HRP20241036T1 - Liofilizirana formulacija konjugata protutijelo-lijek - Google Patents

Liofilizirana formulacija konjugata protutijelo-lijek Download PDF

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HRP20241036T1
HRP20241036T1 HRP20241036TT HRP20241036T HRP20241036T1 HR P20241036 T1 HRP20241036 T1 HR P20241036T1 HR P20241036T T HRP20241036T T HR P20241036TT HR P20241036 T HRP20241036 T HR P20241036T HR P20241036 T1 HRP20241036 T1 HR P20241036T1
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months
formulation according
lyophilized formulation
amino acid
adc
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HRP20241036TT
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Jesper VALBJØRN
Xiaona JING
Kelly Ann ROBY
Timothy Warren PAUL
Gregory Allan SACHA
Nathan Alan PEASE
Bodil WILLUMSEN
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Genmab A/S
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    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • A—HUMAN NECESSITIES
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    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • 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
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    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/68031—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being an auristatin
    • 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
    • A61K47/6843—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 material from animals or humans
    • 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
    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • 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
    • 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
    • C07K2317/50—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
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C07K2317/77—Internalization into the cell
    • 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

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  • Molecular Biology (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (17)

1. Liofilizirana formulacija anti-tkivni faktor (TF) konjugata protutijelo-lijek (ADC), naznačena time, da se može dobiti ili se dobiva putem liofiliziranja vodene formulacije koja sadrži od oko 9 do oko 11 g/L od spomenutog konjugata anti-TF ADC i farmaceutski prihvatljivih pomoćnih tvari koje sadrže oko 29 do oko 31 mM histidinskog pufera koji ima pH od oko 5,5 do oko 6,5; oko 84 do oko 92 mM saharoze i oko 158 do oko 172 mM manitola, te time, da: a. formulacija je oslobođena od surfaktanta, b. anti-TF dio protutijela od ADC sadrži varijabilnu tešku regiju (VH) koja sadrži CDR1 regiju koja ima aminokiselinski slijed prikazan u SEQ ID NO: 6, CDR2 regiju koja ima aminokiselinski slijed prikazan u SEQ ID NO: 7, i CDR3 regiju koja ima aminokiselinski slijed prikazan u SEQ ID NO: 8, i varijabilnu laku regiju (VL) koja sadrži CDR1 regiju koja ima aminokiselinski slijed prikazan u SEQ ID NO: 46, CDR2 regiju koja ima aminokiselinski slijed prikazan u SEQ ID NO: 47, i CDR3 regiju koja ima aminokiselinski slijed prikazan u SEQ ID NO: 48, ili varijantu koja ima najviše 1, 2, ili 3 aminokiselinske modifikacije, još poželjnije aminokiselinske supstitucije kao što su konzervativne aminokiselinske supstitucije u navedenim sljedovima, c. dio lijeka od ADC je vcMMAE.
2. Liofilizirana formulacija prema patentnom zahtjevu 1, naznačena time, da vodena formulacija sadrži histidinski pufer s koncentracijom od oko 30 mM pufera.
3. Liofilizirana formulacija prema bilo kojem od patentnih zahtjeva 1 ili 2, naznačena time, da vodena formulacija sadrži saharozu s koncentracijom od oko 88 mM.
