JP2019509988A5 - - Google Patents
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- JP2019509988A5 JP2019509988A5 JP2018540786A JP2018540786A JP2019509988A5 JP 2019509988 A5 JP2019509988 A5 JP 2019509988A5 JP 2018540786 A JP2018540786 A JP 2018540786A JP 2018540786 A JP2018540786 A JP 2018540786A JP 2019509988 A5 JP2019509988 A5 JP 2019509988A5
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- diabetes
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- tnf
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- 206010012601 Diabetes mellitus Diseases 0.000 claims 12
- 239000008194 pharmaceutical composition Substances 0.000 claims 8
- 102000004965 antibodies Human genes 0.000 claims 7
- 108090001123 antibodies Proteins 0.000 claims 7
- 125000003275 alpha amino acid group Chemical group 0.000 claims 6
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 6
- 239000000427 antigen Substances 0.000 claims 5
- 102000038129 antigens Human genes 0.000 claims 5
- 108091007172 antigens Proteins 0.000 claims 5
- 229940071643 Prefilled Syringe Drugs 0.000 claims 4
- 102000003852 Autoantibodies Human genes 0.000 claims 3
- 108090000206 Autoantibodies Proteins 0.000 claims 3
- 102000004877 Insulin Human genes 0.000 claims 3
- 108090001061 Insulin Proteins 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
Claims (12)
- 被験体におけるＴＮＦ関連状態の処置又は予防に使用するための、配列番号３６で表されるアミノ酸配列を含む重鎖（ＨＣ）及び配列番号３７で表されるアミノ酸配列を含む軽鎖（ＬＣ）を有する、少なくとも１つの単離された哺乳類抗ＴＮＦ抗体又はその抗原結合断片あって、前記ＴＮＦ関連状態は、Ｉ型糖尿病又は前Ｉ型糖尿病であり、前Ｉ型糖尿病は、症状の発症前かつ外因性インスリンを必要とする前である、前記抗体又は抗原結合断片。
- 前記被験体は、Ｉ型糖尿病の２以上の自己抗体を有する６〜２１歳の患者である、請求項１に記載の抗体又は抗原結合断片。
- 配列番号３６で表されるアミノ酸配列を含む重鎖（ＨＣ）及び配列番号３７で表されるアミノ酸配列を含む軽鎖（ＬＣ）を有する、少なくとも１つの単離された哺乳類抗ＴＮＦ抗体又はその抗原結合断片と、少なくとも１つの製薬学的に許容できる担体又は希釈剤とを含む、被験体におけるＴＮＦ関連状態の処置又は予防用の医薬組成物であって、前記ＴＮＦ関連状態は、Ｉ型糖尿病又は前Ｉ型糖尿病であり、前Ｉ型糖尿病は、症状の発症前かつ外因性インスリンを必要とする前である、前記医薬組成物。
- 前記医薬組成物は、前記抗ＴＮＦ抗体が、前記被験体の体重が４５ｋｇ未満の場合、第０週及び第２週に６０ｍｇ／ｍ２の導入量、続いて第４週及びｑ２ｗで第５２週まで３０ｍｇ／ｍ２の維持量で投与され、前記被験体の体重が４５ｋｇ以上の場合、第０週及び第２週に１００ｍｇ／ｍ２の導入量、続いて第４週及びｑ２ｗで第５２週まで５０ｍｇ／ｍ２の維持量で投与されるように、前記被験体に皮下（ＳＣ）投与されるものであり、請求項３に記載の医薬組成物。
- 前記被験体は、Ｉ型糖尿病の２以上の自己抗体を有する６〜２１歳の患者である、請求項３又は４に記載の医薬組成物。
- 前記医薬組成物は、自己投与に適した医療用デバイスで投与されるものであり、前記デバイスは、プレフィルドシリンジ、ＵｌｔｒａＳａｆｅ Ｐａｓｓｉｖｅニードルガードを有するプレフィルドシリンジ、ＶａｒｉｏＪｅｃｔ、及びＶａｒｉｏＪｅｃｔとＵｌｔｒａＳａｆｅ Ｐａｓｓｉｖｅニードルガードを有するプレフィルドシリンジとの組み合わせからなる群から選択される、請求項４に記載の医薬組成物。
- 前記デバイスは、前記被験体の体重が４５ｋｇ以上の場合、ＵｌｔｒａＳａｆｅ Ｐａｓｓｉｖｅニードルガードを有するプレフィルドシリンジであり、前記被験体の体重が４５ｋｇ未満の場合、ＶａｒｉｏＪｅｃｔである、請求項６に記載の医薬組成物。
- 前記デバイスは、針の長さが４．５ｍｍのＶａｒｉｏＪｅｃｔである、請求項６に記載の医薬組成物。
- 被験体におけるＴＮＦ関連状態の処置又は予防に使用するための医療用デバイスであって、配列番号３６で表されるアミノ酸配列を含む重鎖（ＨＣ）及び配列番号３７で表されるアミノ酸配列を含む軽鎖（ＬＣ）を有する、少なくとも１つの単離された哺乳類抗ＴＮＦ抗体又はその抗原結合断片を含み、前記デバイスは、前記少なくとも１つの抗ＴＮＦ抗体を皮下（ＳＣ）投与するのに適しているものであり、前記ＴＮＦ関連状態は、Ｉ型糖尿病又は前Ｉ型糖尿病であり、前Ｉ型糖尿病は、症状の発症前かつ外因性インスリンを必要とする前である、前記医療用デバイス。
- 前記デバイスは、自己投与に適しており、前記デバイスは、プレフィルドシリンジ、ＵｌｔｒａＳａｆｅ Ｐａｓｓｉｖｅニードルガードを有するプレフィルドシリンジ、及びＶａｒｉｏＪｅｃｔからなる群から選択される、請求項９に記載の医療用デバイス。
- 前記デバイスは、針の長さが４．５ｍｍのＶａｒｉｏＪｅｃｔである、請求項９に記載の医療用デバイス。
- 前記被験体は、Ｉ型糖尿病の２以上の自己抗体を有する６〜２１歳の患者である、請求項９に記載の医療用デバイス。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662291673P | 2016-02-05 | 2016-02-05 | |
