AU2018210312B2 - Subcutaneous HER2 antibody formulations - Google Patents

Subcutaneous HER2 antibody formulations Download PDF

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Publication number
AU2018210312B2
AU2018210312B2 AU2018210312A AU2018210312A AU2018210312B2 AU 2018210312 B2 AU2018210312 B2 AU 2018210312B2 AU 2018210312 A AU2018210312 A AU 2018210312A AU 2018210312 A AU2018210312 A AU 2018210312A AU 2018210312 B2 AU2018210312 B2 AU 2018210312B2
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AU
Australia
Prior art keywords
pertuzumab
trastuzumab
cancer
dose
her2
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2018210312A
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English (en)
Other versions
AU2018210312A1 (en
Inventor
Sreedhara Alavattam
Tanja BADOVINAC-CRNJEVIC
Jennifer ENG-WONG
Amit Garg
Sarah HEESON
Tarik KHAN
Whitney KIRSCHBROWN
Jasper Lin
Christine Wurth
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Genentech Inc
Original Assignee
F Hoffmann La Roche AG
Genentech Inc
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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=AU2018210312(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by F Hoffmann La Roche AG, Genentech Inc filed Critical F Hoffmann La Roche AG
Publication of AU2018210312A1 publication Critical patent/AU2018210312A1/en
Application granted granted Critical
Publication of AU2018210312B2 publication Critical patent/AU2018210312B2/en
Priority to AU2020203066A priority Critical patent/AU2020203066A1/en
Priority to AU2023210566A priority patent/AU2023210566A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • 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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/01—Hydrocarbons
    • A61K31/015—Hydrocarbons carbocyclic
    • 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
    • A61K38/43—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
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    • A61K39/001106—Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ErbB4
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    • 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
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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
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    • 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
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    • 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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    • A61K47/26—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
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61P35/00—Antineoplastic agents
    • 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
    • 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
    • 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
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    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
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    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C—CHEMISTRY; METALLURGY
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    • 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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    • C07K—PEPTIDES
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    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

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  • Medicinal Chemistry (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Immunology (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
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  • Molecular Biology (AREA)
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  • Oncology (AREA)
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  • Mycology (AREA)
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  • Cell Biology (AREA)
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  • Gastroenterology & Hepatology (AREA)
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  • Wood Science & Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2018210312A 2017-01-17 2018-01-16 Subcutaneous HER2 antibody formulations Active AU2018210312B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2020203066A AU2020203066A1 (en) 2017-01-17 2020-05-08 Subcutaneous HER2 antibody formulations
AU2023210566A AU2023210566A1 (en) 2017-01-17 2023-08-01 Subcutaneous HER2 antibody formulations

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762447359P 2017-01-17 2017-01-17
US62/447,359 2017-01-17
PCT/US2018/013854 WO2018136412A2 (en) 2017-01-17 2018-01-16 Subcutaneous her2 antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2020203066A Division AU2020203066A1 (en) 2017-01-17 2020-05-08 Subcutaneous HER2 antibody formulations

Publications (2)

Publication Number Publication Date
AU2018210312A1 AU2018210312A1 (en) 2019-07-04
AU2018210312B2 true AU2018210312B2 (en) 2020-03-19

Family

ID=61800658

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2018210312A Active AU2018210312B2 (en) 2017-01-17 2018-01-16 Subcutaneous HER2 antibody formulations
AU2020203066A Withdrawn AU2020203066A1 (en) 2017-01-17 2020-05-08 Subcutaneous HER2 antibody formulations
AU2023210566A Pending AU2023210566A1 (en) 2017-01-17 2023-08-01 Subcutaneous HER2 antibody formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2020203066A Withdrawn AU2020203066A1 (en) 2017-01-17 2020-05-08 Subcutaneous HER2 antibody formulations
AU2023210566A Pending AU2023210566A1 (en) 2017-01-17 2023-08-01 Subcutaneous HER2 antibody formulations

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US (4) US10849849B2 (cg-RX-API-DMAC7.html)
EP (2) EP3570884B1 (cg-RX-API-DMAC7.html)
JP (4) JP6741875B2 (cg-RX-API-DMAC7.html)
KR (5) KR20210134432A (cg-RX-API-DMAC7.html)
CN (4) CN110167594B (cg-RX-API-DMAC7.html)
AU (3) AU2018210312B2 (cg-RX-API-DMAC7.html)
CA (1) CA3047349C (cg-RX-API-DMAC7.html)
CR (1) CR20190376A (cg-RX-API-DMAC7.html)
CY (1) CY1123586T1 (cg-RX-API-DMAC7.html)
DK (1) DK3570884T3 (cg-RX-API-DMAC7.html)
ES (1) ES2835376T3 (cg-RX-API-DMAC7.html)
HR (1) HRP20201866T1 (cg-RX-API-DMAC7.html)
HU (1) HUE052551T2 (cg-RX-API-DMAC7.html)
IL (2) IL288948B2 (cg-RX-API-DMAC7.html)
LT (1) LT3570884T (cg-RX-API-DMAC7.html)
MA (2) MA47313B1 (cg-RX-API-DMAC7.html)
MX (2) MX374501B (cg-RX-API-DMAC7.html)
MY (1) MY189536A (cg-RX-API-DMAC7.html)
PT (1) PT3570884T (cg-RX-API-DMAC7.html)
RS (1) RS61236B1 (cg-RX-API-DMAC7.html)
RU (1) RU2750821C2 (cg-RX-API-DMAC7.html)
SG (2) SG10202011384XA (cg-RX-API-DMAC7.html)
SI (1) SI3570884T1 (cg-RX-API-DMAC7.html)
SM (1) SMT202000640T1 (cg-RX-API-DMAC7.html)
TW (3) TW202508629A (cg-RX-API-DMAC7.html)
UA (1) UA123292C2 (cg-RX-API-DMAC7.html)
WO (1) WO2018136412A2 (cg-RX-API-DMAC7.html)

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US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
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WO2020060179A1 (ko) * 2018-09-18 2020-03-26 삼성바이오에피스 주식회사 완충화제를 포함하지 않는 트라스투주맙 항체 안정화 제제
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KR20210059646A (ko) * 2019-11-15 2021-05-25 삼성바이오에피스 주식회사 항체 의약품용 액상 조성물
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JP7735291B2 (ja) 2020-02-21 2025-09-08 エーアールエス ファーマシューティカルズ、インコーポレイテッド ネクチン－４抗体コンジュゲートおよびその使用
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