4. Liofilizirana formulacija prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da vodena formulacija sadrži manitol s koncentracijom od oko 165 mM.
5. Liofilizirana formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da vodena formulacija sadrži oko 10 g/L anti-TF ADC.
6. Liofilizirana formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da vodena formulacija sadrži od oko 9 do oko 11 g/L anti-TF ADC, kao primjerice oko 10 mg/ml konjugata anti-TF ADC, oko 30 mM histidina, oko 88 mM saharoze i oko 165 mM manitola.
7. Liofilizirana formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da protutijelo sadrži VH regiju koja ima aminokiselinski slijed od SEQ ID NO: 5, i VL regiju koja ima aminokiselinski slijed od SEQ ID NO: 45.
8. Liofilizirana formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da prosječni apsolutni broj ostataka lijeka po molekuli protutijela iznosi 1, 2, 3, 4, 5, 6, 7, ili 8, primjerice 3, 4, ili 5, poželjno 4.
9. Liofilizirana formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da anti-TF protutijelo je protutijelo pune duljine.
10. Liofilizirana formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da je anti-TF ADC stabilan na 2-8°C, kao što je primjerice na 5°C, za farmaceutsku uporabu u trajanju od najmanje 6 mjeseci, kao primjerice najmanje 9 mjeseci, kao primjerice najmanje 15 mjeseci ili poželjno u trajanju od najmanje 18 mjeseci, ili čak još više prednosno najmanje 24 mjeseca, ili najviše prednosno najmanje 36 mjeseci.
11. Liofilizirana formulacija prema patentnom zahtjevu 10, naznačena time, da je formulacija stabilna kada ima manje od 3,0% agregata, kao što je primjerice manje od 2,0% agregata kada je pohranjena na 5°C u trajanju od najmanje 6 mjeseci, kao primjerice najmanje 9 mjeseci, kao primjerice najmanje 15 mjeseci ili poželjno u trajanju od najmanje 18 mjeseci, ili čak još više prednosno najmanje 24 mjeseca, ili najviše prednosno najmanje 36 mjeseci.
12. Liofilizirana formulacija prema patentnom zahtjevu 10 ili 11, naznačena time, da se stabilnost određuje putem SEC analize u skladu s Primjerom 10.
13. Liofilizirana formulacija prema bilo kojem od prethodnih patentnih zahtjeva, naznačena time, da je formulacija oslobođena od bilo kojih anorganskih soli.
14. Farmaceutski prihvatljiva tekuća formulacija, naznačena time, da se dobiva putem rekonstituiranja liofilizirane formulacije prema bilo kojem od patentnih zahtjeva 1 do 13 u sterilnom vodenom razrjeđivaču.
15. Tekuća formulacija prema patentnom zahtjevu 14, naznačena time, da sadrži oko 9 do oko 11 mg/mL konjugata anti-TF ADC, oko 28 do oko 34 mM histidina, oko 84 do oko 92 mM saharoze i oko 158 do oko 172 mM manitola.
16. Postupak za proizvodnju liofilizirane formulacije prema bilo kojem od patentnih zahtjeva 1 do 13, naznačen time, da obuhvaća sljedeće korake: a. hlađenje vodene otopine brzinom od 0,5°C/min do 1°C/min na temperaturu od -40°C ili nižu; b. izotermno zadržavanje u trajanju od najmanje 120 minuta; c. zagrijavanje do između -20°C i -15°C brzinom od 0,5°C/min do 3°C/min; d. izotermno zadržavanje u trajanju od najmanje 180 minuta; e. primjenjivanje vakuuma uporabom tlaka između 50 mTorr i 200 mTorr na temperaturi između -30°C i -10°C; f. povisivanje temperature do između 35°C i 50°C brzinom od 0,5°C/min do 1°C/min; i g. izotermno zadržavanje u trajanju od najmanje 10 sati;
17. Postupak za proizvodnju injektibilne otopine od anti-TF ADC, naznačen time, da obuhvaća korak rekonstituiranja liofilizirane formulacije prema bilo kojem od patentnih zahtjeva 1 do 13 u sterilnom vodenom razrjeđivaču.
HRP20241036TT 2013-11-21 2014-11-21 Liofilizirana formulacija konjugata protutijelo-lijek HRP20241036T1 (hr)

