ME02333B - FARMACEUTSKE SMEŠE KOJE SADRŽE AKTIVIN-ActRIIA ANTAGONISTE I NJIHOVA UPOTREBA U PREVENCIJI ILI LEČENJU MULTIPLOG MIJELOMA - Google Patents

FARMACEUTSKE SMEŠE KOJE SADRŽE AKTIVIN-ActRIIA ANTAGONISTE I NJIHOVA UPOTREBA U PREVENCIJI ILI LEČENJU MULTIPLOG MIJELOMA

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Publication number
ME02333B
ME02333B MEP-2016-80A MEP8016A ME02333B ME 02333 B ME02333 B ME 02333B ME P8016 A MEP8016 A ME P8016A ME 02333 B ME02333 B ME 02333B
Authority
ME
Montenegro
Prior art keywords
fusion protein
actriia
amino acids
pharmaceutical composition
pharmaceutical
Prior art date
Application number
MEP-2016-80A
Other languages
English (en)
Inventor
John Knopf
Jasbir Seehra
Ravindra Kumar
Original Assignee
Acceleron Pharma Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Acceleron Pharma Inc filed Critical Acceleron Pharma Inc
Publication of ME02333B publication Critical patent/ME02333B/me

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • 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
    • 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
    • C07K16/3061—Blood cells
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W8/00—Network data management
    • H04W8/02—Processing of mobility data, e.g. registration information at HLR [Home Location Register] or VLR [Visitor Location Register]; Transfer of mobility data, e.g. between HLR, VLR or external networks
    • H04W8/08—Mobility data transfer
    • H04W8/082—Mobility data transfer for traffic bypassing of mobility servers, e.g. location registers, home PLMNs or home agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1796—Receptors; Cell surface antigens; Cell surface determinants for hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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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
    • C07K14/705—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
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W40/00—Communication routing or communication path finding
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W80/00—Wireless network protocols or protocol adaptations to wireless operation
    • H04W80/04—Network layer protocols, e.g. mobile IP [Internet Protocol]
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04W—WIRELESS COMMUNICATION NETWORKS
    • H04W84/00—Network topologies
    • H04W84/18—Self-organising networks, e.g. ad-hoc networks or sensor networks
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02—Fusion polypeptide containing a localisation/targetting motif containing a signal sequence
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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  • Cell Biology (AREA)
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  • Gastroenterology & Hepatology (AREA)
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Claims (12)

