HRP20210547T1 - Sastavi koji sadrže konjugate lijeka antitijela-duocarmycin - Google Patents
Sastavi koji sadrže konjugate lijeka antitijela-duocarmycin Download PDFInfo
- Publication number
- HRP20210547T1 HRP20210547T1 HRP20210547TT HRP20210547T HRP20210547T1 HR P20210547 T1 HRP20210547 T1 HR P20210547T1 HR P20210547T T HRP20210547T T HR P20210547TT HR P20210547 T HRP20210547 T HR P20210547T HR P20210547 T1 HRP20210547 T1 HR P20210547T1
- Authority
- HR
- Croatia
- Prior art keywords
- antibody
- drug conjugate
- composition according
- lyoprotectant
- polysorbate
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 15
- 239000003814 drug Substances 0.000 title 1
- 229940079593 drug Drugs 0.000 title 1
- 229960005501 duocarmycin Drugs 0.000 title 1
- 239000000611 antibody drug conjugate Substances 0.000 claims 13
- 229940049595 antibody-drug conjugate Drugs 0.000 claims 13
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 5
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 5
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 5
- 229920001213 Polysorbate 20 Polymers 0.000 claims 4
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 4
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 4
- 229940068977 polysorbate 20 Drugs 0.000 claims 4
- 239000006172 buffering agent Substances 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- 238000000137 annealing Methods 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 238000007710 freezing Methods 0.000 claims 2
- 230000008014 freezing Effects 0.000 claims 2
- -1 lyoprotectant Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 1
- 239000000872 buffer Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000000354 decomposition reaction Methods 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 230000009477 glass transition Effects 0.000 claims 1
- 229930182470 glycoside Natural products 0.000 claims 1
- 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims 1
- 229920001983 poloxamer Polymers 0.000 claims 1
- 229960000502 poloxamer Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
- 125000000647 trehalose group Chemical group 0.000 claims 1
Classifications
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- 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
- A61K47/6807—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug or compound being a sugar, nucleoside, nucleotide, nucleic acid, e.g. RNA antisense
- A61K47/6809—Antibiotics, e.g. antitumor antibiotics anthracyclins, adriamycin, doxorubicin or daunomycin
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
-
- 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
- A61K39/39533—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
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
-
- 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
- A61K47/6835—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
- A61K47/6851—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
-
- 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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
-
- 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
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Cell Biology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Oncology (AREA)
- Endocrinology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (13)
1. Liofilizirani sastav koja sadrži konjugat antitijelo lijek formule (I),
[image]
pufersko sredstvo, lioprotektant, i površinski aktivno sredstvo gdje je molarni omjer lioprotektora i konjugata antitijelo-lijek 1.400-3.200 do 1, a gdje je lioprotektant trehaloza.
2. Sastav sukladno patentnom zahtjevu 1 pri čemu je konjugat antitijelo-lijek prisutan u koncentraciji od 1-30 mg/ml nakon rekonstrukcije s vodom.
3. Sastav sukladno patentnom zahtjevu 1 ili 2 pri čemu je pufersko sredstvo histidin, citrat il sukcinat.
4. Sastav sukladno bilo kojem od patentnih zahtjeva 1-3 pri čemu je pufersko sredstvo prisutan u koncentraciji od 2,5-25 mM nakon rekonstrukcije s vodom.
5. Sastav sukladno bilo kojem od patentnih zahtjeva 1-4 pri čemu je površinsko aktivno sredstvo alkil glikozid, poloksamer ili polisorbat.
6. Sastav sukladno bilo kojem od patentnih zahtjeva 1-5 pri čemu, nakon rekonstrukcije s vodom, vodena otopina je pH vrijednosti od 5,3-6,0.
7. Sastav sukladno bilo kojem od patentnih zahtjeva 1-6 pri čemu monoklonalno antitijelo mAb u konjugatu antitijelo-lijek formule (I) je anti-HER2 antitijelo.