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Application Number Priority Date Filing Date Title
US201361907001P 2013-11-21 2013-11-21
EP14802428.4A EP3071237B1 (en) 2013-11-21 2014-11-21 Antibody-drug conjugate lyophilised formulation
PCT/EP2014/075326 WO2015075201A1 (en) 2013-11-21 2014-11-21 Antibody-drug conjugate lyophilised formulation

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EP (2) EP4420729A3 (hr)
JP (3) JP6590803B2 (hr)
KR (1) KR102372245B1 (hr)
CN (2) CN106163567B (hr)
DK (1) DK3071237T3 (hr)
ES (1) ES2983564T3 (hr)
FI (1) FI3071237T3 (hr)
HR (1) HRP20241036T1 (hr)
MX (1) MX2016006488A (hr)
PT (1) PT3071237T (hr)
WO (1) WO2015075201A1 (hr)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2582728T3 (pl) * 2010-06-15 2018-01-31 Genmab As Koniugaty ludzkie przeciwciało-lek przeciwko czynnikowi tkankowemu
WO2015075201A1 (en) * 2013-11-21 2015-05-28 Genmab A/S Antibody-drug conjugate lyophilised formulation
PT3319597T (pt) * 2015-07-10 2021-04-27 Byondis Bv Composições compreendendo conjugados de fármacos anticorpoduocarmicina
HUE055109T2 (hu) 2015-09-11 2021-11-29 Genmab As Adagolási rendek TF elleni antitest és gyógyszer konjugátumaihoz
JP2019501139A (ja) * 2015-11-25 2019-01-17 イミュノジェン・インコーポレーテッド 医薬製剤及びその使用
US12115227B2 (en) 2016-01-13 2024-10-15 Genmab A/S Formulation for antibody and drug conjugate thereof
CA3029137A1 (en) * 2016-06-27 2018-01-04 Morphosys Ag Anti-cd19 antibody formulations
CN106938051B (zh) 2016-08-22 2019-10-11 复旦大学 靶向于组织因子的抗体-药物偶联物
EP3735271A4 (en) 2018-01-04 2022-06-15 Iconic Therapeutics, Inc. ANTI-TISSUE FACTOR ANTIBODIES, ANTIBODY DRUG CONJUGATES AND RELATED METHODS
TWI841554B (zh) * 2018-03-21 2024-05-11 丹麥商珍美寶股份有限公司 以鉑為主之劑與抗組織因子抗體－藥物共軛物的組合治療癌症之方法
JP6761506B2 (ja) * 2018-04-13 2020-09-23 ジェネンテック， インコーポレイテッド 安定した抗ｃｄ７９ｂイムノコンジュゲート製剤
EP3790584A4 (en) 2018-05-07 2022-03-30 Genmab A/S METHOD OF TREATMENT OF CANCER WITH A COMBINATION OF AN ANTI-PD-1 ANTIBODY AND AN ANTI-TISSUE FACTOR ANTIBODY-DUG CONJUGATE
AU2019266203A1 (en) * 2018-05-07 2020-11-26 Genmab A/S Methods of treating cancer with a combination of an anti-PD-1 antibody and an anti-tissue factor antibody-drug conjugate
BR112021001691A2 (pt) * 2018-08-16 2021-05-04 Genmab A/S método de tratamento de câncer de ovário, câncer peritoneal ou câncer de trompa de falópio, e, kit
TWI844571B (zh) 2018-10-30 2024-06-11 丹麥商珍美寶股份有限公司 使用抗血管內皮生長因子（ｖｅｇｆ）抗體與抗組織因子（ｔｆ）抗體－藥物共軛體之組合以治療癌症之方法
KR20210114989A (ko) 2019-02-18 2021-09-24 일라이 릴리 앤드 캄파니 치료 항체 제제
BR112022002720A2 (pt) * 2019-08-15 2022-10-11 Silverback Therapeutics Inc Formulações de conjugados de benzazepinas e usos das mesmas
EP4055051A1 (en) 2019-11-07 2022-09-14 Genmab A/S Methods of treating cancer with a combination of an anti-pd-1 antibody and an anti-tissue factor antibody-drug conjugate
TW202131954A (zh) 2019-11-07 2021-09-01 丹麥商珍美寶股份有限公司 利用鉑類劑與抗組織因子抗體－藥物共軛體之組合來治療癌症之方法
CN116322787A (zh) 2020-06-29 2023-06-23 展马博联合股份有限公司 抗组织因子抗体-药物偶联物及其在癌症治疗中的用途
MX2023005345A (es) * 2020-11-10 2023-05-22 Sanofi Sa Formulacion del conjugado anticuerpo-farmaco para ceacam5.
TW202408583A (zh) 2022-05-06 2024-03-01 丹麥商珍美寶股份有限公司 使用抗組織因子抗體－藥物共軛體以治療癌症之方法
WO2024222868A1 (zh) * 2023-04-28 2024-10-31 江苏恒瑞医药股份有限公司 抗tf抗体和抗tf抗体-药物偶联物及其医药用途

