HRP20211926T1 - Konstrukti proteina uspa2 i njihova upotreba - Google Patents

Konstrukti proteina uspa2 i njihova upotreba Download PDF

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Publication number
HRP20211926T1
HRP20211926T1 HRP20211926TT HRP20211926T HRP20211926T1 HR P20211926 T1 HRP20211926 T1 HR P20211926T1 HR P20211926T T HRP20211926T T HR P20211926TT HR P20211926 T HRP20211926 T HR P20211926T HR P20211926 T1 HRP20211926 T1 HR P20211926T1
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protein
seq
pila
vaccine
immunogenic preparation
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HRP20211926TT
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Normand Blais
Cindy Castado
Patrick Chomez
Marianne Dewerchin
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Glaxosmithkline Biologicals Sa
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Publication of HRP20211926T1 publication Critical patent/HRP20211926T1/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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/095Neisseria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/102Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/104Pseudomonadales, e.g. Pseudomonas
    • A61K39/1045Moraxella
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/21Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Pseudomonadaceae (F)
    • C07K14/212Moraxellaceae, e.g. Acinetobacter, Moraxella, Oligella, Psychrobacter
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/22Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Neisseriaceae (F)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria
    • C07K16/1217Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria from Neisseriaceae (F)
    • 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
    • A61K2039/55505Inorganic adjuvants
    • 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
    • A61K2039/55566Emulsions, e.g. Freund's adjuvant, MF59
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pulmonology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (15)

1. Protein formule I: A—(R1)m—(B)n (formula I) naznačen time što: A je imunogeni fragment UspA2 iz bakterije Moraxella catarrhalis koji je najmanje 90% istovjetan SEQ ID NO: 43; R1 je aminokiselina; m je 0; B je histidin; i n je 1, 2, 3, 4, 5 ili 6.
2. Protein u skladu s patentnim zahtjevom 1, naznačen time što n je 2.
3. Protein u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačen time što dodatno sadrži metionin na amino kraju.
4. Protein u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što je A SEQ ID NO: 43.
5. Protein u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što je A imunogeni fragment UspA2 koji sadrži domenu koja se veže na laminin, domenu koja se veže na fibronektin i domenu koja se veže na C3.
6. Imunogeni pripravak, naznačen time što sadrži protein formule (I) u skladu s bilo kojim od patentnim zahtjevima 1-5.
7. Imunogeni pripravak u skladu s patentnim zahtjevom 6, naznačen time što dodatno sadrži najmanje jedan antigen iz bakterije Haemophilus influenzae, gdje je najmanje jedan antigen protein D.
8. Imunogeni pripravak u skladu s patentnim zahtjevom 7, naznačen time što dodatno sadrži protein E i PilA, gdje su PE i PilA prisutni u obliku fuzijskog proteina.
9. Cjepivo, naznačeno time što sadrži protein u skladu s bilo kojim od patentnih zahtjeva 1-5 ili imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 6-8.
10. Cjepivo u skladu s patentnim zahtjevom 9, naznačen time što imunogeni pripravak sadrži protein sa SEQ ID NO: 69, protein D i fuzijski protein PE-PilA, gdje fuzijski protein PE-PilA može biti LVL-735, te gdje navedeni pripravak sadrži pomoćno sredstvo kojeg se bira između arginina, pluronske kiseline i/ili polisorbata.
11. Cjepivo u skladu s bilo kojim od patentnih zahtjeva 9-10, naznačeno time što sadrži (i) 10 µg proteina D, 10 µg fuzijskog proteina PE-PilA (LVL735), 10 µg konstrukta UspA2 sa SEQ ID NO: 69 (MC-009) i adjuvans AS01E, ili (ii) 10 µg proteina D, 10 µg fuzijskog proteina PE-PiIA LVL735, 3,3 µg konstrukta UspA2 sa SEQ ID NO: 69 (MC-009) i adjuvans AS01E.
12. Cjepivo u skladu s patentnim zahtjevom 11, naznačen time što adjuvans AS01E sadrži 3-O-deacil-4’ monofosforilirani lipid A (MPL), frakciju 21 iz biljke Quillaja saponaria Molina (QS21) i liposome (25 µg MPL i 25 µg QS21).
13. Cjepivo u skladu s patentnim zahtjevima 9-12, naznačen time što je prilagođeno za intramuskularnu primjenu.
14. Protein u skladu s patentnim zahtjevima 1-5, ili imunogeni pripravak u skladu s patentnim zahtjevima 6-8, ili cjepivo u skladu s patentnim zahtjevima 9-13, naznačeni time što su namijenjeni upotrebi u liječenju ili sprječavanju akutnih pogoršanja kronične opstruktivne plućne bolesti (AECOPD).
15. Protein u skladu s patentnim zahtjevima 1-5, ili imunogeni pripravak u skladu s patentnim zahtjevima 6-8, ili cjepivo u skladu s patentnim zahtjevima 9-13, naznačeni time što su namijenjeni upotrebi u liječenju ili sprječavanju infekcije ili bolesti koju uzrokuje bakterija M. catarrhalis.
HRP20211926TT 2014-02-24 2015-02-20 Konstrukti proteina uspa2 i njihova upotreba HRP20211926T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201461943909P 2014-02-24 2014-02-24
US201461946937P 2014-03-03 2014-03-03
US201461946932P 2014-03-03 2014-03-03
EP18211544.4A EP3498292B1 (en) 2014-02-24 2015-02-20 Uspa2 protein constructs and uses thereof