8. Sastav sukladno bilo kojem od patentnih zahtjeva 1-7 koji se u osnovi sastoji od konjugata antitijelo-lijek formule (I), pufersko sredstvo, lioprotektant, površinski aktivno sredstvo pri čemu molarni odnos lioprotektora sukladno konjugatu antitijela-lijek je 1.400-3.200 prema 1.
9. Sastav sukladno bilo kojem od patentnih zahtjeva 1-8, pri čemu molarni odnos lioprotektora i konjugatu antitijela-lijek je 1.400-2.000 prema 1 ili 1.400-1.800 do 1.
10. Sastav sukladno bilo kojem od patentnih zahtjeva 1-9 koja sadrži konjugat antitijelo-lijek formule (II),
[image]
histidin, trehalozu, i polisorbat 20, pri čemu je molarni odnos trehaloze sukladno konjugatu antitijela-lijek oko 1.605 sukladno 1, i, kada je nakon rekonstrukcije s vodom, konjugat antitijelo-lijek je prisutan u količini od oko 10 mg/ml, koncentracija histidina je oko 5 mM, količina polisorbata 20 je oko 0,01% (m/v), i pH vrijednost je oko 5,7.
11. Sastav sukladno patentnom zahtjevu 10 koji sadrži u osnovi konjugat antitijelo-lijek formule (II), histidin, trehalozu, i polisorbat 20, pri čemu je molarni odnos trehaloze sukladno konjugatu antitijelo-lijek oko 1.605 sukladno 1, i, nakon rekonstrukcije s vodom, konjugat antitijelo-lijek je prisutan u količini od oko 10 mg/ml, koncentracija histidina je oko 5 mM, količina polisorbata 20 je oko 0,01% (m/v), i pH vrijednost je oko 5,7.
12. Postupak dobivanja sastava sukladno bilo kojem od patentnih zahtjeva 1-11 sadrži korake a) smrzavanja vodene otopine pripravka prije liofilizacije sukladno bilo kojem od patentnih zahtjeva 1-11, b) primarno sušenje na temperaturi proizvoda ispod temperature raspadanja smjese pod tlakom ispod atmosferskog tlaka, i c) sekundarno sušenje na temperaturi proizvoda iznad 0°C i ispod temperature prijelaza u staklo te smjese pod tlakom ispod atmosferske temperature.
13. Postupak sukladno patentnom zahtjevu 12 pri čemu korak smrzavanja a) sadrži korak žarenja, pri čemu je taj korak žarenja izveden tokom 0,5 do 6 sati na temperaturi police u rasponu od -25°C do -10°C.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15176307 | 2015-07-10 | ||
| EP16736481.9A EP3319597B1 (en) | 2015-07-10 | 2016-07-08 | Compositions comprising antibody-duocarmycin drug conjugates |
| PCT/EP2016/066347 WO2017009255A1 (en) | 2015-07-10 | 2016-07-08 | Compositions comprising antibody-duocarmycin drug conjugates |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210547T1 true HRP20210547T1 (hr) | 2021-05-14 |
Family
ID=53673006
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210547TT HRP20210547T1 (hr) | 2015-07-10 | 2021-04-06 | Sastavi koji sadrže konjugate lijeka antitijela-duocarmycin |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US11077204B2 (hr) |
| EP (1) | EP3319597B1 (hr) |
| JP (1) | JP6522806B2 (hr) |
| CN (1) | CN107847449B (hr) |
| AU (2) | AU2016292759B2 (hr) |
| CA (1) | CA2986508C (hr) |
| CY (1) | CY1124425T1 (hr) |
