claims 8
- 108020001507 fusion proteins Proteins 0.000 title claims 8
- 150000007523 nucleic acids Chemical class 0.000 claims 4
- 102000018071 Immunoglobulin Fc Fragments Human genes 0.000 claims 3
- 108010091135 Immunoglobulin Fc Fragments Proteins 0.000 claims 3
- 102000004877 Insulin Human genes 0.000 claims 3
- 108090001061 Insulin Proteins 0.000 claims 3
- 239000006143 cell culture medium Substances 0.000 claims 3
- 108020004707 nucleic acids Proteins 0.000 claims 3
- 102000039446 nucleic acids Human genes 0.000 claims 3
- 238000004113 cell culture Methods 0.000 claims 2
- 239000002299 complementary DNA Substances 0.000 claims 2
- 239000012228 culture supernatant Substances 0.000 claims 2
- 238000002955 isolation Methods 0.000 claims 2
- 238000000746 purification Methods 0.000 claims 2
- 238000001890 transfection Methods 0.000 claims 2
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 238000003153 stable transfection Methods 0.000 claims 1
Classifications
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- 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
- 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
- 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
- A61K47/62—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 a protein, peptide or polyamino acid
- A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
-
- 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
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
-
- 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
- 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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
- C07H21/00—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
- C07H21/04—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/16—Extraction; Separation; Purification by chromatography
- C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2869—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
-
- 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
- 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
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Diabetes (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Endocrinology (AREA)
- Biophysics (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Dermatology (AREA)
- Toxicology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Gastroenterology & Hepatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Wood Science & Technology (AREA)
- General Engineering & Computer Science (AREA)
- Physics & Mathematics (AREA)
- Neurology (AREA)
- Microbiology (AREA)
- Plant Pathology (AREA)
- Analytical Chemistry (AREA)
Claims (7)
1. Metoda pripreme rekombinantne stanice koja sadrži nukleinsku kiselinu koja kodira fuzijski protein, navedeni fuzijski protein sadrži polipeptid inzulina i Fc fragment,
pri čemu su polipeptid inzulina i Fc fragment povezani poveznicom, pri čemu Fc fragment sadrži sljedeću sekvencu:
[image]
i pri čemu polipeptid inzulina sadrži sljedeću sekvencu:
[image]
i pri čemu Xi nije D i X2 nije H,
navedena metoda sadrži:
transfektiranje stanice domaćina s nukleinskom kiselinom koja kodira navedeni fuzijski protein, pri čemu se navedeni fuzijski protein eksprimira u navedenoj rekombinantnoj stanici nakon navedenog koraka transfekcije.
2. Metoda prema zahtjevu 1, nadalje sadrži:
uzgoj navedene rekombinantne stanice u mediju stanične kulture; i
prikupljanje supernatanta stanične kulture iz navedenog medija stanične kulture, navedeni supernatant stanične kulture sadrži navedeni eksprimirani fuzijski protein.
3. Metoda prema zahtjevu 2, nadalje sadrži:
pročišćavanje ili izolaciju iz medija kulture stanica.
4. Metoda prema zahtjevu 3, naznačena time što navedeni koraci pročišćavanja ili izolacije sadrže centrifugiranje, filtraciju, i/ili kromatografiju.
5. Metoda prema zahtjevu 1, naznačena time što navedeni korak transfekcije sadrži stabilnu transfekciju navedene stanice domaćina.
