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HRP20201866T1 - Formulacije protutijela za her2 za supkutanu primjenu - Google Patents

Formulacije protutijela za her2 za supkutanu primjenu Download PDF

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Publication number
HRP20201866T1
HRP20201866T1 HRP20201866TT HRP20201866T HRP20201866T1 HR P20201866 T1 HRP20201866 T1 HR P20201866T1 HR P20201866T T HRP20201866T T HR P20201866TT HR P20201866 T HRP20201866 T HR P20201866T HR P20201866 T1 HRP20201866 T1 HR P20201866T1
Authority
HR
Croatia
Prior art keywords
pertuzumab
cancer
her2
treatment
positive cancer
Prior art date
Application number
HRP20201866TT
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English (en)
Inventor
Jennifer ENG-WONG
Whitney KIRSCHBROWN
Tarik KHAN
Jasper Lin
Sreedhara Alavattam
Amit Garg
Sarah HEESON
Tanja BADOVINAC-CRNJEVIC
Christine Wurth
Original Assignee
Genentech, Inc.
F. Hoffmann - La Roche Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=61800658&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20201866(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech, Inc., F. Hoffmann - La Roche Ag filed Critical Genentech, Inc.
Publication of HRP20201866T1 publication Critical patent/HRP20201866T1/hr

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    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/01—Hydrocarbons
    • A61K31/015—Hydrocarbons carbocyclic
    • A—HUMAN NECESSITIES
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    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K39/0005—Vertebrate antigens
    • A61K39/0011—Cancer antigens
    • A61K39/001102—Receptors, cell surface antigens or cell surface determinants
    • A61K39/001103—Receptors for growth factors
    • A61K39/001106—Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ErbB4
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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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
    • A61K47/16—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
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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    • 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
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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    • 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
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    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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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
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    • 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
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (21)