1. Farmaceutska smeša, naznačena time, što sadrži ActRIIa-Fc fuzioni protein eksprimiran u CHO ćelijama, pri čemu je ActRIIa-Fc fuzioni protein dimer sačinjen od dva polipeptida, od kojih svaki ima aminokiselinsku sekvencu koja je najmanje90% ili 95% identična sa aminokiselinskom sekvencom SEQ ID N0:7, povezan a disulfidnom vezom, i gde dimer poseduje između 3 i 5 ostataka sijalinske kiseline.
2. Farmaceutska smeša iz zahteva l , naznačena time, što ActRIIa-Fc fuzioni protein jeste dimer formiran od dva polipeptida SEQ ID N0:7, i gde jedan ili oba polipeptida opciono imaju jednu amino-kiselinu manje na amino- ili karboksi-terminusu nego što je pokazano u SEQ ID N0:7.
3. Farmaceutska smeša iz zahteva l ili 2, naznačena time, što se ActRIIa-Fc fuzioni protein rekombinantno eksprimira u CJ-10 ćelijama, uz korišćenje TPA liderske sekvence SEQ ID NO: 9.
4. Farmaceutska smeša iz bilo kojeg od prethodnih zahteva, naznačena time, što dimer ima 4 ostatka sijalinske kiseline.
5. Farmaceutska smeša iz bilo kojeg od prethodnih zahteva, naznačena time, što ActRIIa-Fc fuzioni protein im a poluživot u serumu, kod normalnih, zdravih ljudi , u proseku od 25 do 32 dana, i ekvivalentnu bioraspoloživost, kada se primeni intravenski ili subkutano.
6. Farmaceutska smeša iz bilo kojeg od prethodnih zahteva, naznačena time, što je farmaceutska smeša pogodna za subkutanu primenu
7. Farmace utska smeša i z bilo kojeg od prethodnih zahteva, naznačena time, što je ActR II a-Fc fuzioni protein najmanje 90% čist u pogledu prisustva drugih proteinskih komponenti.
8. Fa rm aceutska smeša IZ bilo kojeg od prethodnih za hteva, naznačena time, što ActRIIa-Fc fuzioni protein uključuje jednu ili više modifikovanih aminokiselinskih rezidua odabranih između: glikozilovane amino- kiseline, PEGilisane amino-kiseline, farnezi l ovane am i no-k ise l ine, acet i l isa ne am ino-k isel ine, bioti n izovane am i no kiseline, ami n o-ki se line konjugovane sa lipidnom komponentom i amino-kiseline konjugovane sa organskim derivatizujućim sredstvom .
9. Farmaceutska smeša iz bilo kojeg od prethodnih zahteva, naznačena time, što dalje sadrži bisfosfonatno sredstvo.
10. Farmaceutska smeša iz zahteva 9, naznačena time, što se bisfosfonatno sredstvo bira između alendro nata, ibandronata i risedronata.
11. Farmaceutska smeša, naznačena time, što sadrži ActR II a-Fc fuzioni protein za upotrebu u l ečenju ili prevenciji multiplog mijeloma kod humanog pacijenta, pri čemu je farmaceutska smeša onakva kako je definisano u bilo kojem od zahteva l do l O.
12. Upotreba ActR II a-Fc fuzionog proteina, naznačena time, što se koristi za izradu leka za lečenje ili prevenciju multiplog mijeloma kod humanog pacijenta, pri čemu je ActRIIa-Fc fuzioni protein onakav kako je definisano u bilo kojem od zahteva l do l O.
MEP-2016-80A 2007-02-09 2008-02-01 FARMACEUTSKE SMEŠE KOJE SADRŽE AKTIVIN-ActRIIA ANTAGONISTE I NJIHOVA UPOTREBA U PREVENCIJI ILI LEČENJU MULTIPLOG MIJELOMA ME02333B (me)

Applications Claiming Priority (6)

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
EP08725055A EP2120999B1 (en) 2007-02-09 2008-02-01 Pharmaceutical compositions comprising Activin-ActRIIA antagonists and use thereof in preventing or treating multiple myeloma
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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ME02333B true ME02333B (me) 2013-04-30

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US (4) US8173601B2 (me)
EP (3) EP2120999B1 (me)
JP (6) JP5574711B2 (me)
KR (7) KR101672156B1 (me)
CN (3) CN104548056B (me)
AR (1) AR065289A1 (me)
AU (1) AU2008216896B2 (me)
BR (1) BRPI0807506B1 (me)
CA (3) CA2677605C (me)
CY (1) CY1113963T1 (me)
DK (1) DK2120999T3 (me)
EA (3) EA201690994A1 (me)
ES (2) ES2394123T3 (me)
HR (1) HRP20120947T1 (me)
IL (3) IL200242B (me)
ME (1) ME02333B (me)
MX (2) MX368173B (me)
PL (1) PL2120999T3 (me)
PT (1) PT2120999E (me)
RS (1) RS52535B (me)
SI (1) SI2120999T1 (me)
TR (1) TR200906329T1 (me)
TW (7) TWI667038B (me)
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US8895016B2 (en) 2006-12-18 2014-11-25 Acceleron Pharma, Inc. Antagonists of activin-actriia and uses for increasing red blood cell levels
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TWI748373B (zh) 2008-08-14 2021-12-01 美商艾瑟勒朗法瑪公司 使用gdf阱以增加紅血球水平
US8138142B2 (en) * 2009-01-13 2012-03-20 Acceleron Pharma Inc. Methods for increasing adiponectin in a patient in need thereof
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