6. Metoda prema zahtjevu 1, naznačena time što navedena nukleinska kiselina sadrži cDNA koja kodira navedeni fuzijski protein, navedeni fuzijski protein sadrži sljedeću sekvencu:
[image]
7. Metoda prema zahtjevu 6, naznačena time što cDNA sadrži sljedeću sekvencu nukleinske kiseline:
[image]
Applications Claiming Priority (16)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862692507P | 2018-06-29 | 2018-06-29 | |
| US201862692498P | 2018-06-29 | 2018-06-29 | |
| US201862693814P | 2018-07-03 | 2018-07-03 | |
| US201862696645P | 2018-07-11 | 2018-07-11 | |
| US201862698648P | 2018-07-16 | 2018-07-16 | |
| US201862702167P | 2018-07-23 | 2018-07-23 | |
| US201862719347P | 2018-08-17 | 2018-08-17 | |
| US201862740735P | 2018-10-03 | 2018-10-03 | |
| US201862743358P | 2018-10-09 | 2018-10-09 | |
| US201862774682P | 2018-12-03 | 2018-12-03 | |
| US201862781368P | 2018-12-18 | 2018-12-18 | |
| US201862781378P | 2018-12-18 | 2018-12-18 | |
| US201962824176P | 2019-03-26 | 2019-03-26 | |
| US201962827809P | 2019-04-01 | 2019-04-01 | |
| US201962837188P | 2019-04-22 | 2019-04-22 | |
| EP21207279.7A EP4011908B1 (en) | 2018-06-29 | 2019-06-28 | Ultra-long acting insulin-fc fusion proteins and methods of use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230991T1 true HRP20230991T1 (hr) | 2023-12-08 |
Family
ID=68985236
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220091TT HRP20220091T1 (hr) | 2018-06-29 | 2019-06-28 | Inzulin-fc fuzijski proteini ultradugog djelovanja i postupci uporabe |
| HRP20240408TT HRP20240408T1 (hr) | 2018-06-29 | 2019-06-28 | Inzulin-fc fuzijski proteini ultradugog djelovanja i metode uporabe |
| HRP20230991TT HRP20230991T1 (hr) | 2018-06-29 | 2019-06-28 | Inzulin-fc fuzijski proteini ultradugog djelovanja i metode uporabe |
| HRP20221418TT HRP20221418T1 (hr) | 2018-06-29 | 2019-06-28 | Inzulin-fc fuzijski proteini ultra-dugog djelovanja i postupci uporabe |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220091TT HRP20220091T1 (hr) | 2018-06-29 | 2019-06-28 | Inzulin-fc fuzijski proteini ultradugog djelovanja i postupci uporabe |
| HRP20240408TT HRP20240408T1 (hr) | 2018-06-29 | 2019-06-28 | Inzulin-fc fuzijski proteini ultradugog djelovanja i metode uporabe |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221418TT HRP20221418T1 (hr) | 2018-06-29 | 2019-06-28 | Inzulin-fc fuzijski proteini ultra-dugog djelovanja i postupci uporabe |
Country Status (15)
| Country | Link |
|---|---|
| US (8) | US10947292B2 (hr) |
| EP (5) | EP4011908B1 (hr) |
| JP (2) | JP7417277B2 (hr) |
| KR (1) | KR20210029210A (hr) |
| CN (1) | CN113038964A (hr) |
| AU (1) | AU2019291945A1 (hr) |
| BR (1) | BR112020026777A2 (hr) |
| CA (1) | CA3104144A1 (hr) |
| DK (4) | DK4011908T3 (hr) |
| FI (2) | FI4186920T3 (hr) |
| HR (4) | HRP20220091T1 (hr) |
| HU (3) | HUE062719T2 (hr) |
| LT (4) | LT4186920T (hr) |
| SI (4) | SI4186920T1 (hr) |
| WO (1) | WO2020006529A1 (hr) |
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| US11267862B2 (en) | 2018-06-29 | 2022-03-08 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
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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 |
| HRP20230990T1 (hr) | 2020-04-10 | 2023-12-08 | Akston Biosciences Corporation | Antigen specifična imunoterapija za fuzijske proteine covid-19 i postupci uporabe |
| 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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| LT4186920T (lt) | 2018-06-29 | 2024-04-25 | Akston Biosciences Corporation | Itin ilgai veikiantys insulino-fc sulieti baltymai ir naudojimo būdai |
| US11267862B2 (en) | 2018-06-29 | 2022-03-08 | Akston Biosciences Corporation | Ultra-long acting insulin-Fc fusion proteins and methods of use |
| BR112021005634A2 (pt) | 2018-09-25 | 2021-06-29 | Absci, Llc | métodos de purificação de proteína |
| TW202028229A (zh) | 2018-10-05 | 2020-08-01 | 丹麥商諾佛 儂迪克股份有限公司 | 包含胰島素肽及ｅｇｆ（ａ）肽之雙功能化合物 |
| US20220002373A1 (en) | 2018-11-19 | 2022-01-06 | Case Western Reserve University | Single-chain insulin analogues with poly-alanine c-domain sub-segments |
| EP3969467A4 (en) | 2019-05-17 | 2023-07-05 | Case Western Reserve University | VARIANT SINGLE STREAM INSULIN ANALOGS |
| WO2021011827A1 (en) | 2019-07-16 | 2021-01-21 | Akston Biosciences Corporation | Ultra-long acting insulin-fc fusion proteins and methods of use |
| KR20220031044A (ko) | 2019-07-31 | 2022-03-11 | 일라이 릴리 앤드 캄파니 | 릴랙신 유사체 및 이를 사용하는 방법 |
| IL294051A (en) | 2019-12-19 | 2022-08-01 | Akston Biosciences Corp | Long-acting insulin-fc fusion proteins, and methods of use |
| 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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