HRP20210393T1 - Anti-tfr antitijela i njihova uporaba u liječenju proliferativnih i upalnih poremećaja - Google Patents

Anti-tfr antitijela i njihova uporaba u liječenju proliferativnih i upalnih poremećaja Download PDF

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HRP20210393T1
HRP20210393T1 HRP20210393TT HRP20210393T HRP20210393T1 HR P20210393 T1 HRP20210393 T1 HR P20210393T1 HR P20210393T T HRP20210393T T HR P20210393TT HR P20210393 T HRP20210393 T HR P20210393T HR P20210393 T1 HRP20210393 T1 HR P20210393T1
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seq
antibody
humanized anti
protein
tfr
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HRP20210393TT
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Pierre Launay
Coralie BELANGER
Hervé Souchet
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Inatherys
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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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2881Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD71
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • 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
    • C07K2317/56Immunoglobulins 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
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
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  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Transplantation (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)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)

Claims (16)

1. Izolirano humanizirano antitijelo anti-transferin receptora (anti-TfR) ili protein s dijelom koji veže antigen humaniziranog anti-TfR antitijela, koje sadrži bilo koji (a) varijabilni polipeptid teškog lanca koji sadrži HCDR1 iz SEQ ID NO: 1, HCDR2 iz SEQ ID NO: 2, HCDR3 iz SEQ ID NO: 3 i varijabilni polipeptid lakog lanca koji sadrži LCDR1 iz SEQ ID NO: 4, LCDR2 iz SEQ ID NO: 5 i LCDR3 iz SEQ ID NO: 6; (b) varijabilni polipeptid teškog lanca koji sadrži HCDR1 iz SEQ ID NO: 1, HCDR2 iz SEQ ID NO: 2, HCDR3 iz SEQ ID NO: 3 i varijabilni polipeptid lakog lanca koji sadrži LCDR1 iz SEQ ID NO: 4, LCDR2 iz SEQ ID NO: 8 i LCDR3 iz SEQ ID NO: 6; (c) varijabilni polipeptid teškog lanca koji sadrži VH SEQ ID NO: 11 i varijabilni polipeptid lakog lanca koji sadrži VL SEQ ID NO: 13; (d) varijabilni polipeptid teškog lanca koji sadrži VH SEQ ID NO: 11 i varijabilni polipeptid lakog lanca koji sadrži VL SEQ ID NO: 14; (e) varijabilni polipeptid teškog lanca koji sadrži VH SEQ ID NO: 12 i varijabilni polipeptid lakog lanca koji sadrži VL SEQ ID NO: 13; ili, (f) varijabilni polipeptid teškog lanca koji sadrži VH iz SEQ ID NO: 12 i varijabilni polipeptid lakog lanca koji sadrži VL iz SEQ ID NO: 14; pri čemu se navedeno anti-TfR antitijelo ili protein specifično veže na receptor za transferinski receptor (TfR) iz SEQ ID NO: 16.
2. Izolirano humanizirano anti-TfR antitijelo ili protein iz zahtjeva 1, naznačeno time što se navedeno antitijelo ili protein vežu na transferinski receptor s KD od 10 nM ili manje, poželjno s KD od 1 nM ili manje.
3. Izolirano humanizirano anti-TfR antitijelo ili protein prema zahtjevu 1 ili 2, naznačeno time što navedeno antitijelo ili protein induciraju apoptozu stanične linije HL-60 do razine jednake ili veće od razine indukcije odgovarajućeg referentnog himernog antitijela koje ima VH iz SEQ ID NO : 9 i VL iz SEQ ID NO: 10.
4. Izolirano humanizirano anti-TfR antitijelo ili protein prema zahtjevu 1, 2 ili 3, koje obuhvaća konstantnu regiju ljudskog izotipa IgG4, ili mutantnu ili kemijski modificiranu konstantnu regiju, pri čemu navedena mutantna ili kemijski modificirana konstantna regija ne daje ili smanjuje ADCC aktivnost na navedeno antitijelo kada se usporedi s odgovarajućim antitijelom s konstantnom regijom izotipa IgG1 divljeg tipa.
5. Izolirano humanizirano anti-TfR antitijelo ili protein prema zahtjevu 1, 2 ili 3, koje obuhvaća konstantnu regiju humanog IgG1 izotipa, ili mutantnu ili kemijski modificiranu konstantnu regiju, pri čemu navedena mutantna ili kemijski modificirana konstantna regija daje povećanu ADCC aktivnost navedenog antitijela kada se usporedi s odgovarajućim antitijelima s konstantnom regijom izotipa IgG1 divljeg tipa.
6. Izolirano humanizirano anti-TfR antitijelo ili protein prema bilo kojem od zahtjeva 1-5, koji je mAb1 koji sadrži teški lanac iz SEQ ID NO: 18 i laki lanac iz SEQ ID NO: 17.
7. Izolirano humanizirano anti-TfR antitijelo ili protein prema bilo kojem od zahtjeva 1-6, za uporabu (i) kao lijek ili (ii) kao dijagnostika.
8. Izolirano humanizirano anti-TfR antitijelo ili protein prema bilo kojem od zahtjeva 1-6, za uporabu u liječenju tumora, na primjer hematološkog tumora, i preciznije limfoma ili leukemije.
9. Izolirano humanizirano anti-TfR antitijelo ili protein prema bilo kojem od zahtjeva 1-6, za uporabu u liječenju solidnog tumora ili bolesti transplantata naspram domaćina.
10. Farmaceutski pripravak koji sadrži humanizirano anti-TfR antitijelo ili protein prema bilo kojem od zahtjeva 1-9, u kombinaciji s jednim ili više farmaceutski prihvatljivih ekscipijenta, razrjeđivača ili nosača, izborno sadrži i druge aktivne sastojke.
11. Formulacija liofilizata, napunjena štrcaljka ili bočica koja sadrži humanizirano anti-TfR antitijelo ili protein prema bilo kojem od zahtjeva 1-6.
12. Humanizirano anti-TfR antitijelo prema bilo kojem od zahtjeva 1-6, povezano s terapijskim dijelom, na primjer, citotoksinom, lijekom ili radiotoksinom.
13. Vektor kloniranja ili ekspresije za rekombinantnu proizvodnju humaniziranog anti-TfR antitijela prema bilo kojem od zahtjeva 1-6 u stanici domaćina, sadrži barem jednu nukleinsku kiselinu koja kodira navedeno anti-TfR antitijelo.
14. Vektor kloniranja ili ekspresije prema zahtjevu 13, sadrži barem jednu od nukleinskih kiselina koje kodiraju mAb1 kako je definirano u zahtjevu 6.
15. Stanica domaćina koja sadrži vektor kloniranja ili ekspresije prema zahtjevu 13 ili 14.
16. Postupak za proizvodnju humaniziranog anti-TfR antitijela ili proteina prema bilo kojem od zahtjeva 1-6, koji sadrži: (i) uzgoj stanice domaćina prema zahtjevu 15 za ekspresiju navedenog antitijela ili proteina od strane stanice domaćina; izborno (ii) pročišćavanje navedenog antitijela ili proteina; i, (iii) obnavljanje navedenog antitijela ili proteina.
HRP20210393TT 2015-07-22 2021-03-08 Anti-tfr antitijela i njihova uporaba u liječenju proliferativnih i upalnih poremećaja HRP20210393T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15306192 2015-07-22
EP16744353.0A EP3325509B1 (en) 2015-07-22 2016-07-21 Anti-tfr antibodies and their use in treating proliferative and inflammatory disorders
PCT/EP2016/067465 WO2017013230A1 (en) 2015-07-22 2016-07-21 ANTI-TfR ANTIBODIES AND THEIR USE IN TREATING PROLIFERATIVE AND INFLAMMATORY DISORDERS

