KR100887482B1 - 효과기 기능이 변화된 폴리펩티드 변이체 - Google Patents
효과기 기능이 변화된 폴리펩티드 변이체 Download PDFInfo
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- KR100887482B1 KR100887482B1 KR1020017008932A KR20017008932A KR100887482B1 KR 100887482 B1 KR100887482 B1 KR 100887482B1 KR 1020017008932 A KR1020017008932 A KR 1020017008932A KR 20017008932 A KR20017008932 A KR 20017008932A KR 100887482 B1 KR100887482 B1 KR 100887482B1
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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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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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
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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
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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
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- 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
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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- C07—ORGANIC CHEMISTRY
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- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
- C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
- C07K16/4291—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
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- C07—ORGANIC CHEMISTRY
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K2317/734—Complement-dependent cytotoxicity [CDC]
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- C07—ORGANIC CHEMISTRY
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- C07K2319/00—Fusion polypeptide
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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- C12N2799/00—Uses of viruses
- C12N2799/02—Uses of viruses as vector
- C12N2799/021—Uses of viruses as vector for the expression of a heterologous nucleic acid
- C12N2799/022—Uses of viruses as vector for the expression of a heterologous nucleic acid where the vector is derived from an adenovirus
Abstract
Description
본래 잔기 | 예시적인 치환체 | 바람직한 치환체 |
Ala (A) | val; leu; ile | val |
Arg (R) | lys; gln; asn | lys |
Asn (N) | gln; his; lys; arg | gln |
Asp (D) | glu | glu |
Cys (C) | ser | ser |
Gln (Q) | asn | asn |
Glu (E) | asp | asp |
Gly (G) | pro; ala | ala |
His (H) | asn; gln; lys; arg | arg |
Ile (I) | leu; val; met; ala; phe; norleucine | leu |
Leu (L) | norleucine; ile;val; met; ala; phe | ile |
Lys (K) | arg; gln; asn | arg |
Met (M) | leu; phe; ile | leu |
Phe (F) | leu; val; ile; ala; tyr | leu |
Pro (P) | ala | ala |
Ser (S) | thr | thr |
Thr (T) | ser | ser |
Trp (W) | tyr, phe | tyr |
Tyr (Y) | trp; phe; thr; ser | phe |
Val (V) | ile; leu; met; phe; ala; norleucine | leu |
Fc 영역 변이체의 종류 | ||
종류 | FcR 결합 특성 | Fc 영역의 치환 위치 |
