DK3242678T3 - Kombinationspræparater til behandling af cancer eller infektion - Google Patents

Kombinationspræparater til behandling af cancer eller infektion Download PDF

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DK3242678T3
DK3242678T3 DK16700138.7T DK16700138T DK3242678T3 DK 3242678 T3 DK3242678 T3 DK 3242678T3 DK 16700138 T DK16700138 T DK 16700138T DK 3242678 T3 DK3242678 T3 DK 3242678T3
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lag
virus
protein
derivative
cancer
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Frédéric Triebel
Chrystelle Brignone
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Immutep Sas
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1774Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39541Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/20Antivirals for DNA viruses
    • A61P31/22Antivirals for DNA viruses for herpes viruses
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • A61P33/02Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
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    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • C07K14/70503Immunoglobulin superfamily
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IG], 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
    • C07K16/2818Immunoglobulins [IG], 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 against CD28 or CD152
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56966Animal cells
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6872Intracellular protein regulatory factors and their receptors, e.g. including ion channels
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    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
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    • C07K2317/00Immunoglobulins specific features
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    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/32Fusion polypeptide fusions with soluble part of a cell surface receptor, "decoy receptors"
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    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/705Assays involving receptors, cell surface antigens or cell surface determinants
    • G01N2333/70503Immunoglobulin superfamily, e.g. VCAMs, PECAM, LFA-3
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Claims (17)

