HRP20230146T1 - Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem - Google Patents

Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem Download PDF

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HRP20230146T1
HRP20230146T1 HRP20230146TT HRP20230146T HRP20230146T1 HR P20230146 T1 HRP20230146 T1 HR P20230146T1 HR P20230146T T HRP20230146T T HR P20230146TT HR P20230146 T HRP20230146 T HR P20230146T HR P20230146 T1 HRP20230146 T1 HR P20230146T1
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fragment
antibody
monoclonal antibody
adm
human
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HRP20230146TT
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Andreas Bergmann
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Adrenomed Ag
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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K38/22Hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
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    • A61K39/001144Hormones, e.g. calcitonin
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    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
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    • 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
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/02Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54F(ab')2
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)
    • 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
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/70Mechanisms involved in disease identification
    • G01N2800/7095Inflammation
    • 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
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere

Claims (17)

1. Monoklonsko protutijelo ili njegov fragment protutijela, naznačeno time što se protutijelo ili fragment veže na regiju adrenomedulina (ADM) koja se nalazi u N-terminalnom dijelu, aminokiseline 1-21 SEQ ID br. 23, pri čemu je monoklonsko protutijelo ili njegov fragment protutijela ljudsko ili humanizirano protutijelo i pri čemu teški lanac (H lanac) sadrži sekvence SEQ ID NO: 1 GYTFSRYW SEQ ID NO: 2 ILPGSGST SEQ ID NO: 3 TEGYEYDGFDY te gdje laki lanac sadrži sljedove SEQ ID NO: 4 QSIVYSNGNTY SEQ ID NO: 5 RVS SEQ ID NO: 6 FQGSHIPYT.
2. Monoklonsko protutijelo ili fragment prema zahtjevu 1, naznačeno time što je protutijelo ili fragment proizveden rekombinantno.
3. Monoklonsko protutijelo ili fragment prema zahtjevu 2, naznačeno time što je protutijelo IgG.
4. Monoklonsko protutijelo ili fragment prema zahtjevu 1, naznačeno time što je fragment Fv fragment, scFv fragment, Fab fragment, scFab fragment, F(ab)2 fragment ili scFv-Fc fuzijski protein.
5. Monoklonsko protutijelo ili fragment prema bilo kojem od prethodnih zahtjeva, naznačeno time što je protutijelo ili fragment ljudsko protutijelo.
6. Monoklonsko protutijelo ili fragment prema bilo kojem od zahtjeva 1-4, naznačeno time što je protutijelo ili fragment humanizirano protutijelo.
7. Monoklonsko protutijelo ili fragment prema zahtjevu 6, naznačeno time što je protutijelo ili fragment proizveden humanizacijom mišjeg protutijela, npr. presađivanjem mišjih CDR-ova u ljudsko protutijelo ili fragment.
8. Monoklonsko protutijelo ili fragment prema zahtjevu 7, naznačeno time što proces humanizacije uključuje: a. analizu sekvence protutijela mišjeg protutijela za strukturnu interakciju okvirnih regija (FR) s regijama koje određuju komplementarnost (CDR) i antigen; b. odabir odgovarajućeg FR ljudskog podrijetla na temelju strukturnog modeliranja; i c. transplantaciju mišjih CDR sekvenci u ljudski FR.
9. Monoklonsko protutijelo ili fragment prema bilo kojem od prethodnih zahtjeva, naznačeno time što je protutijelo ili fragment stabilizirajuće protutijelo ili fragment koji produljuje poluživot ADM-a u serumu, krvi, plazmi za najmanje 10%, poželjno najmanje 50%, poželjnije >50%, najpoželjnije >100%.
10. Monoklonsko protutijelo ili fragment prema bilo kojem od prethodnih zahtjeva, naznačeno time što je protutijelo ili fragment ne-neutralizirajuće protutijelo ili fragment.
11. Monoklonsko protutijelo ili fragment prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili fragment blokira bioaktivnost ADM-a na manje od 80%, poželjno manje od 50%, pri određivanju bioaktivnosti ADM-a u ljudskom rekombinantnom funkcionalnom testu cAMP receptora adrenomedulina prema primjeru 2.
12. Monoklonsko protutijelo ili fragment prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo ili fragment pokazuju afinitet prema ljudskom ADM tako da je konstanta afiniteta veća od 10-7 M pri čemu je navedeni afinitet vezanja određen prema Primjeru 1.
13. Monoklonsko protutijelo ili fragment prema bilo kojem od prethodnih zahtjeva, za uporabu u metodi liječenja koja uključuje smanjenje rizika od smrtnosti tijekom kronične ili akutne bolesti ili akutnog stanja.
14. Monoklonsko protutijelo ili fragment za uporabu prema zahtjevu 13, naznačeno time što se kronična ili akutna bolest ili akutno stanje bira između teške infekcije, npr. meningitisa; sindroma sistemskog upalnog odgovora (SIRS); sepse; dijabetesa; raka; akutne i kronične bolesti krvnih žila, npr. zatajenje srca, infarkt miokarda, moždani udar, ateroskleroza; šok, npr. septički šok; disfunkcija organa, npr. disfunkcija bubrega, disfunkcija jetre; opekline; kirurgija; trauma; trovanje; i oštećenja kemoterapijom.
15. Farmaceutska formulacija koja sadrži monoklonsko protutijelo ili fragment prema bilo kojem od zahtjeva 1-12.
16. Farmaceutska formulacija prema zahtjevu 15, naznačena time što je farmaceutska formulacija za primjenu putem infuzije.
17. Farmaceutska formulacija prema zahtjevu 15 ili 16, naznačena time što je farmaceutska formulacija u osušenom stanju da se rekonstituira prije uporabe.
HRP20230146TT 2011-11-16 2012-11-16 Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem HRP20230146T1 (hr)