Family Cites Families (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5223427A (en) * 1987-03-31 1993-06-29 The Scripps Research Institute Hybridomas producing monoclonal antibodies reactive with human tissue-factor glycoprotein heavy chain
JPH03504605A (ja) * 1988-05-27 1991-10-09 セントカー・インコーポレーテツド 抗体産生物の凍結乾燥した配合物
WO1994005328A1 (en) * 1992-08-28 1994-03-17 The Scripps Research Institute Inhibition of tumor metastasis via neutralization of tissue factor function
US5635483A (en) 1992-12-03 1997-06-03 Arizona Board Of Regents Acting On Behalf Of Arizona State University Tumor inhibiting tetrapeptide bearing modified phenethyl amides
US5780588A (en) 1993-01-26 1998-07-14 Arizona Board Of Regents Elucidation and synthesis of selected pentapeptides
US6214345B1 (en) 1993-05-14 2001-04-10 Bristol-Myers Squibb Co. Lysosomal enzyme-cleavable antitumor drug conjugates
US5663149A (en) 1994-12-13 1997-09-02 Arizona Board Of Regents Acting On Behalf Of Arizona State University Human cancer inhibitory pentapeptide heterocyclic and halophenyl amides
DK1516628T3 (da) 1995-07-27 2013-09-08 Genentech Inc Stabil, isotonisk lyofiliseret proteinformulering
US5986065A (en) * 1997-03-10 1999-11-16 Sunol Molecular Corporation Antibodies for inhibiting blood coagulation and methods of use thereof
ES2190087T3 (es) 1997-06-13 2003-07-16 Genentech Inc Formulacion estabilizada de un anticuerpo.
JP5490972B2 (ja) 2000-08-04 2014-05-14 中外製薬株式会社 タンパク質注射製剤
GB0113179D0 (en) 2001-05-31 2001-07-25 Novartis Ag Organic compounds
EP1409018B1 (en) 2001-07-25 2010-01-06 Facet Biotech Corporation Stable lyophilized pharmaceutical formulation the igg antibody daclizumab
DK1441589T3 (da) 2001-11-08 2012-08-06 Abbott Biotherapeutics Corp Stabil, flydende, farmaceutisk sammensætning af IgG-antistoffer
US20060246060A1 (en) 2002-07-02 2006-11-02 Nesta Douglas P Novel stable formulation
AU2003242506A1 (en) * 2002-07-12 2004-02-02 Novo Nordisk A/S Tf antagonist
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
US20040191243A1 (en) 2002-12-13 2004-09-30 Bei Chen System and method for stabilizing antibodies with histidine
DK3417875T3 (da) 2003-02-10 2020-08-31 Biogen Ma Inc Immunglobulinformulering og fremgangsmåde til fremstilling deraf
US7605235B2 (en) * 2003-05-30 2009-10-20 Centocor, Inc. Anti-tissue factor antibodies and compositions
PT1725249E (pt) 2003-11-06 2014-04-10 Seattle Genetics Inc Compostos de monometilvalina capazes de conjugação a ligandos
WO2006014965A2 (en) 2004-07-27 2006-02-09 Human Genome Sciences, Inc. Pharmaceutical formulation and process
US20070196364A1 (en) * 2004-07-27 2007-08-23 Human Genome Sciences, Inc. Pharmaceutical Formulation and Process
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
JP2007034443A (ja) * 2005-07-22 2007-02-08 Konica Minolta Business Technologies Inc 画像形成システム、画像形成装置及び画像形成処理方法
CN101237881B (zh) * 2005-08-03 2015-04-22 伊缪诺金公司 免疫偶联物剂型
EA014513B1 (ru) 2005-08-03 2010-12-30 Иммьюноджен, Инк. Композиция иммуноконъюгата
JP5525729B2 (ja) 2005-11-28 2014-06-18 ゲンマブ エー／エス 組換え一価抗体およびその作製方法
EP2170319A4 (en) * 2007-06-22 2011-10-12 Scidose Llc SOLVENT FORMULATION FROM DOCETAXEL WITHOUT TWEEN 80
KR20090001217A (ko) * 2007-06-29 2009-01-08 삼성전자주식회사 미싱 노즐 검출방법 및 이를 이용하는 잉크젯 프린트 헤드
JP4824710B2 (ja) * 2008-02-08 2011-11-30 国立清華大学 グラフト共重合体およびブロック共重合体の多機能混合ミセルならびにその製造方法
UA109633C2 (uk) 2008-12-09 2015-09-25 Антитіло людини проти тканинного фактора
JP5005023B2 (ja) * 2009-12-25 2012-08-22 インターナショナル・ビジネス・マシーンズ・コーポレーション 読出し及び書込み命令の混在するコマンド列を受け取った場合の最適な書込みを実行するリニア記録方式の装置、その方法、及びプログラム。
US9068011B2 (en) 2010-03-10 2015-06-30 Genmab A+S Monoclonal antibodies against c-Met
CN103124564B (zh) * 2010-03-22 2016-11-09 弗·哈夫曼-拉罗切有限公司 对于稳定含有蛋白质的制剂有用的组合物和方法
PL2582728T3 (pl) 2010-06-15 2018-01-31 Genmab As Koniugaty ludzkie przeciwciało-lek przeciwko czynnikowi tkankowemu
WO2015075201A1 (en) * 2013-11-21 2015-05-28 Genmab A/S Antibody-drug conjugate lyophilised formulation
HUE055109T2 (hu) 2015-09-11 2021-11-29 Genmab As Adagolási rendek TF elleni antitest és gyógyszer konjugátumaihoz

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