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HRP20191335T1 - Anti-egfrviii antitijela i njihove primjene - Google Patents

Anti-egfrviii antitijela i njihove primjene Download PDF

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Publication number
HRP20191335T1
HRP20191335T1 HRP20191335TT HRP20191335T HRP20191335T1 HR P20191335 T1 HRP20191335 T1 HR P20191335T1 HR P20191335T T HRP20191335T T HR P20191335TT HR P20191335 T HRP20191335 T HR P20191335T HR P20191335 T1 HRP20191335 T1 HR P20191335T1
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Croatia
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antibody
fragment
antigen
seq
adc
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HRP20191335TT
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English (en)
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Jessica R. Kirshner
Douglas Macdonald
Gavin Thurston
Joel H Martin
Frank DELFINO
Thomas Nittoli
Marcus KELLY
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Regeneron Pharmaceuticals, Inc.
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=52875228&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20191335(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Regeneron Pharmaceuticals, Inc. filed Critical Regeneron Pharmaceuticals, Inc.
Publication of HRP20191335T1 publication Critical patent/HRP20191335T1/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
    • 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
    • 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
    • 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
    • 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
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • 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
    • C07K16/30—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
    • C07K16/28—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
    • C07K16/3015—Breast
    • 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
    • C07K16/3023—Lung
    • 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
    • C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
    • 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
    • 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
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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
    • C07K2317/70—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

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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (13)

