HRP20192045T1 - Stabilni heterodimerni dizajn antitijela s mutacijama u fc domeni - Google Patents
Stabilni heterodimerni dizajn antitijela s mutacijama u fc domeni Download PDFInfo
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- HRP20192045T1 HRP20192045T1 HRP20192045TT HRP20192045T HRP20192045T1 HR P20192045 T1 HRP20192045 T1 HR P20192045T1 HR P20192045T T HRP20192045T T HR P20192045TT HR P20192045 T HRP20192045 T HR P20192045T HR P20192045 T1 HRP20192045 T1 HR P20192045T1
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- amino acid
- domain polypeptide
- acid substitution
- acid substitutions
- polypeptide contains
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- 230000035772 mutation Effects 0.000 title 1
- 238000006467 substitution reaction Methods 0.000 claims 93
- 125000003275 alpha amino acid group Chemical group 0.000 claims 92
- 229920001184 polypeptide Polymers 0.000 claims 51
- 102000004196 processed proteins & peptides Human genes 0.000 claims 51
- 108090000765 processed proteins & peptides Proteins 0.000 claims 51
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 1
- 125000000539 amino acid group Chemical group 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 210000004962 mammalian cell Anatomy 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 229940124597 therapeutic agent Drugs 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/524—CH2 domain
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
- C07K2317/526—CH3 domain
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
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- Immunology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
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- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Transplantation (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (22)
1. Izolirani heteromultimer koji sadrži heterodimernu humanu IgG Fc regiju, pri čemu heterodimerna Fc regija sadrži varijantu CH3 domene koja sadrži zamjene aminokiseline koje promiču formiranje heterodimerne Fc regije, pri čemu heterodimerna Fc regija ima čistoću veću od 90 %, pri čemu varijanta CH3 domene ima temperaturu tališta (Tm) od 72°C ili veću,
pri čemu:
(a) prvi polipeptid CH3 domene sadrži zamjene aminokiseline F405A i Y407V, i drugi polipeptid CH3 domene sadrži zamjene aminokiseline T394W i jednu od T366I ili T366L, ili
(b) prvi polipeptid CH3 sadrži zamjenu aminokiseline na poziciji F405 i zamjene aminokiseline L351Y i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, pri čemu zamjena aminokiseline na poziciji F405 je F405A, F405I, F405M, F405T, F405S, F405V ili F405W, ili
(c) prvi polipeptid CH3 domene sadrži zamjene aminokiseline na pozicijama L351 i Y407, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline na poziciji T366 i zamjenu aminokiseline K409F, pri čemu zamjena aminokiseline na poziciji L351 je L351Y, L351I, L351D, L351R ili L351F; zamjena aminokiseline na poziciji Y407 je Y407A, Y407V ili Y407S, i zamjena aminokiseline na poziciji T366 je T366A, T366I, T366L, T366M, T366Y, T366S, T366C, T366V ili T366W, i
pri čemu je numeracija ostataka aminokiselina prema EU indeksu izloženom prema Kabatu.
2. Izolirani heteromultimer prema zahtjevu 1, pri čemu heterodimerna Fc regija ima čistoću od 95 % ili veću; poželjno pri čemu heterodimerna Fc regija ima čistoću od 98 % ili veću.
3. Izolirani heteromultimer prema zahtjevu 1 ili 2, pri čemu je Tm 74ºC ili veća.
4. Izolirani heteromultimer prema zahtjevu 1(a), pri čemu prvi polipeptid CH3 domene dalje sadrži zamjenu aminokiseline L351Y ili L351L, i/ili drugi polipeptid CH3 domene dalje sadrži zamjenu aminokiseline K392F, K392L ili K392M.
5. Izolirani heteromultimer prema zahtjevu 1(a) ili 4, pri čemu drugi polipeptid CH3 domene dalje sadrži zamjenu aminokiseline K392M.
6. Izolirani heteromultimer prema zahtjevu 1(b), pri čemu zamjena aminokiseline na poziciji F405 je F405A.
7. Izolirani heteromultimer prema zahtjevu 6, pri čemu drugi polipeptid CH3 domene dalje sadrži zamjenu aminokiseline T366I ili T366L.