1. Kombinationspræparat, der omfatter: (a) LAG-3-protein, eller et derivat deraf, der kan binde til MHC-klasse-II-molekyler, hvor derivatet af LAG-3-protein omfatter en aminosyresekvens, der har mindst 70 % aminosyreidentitet med domæne Dl, og eventuelt domæne D2, af LAG-3-protein, eller hvor derivatet af LAG-3-protein omfatter en aminosyresekvens, der har mindst 70 % aminosyreidentitet med domænerne Dl, D2, D3, og eventuelt D4, af LAG-3-protein; og (b) en programmeret celledødsprotein-1- (PD-1) banehæmmer, hvor PD-1-banehæmmeren omfatter et anti-PD-1-antistof, eller et derivat eller fragment deraf, der bevarer evne til at hæmme binding af PD-1 til PD-L1 og/eller PD-L2, eller hvor PD-1-banehæmmeren omfatter et anti-PD-Ll-antistof, eller et derivat eller fragment deraf, der bevarer evne til at hæmme binding af PD-L1 til PD-1.
2. Farmaceutisk sammensætning, der omfatter: (a) LAG-3-protein, eller et derivat deraf, der kan binde til MHC-klasse-II-molekyler, hvor derivatet af LAG-3-protein omfatter en aminosyresekvens, der har mindst 70 % aminosyreidentitet med domain Dl, og eventuelt domæne D2, af LAG-3-protein, eller hvor derivatet af LAG-3-protein omfatter en aminosyresekvens, der har mindst 70 % aminosyreidentitet med domænerne Dl, D2, D3, og eventuelt D4, af LAG-3-protein; (b) en PD-1-banehæmmer, hvor PD-l-banehæmmeren omfatter et anti-PD-1-antistof, eller et derivat eller fragment deraf, der bevarer evne til at hæmme binding af PD-1 til PD-L1 og/eller PD-L2, eller hvor PD-l-banehæmmeren omfatter et anti-PD-Ll-antistof, eller et derivat eller fragment deraf, der bevarer evne til at hæmme binding af PD-L1 til PD-1; og (c) en farmaceutisk acceptabel bærer, excipiens eller fortynder.
3. Kombinationspræparat ifølge krav 1, eller farmaceutisk sammensætning ifølge krav 2, til coadministration eller sekventiel administration af LAG-3-proteinet, eller et derivat deraf, og PD-1 -banehæmmeren.
4. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, hvor LAG-3-proteinet, eller et derivat deraf, er adskilt fra PD-1- banehæmmeren.
5. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, hvor LAG-3-proteinet, eller et derivat deraf, er til stede i en dosis, der er en molækvivalent af 0,25-30 mg af LAG-3 Ig-fusionsprotein IMP321.
6. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, der omfatter en flerhed af doser af LAG-3-proteinet, eller et derivat deraf og/eller en flerhed af doser af PD-1-banehæmmeren.
7. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, hvor PD-1-banehæmmeren omfatter: et anti-PD-1 -antistof, eller et derivat eller fragment deraf, der bevarer evne til at hæmme binding af PD-1 til PD-L1 og/eller PD-L2, og hvor PD-1-banehæmmeren er pembrolizumab eller nivolumab eller pidilizumab; eller et anti-PD-Ll-antistof, eller et derivat eller fragment deraf, der bevarer evne til at hæmme binding af PD-L1 til PD-1, og hvor PD-1-banehæmmeren er BMS-936559, MED14736, MPDL3280A eller MSB0010718C.
8. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, hvor PD-1-banehæmmeren er til stede ved en dosis, der er op til 50 %, 1-50 %, 1-25 %, eller 1-10 %, af en typisk ordineret dosis af PD-1-banehæmmeren som en monoterapi, eller hvor PD-1-banehæmmeren er til stede ved en dosis, der er 0,1-50 %, 0,1-25 %, 0,1-20 %, 0,1-10 %, <20 %, <10 %, 0,1-<20 %, 0, l-<10 %, 0,01-<20 % eller 0,01-<10 % af en typisk ordineret dosis af PD-1-banehæmmeren som en monoterapi.
9. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, hvor LAG-3-proteinet eller et derivat deraf, og PD-1-banehæmmeren, er til stede i en hvilken som helst af kombinationerne af de doseringsmængder, der vises i nedenstående tabel:
10. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, hvor derivatet af LAG-3-protein omfatter en aminosyresekvens, der har mindst 70 % aminosyreidentitet med domæne Dl, og eventuelt domæne D2, af humant LAG-3-protein, eller hvor derivatet af LAG-3-protein omfatter en aminosyresekvens, der har mindst 70 % aminosyreidentitet med domænerne Dl, D2, D3, og eventuelt D4, af humant LAG-3-protein.
11. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst foregående krav, hvor derivatet af LAG-3-protein er kondenseret til immunoglobulin Fc-sekvensen, fortrinsvis hvor derivatet af LAG-3-protein er det rekombinante opløselige humane LAG-3Ig-fusionsprotein IMP321.
12. Kombinationspræparat eller a farmaceutisk sammensætning ifølge et hvilket som helst af følgende krav til anvendelse som et medikament.
13. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11 til anvendelse i forebyggelse, behandling eller bedring af cancer.
