AU2019355995B2 - Anti-FGFR2 antibody formulations - Google Patents

Anti-FGFR2 antibody formulations

Info

Publication number
AU2019355995B2
AU2019355995B2 AU2019355995A AU2019355995A AU2019355995B2 AU 2019355995 B2 AU2019355995 B2 AU 2019355995B2 AU 2019355995 A AU2019355995 A AU 2019355995A AU 2019355995 A AU2019355995 A AU 2019355995A AU 2019355995 B2 AU2019355995 B2 AU 2019355995B2
Authority
AU
Australia
Prior art keywords
arg
sucrose
months
nacl
antibody
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
AU2019355995A
Other languages
English (en)
Other versions
AU2019355995A1 (en
Inventor
Chin-Yi Huang
Isaias PRADO
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.)
Five Prime Therapeutics Inc
Original Assignee
Five Prime Therapeutics Inc
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
Application filed by Five Prime Therapeutics Inc filed Critical Five Prime Therapeutics Inc
Publication of AU2019355995A1 publication Critical patent/AU2019355995A1/en
Application granted granted Critical
Publication of AU2019355995B2 publication Critical patent/AU2019355995B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22—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
    • A61K47/06—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
    • 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
    • A61K9/08—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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IG], 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
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (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)
AU2019355995A 2018-10-05 2019-10-04 Anti-FGFR2 antibody formulations Active AU2019355995B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862741772P 2018-10-05 2018-10-05
US62/741,772 2018-10-05
PCT/US2019/054684 WO2020072896A1 (en) 2018-10-05 2019-10-04 Anti-fgfr2 antibody formulations

Publications (2)

Publication Number Publication Date
AU2019355995A1 AU2019355995A1 (en) 2021-04-08
AU2019355995B2 true AU2019355995B2 (en) 2026-04-09

Family

ID=68343457

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019355995A Active AU2019355995B2 (en) 2018-10-05 2019-10-04 Anti-FGFR2 antibody formulations

Country Status (20)

Country Link
US (1) US20220010020A1 (cg-RX-API-DMAC10.html)
EP (1) EP3860563A1 (cg-RX-API-DMAC10.html)
JP (2) JP7595567B2 (cg-RX-API-DMAC10.html)
KR (1) KR20210074286A (cg-RX-API-DMAC10.html)
CN (1) CN112804989A (cg-RX-API-DMAC10.html)
AU (1) AU2019355995B2 (cg-RX-API-DMAC10.html)
BR (1) BR112021005204A2 (cg-RX-API-DMAC10.html)
CA (1) CA3112215A1 (cg-RX-API-DMAC10.html)
CO (1) CO2021004985A2 (cg-RX-API-DMAC10.html)
CR (1) CR20210217A (cg-RX-API-DMAC10.html)
EA (1) EA202190878A1 (cg-RX-API-DMAC10.html)
EC (1) ECSP21031139A (cg-RX-API-DMAC10.html)
IL (1) IL281976A (cg-RX-API-DMAC10.html)
MX (1) MX2021003766A (cg-RX-API-DMAC10.html)
MY (1) MY208925A (cg-RX-API-DMAC10.html)
PE (1) PE20211213A1 (cg-RX-API-DMAC10.html)
PH (1) PH12021550670A1 (cg-RX-API-DMAC10.html)
SG (1) SG11202102875YA (cg-RX-API-DMAC10.html)
UA (1) UA130250C2 (cg-RX-API-DMAC10.html)
WO (1) WO2020072896A1 (cg-RX-API-DMAC10.html)

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Publication number Priority date Publication date Assignee Title
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
EP4273166A4 (en) * 2020-12-29 2025-04-16 Shenzhen Forward Pharmaceuticals Co., Limited ANTI-FGFR2 ANTIBODIES AND USE THEREOF
TW202342527A (zh) * 2022-02-25 2023-11-01 美商安進公司 鱗狀非小細胞肺癌之治療
AU2023243773A1 (en) * 2022-03-28 2024-10-24 Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd. Novel anti-fgfr2 antibodies.
WO2024199362A1 (en) * 2023-03-31 2024-10-03 Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd. Novel anti-FGFR2 antibodies
EP4786494A1 (en) * 2023-09-28 2026-08-05 Nanjing Leads Biolabs Co., Ltd. Anti-fgfr2 antibody and multispecific binding molecule comprising same

Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2015017600A1 (en) * 2013-08-01 2015-02-05 Five Prime Therapeutics, Inc. Afucosylated anti-fgfr2iiib antibodies

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EP0590058B1 (en) 1991-06-14 2003-11-26 Genentech, Inc. HUMANIZED Heregulin ANTIBODy
GB9603256D0 (en) 1996-02-16 1996-04-17 Wellcome Found Antibodies
JP2002506353A (ja) 1997-06-24 2002-02-26 ジェネンテック・インコーポレーテッド ガラクトシル化糖タンパク質の方法及び組成物
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Also Published As

Publication number Publication date
WO2020072896A1 (en) 2020-04-09
EP3860563A1 (en) 2021-08-11
IL281976A (en) 2021-05-31
UA130250C2 (uk) 2025-12-31
CR20210217A (es) 2021-06-18
JP2022503886A (ja) 2022-01-12
EA202190878A1 (ru) 2021-07-02
JP7595567B2 (ja) 2024-12-06
CA3112215A1 (en) 2020-04-09
MX2021003766A (es) 2021-05-27
BR112021005204A2 (pt) 2021-06-08
MY208925A (en) 2025-06-11
ECSP21031139A (es) 2021-06-30
PE20211213A1 (es) 2021-07-05
SG11202102875YA (en) 2021-04-29
PH12021550670A1 (en) 2022-01-03
KR20210074286A (ko) 2021-06-21
CN112804989A (zh) 2021-05-14
JP2024138284A (ja) 2024-10-08
US20220010020A1 (en) 2022-01-13
CO2021004985A2 (es) 2021-04-30
AU2019355995A1 (en) 2021-04-08

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