PE20211214A1 - Variantes de pertuzumab y su evaluacion - Google Patents

Variantes de pertuzumab y su evaluacion

Info

Publication number
PE20211214A1
PE20211214A1 PE2021000128A PE2021000128A PE20211214A1 PE 20211214 A1 PE20211214 A1 PE 20211214A1 PE 2021000128 A PE2021000128 A PE 2021000128A PE 2021000128 A PE2021000128 A PE 2021000128A PE 20211214 A1 PE20211214 A1 PE 20211214A1
Authority
PE
Peru
Prior art keywords
variant
pertuzumab
amount
composition
measured
Prior art date
Application number
PE2021000128A
Other languages
English (en)
Inventor
Lynn A Gennaro
Yung-Hsiang Kao
Yonghua Zhang
Original Assignee
Genentech 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50694078&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20211214(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of PE20211214A1 publication Critical patent/PE20211214A1/es

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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
    • C07K16/30—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
    • 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
    • A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
    • 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
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • 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
    • A61P35/04—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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416—Systems
    • G01N27/447—Systems using electrophoresis
    • G01N27/44704—Details; Accessories
    • G01N27/44747—Composition of gel or of carrier mixture
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • 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
    • C07K2317/567—Framework region [FR]
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Oncology (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Electrochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Referida a un metodo para preparar una composicion que comprende Pertuzumab y una o mas variantes del mismo caracterizado porque el Pertuzumab y la variante/s cada uno comprende las secuencias de aminoacidos variable liviana y variable pesada de SEQ ID NO: 7 y 8, respectivamente, y el metodo comprende: a) expresar Pertuzumab y la(s) variante(s) a partir de una celula recombinante de ovario de hamster chino (CHO) en escala de fabricacion y purificar la composicion que comprende el Pertuzumab y la(s) variante(s); y b) someter la composicion purificada a un ensayo de analisis para evaluar la cantidad de variante (s) en ella, donde: i) la variante es una variante de cisteina no apareada que comprende cisteinas Cys23/Cys88 no apareadas en uno o ambos dominios variables de Pertuzumab en una cantidad ? 25% determinada mediante HIC (cromatografia de interaccion hidrofoba) del anticuerpo intacto; ii) la variante es una variante afucosilada en el rango de >2% a 4,1% determinada por fluorescencia inducida por laser de electroforesis capilar (CE-LIF); iii) la variante es una especie de bajo peso molecular (LMWS) en una cantidad < 1,6% de la composicion medida por SE-HPLC (cromatografia liquida de alto rendimiento de exclusion de tamano); iv) la variante es una especie de alto peso molecular (HMWS) en una cantidad < 1,7% de la composicion medida por SE-HPLC (cromatografia liquida de alto rendimiento de exclusion de tamano); v. la variante es el fragmento del Pico 1 de Pertuzumab en una cantidad de ? 0,5% o el fragmento del Pico 2 de Pertuzumab en una cantidad ? 1,0% medida por electroforesis capilar reducida de dodecilsulfato de sodio (R-CE-SDS).
PE2021000128A 2013-04-16 2014-04-15 Variantes de pertuzumab y su evaluacion PE20211214A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361812603P 2013-04-16 2013-04-16
PCT/US2014/034200 WO2014172371A2 (en) 2013-04-16 2014-04-15 Pertuzumab variants and evaluation thereof

Publications (1)

Publication Number Publication Date
PE20211214A1 true PE20211214A1 (es) 2021-07-05

Family

ID=50694078

Family Applications (2)

Application Number Title Priority Date Filing Date
PE2015002163A PE20151769A1 (es) 2013-04-16 2014-04-15 Variantes de pertuzumab y su evalaucion
PE2021000128A PE20211214A1 (es) 2013-04-16 2014-04-15 Variantes de pertuzumab y su evaluacion

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PE2015002163A PE20151769A1 (es) 2013-04-16 2014-04-15 Variantes de pertuzumab y su evalaucion

Country Status (25)

Country Link
US (7) US9815904B2 (es)
EP (2) EP2986643A2 (es)
JP (2) JP2016522176A (es)
KR (2) KR20200085942A (es)
CN (1) CN105121471A (es)
AR (1) AR095863A1 (es)
AU (3) AU2014254086B2 (es)
BR (1) BR112015024926A2 (es)
CA (2) CA2907776C (es)
CL (3) CL2015003049A1 (es)
CR (1) CR20150576A (es)
EA (1) EA201591643A1 (es)
HK (1) HK1211948A1 (es)
IL (2) IL241103B (es)
MA (1) MA38567A1 (es)
MX (2) MX368259B (es)
MY (1) MY173295A (es)
NZ (2) NZ712012A (es)
PE (2) PE20151769A1 (es)
PH (1) PH12015502382A1 (es)
RU (2) RU2019115089A (es)
SG (3) SG10201706045RA (es)
TW (1) TWI554284B (es)
WO (1) WO2014172371A2 (es)
ZA (1) ZA201506594B (es)

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