1A | 모든 FcγR에 대한 결합의 감소 | 238, 265, 269, 270, 297*, 327, 329 |
1B | FcγRII 및 FcγRIII에 대한 결합의 감소 | 239, 294, 295, 303, 338, 373, 376, 416, 435 |
2 | FcγRII 및 FcγRIII 모두에 대한 결합의 향상 | 256, 290, 312, 326, 330, 339#, 378, 430 |
3 | FcγRII에 대한 결합의 향상 및 FcγRIII에 대해 영향을 주지 않음 | 255, 258, 267, 276, 280, 283, 285, 286, 305, 307, 309, 315, 320, 331, 337, 398 |
4 | FcγRII에 대한 결합의 향상 및 FcγRIII에 대한 결합 감소 | 268, 272, 301, 322, 340 |
5 | FcγRII에 대한 결합의 감소 및 FcγRIII에 대해 영향을 주지 않음 | 292, 324, 335, 414, 419, 438, 439 |
6 | FcγRII에 대한 결합의 감소 및 FcγRIII에 대한 결합 향상 | 298, 333 |
7 | FcγRII에 대해 영향을 주지 않고 FcγRIII에 대한 결합의 감소 | 248, 249, 252, 254, 278, 289, 293, 296, 338, 382, 388, 389, 434, 437 |
8 | FcγRII에 대해 영향을 주지 않고 FcγRIII에 대한 결합의 향상 | 334, 360 |
* 디클리콜실화됨 # 다른 Fc 영역 변형(예, 본원에 개시된 바와 같이)과 바람직하게 조합됨 |
야생형 | E318A | K320A | K322A | P329A | P331A | |
FcRn | + | + | + | + | ||
CD20 | + | + | + | + | + | + |
FcγRI | + | + | + | + | + | + |
FcγRII | + | + | + | + | + | + |
FcγRIII | + | + | + | + | + | + |
*C1q | +++ | ++ | +++ | - | - | - |
CDC | + | + | + | - | - | - |
(+)는 결합을 나타내고 (-)는 결합이 없음을 의미함 *C1q 결합과 관련된 각 + 표시는 약 33% 결합과 동등함. |
야생형 | E318A | K320A | K322A | P329A | P331A | |
CD20 | 100 | 89 | 102 | 86 | 112 | 103 |
aFcγRI | 100 | 93 | 102 | 90 | 104 | 74 |
aFcγRIIA | 100 | 113 | 94 | 109 | 111 | 86 |
aFcγRIIB | 100 | 106 | 83 | 101 | 96 | 58 |
aFcγRIII | 100 | 104 | 72 | 90 | 85 | 73 |
CDC | 100 | 108 | 108 | 무 | 무 | 무 |
aFcγR에 대한 결합의 경우, 변이체는 E27 배경 (항-IgE)에서 만들어짐. 상기 결과는 야생형 비율 (%)로서 나타냄. |
변이체 | EC50 값 |
야생형 | 1.53 |
K326V | 1.30 |
K326A | 1.03 |
K326E | 1.08 |
K326G | 0.95 |
K326D | 0.76 |
K326M | 0.67 |
K326W | 0.47 |
E333S | 0.81 |
E333A | 0.98 |
E333G | 1.14 |
E333V | 1.18 |
E333D | 1.22 |
E333Q | 1.52 |
K334A | 1.07 |
Claims (49)
- 인간 효과기 세포의 존재하에서 모 폴리펩티드보다 효과적으로 항체 의존성 세포 매개의 세포독성 (ADCC)을 매개하거나 모 폴리펩티드보다 높은 친화도로 Fc 감마 수용체 III (FcγR III)에 결합하고, Fc 영역의 아미노산 위치 256, 290, 298, 312, 326, 330, 333, 334, 360, 378 또는 430 중 하나 이상에서 아미노산 치환을 포함하는, Fc 영역을 포함하는 모 폴리펩티드의 변이체 (여기서 Fc 영역의 잔기의 번호는 카밧 (Kabat)의 문헌에서와 같은 EU 지수 번호임).
- 제1항에 있어서, 항체를 포함하는 변이체.
- 제1항에 있어서, 모 폴리펩티드 Fc 영역이 인간 IgG Fc 영역을 포함하는 것인 변이체.
- 제3항에 있어서, 인간 IgG Fc 영역이 인간 IgG1, IgG2, IgG3 또는 IgG4 Fc 영역을 포함하는 것인 변이체.
- 제1항에 있어서, 모 폴리펩티드보다 약 1.5 배 내지 약 100 배 더 효과적으로 ADCC를 매개하는 변이체.
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- 제1항에 있어서, 또한 모 폴리펩티드보다 낮은 친화도로 FcγRII에 결합하는 변이체.
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- 제1항에 있어서, Fc 영역의 CH2 도메인 내에 하나 이상의 아미노산 변형을 포함하는 변이체.
- 제1항에 있어서, 하부 힌지 영역을 제외한 Fc 영역에 하나 이상의 아미노산 변형을 포함하는 변이체.
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- 제1항에 있어서, 열거된 아미노산 위치에서 2개 이상의 아미노산 치환을 포함하는 변이체.
- 제1항에 있어서, 열거된 아미노산 위치에서 3개 이상의 아미노산 치환을 포함하는 변이체.
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- 제1항의 폴리펩티드 변이체 및 제약적으로 허용되는 담체를 포함하는, 암, 염증 질환, 감염 및 갑상선종의 치료용 조성물.
- 제36항에 있어서, 멸균된 조성물.
- 제1항의 폴리펩티드 변이체를 코딩하는 단리된 핵산.
- 제38항의 핵산을 포함하는 벡터.
- 제39항의 벡터를 포함하는 숙주 세포.
