HRP20120947T1 - FARMACEUTSKE SMJESE KOJE SADRŽE AKTIVIN-ActRIIA ANTAGONISTE I NJIHOVA UPORABA U PREVENCIJI ILI LIJEÄŚENJU MULTIPLOG MIJELOMA - Google Patents

FARMACEUTSKE SMJESE KOJE SADRŽE AKTIVIN-ActRIIA ANTAGONISTE I NJIHOVA UPORABA U PREVENCIJI ILI LIJEÄŚENJU MULTIPLOG MIJELOMA Download PDF

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HRP20120947T1
HRP20120947T1 HRP20120947AT HRP20120947T HRP20120947T1 HR P20120947 T1 HRP20120947 T1 HR P20120947T1 HR P20120947A T HRP20120947A T HR P20120947AT HR P20120947 T HRP20120947 T HR P20120947T HR P20120947 T1 HRP20120947 T1 HR P20120947T1
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actriia
fusion protein
pharmaceutical composition
amino acids
pharmaceutical
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HRP20120947AT
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John Knopf
Jasbir Seehra
Ravindra Kumar
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Acceleron Pharma, Inc.
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Publication of HRP20120947T1 publication Critical patent/HRP20120947T1/hr

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    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4702—Regulators; Modulating activity
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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    • 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
    • C07K16/3061—Blood cells
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A—HUMAN NECESSITIES
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    • 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
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    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
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    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
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    • H04W80/00—Wireless network protocols or protocol adaptations to wireless operation
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    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W84/00—Network topologies
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    • C—CHEMISTRY; METALLURGY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C07K2319/00—Fusion polypeptide
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    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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Claims (12)

1. Farmaceutska smjesa, naznačena time, što sadrži ActRIIa-Fc fuzijski protein eksprimiran u CHO stanicama, pri čemu je ActRIIa-Fc fuzijski protein dimer sačinjen od dva polipeptida, od kojih svaki ima aminokiselinsku sekvencu koja je najmanje 90% ili 95% identična sa aminokiselinskom sekvencom SEQ ID NO:7, povezana disulfidnom vezom, i gdje dimer ima između 3 i 5 ostataka sijalinske kiseline.
2. Farmaceutska smjesa iz zahtjeva 1, naznačena time, što ActRIIa-Fc fuzijski protein je dimer formiran od dva polipeptida SEQ ID NO:7, i gdje jedan ili oba polipeptida opcijski imaju jednu amino-kiselinu manje na amino- ili karboksi-terminusu nego što je pokazano u SEQ ID NO:7.
3. Farmaceutska smjesa iz zahtjeva 1 ili 2, naznačena time, što se ActRIIa-Fc fuzijski protein rekombinantno eksprimira u CHO stanicama, uz korištenje TPA liderske sekvence SEQ ID NO: 9.
4. Farmaceutska smjesa iz bilo kojeg od prethodnih zahtjeva, naznačena time, što dimer ima 4 ostatka sijalinske kiseline.
5. Farmaceutska smjesa iz bilo kojeg od prethodnih zahtjeva, naznačena time, što ActRIIa-Fc fuzijski protein ima poluživot u serumu, kod normalnih, zdravih ljudi, u prosjeku od 25 do 32 dana, i ekvivalentnu bioraspoloživost, kada se primjeni intravenski ili subkutano.
6. Farmaceutska smjesa iz bilo kojeg od prethodnih zahtjeva, naznačena time, što je farmaceutska smjesa pogodna za subkutanu primjenu.
7. Farmaceutska smjesa iz bilo kojeg od prethodnih zahtjeva, naznačena time, što je ActRIIa-Fc fuzijski protein najmanje 90% čist u pogledu prisustva drugih proteinskih komponenti.
8. Farmaceutska smjesa iz bilo kojeg od prethodnih zahtjeva, naznačena time, što ActRIIa-Fc fuzijski protein uključuje jednu ili više modificiranih aminokiselinskih rezidua odabranih između: glikozilirane amino-kiseline, PEGiligirane amino-kiseline, farnezilizirane amino-kiseline, acetilizirane amino-kiseline, biotinizirane amino- kiseline, amino-kiseline konjugirane sa lipidnom komponentom i amino-kiseline konjugirane sa organskim derivatizirajućim sredstvom.
9. Farmaceutska smjesa iz bilo kojeg od prethodnih zahtjeva, naznačena time, što dalje sadrži bisfosfonatno sredstvo.
10. Farmaceutska smjesa iz zahtjeva 9, naznačena time, što se bisfosfonatno sredstvo bira između alendronata, ibandronata i risedronata.
11. Farmaceutska smjesa, naznačena time, što sadrži ActRIIa-Fc fuzijski protein za uporabu u liječenju ili prevenciji multiplog mijeloma kod humanog pacijenta, pri čemu je farmaceutska smjesa onakva kako je definirano u bilo kojem od zahtjeva 1 do 10.
12. Uporaba ActRIIa-Fc fuzijskog proteina, naznačena time, što se koristi za izradu lijeka za liječenje ili prevenciju multiplog mijeloma kod humanog pacijenta, pri čemu je ActRIIa-Fc fuzijski protein onakav kako je definirano u bilo kojem od zahtjeva 1 do 10.
HRP20120947AT 2007-02-09 2012-11-20 FARMACEUTSKE SMJESE KOJE SADRŽE AKTIVIN-ActRIIA ANTAGONISTE I NJIHOVA UPORABA U PREVENCIJI ILI LIJEÄŚENJU MULTIPLOG MIJELOMA HRP20120947T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US90058007P 2007-02-09 2007-02-09
US93276207P 2007-05-31 2007-05-31
US93736507P 2007-06-26 2007-06-26
US52807P 2007-10-25 2007-10-25
PCT/US2008/001354 WO2008100384A2 (en) 2007-02-09 2008-02-01 Activin-actriia antagonists and uses for promoting bone growth in cancer patients

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HRP20120947T1 true HRP20120947T1 (hr) 2012-12-31

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US (4) US8173601B2 (hr)
EP (3) EP2484372A1 (hr)
JP (6) JP5574711B2 (hr)
KR (7) KR20160129095A (hr)
CN (3) CN101687016B (hr)
AR (1) AR065289A1 (hr)
AU (1) AU2008216896B2 (hr)
BR (1) BRPI0807506B1 (hr)
CA (3) CA2913992C (hr)
CY (1) CY1113963T1 (hr)
DK (1) DK2120999T3 (hr)
EA (3) EA201690994A1 (hr)
ES (2) ES2756725T3 (hr)
HK (1) HK1137366A1 (hr)
HR (1) HRP20120947T1 (hr)
IL (3) IL200242B (hr)
ME (1) ME02333B (hr)
MX (2) MX2009008510A (hr)
PL (1) PL2120999T3 (hr)
PT (1) PT2120999E (hr)
RS (1) RS52535B (hr)
SI (1) SI2120999T1 (hr)
TR (1) TR200906329T1 (hr)
TW (7) TW201934141A (hr)
WO (1) WO2008100384A2 (hr)

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