1. Tekući farmaceutski pripravak, naznačen time, da sadrži 600 mg pertuzumaba u koncentraciji od 60 mg/ml, 600 mg trastuzumaba u koncentraciji od 60 mg/ml, 2.000 U/ml rHuPH20, 20 mM His-HCl pH 5,5, 105 mM trehaloze, 100 mM saharoze, 0,04 % polisorbata 20, 10 mM metionina, i sterilnu vodu za injekcije do ukupnog volumena od 10 ml.
2. Tekući farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time, da se nalazi u ampuli od 15 ml.
3. Tekući farmaceutski pripravak, naznačen time, da sadrži 1.200 mg pertuzumaba u koncentraciji od 80 mg/ml, 600 mg trastuzumaba u koncentraciji od 40 mg/ml, 2.000 U/ml rHuPH20, 20 mM His-HCl pH 5,5, 70 mM trehaloze, 133 mM saharoze, 0,04 % polisorbata 20, 10 mM metionina, i sterilnu vodu za injekcije do ukupnog volumena od 15 ml.
4. Tekući farmaceutski pripravak prema patentnom zahtjevu 3, naznačen time, da se nalazi u ampuli od 20 ml.
5. Proizvod, naznačen time, da sadrži tekući farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4.
6. Proizvod prema patentnom zahtjevu 5, naznačen time, da dodatno sadrži prilog u ambalaži s uputama za supkutanu primjenu tekućeg farmaceutskog pripravka sadržanog u pakiranju, na ljudskom pojedincu s HER2-pozitivnim rakom.
7. Proizvod prema patentnom zahtjevu 6, naznačen time, da je HER2-pozitivni rak odabran iz skupine koju čine rak dojke, peritonealni rak, rak jajovoda, rak pluća, rak debelog crijeva, rak žučnih vodova i rak mokraćnog mjehura.
8. Proizvod prema patentnom zahtjevu 7, naznačen time, da je rak dojke rani rak dojke (EBC) ili metastatski rak dojke (MBC).
9. Pertuzumab, naznačen time, da je za uporabu u postupku liječenja HER2-pozitivnog raka, koji obuhvaća supkutanu primjenu pertuzumaba na ljudskom pojedincu u fiksnoj punoj dozi od 1200 mg, nakon čega slijedi barem jedna doza održavanja od 600 mg.
10. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema patentnom zahtjevu 9, naznačen time, da nakon davanja pune doze slijedi davanje više doza održavanja.
11. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema bilo kojem od patentnih zahtjeva 9 ili 10, naznačen time, da se prva doza održavanja pertuzumaba daje navedenom ljudskom pojedincu otprilike dva tjedna ili otprilike tri tjedna nakon primjene pune doze pertuzumaba.
12. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema bilo kojem od patentnih zahtjeva 9 do 11, naznačen time, da se fiksne doze pertuzumaba daju navedenom ljudskom pojedincu otprilike svaka dva tjedna ili otprilike svaka tri tjedna.
13. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema bilo kojem od patentnih zahtjeva 9 do 12, naznačen time, da je rak odabran iz skupine koju čine rak dojke, peritonealni rak, rak jajovoda, rak pluća, rak debelog crijeva, rak žučnih vodova i rak mokraćnog mjehura.
14. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema patentnom zahtjevu 13, naznačen time, da je rak rani rak dojke (EBC) ili metastatski rak dojke (MBC).
15. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema bilo kojem od patentnih zahtjeva 9 do 14, naznačen time, da obuhvaća davanje pacijentu još jednog terapeutskog sredstva.
16. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema bilo kojem od patentnih zahtjeva 9 do 15, naznačen time, da se fiksna doza pertuzumaba daje supkutano u kombinaciji sa supkutano primijenjenim trastuzumabom.
17. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema patentnom zahtjevu 16, naznačen time, da se fiksna doza pertuzumaba i trastuzumaba istodobno daju supkutano u dvije posebne supkutane injekcije ili time, da se fiksna doza pertuzumaba kombinira zajedno s fiksnom dozom trastuzumaba i primijenjuje kao jedna supkutana injekcija.
18. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema patentnom zahtjevu 16, naznačen time, da se fiksna doza pertuzumaba i fiksna doza trastuzumaba daju kao jedinstvena zajednička formulacija za supkutanu primjenu.
19. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema bilo kojem od patentnih zahtjeva 16 do 18, naznačen time, da je zajednička formulacija tekući farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 1 do 4.
20. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema patentnom zahtjevu 15, naznačen time, da je drugo terapeutsko sredstvo kemoterapeutsko sredstvo, s time, da je prema potrebi kemoterapeutsko sredstvo odabrano iz skupine koju čine taksani i antraciklini.
21. Pertuzumab za uporabu u postupku za liječenje HER2-pozitivnog raka prema patentnom zahtjevu 20, naznačen time, da je taksan paklitaksel ili docetaksel, te time, da antraciklin sadrži daunorubicin, doksorubicin ili epirubicin.
HRP20201866TT 2017-01-17 2020-11-24 Formulacije protutijela za her2 za supkutanu primjenu HRP20201866T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762447359P 2017-01-17 2017-01-17
PCT/US2018/013854 WO2018136412A2 (en) 2017-01-17 2018-01-16 Subcutaneous her2 antibody formulations
EP18713735.1A EP3570884B1 (en) 2017-01-17 2018-01-16 Subcutaneous her2 antibody formulations

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HRP20201866T1 true HRP20201866T1 (hr) 2021-01-22

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EP (2) EP3570884B1 (hr)
JP (4) JP6741875B2 (hr)
KR (5) KR20190104554A (hr)
CN (4) CN110167594B (hr)
AU (3) AU2018210312B2 (hr)
CA (1) CA3047349C (hr)
CR (1) CR20190376A (hr)
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MA (2) MA47313B1 (hr)
MX (2) MX2019008350A (hr)
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PT (1) PT3570884T (hr)
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RU (1) RU2750821C2 (hr)
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TWI472339B (zh) 2008-01-30 2015-02-11 Genentech Inc 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物
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