14. Kombinationspræparat eller farmaceutisk sammensætning til anvendelse ifølge krav 13, hvor canceren er en PD-L1-positiv eller en PD-L2-positiv cancer, eller hvor canceren er hud-, lunge- (navnlig pladeepitel- eller ikke-pladeepitel- ikke-småcellet lungekarcinom, NSCLC), ovarie-, nyre-, colon-, kolorektal-, bryst-, gastrisk, øsofagus-, pankreas-, blære-, urotelial- eller levercancer, eller et melanom (for eksempel, metastatisk malignt melanom), en prostatacancer (for eksempel hormonrefraktært prostataadenokarcinom), cancer i hoved eller hals (for eksempel pladeepitelkarcinom i hoved og hals), en cervixcancer, en thyroideacancer, et glioblastom, et gliom, leukæmi, et lymfom (for eksempel, et B-cellelymfom), en binyrecancer, en aids-associeret cancer, et alveolært bløddelssarkom, en astrocytisk tumor, knoglecancer, en cancer i hjerne og rygmarv, en metastatisk hjernetumor, en karotidlegemetumor, et chondrosarkom, et chordom, et kromofobt nyrecellekarcinom, et spytkirtelkarcinom, kutant benignt fibrøst histiocytom, en desmoplastisk småcellet rund tumor, et ependymom, en Ewings tumor, et ekstraskeletalt myksoidt chondrosarkom, fibrogenesis imperfecta ossium, fibrøst knogledysplasi, en gæIdeblære- eller galdevejscancer, en gestational trofoblastisk sygdom, en kimcelletumor, en hæmatologisk malignitet, et hepatocellulært karcinom, en øcelletumor, et Kaposis sarkom, en nyrecancer, et lipom/en benign lipomatøs tumor, et liposarkom/en malign lipomatøs tumor, et medulloblastom, et meningiom, et Merkelcellekarcinom, en multipel endokrin neoplasi, et multiplet myelom, et myelodysplasisyndrom, et neuroblastom, en neuroendokrin tumor, et papillært thyroideakarcinom, et parathyroideatumor, en pædiatrisk cancer, en perifer nerveskedetumor, et phæochromocytom, en hypofysetumor, en prostatacancer, et posteriori uvealt melanom, en sjælden hæmatologisk forstyrrelse, en metastatisk nyrecancer, en rhabdoid tumor, et rhabdomysarkom, et sarkom, et blødvævssarkom, en pladeepitelcancer, en mavecancer, et synovialsarkom, en testiscancer, et thymuskarcinom, et thymom, en metastatisk thyreoideacancer eller en uteruscancer.
15. Kombinationspræparat eller farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 11 til anvendelse i forebyggelse, behandling eller bedring af en infektion.
16. Kombinationspræparat til anvendelse ifølge krav 15, hvor infektionen er en kronisk eller vedvarende infektion.
17. Kombinationspræparat til anvendelse ifølge krav 15 eller 16, hvor infektionen er en virus-, bakterie-, svampe- eller protozoinfektion, fortrinsvis hvor virusinfektionen er forårsaget af et adenovirus, et adenoassocieret virus, et B-virus (macacine herpesvirus I), et BK-virus, et bunyavirus, et chikungunya-virus, et cocksackie-virus, et coronavirus, et cytomegalovirus, et østligt hesteencephalitis-virus, et ebolavirus, et enterovirus, et Epstein-Barr-virus, et hantavirus, et hepatitis A-virus, et hepatitis B-virus, et hepatitis C-virus, et hepatitis D-virus, et hepatitis E-virus, et herpesvirus, et herpes simplex virus 1, et herpes simplex virus 2, et humant spumavirus, et humant herpesvirus 3, et humant herpesvirus 5, et humant herpesvirus 6, et humant herpesvirus 7, et humant immundefektvirus, et humant papillomavirus, et humant β-lymfotrofisk virus, et humant T-celle-leukæmivirus I, et humant T-celle-leukæmivirus II, et influenzavirus, et JC-virus, et JEV, et Kaposis sarkom-associeret herpesvirus, et Lassa-virus, et lymfocytisk choriomeningitisvirus, et Marburg-virus, et mæslingevirus, et fåresygevirus, et Nipah-virus, et norovirus, et Norwalk-virus, et orthoreovirus, et parainfluenzavirus, et parvovirus, et poliovirus, et rabiesvirus, et reovirus, et respiratorisk syncytialvirus, rhinovirus, et Rift Valley-febervirus, et rotavirus, rubellavirus, et koppervirus, et St Louis encephalitisvirus, et variola major virus, et variola minor virus, et vericella-zoster-virus, et vestnilvirus, et vestligt hesteencephalitis-virus eller et gul febervirus, eller hvor bakterieinfektionen er forårsaget af Escherichia coli, Clostridium difficile, Salmonella thyphimurium, Pseudomonas aeruginosa, Vibrio cholerae, Neisseria gonorrhoeae, Helicobacter pylori, Hemophilus influenzae, Shigella dysenteriae, Staphylococcus aureus, Mycobacterium tuberculosis, Streptococcus pneumonia eller Chlamydia trachomatis, eller hvor svampeinfektionen er forårsaget af Candida, Aspergillus, Cryptococcus, Coccidioides, Histoplasma, Pneumocystis, eller Stachybotrys, eller hvor protozoinfektionen er forårsaget af Amoebozoa, Excavata, Chromalveolata, Entamoeba, Plasmodium, Giardia, Trypanosoma, Coccidia, Besnoitia, Dicrocoelium eller Leishmania.
DK16700138.7T 2015-01-09 2016-01-08 Kombinationspræparater til behandling af cancer eller infektion DK3242678T3 (da)

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GBGB1500374.2A GB201500374D0 (en) 2015-01-09 2015-01-09 Combined preparations for the treatment of cancer
PCT/EP2016/050321 WO2016110593A1 (en) 2015-01-09 2016-01-08 Combined preparations for the treatment of cancer or infection

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