1. Izolirano antitijelo ili njegov fragment koji se vezuje za antigen koji se specifično vezuje za humani EGFRvIII, naznačen time, što antitijelo ili njegov fragment obuhvaća kombinaciju aminokiselinskih sekvenci HCDR1/HCDR2/HCDR3/LCDR1/LCDR2/LCDR3 sa SEQ ID NO: 36/38/40/44/46/48.
2. Antitijelo ili fragment koji se vezuje za antigen, naznačen time, što antitijelo ili njegov fragment ispoljava konstantu disocijacije ravnoteže (KD) za humani EGFRvIII dimer od oko 50 nM ili manje, oko 20 nM ili manje, oko 10 nM ili manje, oko 5,0 nM ili manje, oko 1,0 nM ili manje, ili oko 0,5 nM ili manje, kada se mjeri testom rezonancije površinskih plazmona.
3. Antitijelo ili fragment koji se vezuje za antigen prema patentnom zahtjevu 1, naznačen time, što je antitijelo ili fragment koji se vezuje za antigen konjugiran citotoksinom, opcionalno naznačeno time, što je citotoksin odabran iz skupine koja se sastoji od (i) biotoksina, kemoterapijskih sredstava i radioizotopa ili (ii) maitansinoida, auristatina, tomaimicina, duokarmicina, 225Ac, 227Th i bilo kojih njihovih derivata.
4. Antitijelo ili fragment koji se vezuje za antigen prema patentnom zahtjevu 2, naznačen time, što antitijelo ili njegov fragment ispoljava KD za humani EGFR dimer veći nego za EGFRvIII dimer u vrijednosti od najmanje 4 puta, najmanje 10 puta, najmanje 50 puta, najmanje 100 puta, najmanje 500 puta, najmanje 1000 puta, najmanje 2000 puta, ili najmanje 3000 puta, kada se mjeri testom rezonancije površinskih plazmona, opcionalno naznačeno time, što se antitijelo ili njegov fragment ne vezuje za EGFR dimer u razini koju može detektirati test rezonancije površinskih plazmona.
5. Antitijelo ili fragment koji se vezuje za antigen prema patentnom zahtjevu 1, naznačen time, što: (a) HCVR obuhvaća aminokiselinsku kiselinu sa SEQ ID NO: 34; ili (b) LCVR obuhvaća aminokiselinsku sekvencu sa SEQ ID NO: 42.
6. Antitijelo ili fragment koji se vezuje za antigen prema patentnom zahtjevu 5, naznačen time, što antitijelo ili fragment obuhvaća par sekvenci HCVR/LCVR sa SEQ ID NO:34/42.
7. Farmaceutski pripravak koji obuhvaća antitijelo ili fragment koji se vezuje za antigen prema patentnom zahtjevu 1, farmaceutski prihvatljivi nosač i opcionalno jedno ili više dodatnih terapijskih sredstava odabranih iz skupine koja se sastoji od kemoterapijskog sredstva, protuupalnih sredstava i analgetika.
8. Farmaceutski pripravak kako je definirano u patentnom zahtjevu 7 za primjenu u metodi za liječenje raka ili tumora koji izražava EGFRvIII, pri čemu metoda obuhvaća primjenu terapijski učinkovite količine farmaceutskog pripravka prema patentnom zahtjevu 7 kod subjekta kojemu je potreban.
9. Farmaceutski pripravak za primjenu prema patentnom zahtjevu 8, naznačen time, što je rak ili tumor odabran iz skupine koja se sastoji od glioblastoma, duktalnog ili intraduktalnog karcinoma dojke, nemikrocelularnih karcinoma pluća, karcinoma jajnika, raka prostate i karcinoma skvamoznih stanica glave i vrata.
10. Konjugat antitijela i lijeka (engl. antibody-drug conjugate, ADC) za primjenu u metodi za liječenje raka, koji smanjuje rast tumora i/ili izaziva regresiju tumora kod pacijenta, pri čemu ADC obuhvaća antitijelo ili njegov fragment koji se vezuje za antigen i citotoksin, naznačeno time, što se antitijelo ili njegov fragment koji se vezuje za antigen iz ADC-a specifično vezuje za EGFRvIII, ali se ne vezuje za zglobni peptid sa SEQ ID NO:148 ili peptid sa SEQ ID NO:165, i naznačeno time, što antitijelo ili njegov fragment obuhvaća kombinaciju aminokiselinskih sekvenci HCDR1/HCDR2/HCDR3/LCDR1/LCDR2/LCDR3 sa SEQ ID NO: 36/38/40/44/46/48, a metoda obuhvaća primjenu ADC-a kod pacijenta kojemu je potreban.
11. ADC za primjenu prema patentnom zahtjevu 10, naznačen time, što metoda dodatno obuhvaća primjenu dodatnog ADC-a koji obuhvaća antitijelo ili njegov fragment koji se vezuje za antigen i citotoksina kod pacijenta, naznačeno time, što se antitijelo ili fragment koji se vezuje za antigen iz dodatnog ADC-a specifično vezuje za EGFRvIII i također vezuje za zglobni peptid sa SEQ ID NO:148 i/ili peptid sa SEQ ID NO:165.
12. ADC za primjenu prema patentnom zahtjevu 10, naznačen time, što antitijelo ili fragment koji se vezuje za antigen iz ADC-a obuhvaća varijabilnu regiju teškog lanca koja obuhvaća SEQ ID NO: 34 i varijabilnu regiju lakog lanca koja obuhvaća SEQ ID NO:42.
13. Konjugat antitijela i lijeka (ADC) za primjenu u metodi za liječenje raka, koji smanjuje rast tumora i/ili izaziva regresiju tumora kod pacijenta, pri čemu ADC obuhvaća antitijelo ili njegov fragment koji se vezuje za antigen i citotoksin, naznačeno time, što se antitijelo ili njegov fragment koji se vezuje za antigen iz ADC-a specifično vezuje za EGFRvIII i također se vezuje za zglobni peptid sa SEQ ID NO:148 i/ili peptid sa SEQ ID NO:165, a metoda obuhvaća primjenu ADC-a i dodatnog ADC-a koji obuhvaća antitijelo ili njegov fragment koji se vezuje za antigen i citotoksina kod pacijenta kojemu je potreban, naznačeno time, što se antitijelo ili fragment koji se vezuje za antigen iz dodatnog ADC-a specifično vezuje za EGFRvIII, ali se ne vezuje za zglobni peptid sa SEQ ID NO:148 ili peptid sa SEQ ID NO:165, i naznačeno time, što antitijelo ili njegov fragment iz dodatnog ADC-a obuhvaća kombinaciju aminokiselinskih sekvenci HCDR1/HCDR2/HCDR3/LCDR1/LCDR2/LCDR3 sa SEQ ID NO: 36/38/40/44/46/48.
HRP20191335TT 2014-03-11 2019-07-23 Anti-egfrviii antitijela i njihove primjene HRP20191335T1 (hr)

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Application Number Priority Date Filing Date Title
US201461950963P 2014-03-11 2014-03-11
EP15712472.8A EP3126388B1 (en) 2014-03-11 2015-03-10 Anti-egfrviii antibodies and uses thereof
PCT/US2015/019722 WO2015138460A1 (en) 2014-03-11 2015-03-10 Anti-egfrviii antibodies and uses thereof

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JP (1) JP6632984B2 (hr)
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