| DK (1) | DK3319597T3 (hr) |
| ES (1) | ES2866050T3 (hr) |
| HR (1) | HRP20210547T1 (hr) |
| HU (1) | HUE053799T2 (hr) |
| LT (1) | LT3319597T (hr) |
| PL (1) | PL3319597T3 (hr) |
| PT (1) | PT3319597T (hr) |
| RU (1) | RU2687237C1 (hr) |
| WO (1) | WO2017009255A1 (hr) |
| ZA (1) | ZA201707475B (hr) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20160099725A (ko) | 2014-01-10 | 2016-08-22 | 신톤 바이오파머슈티칼즈 비.브이. | 자궁내막암의 치료에서 사용하기 위한 듀오카르마이신 adc |
| EP3069735B1 (en) | 2014-01-10 | 2018-03-14 | Synthon Biopharmaceuticals B.V. | Duocarmycin adcs for use in the treatment of bladder cancer |
| EP3319597B1 (en) | 2015-07-10 | 2021-02-17 | Byondis B.V. | Compositions comprising antibody-duocarmycin drug conjugates |
| KR20200044044A (ko) * | 2017-08-23 | 2020-04-28 | 다이이찌 산쿄 가부시키가이샤 | 항체-약물 콘주게이트의 제제 및 그 동결 건조 방법 |
| CN110960490A (zh) * | 2018-09-28 | 2020-04-07 | 江苏恒瑞医药股份有限公司 | 一种抗egfr抗体偶联药物组合物及其用途 |
| US20210386867A1 (en) * | 2018-11-09 | 2021-12-16 | Byondis B.V. | Filterable duocarmycin-containing antibody-drug conjugate compositions and related methods |
| CN113365665A (zh) * | 2019-03-26 | 2021-09-07 | 荣昌生物制药(烟台)股份有限公司 | 抗Her2抗体药物偶联物药物制剂 |
| CN111939267A (zh) * | 2019-05-17 | 2020-11-17 | 百奥泰生物制药股份有限公司 | 抗体-药物偶联物制剂、制备方法及应用 |
| CN113116812A (zh) * | 2019-12-30 | 2021-07-16 | 百奥泰生物制药股份有限公司 | 含抗Trop2抗体-药物偶联物的制剂及其制备方法和应用 |
| JP2023517477A (ja) * | 2020-02-06 | 2023-04-26 | ビョンディス・ビー．ブイ． | デュオカルマイシン誘導体含有抗体薬物複合体及びチオ硫酸類を含む組合せ |
| WO2023143154A1 (zh) * | 2022-01-28 | 2023-08-03 | 四川科伦博泰生物医药股份有限公司 | 一种药物组合物及其制备方法和应用 |
| WO2023185907A1 (en) * | 2022-03-29 | 2023-10-05 | Genequantum Healthcare (Suzhou) Co., Ltd. | A freeze-drying process for an ADC |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2737127C (en) * | 2003-05-14 | 2016-07-26 | Immunogen, Inc. | Maytansinoid-antibody conjugate compositions |
| EP2173739B1 (en) | 2007-08-01 | 2013-07-31 | Syntarga B.V. | Substituted cc-1065 analogs and their conjugates |
| US8541178B2 (en) | 2008-05-13 | 2013-09-24 | Genentech, Inc. | Analysis of antibody drug conjugates by bead-based affinity capture and mass spectrometry |
| ES2647317T3 (es) | 2008-11-03 | 2017-12-20 | Syntarga B.V. | Análogos de CC-1065 y sus conjugados |
| DK3108886T3 (da) | 2010-04-21 | 2020-08-10 | Syntarga Bv | Konjugater af CC-1065-analoger og bifunktionelle linkere |
| DK2585104T3 (da) * | 2010-06-25 | 2019-10-14 | Shire Human Genetic Therapies | Fremgangsmåder og sammensætninger tilcns-levering af arylsulfatase a |
| US8852599B2 (en) | 2011-05-26 | 2014-10-07 | Bristol-Myers Squibb Company | Immunoconjugates, compositions for making them, and methods of making and use |
| BR112014006798A2 (pt) * | 2011-09-26 | 2017-06-13 | Swedish Orphan Biovitrum Ab (Publ) | formulações melhoradas de lípase estimulada por sal billiar humana recombinantes |