8. Izolirani heteromultimer prema zahtjevu 7, pri čemu drugi polipeptid CH3 domene dalje sadrži zamjenu aminokiseline K392M.
9. Izolirani heteromultimer prema zahtjevu 1(b), pri čemu prvi ili drugi polipeptid CH3 domene dalje sadrži zamjenu aminokiseline na jednoj ili više od pozicija K392, T411, T366, L368 ili S400, i pri čemu:
zamjena aminokiseline na poziciji K392 je K392V, K392M, K392R, K392L, K392F ili K392E;
zamjena aminokiseline na poziciji T411 je T411N, T411R, T411Q, T411K, T411D, T411E ili T411W;
zamjena aminokiseline na poziciji T366 je T366A, T366I, T366L, T366M, T366Y, T366S, T366C, T366V ili T366W;
zamjena aminokiseline na poziciji L368 je L368D, L368R, L368T, L368M, L368V, L368F, L368S ili L368A, i
zamjena aminokiseline na poziciji S400 je S400E, S400D, S400R ili S400K.
10. Izolirani heteromultimer prema zahtjevu 1(b), pri čemu:
(a) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405A i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392F; ili
(b) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405S i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392L; ili
(c) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405S i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392M; ili
(d) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405S i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392F; ili
(e) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405T i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392L; ili
(f) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405T i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392M; ili
(g) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405T i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392F; ili
(h) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405V i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392L; ili
(i) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405V i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392M; ili
(j) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405V i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366L i K392F; ili
(k) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405A i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjenu aminokiseline T366I; ili
(l) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405A i Y407V, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366I i K392M; ili
(m) prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y, F405A i Y407V, i dalje sadrži zamjenu aminokiseline S400E, i drugi polipeptid CH3 domene sadrži zamjenu aminokiseline T394W, i dalje sadrži zamjene aminokiseline T366I, N390R i K392M.
11. Izolirani heteromultimer prema zahtjevu 1(a), pri čemu:
(a) prvi polipeptid CH3 domene sadrži zamjene aminokiseline F405A i Y407V, i dalje sadrži zamjenu aminokiseline L351Y, i drugi polipeptid CH3 domene sadrži zamjene aminokiseline T366L i T394W, i dalje sadrži zamjenu aminokiseline K392L; ili
(b) prvi polipeptid CH3 domene sadrži zamjene aminokiseline F405A i Y407V, i dalje sadrži zamjenu aminokiseline L351Y, i drugi polipeptid CH3 domene sadrži zamjene aminokiseline T366L i T394W, i dalje sadrži zamjenu aminokiseline K392M; ili
(c) prvi polipeptid CH3 domene sadrži zamjene aminokiseline F405A i Y407V, i dalje sadrži zamjene aminokiseline L351Y i S400E, i drugi polipeptid CH3 domene sadrži zamjene aminokiseline T366L i T394W, i dalje sadrži zamjene aminokiseline N390R i K392L; ili
(d) prvi polipeptid CH3 domene sadrži zamjene aminokiseline F405A i Y407V, i dalje sadrži zamjene aminokiseline L351Y i S400E, i drugi polipeptid CH3 domene sadrži zamjene aminokiseline T366L i T394W, i dalje sadrži zamjene aminokiseline N390R i K392M.
12. Izolirani heteromultimer prema zahtjevu 1(c), pri čemu zamjena aminokiseline na poziciji Y407 je Y407A.
13. Izolirani heteromultimer prema zahtjevu 12, pri čemu zamjena aminokiseline na poziciji L351 je L351Y.
14. Izolirani heteromultimer prema zahtjevu 12 ili 13, pri čemu zamjena aminokiseline na poziciji T366 je T366A, T366I, T366M ili T366V.
