HRP20192174T1 - Kombinirani farmaceutski pripravak - Google Patents

Kombinirani farmaceutski pripravak Download PDF

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HRP20192174T1
HRP20192174T1 HRP20192174TT HRP20192174T HRP20192174T1 HR P20192174 T1 HRP20192174 T1 HR P20192174T1 HR P20192174T T HRP20192174T T HR P20192174TT HR P20192174 T HRP20192174 T HR P20192174T HR P20192174 T1 HRP20192174 T1 HR P20192174T1
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pharmaceutical preparation
antibody
seq
amino acid
acid sequence
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HRP20192174TT
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David Bechard
Nathalie CHAPUT
Mélanie DESBOIS
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Cytune Pharma
Institut Gustave Roussy
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Publication of HRP20192174T1 publication Critical patent/HRP20192174T1/hr

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    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/2086IL-13 to IL-16
    • 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
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/54Interleukins [IL]
    • C07K14/5443IL-15
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • 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
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7155Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for interleukins [IL]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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 against CD28 or CD152
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2827Immunoglobulins [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 against B7 molecules, e.g. CD80, CD86
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • C07K16/3015Breast
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • C07K16/3023Lung
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • C07K16/3038Kidney, bladder
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • C07K16/3053Skin, nerves, brain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • C07K16/3069Reproductive system, e.g. ovaria, uterus, testes, prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide

Claims (12)