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HRP20210393T1 true HRP20210393T1 (hr) 2021-04-30

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US (2) US11230605B2 (hr)
EP (1) EP3325509B1 (hr)
JP (1) JP6858185B2 (hr)
KR (1) KR20180028519A (hr)
CN (1) CN107849136B (hr)
AU (1) AU2016296321B2 (hr)
BR (1) BR112018000650A2 (hr)
CA (1) CA2992509A1 (hr)
CY (1) CY1123941T1 (hr)
DK (1) DK3325509T3 (hr)
ES (1) ES2860988T3 (hr)
HK (1) HK1256088A1 (hr)
HR (1) HRP20210393T1 (hr)
HU (1) HUE053296T2 (hr)
IL (1) IL257065B (hr)
LT (1) LT3325509T (hr)
MX (1) MX2018000569A (hr)
PL (1) PL3325509T3 (hr)
PT (1) PT3325509T (hr)
RS (1) RS61586B1 (hr)
RU (1) RU2737637C2 (hr)
SI (1) SI3325509T1 (hr)
WO (1) WO2017013230A1 (hr)

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FR3062213B1 (fr) 2017-01-20 2021-02-26 Endodiag Utilisation du recepteur cd71 dans la detection et le traitement de l’endometriose
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KR20210081324A (ko) 2018-08-02 2021-07-01 다인 세라퓨틱스, 인크. 근육 표적화 복합체 및 안면견갑상완 근육 이영양증을 치료하기 위한 그의 용도
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BR112022014771A2 (pt) * 2020-01-31 2022-10-11 Dyne Therapeutics Inc Anticorpo anti-receptor de transferrina (tfr) e usos do mesmo
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US20190092870A1 (en) 2019-03-28
EP3325509A1 (en) 2018-05-30
RU2018106364A (ru) 2019-08-22
CY1123941T1 (el) 2022-05-27
AU2016296321A1 (en) 2018-01-25
HK1256088A1 (zh) 2019-09-13
CN107849136A (zh) 2018-03-27
RU2737637C2 (ru) 2020-12-01
IL257065A (en) 2018-03-29
RU2018106364A3 (hr) 2019-08-22
CN107849136B (zh) 2022-04-01
DK3325509T3 (da) 2021-03-08
HUE053296T2 (hu) 2021-06-28
US20220119543A1 (en) 2022-04-21
RS61586B1 (sr) 2021-04-29
BR112018000650A2 (pt) 2018-09-18
AU2016296321B2 (en) 2022-09-08
US11230605B2 (en) 2022-01-25
IL257065B (en) 2022-07-01
JP2018521691A (ja) 2018-08-09
PT3325509T (pt) 2021-03-12
JP6858185B2 (ja) 2021-04-14
ES2860988T3 (es) 2021-10-05
KR20180028519A (ko) 2018-03-16
LT3325509T (lt) 2021-06-10
EP3325509B1 (en) 2020-12-16
WO2017013230A1 (en) 2017-01-26
CA2992509A1 (en) 2017-01-26
MX2018000569A (es) 2018-09-27
SI3325509T1 (sl) 2021-07-30
PL3325509T3 (pl) 2021-07-19

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