JPWO2020139175A5 - - Google Patents
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- JPWO2020139175A5 JPWO2020139175A5 JP2021537707A JP2021537707A JPWO2020139175A5 JP WO2020139175 A5 JPWO2020139175 A5 JP WO2020139175A5 JP 2021537707 A JP2021537707 A JP 2021537707A JP 2021537707 A JP2021537707 A JP 2021537707A JP WO2020139175 A5 JPWO2020139175 A5 JP WO2020139175A5
- Authority
- JP
- Japan
- Prior art keywords
- antibody
- antigen
- binding fragment
- nucleic acid
- pharmaceutical composition
- Prior art date
- Legal status (The legal status 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 status listed.)
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Description
非限定的に、本発明は以下の態様を含む。
［態様１]
ヒトＴＣＲ ＴＲＢＶ９の第９ファミリーのベータ鎖領域に特異的に結合するモノクローナル抗体またはその抗原結合断片であって、アミノ酸配列が配列番号１６に示される重鎖可変ドメイン、およびアミノ酸配列が配列番号１８に示される軽鎖可変ドメインを含む、モノクローナル抗体またはその抗原結合断片。
［態様２]
配列番号２０のアミノ酸配列を有する重鎖、および配列番号２２のアミノ酸配列を有する軽鎖を含む、態様１に記載のモノクローナル抗体。
［態様３]
完全長ＩｇＧ抗体である、態様１または２に記載のモノクローナル抗体。
［態様４]
態様１から３のいずれか一項に記載のモノクローナル抗体またはその抗原結合断片の重鎖をコードする核酸であって、前記抗体またはその抗原結合断片は、ヒトＴＣＲ ＴＲＢＶ９の第９ファミリーのベータ鎖領域に特異的に結合する、核酸。
［態様５]
態様１から３のいずれか一項に記載のモノクローナル抗体またはその抗原結合断片の軽鎖をコードする核酸であって、前記抗体またはその抗原結合断片は、ヒトＴＣＲ ＴＲＢＶ９の第９ファミリーのベータ鎖領域に特異的に結合する、核酸。
［態様６]
態様４に記載の核酸を含有する発現ベクター。
［態様７]
態様５に記載の核酸を含む発現ベクター。
［態様８]
態様１から３のいずれかに記載の抗体またはその抗原結合断片を生産するための宿主細胞を得る方法であって、態様６に記載のベクターおよび態様７に記載のベクターによる細胞の共形質転換を含む、方法。
［態様９]
態様４に記載の核酸および態様５に記載の核酸を含む、態様１から３のいずれか一項に記載の抗体またはその抗原結合断片を得るための宿主細胞。
［態様１０]
態様１から３のいずれかに記載の抗体またはその抗原結合断片を得る方法であって、前記抗体の産生を確実にする条件下で培養培地中で態様９に記載の宿主細胞を培養するステップ、これに続いて得られた抗体を単離および精製するステップを含む、方法。
［態様１１]
ヒトＴＣＲ ＴＲＢＶ９の第９ファミリーのベータ鎖領域によって媒介される疾患または障害を予防または処置するための医薬組成物であって、治療有効量の態様１から３のいずれかに記載の抗体またはその抗原結合断片を、１つまたは複数の医薬的に許容される賦形剤と組み合わせて含む、医薬組成物。
［態様１２]
前記疾患または障害が、強直性脊椎炎、セリアック病、Ｔ細胞白血病、Ｔ細胞リンパ腫の群から選択される、態様１１に記載の医薬組成物。
［態様１３]
ヒトＴＣＲ ＴＲＢＶ９の第９ファミリーのベータ鎖領域によって媒介される疾患または障害を予防または処置するための医薬組成物であって、治療有効量の態様１から３のいずれかに記載の抗体またはその抗原結合断片、および治療有効量の少なくともその他の治療活性化合物を含む、医薬組成物。
［態様１４]
前記疾患または障害が、強直性脊椎炎、セリアック病、Ｔ細胞白血病、Ｔ細胞リンパ腫の群から選択される、態様１３に記載の医薬組成物。
［態様１５]
その他の治療活性化合物が、小分子、抗体またはステロイドホルモンから選択される、態様１３または１４に記載の医薬組成物。
［態様１６]
ヒトＴＣＲ ＴＲＢＶ９の第９ファミリーのベータ鎖領域の生物学的活性を阻害することが必要な対象において、そのような活性を阻害するための方法であって、態様１から３のいずれかに記載の抗体またはその抗原結合断片の有効量を対象に投与するステップを含む、方法。
［態様１７]
ＴＲＢＶ９の第９ファミリーのベータ鎖領域を有するヒトＴＣＲによって媒介される疾患または障害を処置するための方法であって、治療有効量の態様１から３のいずれかに記載の抗体もしくはその抗原結合断片または態様１１から１５のいずれかに記載の医薬組成物を、そのような処置を必要とする対象に投与するステップを含む、方法。
［態様１８]
疾患または障害が、強直性脊椎炎、セリアック病、Ｔ細胞白血病、Ｔ細胞リンパ腫の群から選択される、態様１７に記載の疾患または障害を処置するための方法。
［態様１９]
ヒトＴＣＲ ＴＲＢＶ９の第９ファミリーのベータ鎖領域によって媒介される疾患または障害の処置を必要とする対象において、そのような疾患または障害を処置するための、態様１から３のいずれかに記載の抗体もしくはその抗原結合断片、または態様１１から１５のいずれかに記載の医薬組成物の使用。
［態様２０]
疾患が、強直性脊椎炎、セリアック病、Ｔ細胞白血病、Ｔ細胞リンパ腫の群から選択される、態様１９に記載の使用。
本発明のよりよき理解のために、以下の実施例を提供する。これらの実施例は、例示のみを目的とするものであり、いかようにも本発明の範囲を限定するものとして解釈されるべきではない。