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EP11189447 2011-11-16
EP12160014 2012-03-16
EP19162009.5A EP3553084B1 (en) 2011-11-16 2012-11-16 Anti-adrenomedullin (adm) antibody or anti-adm antibody fragment or anti-adm non-ig scaffold for prevention or reduction of organ dysfunction or organ failure in a patient having a chronic or acute disease or acute condition

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HRP20230146TT HRP20230146T1 (hr) 2011-11-16 2012-11-16 Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem
HRP20191010TT HRP20191010T1 (hr) 2011-11-16 2019-06-04 Protutijelo protiv adrenomedulina (adm) ili fragment protutijela protiv adm ili ne-ig okosnica protutijela protiv adm, namijenjeno sprječavanju ili smanjivanju disfunkcije organa ili insuficijencije organa kod pacijenta s kroničnom ili akutnom bolešću ili akutnim stanjem

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US (4) US20140328853A1 (hr)
EP (3) EP3553084B1 (hr)
JP (2) JP6193871B2 (hr)
AU (1) AU2012338731B2 (hr)
DK (2) DK2780369T3 (hr)
ES (2) ES2938653T3 (hr)
FI (1) FI3553084T3 (hr)
HR (2) HRP20230146T1 (hr)
HU (2) HUE044383T2 (hr)
LT (2) LT3553084T (hr)
NZ (1) NZ624873A (hr)
PL (2) PL2780369T3 (hr)
PT (2) PT3553084T (hr)
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SI (1) SI3553084T1 (hr)
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WO2018109228A1 (en) * 2016-12-16 2018-06-21 Adrenomed Ag Anti-adrenomedullin (adm) antibody or anti-adm antibody fragment or anti-adm non-ig scaffold for use in intervention and therapy of congestion in a patient in need thereof
CN111480076A (zh) 2017-10-18 2020-07-31 艾德里诺医药公司 抗肾上腺髓质素(adm)结合剂治疗下的疗法监测
EP3871689A1 (en) 2020-02-26 2021-09-01 sphingotec GmbH Anti-adm-antibodies binding to the free n-terminus for accelerated transition of adm-gly to bio-adm in patients with adm-gly/ bio-adm ratio above a threshold and combination with vitamin c
CA3172349A1 (en) 2020-02-27 2021-09-02 4TEEN4 Pharmaceuticals GmbH Dpp3 for therapy guidance, monitoring and stratification of nt-adm antibodies in patients with shock
EP4110811A1 (en) 2020-02-27 2023-01-04 AdrenoMed AG Anti-adrenomedullin (adm) antibody or anti-adm antibody fragment or anti-adm non-ig scaffold for use in therapy or prevention of shock
CN115244081A (zh) 2020-02-27 2022-10-25 艾德里诺医药公司 用于治疗休克患者的抗肾上腺髓质素(adm)结合剂
BR112022017890A2 (pt) 2020-03-16 2022-11-01 Sphingotec Gmbh Proadrenomedulina ou fragmento da mesma em pacientes infectados com coronavírus e tratamentos com ligante contra adrenomedulina
CN111627559B (zh) * 2020-06-17 2023-08-29 北京大学第三医院(北京大学第三临床医学院) 预测患者死亡风险的系统
WO2023175035A1 (en) 2022-03-15 2023-09-21 Adrenomed Ag Stable aqueous formulation of an anti-adrenomedullin (adm) antibody or anti-adm antibody fragment
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