HRP20221538T1 - Anti-transtiretinska antitijela - Google Patents

Anti-transtiretinska antitijela Download PDF

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Publication number
HRP20221538T1
HRP20221538T1 HRP20221538TT HRP20221538T HRP20221538T1 HR P20221538 T1 HRP20221538 T1 HR P20221538T1 HR P20221538T T HRP20221538T T HR P20221538TT HR P20221538 T HRP20221538 T HR P20221538T HR P20221538 T1 HRP20221538 T1 HR P20221538T1
Authority
HR
Croatia
Prior art keywords
heavy chain
antibody
seq
mature
variable region
Prior art date
Application number
HRP20221538TT
Other languages
English (en)
Inventor
Yue Liu
Tarlochan S. Nijjar
Avijit Chakrabartty
Jeffrey N. Higaki
Original Assignee
Prothena Biosciences Limited
University Health Network
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 Prothena Biosciences Limited, University Health Network filed Critical Prothena Biosciences Limited
Publication of HRP20221538T1 publication Critical patent/HRP20221538T1/hr

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • 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
    • C07K2317/24Immunoglobulins 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • CCHEMISTRY; METALLURGY
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • 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
    • C07K2317/567Framework region [FR]
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • 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

Claims (15)

1. Humanizirano antitijelo koje se veže na transtiretin i sadrži varijabilnu regiju zrelog teškog lanca SEQ ID NO: 11 i varijabilnu regiju zrelog lakog lanca SEQ ID NO: 19, ili varijabilnu regiju zrelog teškog lanca SEQ ID NO: 65 i varijabilnu regiju zrelog lakog lanca SEQ ID NO: 76.
2. Antitijelo prema zahtjevu 1 koje ima ljudski IgG1 izotip.
3. Antitijelo prema zahtjevu 1 koje ima ljudski IgG2 ili IgG4 izotip.
4. Antitijelo prema zahtjevu 1 koje je vezni fragment, izborno gdje je vezni fragment jedno-lančano antitijelo, Fab, ili F(ab’)2 fragment.
5. Antitijelo prema bilo kojem od zahtjeva 1-3, naznačeno time što je varijabilna regija zrelog lakog lanca spojena s konstantnom regijom lakog lanca i varijabilna regija zrelog teškog lanca spojena je s konstantnom regijom teškog lanca.
6. Antitijelo prema zahtjevu 5, naznačeno time što je konstantna regija teškog lanca mutantni oblik prirodne konstantne regije ljudskog teškog lanca koja ima smanjeno vezanje na Fcγ receptor u odnosu na prirodnu konstantnu regiju ljudskog teškog lanca.
7. Antitijelo prema zahtjevu 5, naznačeno time što je konstantna regija teškog lanca IgG1 izotipa, izborno gdje je varijabilna regija zrelog teškog lanca spojena na konstantnu regiju teškog lanca koja ima sekvencu SEQ ID NO: 103 sa ili bez C-terminalnog lizina i/ili je zrela varijabilna regija lakog lanca spojena na konstantnu regiju lakog lanca koja ima sekvencu SEQ ID NO: 104 ili 105.
8. Antitijelo prema zahtjevu 1, koje sadrži zreli teški lanac koji ima sekvencu SEQ ID NO: 82 sa ili bez C-terminalnog lizina i zreli laki lanac koji ima sekvencu SEQ ID NO: 86.
9. Farmaceutski pripravak koji sadrži antitijelo prema bilo kojem prethodnom zahtjevu i farmaceutski prihvatljiv nosač.
10. Nukleinska kiselina ili nukleinske kiseline koje kodiraju teški lanac i laki lanac antitijela kako je opisano u bilo kojem od zahtjeva 1-8, izborno imaju sekvencu koja sadrži bilo koju od SEQ ID NOS: 50, 52, 92 i 96.
11. Rekombinantni ekspresijski vektor koji sadrži nukleinsku kiselinu prema zahtjevu 10 ili rekombinantne ekspresijske vektore koji sadrže nukleinske kiseline prema zahtjevu 10.
12. Stanica domaćina transformirana s rekombinantnim ekspresijskim vektorom(ima) prema zahtjevu 11.
13. Postupak proizvodnje antitijela prema zahtjevu 1, naznačen time što postupak sadrži: (a) uzgoj stanica transformiranih nukleinskim kiselinama koje kodiraju teške i lake lance antitijela, tako da stanice luče antitijelo; i (b) pročišćavanje antitijela iz medija stanične kulture.
14. Antitijelo prema bilo kojem od zahtjeva 1-8 za uporabu u liječenju ili učinku na profilaksu transtiretinom posredovane amiloidoze, ili odgađanje početka transtiretinom posredovane amiloidoze kod subjekta.
15. In vitro postupak dijagnosticiranja transtiretinom posredovane amiloidoze kod subjekta, koji sadrži kontaktiranje biološkog uzorka od subjekta s učinkovitom količinom antitijela prema bilo kojem od zahtjeva 1-8, izborno gdje je biološki uzorak i/ili kontrolni uzorak krv, serum, plazma, ili čvrsto tkivo; izborno pri čemu je čvrsto tkivo iz srca, perifernog živčanog sustava, autonomnog živčanog sustava, bubrega, očiju, ili gastrointestinalnog trakta.
HRP20221538TT 2015-01-28 2016-01-28 Anti-transtiretinska antitijela HRP20221538T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562109002P 2015-01-28 2015-01-28
US201562266556P 2015-12-11 2015-12-11
PCT/IB2016/050415 WO2016120810A1 (en) 2015-01-28 2016-01-28 Anti-transthyretin antibodies
EP16702812.5A EP3250592B1 (en) 2015-01-28 2016-01-28 Anti-transthyretin antibodies