Non-limiting, the present invention includes the following aspects.
[Aspect 1]
A monoclonal antibody or antigen-binding fragment thereof that specifically binds to the beta chain region of the family 9 of human TCR TRBV9, comprising a heavy chain variable domain whose amino acid sequence is shown in SEQ ID NO: 16 and an amino acid sequence of which is shown in SEQ ID NO: 18 A monoclonal antibody or antigen-binding fragment thereof comprising the indicated light chain variable domain.
[Aspect 2]
The monoclonal antibody of aspect 1, comprising a heavy chain having the amino acid sequence of SEQ ID NO:20 and a light chain having the amino acid sequence of SEQ ID NO:22.
[Aspect 3]
3. The monoclonal antibody according to aspect 1 or 2, which is a full-length IgG antibody.
[Aspect 4]
A nucleic acid encoding the heavy chain of the monoclonal antibody or antigen-binding fragment thereof of any one of aspects 1-3, wherein said antibody or antigen-binding fragment thereof comprises the beta chain region of the family 9 of human TCR TRBV9 a nucleic acid that specifically binds to
[Aspect 5]
4. A nucleic acid encoding the light chain of the monoclonal antibody or antigen-binding fragment thereof of any one of aspects 1-3, wherein said antibody or antigen-binding fragment thereof comprises the beta chain region of the family 9 of human TCR TRBV9 a nucleic acid that specifically binds to
[Aspect 6]
An expression vector containing the nucleic acid of aspect 4.
[Aspect 7]
An expression vector comprising the nucleic acid of aspect 5.
[Aspect 8]
A method of obtaining a host cell for producing an antibody or antigen-binding fragment thereof according to any one of aspects 1 to 3, comprising co-transforming the cell with the vector according to aspect 6 and the vector according to aspect 7. including, method.
[Aspect 9]
A host cell for obtaining an antibody or antigen-binding fragment thereof according to any one of aspects 1 to 3, comprising a nucleic acid according to aspect 4 and a nucleic acid according to aspect 5.
[Aspect 10]
A method of obtaining an antibody or antigen-binding fragment thereof according to any one of aspects 1 to 3, comprising culturing a host cell according to aspect 9 in a culture medium under conditions ensuring production of said antibody; A method comprising the steps of subsequently isolating and purifying the resulting antibody.
[Aspect 11]
4. A pharmaceutical composition for preventing or treating a disease or disorder mediated by the beta chain region of family 9 of human TCR TRBV9, comprising a therapeutically effective amount of the antibody or antigen thereof of any of aspects 1-3. A pharmaceutical composition comprising a binding fragment in combination with one or more pharmaceutically acceptable excipients.
