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DK2906298T3 - Pyrrolobenzodiazepin-antistofkonjugater - Google Patents

Pyrrolobenzodiazepin-antistofkonjugater Download PDF

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Publication number
DK2906298T3
DK2906298T3 DK13785831.2T DK13785831T DK2906298T3 DK 2906298 T3 DK2906298 T3 DK 2906298T3 DK 13785831 T DK13785831 T DK 13785831T DK 2906298 T3 DK2906298 T3 DK 2906298T3
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Prior art keywords
mmol
antibody
methoxy
seq
conjugate
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DK13785831.2T
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English (en)
Inventor
Philip Wilson Howard
Berkel Patricius Hendrikus Cornelis Van
Original Assignee
Adc Therapeutics Sa
Medimmune Ltd
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Publication of DK2906298T3 publication Critical patent/DK2906298T3/da

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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • 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
    • A61K47/68035—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a pyrrolobenzodiazepine
    • 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
    • A61K47/6855—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 the tumour determinant being from breast cancer cell
    • 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
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D403/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings
    • C07D403/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings linked by a chain containing hetero atoms as chain links
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04—Ortho-condensed systems
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D519/00—Heterocyclic compounds containing more than one system of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring system not provided for in groups C07D453/00 or C07D455/00
    • 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
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • 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

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Toxicology (AREA)
  • Hematology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)

Claims (14)

1. Konjugat med formel ConjA:
ConjA ConjB:
ConjC: r> n
ConjC ConjD:
eller ConjE:
hvor Ab er et antistof, som binder til CD19, hvilket antistof omfatter et VH-domæne, som har sekvensen ifølge en af SEQ ID NO. 1 eller 2, eventuelt yderligere omfattende et VL-domæne, der har sekvensen ifølge en af SEQ ID NO 7, 8, 9, 10, 11 eller 12; hvor lægemiddelladningen (p) af lægemidler (D) til antistof (Ab) er et heltal fra 1 til 8.
2. Konjugat ifølge krav 1, hvor antistoffet omfatter et VH-domæne, som er parret med et VL-domæne, hvor VH- og VL-domænerne har sekvenser udvalgt fra gruppen bestående af: SEQ ID NO. 1 parret med en af SEQ ID NO. 7, 8, 9, 10, 11 eller 12; og SEQ ID NO. 2 parret med en af SEQ ID NO. 7, 8, 9, 10, 11 eller 12.
3. Konjugat ifølge krav 2, hvor de parrede VH- og VL-domæner har sekvenserne af: SEQ ID NO. 1 parret med SEQ ID NO. 7 eller SEQ ID NO. 2 parret med SEQ ID NO. 8.
4. Konjugat ifølge krav 1, som er med formlen ConjE, hvor Ab har et VH-domæne af SEQ ID NO.2 og et VL-domæne af SEQ ID NO. 8.
5. Konjugat ifølge et af kravene 1 til 4, hvor antistoffet er et intakt antistof.
6. Konjugat ifølge et af kravene 1 til 5, hvor antistoffet er humaniseret, deim-muniseret eller overfladeomdannet.
7. Konjugat ifølge krav 1, hvor p er 1,2, 3 eller 4.
8. Konjugat ifølge et af kravene 1 til 7, som omfatter en blanding af antistof-lægemiddel-konjugatforbindelserne, hvor den gennemsnitlige lægemiddelladning pr. antistof i blandingen af antistof-lægemiddel-konjugatforbindelser er 2 til 5.
9. Konjugat ifølge et af kravene 1 til 8 til anvendelse inden for terapi.
10. Konjugat ifølge et af kravene 1 til 8 til anvendelse ved behandling af en proliferativ sygdom hos et individ.
11. Konjugat ifølge krav 10, hvor sygdommen er kræft.
12. Konjugat ifølge et af kravene 1 til 8 i kombination med rituximab til anvendelse ved behandling af kræft hos et individ.
13. Farmaceutisk sammensætning omfattende konjugatet ifølge et af kravene 1 til 8 og et farmaceutisk acceptabelt fortyndingsmiddel, bærestof eller hjælpestof.
14. Farmaceutisk sammensætning ifølge krav 13, yderligere omfattende en terapeutisk virksom mængde af et kemoterapeutisk middel.
DK13785831.2T 2012-10-12 2013-10-11 Pyrrolobenzodiazepin-antistofkonjugater DK2906298T3 (da)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201261712924P 2012-10-12 2012-10-12
US201261712928P 2012-10-12 2012-10-12
US201361784421P 2013-03-14 2013-03-14
US201361784383P 2013-03-14 2013-03-14
US201361784362P 2013-03-14 2013-03-14
PCT/EP2013/071346 WO2014057117A1 (en) 2012-10-12 2013-10-11 Pyrrolobenzodiazepine-antibody conjugates

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Publication Number Publication Date
DK2906298T3 true DK2906298T3 (da) 2018-12-17

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US (3) US9931414B2 (da)
EP (1) EP2906298B1 (da)
JP (1) JP6392763B2 (da)
KR (1) KR101995619B1 (da)
CN (1) CN105050661B (da)
AU (1) AU2013328623B8 (da)
BR (1) BR112015008174B1 (da)
CA (1) CA2887895C (da)
CY (2) CY1121349T1 (da)
DK (1) DK2906298T3 (da)
ES (1) ES2703151T3 (da)
FI (1) FIC20230018I1 (da)
FR (1) FR23C1020I2 (da)
HR (1) HRP20182129T1 (da)
HU (2) HUE042731T2 (da)
LT (2) LT2906298T (da)
MX (1) MX364329B (da)
NL (1) NL301231I2 (da)
NZ (1) NZ707534A (da)
PL (1) PL2906298T3 (da)
PT (1) PT2906298T (da)
RS (1) RS57964B1 (da)
SI (1) SI2906298T1 (da)
SM (1) SMT201900017T1 (da)
WO (1) WO2014057117A1 (da)

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SI2906298T1 (sl) 2018-12-31
CY1121349T1 (el) 2020-05-29
CA2887895A1 (en) 2014-04-17
NZ707534A (en) 2018-08-31
EP2906298B1 (en) 2018-10-03
AU2013328623B8 (en) 2017-06-15
CN105050661B (zh) 2018-03-30
MX2015004449A (es) 2015-10-29
BR112015008174A2 (pt) 2018-02-27
RS57964B1 (sr) 2019-01-31
FR23C1020I2 (fr) 2024-05-03
HUS2300020I1 (hu) 2023-05-28
AU2013328623A1 (en) 2015-04-23
BR112015008174B1 (pt) 2022-12-27
CY2023013I2 (el) 2023-11-15
EP2906298A1 (en) 2015-08-19
LTPA2023516I1 (da) 2023-05-25
HUE042731T2 (hu) 2019-07-29
US9931414B2 (en) 2018-04-03
PT2906298T (pt) 2018-12-28
SMT201900017T1 (it) 2019-02-28
JP6392763B2 (ja) 2018-09-19
KR20150083857A (ko) 2015-07-20
US11771775B2 (en) 2023-10-03
US20180250417A1 (en) 2018-09-06
MX364329B (es) 2019-04-23
US20150283262A1 (en) 2015-10-08
CY2023013I1 (el) 2023-11-15
LT2906298T (lt) 2018-12-27
CA2887895C (en) 2019-10-29
NL301231I2 (nl) 2023-11-09
FR23C1020I1 (fr) 2023-06-30
ES2703151T3 (es) 2019-03-07
HRP20182129T1 (hr) 2019-02-08

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