- 제40항의 숙주 세포를 배양하여 핵산을 발현시키는 것을 포함하는, 폴리펩티드 변이체를 생산하는 방법.
- 제41항에 있어서, 숙주 세포 배양물로부터 폴리펩티드 변이체를 회수하는 것을 더 포함하는 방법.
- 치료 유효량의 제1항의 폴리펩티드 변이체를 인간을 제외한 포유동물에게 투여하는 것을 포함하는, 상기 포유동물의 질병을 치료하기 위한 방법.
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Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11602399P | 1999-01-15 | 1999-01-15 | |
US60/116,023 | 1999-01-15 |
Related Child Applications (1)
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KR1020067010091A Division KR20060067983A (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
Publications (2)
Publication Number | Publication Date |
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KR20010102976A KR20010102976A (ko) | 2001-11-17 |
KR100887482B1 true KR100887482B1 (ko) | 2009-03-10 |
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Application Number | Title | Priority Date | Filing Date |
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KR1020087021958A KR100940380B1 (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
KR1020107006514A KR101155191B1 (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
KR1020067010091A KR20060067983A (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
KR1020017008932A KR100887482B1 (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
KR1020097011774A KR101077001B1 (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
Family Applications Before (3)
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KR1020087021958A KR100940380B1 (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
KR1020107006514A KR101155191B1 (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
KR1020067010091A KR20060067983A (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
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KR1020097011774A KR101077001B1 (ko) | 1999-01-15 | 2000-01-14 | 효과기 기능이 변화된 폴리펩티드 변이체 |
Country Status (17)
Country | Link |
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US (4) | US7371826B2 (ko) |
EP (4) | EP1141024B1 (ko) |
JP (4) | JP2003512019A (ko) |
KR (5) | KR100940380B1 (ko) |
CN (2) | CN1763097B (ko) |
AU (2) | AU778683B2 (ko) |
BR (1) | BR0008758A (ko) |
CA (1) | CA2359067C (ko) |
ES (1) | ES2694002T3 (ko) |
HK (1) | HK1090066A1 (ko) |
HU (2) | HUP0104865A3 (ko) |
IL (5) | IL144056A0 (ko) |
MX (2) | MX353234B (ko) |
NZ (1) | NZ539776A (ko) |
PL (3) | PL220113B1 (ko) |
WO (1) | WO2000042072A2 (ko) |
ZA (1) | ZA200105484B (ko) |
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US6737056B1 (en) | 1999-01-15 | 2004-05-18 | Genentech, Inc. | Polypeptide variants with altered effector function |
CA2904259C (en) | 1999-05-07 | 2016-11-15 | Genentech, Inc. | Use of rituximab to treat vasculitis |
EP1355919B1 (en) | 2000-12-12 | 2010-11-24 | MedImmune, LLC | Molecules with extended half-lives, compositions and uses thereof |
US7658921B2 (en) | 2000-12-12 | 2010-02-09 | Medimmune, Llc | Molecules with extended half-lives, compositions and uses thereof |
US20030133939A1 (en) | 2001-01-17 | 2003-07-17 | Genecraft, Inc. | Binding domain-immunoglobulin fusion proteins |
US7754208B2 (en) | 2001-01-17 | 2010-07-13 | Trubion Pharmaceuticals, Inc. | Binding domain-immunoglobulin fusion proteins |
CA2437958C (en) * | 2001-03-09 | 2018-10-30 | University Of Chicago | Polymeric immunoglobulin fusion proteins that target low-affinity fc.gamma.receptors |
US20110045005A1 (en) | 2001-10-19 | 2011-02-24 | Craig Crowley | Compositions and methods for the treatment of tumor of hematopoietic origin |
CN100423777C (zh) * | 2001-10-25 | 2008-10-08 | 杰南技术公司 | 糖蛋白组合物 |
US20040002587A1 (en) * | 2002-02-20 | 2004-01-01 | Watkins Jeffry D. | Fc region variants |
US8093357B2 (en) | 2002-03-01 | 2012-01-10 | Xencor, Inc. | Optimized Fc variants and methods for their generation |
US8188231B2 (en) | 2002-09-27 | 2012-05-29 | Xencor, Inc. | Optimized FC variants |
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