[Aspect 12]
12. The pharmaceutical composition according to aspect 11, wherein said disease or disorder is selected from the group of ankylosing spondylitis, celiac disease, T-cell leukemia, T-cell lymphoma.
[Aspect 13]
4. A pharmaceutical composition for preventing or treating a disease or disorder mediated by the beta chain region of family 9 of human TCR TRBV9, comprising a therapeutically effective amount of the antibody or antigen thereof of any of aspects 1-3. A pharmaceutical composition comprising a binding fragment and a therapeutically effective amount of at least another therapeutically active compound.
[Aspect 14]
14. The pharmaceutical composition according to aspect 13, wherein said disease or disorder is selected from the group of ankylosing spondylitis, celiac disease, T-cell leukemia, T-cell lymphoma.
[Aspect 15]
15. A pharmaceutical composition according to aspect 13 or 14, wherein the other therapeutically active compound is selected from small molecules, antibodies or steroid hormones.
[Aspect 16]
4. A method for inhibiting the biological activity of the beta chain region of family 9 of human TCR TRBV9 in a subject in need thereof, said method according to any of aspects 1-3. A method comprising administering to a subject an effective amount of an antibody or antigen-binding fragment thereof.
[Aspect 17]
4. A method for treating a disease or disorder mediated by a human TCR having a TRBV9 family 9 beta chain region, comprising a therapeutically effective amount of the antibody or antigen-binding fragment thereof of any of aspects 1-3. or administering a pharmaceutical composition according to any of aspects 11-15 to a subject in need of such treatment.
[Aspect 18]
18. A method for treating a disease or disorder according to aspect 17, wherein the disease or disorder is selected from the group of ankylosing spondylitis, celiac disease, T-cell leukemia, T-cell lymphoma.
[Aspect 19]
4. The antibody of any of aspects 1-3 for treating a disease or disorder mediated by the beta chain region of the family 9 of human TCR TRBV9 in a subject in need thereof for treating such disease or disorder or an antigen-binding fragment thereof, or use of a pharmaceutical composition according to any of aspects 11-15.
[Aspect 20]
20. Use according to aspect 19, wherein the disease is selected from the group of ankylosing spondylitis, celiac disease, T-cell leukemia, T-cell lymphoma.
For a better understanding of the invention, the following examples are provided. These examples are for illustrative purposes only and should not be construed as limiting the scope of the invention in any way.
Claims (16)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| RU2018146031A RU2712251C1 (en) | 2018-12-25 | 2018-12-25 | Humanised anti-beta 9 chain antibodies of human trbv9 tkp family, and methods of using |
| PCT/RU2020/050024 WO2020139175A2 (en) | 2018-12-25 | 2020-02-20 | Humanized antibodies against the beta chain region of the trbv9 family of human tcr and methods for the use thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2022532274A JP2022532274A (en) | 2022-07-14 |
| JPWO2020139175A5 true JPWO2020139175A5 (en) | 2023-03-01 |
Family
ID=69184123
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021537707A Pending JP2022532274A (en) | 2018-12-25 | 2020-02-20 | Monoclonal antibody against the beta chain region of human TRBV9 |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20220112286A1 (en) |
| EP (1) | EP3907239A4 (en) |
| JP (1) | JP2022532274A (en) |
| KR (2) | KR20210119404A (en) |
| CN (2) | CN113646333A (en) |
| AR (1) | AR117734A1 (en) |
| AU (1) | AU2020204492A1 (en) |
| BR (1) | BR112021012555A2 (en) |
| CA (2) | CA3127767A1 (en) |
| CL (1) | CL2021001705A1 (en) |
| CO (2) | CO2021008218A2 (en) |
