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HRP20210858T1 - Antitijelo za igf-1r i njegova upotreba u dijagnosticiranju karcinoma - Google Patents

Antitijelo za igf-1r i njegova upotreba u dijagnosticiranju karcinoma Download PDF

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Publication number
HRP20210858T1
HRP20210858T1 HRP20210858TT HRP20210858T HRP20210858T1 HR P20210858 T1 HRP20210858 T1 HR P20210858T1 HR P20210858T T HRP20210858T T HR P20210858TT HR P20210858 T HRP20210858 T HR P20210858T HR P20210858 T1 HRP20210858 T1 HR P20210858T1
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igf
antibody
determining
antigen
expression level
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HRP20210858TT
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Alexandra Jouhanneaud
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Pierre Fabre Médicament
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Publication of HRP20210858T1 publication Critical patent/HRP20210858T1/hr

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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
    • C07K16/2863—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
    • 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
    • A61K47/6849—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 receptor, a cell surface antigen or a cell surface determinant
    • 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
    • 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
    • A61K47/6851—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 determinant of a tumour cell
    • 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
    • C07K16/2869—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G01N33/57492—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds localized on the membrane of tumor or cancer cells
    • 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
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4745—Insulin-like growth factor binding protein
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • G01N2333/65—Insulin-like growth factors (Somatomedins), e.g. IGF-1, IGF-2
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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Claims (13)