15. Izolirani heteromultimer prema zahtjevu 1(c), pri čemu prvi polipeptid CH3 domene sadrži zamjene aminokiseline L351Y i Y407A i drugi polipeptid CH3 domene sadrži zamjene aminokiseline K409F i T366A, i pri čemu prvi polipeptid CH3 domene ili drugi polipeptid CH3 domene sadrži daljnju zamjenu aminokiseline na jednoj ili više pozicija T411, D399, S400, F405, N390 ili K392, i pri čemu:
zamjena aminokiseline na poziciji T411 je T411N, T411R, T411Q, T411K, T411D, T411E ili T411W;
zamjena aminokiseline na poziciji D399 je D399R, D399W, D399Y ili D399K;
zamjena aminokiseline na poziciji S400 je S400E, S400D, S400R ili S400K;
zamjena aminokiseline na poziciji F405 je F405I, F405M, F405T, F405S, F405V ili F405W;
zamjena aminokiseline na poziciji N390 je N390R, N390K ili N390D, i
zamjena aminokiseline na poziciji K392 je K392V, K392M, K392R, K392L, K392F ili K392E.
16. Izolirani heteromultimer prema bilo kojem od zahtjeva 1 do 15, pri čemu IgG Fc regija je IgG1 Fc regija.
17. Izolirani heteromultimer prema bilo kojem od zahtjeva 1 do 16, pri čemu je heteromultimer antitijelo.
18. Izolirani heteromultimer prema zahtjevu 17, pri čemu je antitijelo bispecifično ili multispecifično antitijelo.
19. Izolirani heteromultimer prema zahtjevu 17 ili 18, pri čemu antitijelo veže barem jedan karcinomski antigen.
20. Izolirani heteromultimer prema bilo kojem od zahtjeva 17 do 19, pri čemu je antitijelo konjugirano na terapeutski agens.
21. Izolirani heteromultimer prema bilo kojem od zahtjeva 17 do 20 za uporabu u liječenju raka kod pacijenta kojemu je to potrebno.
22. In vitro postupak izražavanja antitijela prema bilo kojem od zahtjeva 17 do 19, pri čemu su spomenuti prvi i drugi polipeptidi CH3 domene koizraženi iz pojedine stanice sisavca.
Applications Claiming Priority (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US41074610P | 2010-11-05 | 2010-11-05 | |
US201061425375P | 2010-12-21 | 2010-12-21 | |
US201161439341P | 2011-02-03 | 2011-02-03 | |
US201161475614P | 2011-04-14 | 2011-04-14 | |
US201161491846P | 2011-05-31 | 2011-05-31 | |
US201161497861P | 2011-06-16 | 2011-06-16 | |
PCT/CA2011/001238 WO2012058768A1 (en) | 2010-11-05 | 2011-11-04 | Stable heterodimeric antibody design with mutations in the fc domain |
EP11837370.3A EP2635607B1 (en) | 2010-11-05 | 2011-11-04 | Stable heterodimeric antibody design with mutations in the fc domain |
Publications (1)
Publication Number | Publication Date |
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HRP20192045T1 true HRP20192045T1 (hr) | 2020-02-07 |
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Application Number | Title | Priority Date | Filing Date |
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HRP20192045TT HRP20192045T1 (hr) | 2010-11-05 | 2019-11-12 | Stabilni heterodimerni dizajn antitijela s mutacijama u fc domeni |
Country Status (19)
Country | Link |
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US (3) | US9562109B2 (hr) |
EP (1) | EP2635607B1 (hr) |
JP (1) | JP6167040B2 (hr) |
KR (2) | KR20130135866A (hr) |
CN (2) | CN103429620B (hr) |
AU (1) | AU2011325833C1 (hr) |
BR (1) | BR112013011811A2 (hr) |
CA (1) | CA2815266C (hr) |
CY (1) | CY1122409T1 (hr) |
DK (1) | DK2635607T3 (hr) |
ES (1) | ES2758994T3 (hr) |
HR (1) | HRP20192045T1 (hr) |
HU (1) | HUE047228T2 (hr) |
MX (1) | MX352929B (hr) |
PL (1) | PL2635607T3 (hr) |
PT (1) | PT2635607T (hr) |
RS (1) | RS59589B1 (hr) |
RU (1) | RU2604490C2 (hr) |
WO (1) | WO2012058768A1 (hr) |
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