| US62/291,673 | 2016-02-05 | ||
| PCT/US2017/016175 WO2017136524A2 (en) | 2016-02-05 | 2017-02-02 | Anti-tnf antibodies, compositions, methods and use for the treatment or prevention of type 1 diabetes |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2019509988A JP2019509988A (ja) | 2019-04-11 |
| JP2019509988A5 true JP2019509988A5 (ja) | 2020-02-27 |
Family
ID=59500155
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018540786A Pending JP2019509988A (ja) | 2016-02-05 | 2017-02-02 | １型糖尿病の処置又は予防のための抗ｔｎｆ抗体、組成物、方法及び使用 |
Country Status (11)
| Country | Link |
|---|---|
| US (3) | US10465003B2 (ja) |
| EP (1) | EP3411504A4 (ja) |
| JP (1) | JP2019509988A (ja) |
| KR (1) | KR20180105711A (ja) |
| CN (1) | CN109072303A (ja) |
| AU (1) | AU2017215317A1 (ja) |
| BR (1) | BR112018015754A2 (ja) |
| CA (1) | CA3012465A1 (ja) |
| MA (1) | MA43982A (ja) |
| MX (1) | MX2018009498A (ja) |
| WO (1) | WO2017136524A2 (ja) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| LT3781943T (lt) | 2018-04-20 | 2022-07-11 | Janssen Biotech, Inc. | Chromatografinės kolonos kvalifikavimas gamybinių metodų, skirtų pagaminti anti-il-12/il-23 antikūnų kompozicijas, metu |
| MX2021008537A (es) * | 2019-01-15 | 2021-11-12 | Janssen Biotech Inc | Composiciones de anticuerpos anti-tnf y métodos para el tratamiento de la artritis idiopática juvenil. |
| KR20210118878A (ko) * | 2019-01-23 | 2021-10-01 | 얀센 바이오테크 인코포레이티드 | 건선성 관절염의 치료 방법에 사용하기 위한 항-tnf 항체 조성물 |
| MA55282A (fr) * | 2019-03-14 | 2022-01-19 | Janssen Biotech Inc | Procédés de fabrication pour la production de compositions d'anticorps anti-tnf |
| JP7137696B2 (ja) | 2019-05-14 | 2022-09-14 | プロヴェンション・バイオ・インコーポレイテッド | １型糖尿病を予防するための方法および組成物 |
| MX2021014302A (es) | 2019-05-23 | 2022-01-04 | Janssen Biotech Inc | Metodo para tratar la enfermedad inflamatoria del intestino con una terapia de combinacion de anticuerpos contra il-23 y tnf alfa. |
| WO2021028752A1 (en) * | 2019-08-15 | 2021-02-18 | Janssen Biotech, Inc. | Anti-tfn antibodies for treating type i diabetes |
| AU2020368759A1 (en) * | 2019-10-18 | 2022-05-19 | BioZipcode, Inc. | Diabetes therapy targeting abnormal stem cells |
| AU2020367414A1 (en) * | 2019-10-18 | 2022-05-19 | BioZipcode, Inc. | Therapy for diabetes using stem cell migration agent |
| EP4108258A4 (en) * | 2020-02-20 | 2024-03-06 | Bio-Thera Solutions, Ltd. | PREPARATION OF ANTI-TNF-ALPHA ANTIBODY, METHOD OF PREPARATION AND USE THEREOF |
| WO2021234634A1 (en) * | 2020-05-21 | 2021-11-25 | Janssen Biotech, Inc. | Method of treating inflammatory bowel disease with a combination therapy of antibodies to il-23 and tnf alpha |
| WO2021252917A2 (en) | 2020-06-11 | 2021-12-16 | Provention Bio, Inc. | Methods and compositions for preventing type 1 diabetes |
| DE102020129648A1 (de) * | 2020-11-10 | 2022-05-12 | Leopold MTX GmbH | Pharmazeutische zusammensetzung |
| WO2022171685A1 (en) * | 2021-02-10 | 2022-08-18 | INSERM (Institut National de la Santé et de la Recherche Médicale) | Tnf-alpha blocking agent for preventing, suppressing and/or delaying the onset of type 1 diabetes |