1. Kombinirani farmaceutski pripravak koji sadrži: a) konjugat koji sadrži (i) polipeptid koji sadrži aminokiselinsku sekvencu interleukina 15 ili njegovih derivata koji imaju najmanje 10% aktivnosti ljudskog IL-15 na indukciju proliferacije stanice kit225, i (ii) polipeptid koji sadrži aminokiselinski slijed suši domene IL-15Rα ili njegovih derivata koji imaju najmanje 10% aktivnosti vezanja suši domene ljudskog IL-15Rα na humani IL-15, polinukleotid koji kodira, ili vektor koji sadrži takav polinukleotid; i b) antitijelo koje antagonizira imunološki put uključeno u inhibiciju aktivacije T stanice, ili njegov fragment koji može reagirati s istim antigenom kao njegovo odgovarajuće antitijelo, polinukleotid koji kodira, ili vektor koji sadrži takav polinukleotid, pri čemu je spomenuto antitijelo antagonist PD-1/PD-L1/PD-L2, pri čemu se spomenuto antitijelo antagonizira bilo vezanjem PD-1 receptora ili vezanjem PD-L1 ili PD-L2 liganda; pri čemu navedeni konjugat i njegovo antitijelo ili fragment nisu povezani.
2. Farmaceutski pripravak za uporabu u liječenju raka kod subjekta koji sadrži (A) konjugat koji sadrži (i) polipeptid koji sadrži aminokiselinsku sekvencu interleukina 15 ili njegovih derivata koji imaju najmanje 10% aktivnosti ljudskog IL-15 na indukciju proliferacije stanice kit225, i (ii) polipeptid koji sadrži aminokiselinski slijed suši domene IL-15Rα ili njegovih derivata koja ima najmanje 10% aktivnosti vezivanja suši domene ljudskog IL-15Rα na humani IL-15, polinukleotid koji kodira, ili vektor koji sadrži takav polinukleotid, pri čemu se uporaba sastoji istovremeno, odvojeno ili uzastopno davanje (a) navedenog lijeka pripravka i (b) antitijelo koje antagonizira imunološki put uključeno u inhibiciju aktiviranja T stanica, ili njegov fragment koji može reagirati s istim antigenom nego njegovo odgovarajuće antitijelo, polinukleotidno kodiranje prema tome, ili vektor koji sadrži takav polinukleotid, ili (B) antitijelo koje antagonizira imunološki put uključeno u inhibiciju aktivacije T stanice, ili njegov fragment koji je sposoban reagirati s istim antigenom kao njegov kolega s antitijelom, polinukleotid koji kodira, ili vektor koji sadrži takav polinukleotid, pri čemu se upotreba sastoji istovremeno, odvojeno ili uzastopno davanje (a) navedenog farmaceutskog pripravka i (b) konjugat koji sadrži (i) polipeptid koji sadrži aminokiselinski slijed interleukina 15 ili njihovi derivati koji imaju najmanje 10% aktivnosti ljudskog IL-15 na indukciju proliferacije kit225 stanična linija i (ii) polipeptid koji sadrži aminokiselinski slijed suši domene IL-15Rα ili njihovi derivati koji imaju najmanje 10% aktivnosti vezivanja suši domene ljudskog IL-15Rα na humani IL-15, polinukleotid koji kodira, ili vektor koji sadrži takav polinukleotid, i pri čemu je navedeno protutijelo antagonist PD-1/PD-L1/PD-L2, pri čemu se navedeno antitijelo antagonizira bilo vezanjem PD-1 receptora ili vezanjem PD-L1 ili PD-L2 liganda.
3. Farmaceutski pripravak za uporabu u liječenju raka prema zahtjevu 2 ili kombinirani farmaceutski pripravak prema zahtjevu 1, prilagođen za istovremeno, odvojeno ili sekvencijalno davanje za uporabu u liječenju raka kod subjekta.
4. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 3, naznačen time, da: a) konjugat se daje injekcijom u dozi od 60 µg/kg ili manje, poželjno u dozi od 10 µg/kg ili manje, a najpoželjnije u dozi od 5 µg/kg ili manje; i b) antitijelo koje antagonizira imunološki put je uključeno u inhibiciju aktivacije T stanica, ili se njegov fragment daje injekcijom u dozi od 500 µg/kg ili manje, poželjno u dozi od 100 µg/kg ili manje, a najpoželjnije u dozi od 50 µg/kg ili manje.
5. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 4, naznačen time, da je spomenuto antitijelo antagonist PD-1/PD-L1.
6. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 5, naznačen time, da navedeni derivat interleukina 15 ima najmanje 25% aktivnosti humanog interleukina-15 na indukciju proliferacije stanične linije kit225, poželjnije najmanje 50%, ili ima aminokiselinsku sekvencu koja ima postotak identiteta od najmanje 92,5% s aminokiselinskom sekvencom odabranom u grupi koja se sastoji od SEQ ID n°: 1, SEQ ID n°: 2 i SEQ ID nº: 3, po mogućnosti od najmanje 96% i poželjnije najmanje 98,5% ili najmanje 99%.
7. Farmaceutski pripravak ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 6, naznačen time, da navedeni derivat suši domene IL-15Rα ima najmanje 25%, poželjnije najmanje 50% vezivne aktivnosti suši domene ljudskog IL-15Rα, ili ima aminokiselinsku sekvencu koja ima postotak identičnosti od najmanje 92% sa aminokiselinskom sekvencom odabranom u grupi koja se sastoji od SEQ ID n°: 4, SEQ ID n°: 5, SEQ ID n°: 6, SEQ ID n°: 7, SEQ ID n°: 8 i SEQ ID n°: 9, poželjno najmanje 96%, a poželjnije najmanje 98%.
8. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 7, naznačen time, da je spomenuto antitijelo izabrano između antagonista PD-1 / PD-L1 i PD-1 / PD-L2, poželjno nivolumaba, Merck 3745, CT-01 1, lambrolizumaba, AMP514, MDX-1 105 ili YW243.55.S70.
9. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 8, naznačen time što su polipeptidi (i) i (ii) konjugata kovalentno povezani u fuzijskom proteinu.
10. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 9, naznačen time, da navedeni interleukin 15 ima aminokiselinsku sekvencu SEQ ID n°: 1.
11. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 10, naznačen time što suši domena IL-15Rα ima aminokiselinsku sekvencu SEQ ID n°: 4.
12. Farmaceutski pripravak za uporabu u liječenju raka ili kombinirani farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 11, naznačen time da konjugat ima sekvencu SEQ ID n°: 16 ili SEQ ID n°: 17.
HRP20192174TT 2013-08-08 2019-12-02 Kombinirani farmaceutski pripravak HRP20192174T1 (hr)

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EP13003964 2013-08-08
PCT/EP2014/002182 WO2015018529A1 (en) 2013-08-08 2014-08-08 Combined pharmaceutical composition
EP14761281.6A EP3030262B1 (en) 2013-08-08 2014-08-08 Combined pharmaceutical composition

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EP (2) EP3659622A1 (hr)
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KR (2) KR102457731B1 (hr)
CN (1) CN105579062A (hr)
CA (1) CA2920539C (hr)
CY (1) CY1122465T1 (hr)
DK (1) DK3030262T3 (hr)
ES (1) ES2760249T3 (hr)
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HU (1) HUE046964T2 (hr)
LT (1) LT3030262T (hr)
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