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HRP20160362T1 - Antigeni pripravak protiv bakterija iz roda mycobacterium - Google Patents

Antigeni pripravak protiv bakterija iz roda mycobacterium Download PDF

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Publication number
HRP20160362T1
HRP20160362T1 HRP20160362TT HRP20160362T HRP20160362T1 HR P20160362 T1 HRP20160362 T1 HR P20160362T1 HR P20160362T T HRP20160362T T HR P20160362TT HR P20160362 T HRP20160362 T HR P20160362T HR P20160362 T1 HRP20160362 T1 HR P20160362T1
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Croatia
Prior art keywords
preparation according
immunogenic preparation
immunogenic
intended
seq
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HRP20160362TT
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English (en)
Inventor
Stephane Andre Georges Godart
Amina Laanan
Dominique Ingrid Lemoine
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Glaxosmithkline Biologicals S.A.
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Application filed by Glaxosmithkline Biologicals S.A. filed Critical Glaxosmithkline Biologicals S.A.
Publication of HRP20160362T1 publication Critical patent/HRP20160362T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/04Mycobacterium, e.g. Mycobacterium tuberculosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • A61P31/06Antibacterial agents for tuberculosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • 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
    • 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
    • G01N33/56911Bacteria
    • G01N33/5695Mycobacteria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55555Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55572Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55577Saponins; Quil A; QS21; ISCOMS

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Communicable Diseases (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Pulmonology (AREA)
  • Mycology (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Urology & Nephrology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Claims (23)

1. Imunogeni pripravak koji sadrži antigen povezan s M72, naznačen time što antigen povezan s M72 sadrži slijed koji je najmanje 90% istovjetan SEQ ID No: 1, pH navedenog pripravka je u rasponu od 7,0 do 9,0, a vodljivost pripravka je 5 mS/cm ili manja.
2. Imunogeni pripravak u skladu s patentnim zahtjevom 1, naznačen time što je vodljivost pripravka 4 mS/cm ili manja.
3. Imunogeni pripravak u skladu s patentnim zahtjevom 2, naznačen time što je vodljivost pripravka 3 mS/cm ili manja.
4. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je koncentracija soli u navedenom pripravku 40 mM ili manja.
5. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što dodatno sadrži neionsko sredstvo za toničnost.
6. Imunogeni pripravak u skladu s patentnim zahtjevom 5, naznačen time što je neionsko sredstvo za toničnost poliol.
7. Imunogeni pripravak u skladu s patentnim zahtjevom 6, naznačen time što je poliol sorbitol i što je koncentracija sorbitola između otprilike 4 i otprilike 6% (tež./vol.).
8. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je koncentracija saharoze između otprilike 4 i otprilike 6% (tež./vol.).
9. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što dodatno sadrži jedan ili više imunostimulansa.
10. Imunogeni pripravak u skladu s patentnim zahtjevom 9, naznačen time što imunogeni pripravak sadrži QS21.
11. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 9 ili 10, naznačen time što imunogeni pripravak sadrži 3-de-O-acilirani monofosforilirani lipid A.
12. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što je osmolalnost od 250 do 750 mOsm/kg.
13. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačen time što se pripravak daje u obliku jedinične doze koja se kreće između 50 µl i 1 ml.
14. Imunogeni pripravak u skladu s patentnim zahtjevom 13, naznačen time što jedinična doza sadrži 5 do 50 µg proteina povezanog s M72.
15. Imunogeni pripravak u skladu s patentnim zahtjevom 13 ili 14, naznačen time što je jedinična doza doza namijenjena čovjeku i sadrži između 1 i 100 µg 3D-MPL.
16. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 13 to 15, naznačen time što je jedinična doza doza namijenjena čovjeku i sadrži između 1 i 100 µg QS21.
17. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 16, naznačen time što je pH navedenog pripravka u rasponu od 7,5 do 8,5.
18. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 17, naznačen time što antigen povezan s M72 ima aminokiselinski slijed sa SEQ ID No: 3.
19. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 17, naznačen time što antigen povezan s M72 ima slijed koji je najmanje 90% istovjetan SEQ ID No: 1.
20. Imunogeni pripravak u skladu s patentnim zahtjevom 19, naznačen time što antigen povezan s M72 ima aminokiselinski slijed sa SEQ ID No: 3.
21. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 20, naznačen time što je namijenjen upotrebi u medicini.
22. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 21, naznačen time što je namijenjen upotrebi u postupku profilakse, liječenja ili ublažavanja infekcije mikobakterijama.
23. Imunogeni pripravak, namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 21 ili 22, naznačen time što je namijenjen primjeni na čovjeku.
HRP20160362TT 2010-12-14 2011-12-14 Antigeni pripravak protiv bakterija iz roda mycobacterium HRP20160362T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US42272310P 2010-12-14 2010-12-14
EP11799673.6A EP2651437B1 (en) 2010-12-14 2011-12-14 Mycobacterium antigenic composition
PCT/EP2011/072816 WO2012080369A1 (en) 2010-12-14 2011-12-14 Mycobacterium antigenic composition

Publications (1)

Publication Number Publication Date
HRP20160362T1 true HRP20160362T1 (hr) 2016-05-06

Family

ID=45346501

Family Applications (3)

Application Number Title Priority Date Filing Date
HRP20160362TT HRP20160362T1 (hr) 2010-12-14 2011-12-14 Antigeni pripravak protiv bakterija iz roda mycobacterium
HRP20160606TT HRP20160606T1 (hr) 2010-12-14 2011-12-14 Pripravak mikrobakterijskih antigena
HRP20191843TT HRP20191843T1 (hr) 2010-12-14 2019-10-11 Mikobakterijski antigenski pripravak

Family Applications After (2)

Application Number Title Priority Date Filing Date
HRP20160606TT HRP20160606T1 (hr) 2010-12-14 2011-12-14 Pripravak mikrobakterijskih antigena
HRP20191843TT HRP20191843T1 (hr) 2010-12-14 2019-10-11 Mikobakterijski antigenski pripravak

Country Status (33)

Country Link
US (5) US9730992B2 (hr)
EP (4) EP2651436B1 (hr)
JP (2) JP5951633B2 (hr)
KR (3) KR20190022897A (hr)
CN (4) CN106822882A (hr)
AR (1) AR084285A1 (hr)
AU (2) AU2011343368C1 (hr)
BR (2) BR112013014598A2 (hr)
CA (2) CA2819298A1 (hr)
CO (2) CO6751288A2 (hr)
CY (1) CY1122187T1 (hr)
DK (3) DK2651436T3 (hr)
EA (2) EA027504B1 (hr)
ES (3) ES2748651T3 (hr)
HR (3) HRP20160362T1 (hr)
HU (3) HUE027932T2 (hr)
IL (2) IL226450A0 (hr)
LT (1) LT3023106T (hr)
ME (1) ME02380B (hr)
MX (2) MX344706B (hr)
MY (1) MY161412A (hr)
PH (2) PH12013501204A1 (hr)
PL (3) PL2651436T3 (hr)
PT (2) PT2651436E (hr)
RS (1) RS54687B1 (hr)
SG (2) SG190937A1 (hr)
SI (3) SI3023106T1 (hr)
SM (1) SMT201600118B (hr)
TW (1) TW201305192A (hr)
UA (2) UA110806C2 (hr)
UY (1) UY33802A (hr)
WO (2) WO2012080369A1 (hr)
ZA (2) ZA201304015B (hr)

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