Publications (1)

Publication Number Publication Date
HRP20221538T1 true HRP20221538T1 (hr) 2023-03-03

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HRP20221538TT HRP20221538T1 (hr) 2015-01-28 2016-01-28 Anti-transtiretinska antitijela

Country Status (32)

Country Link
US (1) US20160251418A1 (hr)
EP (2) EP4134379A1 (hr)
JP (2) JP6748086B2 (hr)
KR (2) KR20230156164A (hr)
CN (1) CN107406499B (hr)
AU (1) AU2016210888C1 (hr)
BR (1) BR112017016330A2 (hr)
CA (1) CA2974912A1 (hr)
CL (2) CL2017001924A1 (hr)
CO (1) CO2017008476A2 (hr)
CU (1) CU24480B1 (hr)
DK (1) DK3250592T3 (hr)
EA (1) EA036080B1 (hr)
ES (1) ES2934656T3 (hr)
FI (1) FI3250592T3 (hr)
HR (1) HRP20221538T1 (hr)
HU (1) HUE060878T2 (hr)
IL (1) IL253633B (hr)
LT (1) LT3250592T (hr)
MX (1) MX2017009806A (hr)
PE (1) PE20180217A1 (hr)
PH (1) PH12017501318B1 (hr)
PL (1) PL3250592T3 (hr)
PT (1) PT3250592T (hr)
RS (1) RS63906B1 (hr)
SA (1) SA517382002B1 (hr)
SG (2) SG10202101763VA (hr)
SI (1) SI3250592T1 (hr)
TW (2) TWI718122B (hr)
UA (1) UA122142C2 (hr)
WO (1) WO2016120810A1 (hr)
ZA (1) ZA201705663B (hr)

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ZA201705663B (en) 2018-08-29
SG11201706124VA (en) 2017-08-30
CA2974912A1 (en) 2016-08-04
CN107406499A (zh) 2017-11-28
CL2017001924A1 (es) 2018-04-27
JP7028923B2 (ja) 2022-03-02
JP2020185009A (ja) 2020-11-19
AU2016210888B2 (en) 2021-11-04
PL3250592T3 (pl) 2023-06-19
EP4134379A1 (en) 2023-02-15
UA122142C2 (uk) 2020-09-25
SI3250592T1 (sl) 2023-03-31
PT3250592T (pt) 2022-12-28
CU20170097A7 (es) 2018-03-13
RS63906B1 (sr) 2023-02-28
EP3250592B1 (en) 2022-10-05
TWI786505B (zh) 2022-12-11
CO2017008476A2 (es) 2018-01-16
TW202124436A (zh) 2021-07-01
CU24480B1 (es) 2020-03-04
US20160251418A1 (en) 2016-09-01
LT3250592T (lt) 2023-02-10
SA517382002B1 (ar) 2021-11-25
TW201632554A (zh) 2016-09-16
AU2016210888C1 (en) 2022-06-02
DK3250592T3 (en) 2023-01-09
JP6748086B2 (ja) 2020-09-02
PH12017501318A1 (en) 2018-02-05
KR20230156164A (ko) 2023-11-13
MX2017009806A (es) 2018-08-15
SG10202101763VA (en) 2021-04-29
IL253633A0 (en) 2017-09-28
JP2018506277A (ja) 2018-03-08
FI3250592T3 (fi) 2023-01-13
HUE060878T2 (hu) 2023-04-28
CL2022003027A1 (es) 2023-06-09
PH12017501318B1 (en) 2018-02-05
KR20170106469A (ko) 2017-09-20
EP3250592A1 (en) 2017-12-06
BR112017016330A2 (pt) 2018-04-03
KR102598180B1 (ko) 2023-11-03
CN107406499B (zh) 2021-10-22
ES2934656T3 (es) 2023-02-23
IL253633B (en) 2021-06-30
AU2016210888A1 (en) 2017-08-10
WO2016120810A1 (en) 2016-08-04
EA036080B1 (ru) 2020-09-23
TWI718122B (zh) 2021-02-11
PE20180217A1 (es) 2018-01-31
EA201791712A1 (ru) 2017-12-29

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