| CR (1) | CR20210354A (en) |
| EA (1) | EA202191813A1 (en) |
| EC (1) | ECSP21046333A (en) |
| IL (1) | IL284370A (en) |
| JO (1) | JOP20210169A1 (en) |
| MA (1) | MA53689B1 (en) |
| MX (1) | MX2021007719A (en) |
| PE (1) | PE20220217A1 (en) |
| PH (1) | PH12021551532A1 (en) |
| RU (1) | RU2712251C1 (en) |
| SG (1) | SG11202106975VA (en) |
| TW (1) | TW202039574A (en) |
| WO (2) | WO2020091635A2 (en) |
| ZA (1) | ZA202104357B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11845797B2 (en) | 2018-07-03 | 2023-12-19 | Marengo Therapeutics, Inc. | Anti-TCR antibody molecules and uses thereof |
| CN116510006A (en) * | 2022-01-31 | 2023-08-01 | 拜奥卡德联合股份公司 | Pharmaceutical composition of anti-TRBV 9 antibody and application thereof |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5766947A (en) | 1988-12-14 | 1998-06-16 | Astra Ab | Monoclonal antibodies reactive with an epitope of a Vβ3.1 variable region of a T cell receptor |
| US5223426A (en) * | 1988-12-15 | 1993-06-29 | T Cell Sciences, Inc. | Monoclonal antibodies reactive with defined regions of the t-cell antigen receptor |
| RU2539032C2 (en) * | 2009-06-25 | 2015-01-10 | Фред Хатчинсон Кансэр Рисёч Сентер | Method for measuring artificial immunity |
| EP3202784A1 (en) * | 2016-02-08 | 2017-08-09 | Polybiocept AB | T-cell receptor sequences for active immunotherapy |
| RU2694412C9 (en) * | 2017-12-25 | 2019-09-18 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Российский национальный исследовательский медицинский университет им. Н.И. Пирогова" Министерства здравоохранения Российской Федерации (ФГБОУ ВО РНИМУ им. Н.И. Пирогова Минздрава России) | Monoclonal antibodies and methods of using them |
-
2018
- 2018-12-25 RU RU2018146031A patent/RU2712251C1/en active
-
2019
- 2019-12-23 AR ARP190103840A patent/AR117734A1/en unknown
- 2019-12-24 WO PCT/RU2019/050258 patent/WO2020091635A2/en active Application Filing
- 2019-12-24 CA CA3127767A patent/CA3127767A1/en active Pending
- 2019-12-24 TW TW108147432A patent/TW202039574A/en unknown
- 2019-12-24 CN CN201980092905.7A patent/CN113646333A/en active Pending
- 2019-12-24 KR KR1020217023541A patent/KR20210119404A/en not_active Application Discontinuation
-
2020
- 2020-02-20 CR CR20210354A patent/CR20210354A/en unknown
- 2020-02-20 MX MX2021007719A patent/MX2021007719A/en unknown
- 2020-02-20 US US17/417,686 patent/US20220112286A1/en active Pending
- 2020-02-20 KR KR1020217023568A patent/KR20220131489A/en active Search and Examination
- 2020-02-20 BR BR112021012555-8A patent/BR112021012555A2/en unknown
- 2020-02-20 CA CA3124813A patent/CA3124813A1/en active Pending
- 2020-02-20 SG SG11202106975VA patent/SG11202106975VA/en unknown
- 2020-02-20 CN CN202080016346.4A patent/CN114144432A/en active Pending
- 2020-02-20 MA MA53689A patent/MA53689B1/en unknown
- 2020-02-20 AU AU2020204492A patent/AU2020204492A1/en active Pending
- 2020-02-20 WO PCT/RU2020/050024 patent/WO2020139175A2/en unknown
- 2020-02-20 JP JP2021537707A patent/JP2022532274A/en active Pending
- 2020-02-20 EA EA202191813A patent/EA202191813A1/en unknown
- 2020-02-20 PE PE2021001081A patent/PE20220217A1/en unknown
- 2020-02-20 JO JOP/2021/0169A patent/JOP20210169A1/en unknown
- 2020-02-20 EP EP20734640.4A patent/EP3907239A4/en active Pending
-
2021
- 2021-06-23 CO CONC2021/0008218A patent/CO2021008218A2/en unknown
- 2021-06-24 ZA ZA2021/04357A patent/ZA202104357B/en unknown
- 2021-06-24 CL CL2021001705A patent/CL2021001705A1/en unknown
- 2021-06-24 IL IL284370A patent/IL284370A/en unknown
- 2021-06-24 EC ECSENADI202146333A patent/ECSP21046333A/en unknown
- 2021-06-25 PH PH12021551532A patent/PH12021551532A1/en unknown
- 2021-07-23 CO CONC2021/0009689A patent/CO2021009689A2/en unknown
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