| WO2022181797A1 (ja) * | 2021-02-26 | 2022-09-01 | 国立大学法人滋賀医科大学 | 糖尿病および合併症の新規治療、診断および検出のための方法および剤 |
| IL309996A (en) * | 2021-07-09 | 2024-03-01 | Janssen Biotech Inc | Production methods for the production of anti-TNF antibody compositions |
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| HU228630B1 (en) | 1996-02-09 | 2013-04-29 | Abbott Biotech Ltd | Use of human anti bodies that bind human tnf-alpha and process for inhibiting of human tnf-alpha activity |
| GB9702088D0 (en) | 1997-01-31 | 1997-03-19 | Pharmacia & Upjohn Spa | Matrix metalloproteinase inhibitors |
| JPH11127855A (ja) | 1997-10-27 | 1999-05-18 | Japan Energy Corp | 組換え型抗ヒトＴＮＦ−αヒトモノクローナル抗体 |
| UA81743C2 (uk) | 2000-08-07 | 2008-02-11 | Центокор, Инк. | МОНОКЛОНАЛЬНЕ АНТИТІЛО ЛЮДИНИ, ЩО СПЕЦИФІЧНО ЗВ'ЯЗУЄТЬСЯ З ФАКТОРОМ НЕКРОЗУ ПУХЛИН АЛЬФА (ФНПα), ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО ЙОГО МІСТИТЬ, ТА СПОСІБ ЛІКУВАННЯ РЕВМАТОЇДНОГО АРТРИТУ |
| TWI327597B (en) | 2001-08-01 | 2010-07-21 | Centocor Inc | Anti-tnf antibodies, compositions, methods and uses |
| AU2003225976A1 (en) | 2002-03-26 | 2003-10-13 | Centocor, Inc. | Anti-tnf antibodies, compositions, methods and uses |
| MXPA05000815A (es) * | 2002-07-19 | 2005-04-28 | Abbott Biotech Ltd | Tratamiento de trastornos relacionados con tnfa. |
| TW201705980A (zh) * | 2004-04-09 | 2017-02-16 | 艾伯維生物技術有限責任公司 | 用於治療ＴＮＦα相關失調症之多重可變劑量療法 |
| EP2365000A3 (en) * | 2005-05-18 | 2013-01-16 | Ablynx N.V. | Improved nanobodiesTM against tumor necrosis factor-alpha |
| JP2009508476A (ja) * | 2005-08-31 | 2009-03-05 | セントカー・インコーポレーテツド | 高められたエフェクター機能をもつ抗体定常領域の製造用の宿主細胞株 |
| WO2011017294A1 (en) * | 2009-08-07 | 2011-02-10 | Schering Corporation | Human anti-rankl antibodies |
| CN103228142A (zh) * | 2010-09-28 | 2013-07-31 | 加利福尼亚大学董事会 | 治疗代谢综合征相关疾病的gaba激动剂和治疗或预防i型糖尿病的gaba组合 |
| US10087232B2 (en) * | 2013-03-06 | 2018-10-02 | Protalix Ltd. | Use of plant cells expressing a TNFalpha polypeptide inhibitor in therapy |
-
2017
- 2017-02-01 US US15/421,473 patent/US10465003B2/en not_active Expired - Fee Related
- 2017-02-02 JP JP2018540786A patent/JP2019509988A/ja active Pending
- 2017-02-02 AU AU2017215317A patent/AU2017215317A1/en not_active Abandoned
- 2017-02-02 MA MA043982A patent/MA43982A/fr unknown
- 2017-02-02 MX MX2018009498A patent/MX2018009498A/es unknown
- 2017-02-02 US US16/070,385 patent/US20190092849A1/en not_active Abandoned
- 2017-02-02 WO PCT/US2017/016175 patent/WO2017136524A2/en active Application Filing
- 2017-02-02 EP EP17748134.8A patent/EP3411504A4/en not_active Withdrawn
- 2017-02-02 CA CA3012465A patent/CA3012465A1/en not_active Abandoned
- 2017-02-02 KR KR1020187025344A patent/KR20180105711A/ko unknown
- 2017-02-02 CN CN201780021320.7A patent/CN109072303A/zh active Pending
- 2017-02-02 BR BR112018015754A patent/BR112018015754A2/pt not_active IP Right Cessation
-
2019
- 2019-08-14 US US16/540,388 patent/US11124565B2/en active Active
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