1. Antitijelo za IGF-1R, ili njegov na antigen vezujući fragment, naznačeno time da sadrži: i) teški lanac s CDR-H1 sekvencije SEQ ID No. 1, CDR-H2 sekvencije SEQ ID No. 2 te CDR-H3 sekvencije SEQ ID No. 3; te ii) laki lanac s CDR-L1 sekvencije SEQ ID No. 4, CDR-L2 sekvencije SEQ ID No. 5 te CDR-L3 sekvencije SEQ ID No. 6.
2. Antitijelo za IGF-1R prema patentnom zahtjevu 1, naznačeno time da sadrži varijabilnu domenu teškog lanca sekvencije SEQ ID No. 7 te varijabilnu domenu lakog lanca sekvencije SEQ ID No. 8.
3. Antitijelo za IGF-1R, ili njegov na antigen vezujući fragment, naznačeno time da je izlučeno od hibridoma deponiranom u CNCM, Institut Pasteur, Pariz, 17. rujna 2014., pod brojem 1-4894.
4. In vitro ili ex vivo upotreba antitijela za IGF-1R, ili njegovog na antigen vezujućeg fragmenta, prema bilo kojem od patentnih zahtjeva 1 do 3 za detekciju tumorskih stanica koje eksprimiraju IGF-1R ili za određivanje ekspresijske razine tumorskih stanica koje eksprimiraju IGF-1R.
5. In vitro ili ex vivo upotreba antitijela za IGF-1R, ili njegovog na antigen vezujućeg fragmenta, prema bilo kojem od patentnih zahtjeva 1 do 3, za dijagnosticiranje tumora koji eksprimira IGF-1R.
6. Metoda detekcije in vitro ili ex vivo prisutnosti i/ili mjesta tumorskih stanica koje eksprimiraju IGF-1R u subjektu, rečena metoda obuhvaća korake: (a) dovođenje u kontakt biološkog uzorka od rečenog subjekta s antitijelom za IGF-1R, ili njegovom na antigen vezuju čim fragmentom, prema bilo kojem od patentnih zahtjeva 1 do 3; te (b) detekcija vezanja rečenog antitijela za IGF-1R, ili njegovog na antigen vezujućeg fragmenta, s rečenim biološkim uzorkom.
7. Metoda detekcije in vitro ili ex vivo postotka tumorskih stanica koje eksprimiraju IGF-1R u subjektu, rečena metoda obuhvaća korake: (a) dovođenje u kontakt biološkog uzorka od rečenog subjekta s antitijelom za IGF-1R, ili njegovim na antigen vezujućim fragmentom, prema bilo kojem od patentnih zahtjeva 1 do 3; te (b) kvantifikacija postotka stanica koje eksprimiraju IGF-1R u biološkom uzorku.
8. Metoda određivanja in vitro ili ex vivo ekspresijske razine IGF-1R u tumorskim stanicama u subjektu, rečena metoda obuhvaća korake: (a) dovođenje u kontakt biološkog uzorka od rečenog subjekta s antitijelom za IGF-1R, ili njegovim na antigen vezujućim fragmentom, prema bilo kojem od patentnih zahtjeva 1 do 3; te (b) kvantifikacija razine vezivanja rečenog antitijela za IGF-1R, ili njegovog na antigen vezujućeg fragmenta, na IGF-1R u rečenom biološkom uzorku.
9. Metoda određivanja in vitro ili ex vivo količine IGF-1R u tumorskim stanicama ili u tumoru u subjektu, rečena metoda obuhvaća korake: (a) dovođenje u kontakt biološkog uzorka od rečenog subjekta s antitijelom za IGF-1R, ili njegovim na antigen vezujućim fragmentom, prema bilo kojem od patentnih zahtjeva 1 do 3; te (b) kvantifikacija fluorescencijom aktiviranog sortiranja stanica (FACS) ili imunohistokemijskom metodom (IHC) razine vezanja rečenog antitijela za IGF-1R, ili vezanja njegovog na antigen vezujućeg fragmenta, na IGF-1R u rečenom biološkom uzorku; te (c) određivanje količine tumorskih stanica ili tumora usporedbom kvantificirane razine dobivene u koraku (b) s odgovarajućom ljestvicom zasnovanom na dvama parametrima koji su intenzitet bojanja te postotak pozitivnih stanica.
10. Metoda utvrđivanja je li onkogenski poremećaj osjetljiv na liječenje s lijekom koji je antitijelo za IGF-1R, rečena metoda obuhvaća korake: (a) određivanje in vitro ili ex vivo statusa IGF-1R u tumorskim stanicama ili u tumoru u subjektu prema metodi iz patentnog zahtjeva 9, te (b) određivanje, ukoliko status IGF-1R u tumorskim stanicama ili u tumoru jest IGF-1R(+), je li onkogenski poremećaj osjetljiv na liječenje s lijekom koji je antitijelo za IGF-1R.
11. Metoda određivanja in vitro ili ex vivo učinkovitosti terapijskog režima namijenjenog da ublaži karcinom koji eksprimira IGF-1R u subjektu koji pati od rečenog poremećaja, rečena metoda obuhvaća korake: (a) određivanje prve ekspresijske razine IGF-1R prema patentnom zahtjevu 8 u prvom biološkom uzorku, rečeni prvi biološki uzorak odgovara početnom vremenu rečenog liječenja; (b) određivanje druge ekspresijske razine IGF-1R prema patentnom zahtjevu 8 u drugom biološkom uzorku, rečeni drugi biološki uzorak odgovara drugom, kasnijem vremenu rečenog liječenja, (c) izračunavanje omjera rečene prve ekspresijske razine dobivene u koraku (a) i rečene druge ekspresijske razine dobivene u koraku (b); te (d) utvrđivanje da je učinkovitost rečenog terapijskog režima visoka kad je omjer iz koraka (c) veći od 1; ili utvrđivanje da je učinkovitost rečenog terapijskog režima niska kad je omjer iz koraka (c) manji ili jednak 1.
12. Metoda odabira pacijenta koji ima karcinom za kojeg se procjenjuje da ima ili nema koristi od davanja terapijske količine lijeka koji je antitijelo za IGF-1R, rečena metoda obuhvaća korake: (a) određivanje ekspresijske razine IGF-1R prema metodi iz patentnom zahtjevu 8; (b) usporedba ekspresijske razine iz prethodnog koraka (a) s referentnom ekspresijskom razinom; te (c) odabir pacijenta za kojeg se procjenjuje da ima koristi od liječenja lijekom koji je antitijelo za IGF-1R, ako je omjer ekspresijske razine dobiven u (a) i referente ekspresijske razine veći od 1; ili (d) odabir pacijenta za kojeg se ne procjenjuje da ima koristi od liječenja lijekom koji je antitijelo za IGF-1R, ako je omjer ekspresijske razine dobiven u (a) i referentne ekspresijske razine manji ili jednak 1.
13. Paket za detekciju tumorskih stanica koje eksprimiraju IGF-1R u pacijentu, naznačeno time da rečeni paket sadrži najmanje antitijelo za IGF-1R, ili njegov na antigen vezujući fragment, prema bilo kojem od patentnih zahtjeva 1 do 3.
HRP20210858TT 2015-04-27 2021-05-31 Antitijelo za igf-1r i njegova upotreba u dijagnosticiranju karcinoma HRP20210858T1 (hr)

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EP15305642 2015-04-27
EP16722812.1A EP3288979B1 (en) 2015-04-27 2016-04-27 Igf-1r antibody and its use for the diagnosis of cancer
PCT/EP2016/059338 WO2016174053A1 (en) 2015-04-27 2016-04-27 Igf-1r antibody and its use for the diagnosis of cancer

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