| BR112014024057A8 (pt) * | 2012-03-28 | 2018-01-16 | Discovery Lab Inc | processo para fabricar um tensoativo pulmonar sintético liofilizado, composição de tensoativo pulmonar sintético liofilizado, e, tensoativo pulmonar sintético liofilizado |
| US10617764B2 (en) * | 2013-11-21 | 2020-04-14 | Genmab A/S | Lyophilized anti-tissue factor antibody-drug conjugates |
| EP3069735B1 (en) | 2014-01-10 | 2018-03-14 | Synthon Biopharmaceuticals B.V. | Duocarmycin adcs for use in the treatment of bladder cancer |
| KR20160099725A (ko) | 2014-01-10 | 2016-08-22 | 신톤 바이오파머슈티칼즈 비.브이. | 자궁내막암의 치료에서 사용하기 위한 듀오카르마이신 adc |
| EP3319597B1 (en) | 2015-07-10 | 2021-02-17 | Byondis B.V. | Compositions comprising antibody-duocarmycin drug conjugates |
-
2016
- 2016-07-08 EP EP16736481.9A patent/EP3319597B1/en active Active
- 2016-07-08 US US15/743,413 patent/US11077204B2/en active Active
- 2016-07-08 PT PT167364819T patent/PT3319597T/pt unknown
- 2016-07-08 LT LTEP16736481.9T patent/LT3319597T/lt unknown
- 2016-07-08 ES ES16736481T patent/ES2866050T3/es active Active
- 2016-07-08 WO PCT/EP2016/066347 patent/WO2017009255A1/en active Application Filing
- 2016-07-08 JP JP2017567296A patent/JP6522806B2/ja active Active
- 2016-07-08 AU AU2016292759A patent/AU2016292759B2/en active Active
- 2016-07-08 DK DK16736481.9T patent/DK3319597T3/da active
- 2016-07-08 HU HUE16736481A patent/HUE053799T2/hu unknown
- 2016-07-08 CA CA2986508A patent/CA2986508C/en active Active
- 2016-07-08 RU RU2018100656A patent/RU2687237C1/ru active
- 2016-07-08 CN CN201680040280.6A patent/CN107847449B/zh active Active
- 2016-07-08 PL PL16736481T patent/PL3319597T3/pl unknown
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2017
- 2017-11-03 ZA ZA2017/07475A patent/ZA201707475B/en unknown
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2021
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- 2021-04-23 CY CY20211100350T patent/CY1124425T1/el unknown
- 2021-05-24 AU AU2021203331A patent/AU2021203331A1/en not_active Abandoned
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|---|---|
| HUE053799T2 (hu) | 2021-07-28 |
| AU2016292759B2 (en) | 2021-05-20 |
| CN107847449A (zh) | 2018-03-27 |
| ES2866050T3 (es) | 2021-10-19 |
| LT3319597T (lt) | 2021-07-26 |
| EP3319597A1 (en) | 2018-05-16 |
| PT3319597T (pt) | 2021-04-27 |
| AU2021203331A1 (en) | 2021-06-24 |
| ZA201707475B (en) | 2021-04-28 |
| AU2016292759A1 (en) | 2017-11-23 |
| RU2687237C1 (ru) | 2019-05-08 |
| DK3319597T3 (da) | 2021-04-06 |
| EP3319597B1 (en) | 2021-02-17 |
| CA2986508A1 (en) | 2017-01-19 |
| JP6522806B2 (ja) | 2019-05-29 |
| CN107847449B (zh) | 2021-04-30 |
| US20180200382A1 (en) | 2018-07-19 |
| US11077204B2 (en) | 2021-08-03 |
| CA2986508C (en) | 2021-06-15 |
| PL3319597T3 (pl) | 2021-10-11 |
| WO2017009255A1 (en) | 2017-01-19 |
| US20190216942A9 (en) | 2019-07-18 |
| CY1124425T1 (el) | 2022-07-22 |
| JP2018519303A (ja) | 2018-07-19 |
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