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HRP20211926T1 true HRP20211926T1 (hr) 2022-03-18

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HRP20211926TT HRP20211926T1 (hr) 2014-02-24 2015-02-20 Konstrukti proteina uspa2 i njihova upotreba
HRP20190412TT HRP20190412T1 (hr) 2014-02-24 2019-03-04 Konstrukti proteina uspa2 i njihova upotreba

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JP (1) JP6585085B2 (hr)
KR (1) KR102515835B1 (hr)
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AU (1) AU2015220369B2 (hr)
BE (1) BE1022345A9 (hr)
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US20200325184A1 (en) 2020-10-15
US10947280B2 (en) 2021-03-16
LT3498292T (lt) 2021-11-25
UY36006A (es) 2015-09-30
HUE042054T2 (hu) 2019-06-28
EP3498292A1 (en) 2019-06-19
BR112016019525B1 (pt) 2024-01-02
US20180354996A1 (en) 2018-12-13
WO2015125118A1 (en) 2015-08-27
SI3498292T1 (sl) 2022-01-31
US20170008932A1 (en) 2017-01-12
EP3498292B1 (en) 2021-10-20
BE1022345A9 (fr) 2016-11-16
KR20160124774A (ko) 2016-10-28
CA2939862A1 (en) 2015-08-27
RS58451B1 (sr) 2019-04-30
ES2715674T3 (es) 2019-06-05
RS62592B1 (sr) 2021-12-31
CA2939862C (en) 2022-12-06
CN111499701A (zh) 2020-08-07
EP3110438A1 (en) 2017-01-04
CY1124979T1 (el) 2022-11-25
CN106061995A (zh) 2016-10-26
SG11201606272PA (en) 2016-09-29
IL246994A0 (en) 2016-09-29
HUE057505T2 (hu) 2022-05-28
JP2017507181A (ja) 2017-03-16
BR112016019525A2 (pt) 2017-10-24
ES2899300T3 (es) 2022-03-10
TW201620927A (zh) 2016-06-16
US10040832B2 (en) 2018-08-07
PL3110438T3 (pl) 2019-06-28
CY1121535T1 (el) 2020-05-29
DK3498292T3 (da) 2022-01-03
DK3110438T3 (en) 2019-03-25
KR102515835B1 (ko) 2023-03-31
IL246994B (en) 2020-11-30
AU2015220369A1 (en) 2016-09-15
JP6585085B2 (ja) 2019-10-02
AU2015220369B2 (en) 2018-02-01
PL3498292T3 (pl) 2022-02-14
US10745449B2 (en) 2020-08-18
LT3110438T (lt) 2019-04-10
ME03335B (me) 2019-10-20
EP3110438B1 (en) 2019-01-02
HRP20190412T1 (hr) 2019-04-19
MX2016010954A (es) 2016-11-11
PT3110438T (pt) 2019-03-29
EA034352B1 (ru) 2020-01-30

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