DK2904011T3 - Kombination af anti-kir-antistoffer og anti-pd-1-antistoffer til behandling af cancer - Google Patents
Kombination af anti-kir-antistoffer og anti-pd-1-antistoffer til behandling af cancer Download PDFInfo
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- DK2904011T3 DK2904011T3 DK13774596.4T DK13774596T DK2904011T3 DK 2904011 T3 DK2904011 T3 DK 2904011T3 DK 13774596 T DK13774596 T DK 13774596T DK 2904011 T3 DK2904011 T3 DK 2904011T3
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- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
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- A61K39/00—Medicinal preparations containing antigens or antibodies
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- A61K2039/507—Comprising a combination of two or more separate antibodies
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- C07—ORGANIC CHEMISTRY
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- 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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Claims (16)
- KOMBINATION AF ANTI-KIR-ANTISTOFEER OG ANTI-PD-1-ANTISTOFFER TIL BEHANDLING AF CANCER1. Anti-KIR-antistof, der omfatter CDR1-, CDR2- og CDR3-domæneme i en variabel tungkæderegion med sekvensen ifølge SEQ ID NO: 3, og CDR1-, CDR2- og CDR3-domænerne i en variabel letkæderegion med sekvensen ifølge SEQ ID NO: 5, og et anti-PD-l-antistof, der omfatter CDR1-, CDR2- og CDR3-domæneme i en variabel tungkæderegion med sekvensen ifølge SEQ ID NO: 19, og CDR1-, CDR2- og CDR3-domænerne i en variabel letkæderegion med sekvensen ifølge SEQ ID NO: 21, til anvendelse i en fremgangsmåde til behandling af cancer hos en human patient, hvor fremgangsmåden omfatter mindst én administrationscyklus, hvor cyklussen er en periode på otte uger, hvor for hver af den mindst ene cyklus to doser af anti-KIR-antistoffet administreres ved en dosis på 0,1, 0,3, 1, 3, 6 eller 10 mg/kg og fire doser af anti-PD-l-antistoffet administreres ved en dosis på 3 mg/kg.
- 2. Antistoffer til anvendelse ifølge krav 1, hvor anti-KIR-antistoffet og anti-PD-l-antistoffet er beregnet til at blive administreret i følgende doser: (a) 0,1 mg/kg anti-KIR-antistof og 3 mg/kg anti-PD-l-antistof; (b) 0,3 mg/kg anti-KIR-antistof og 3 mg/kg anti-PD-l-antistof; (c) 1 mg/kg anti-KIR-antistof og 3 mg/kg anti-PD-l-antistof; (d) 3 mg/kg anti-KIR-antistof og 3 mg/kg anti-PD-l-antistof; (e) 6 mg/kg anti-KIR-antistof og 3 mg/kg anti-PD-l-antistof eller (f) 10 mg/kg anti-KIR-antistof og 3 mg/kg anti-PD-l-antistof.
- 3. Antistoffer til anvendelse ifølge krav 1 eller 2, hvor anti-PD-1- og anti-KIR-antistofferne er formuleret til intravenøs administration.
- 4. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-3, hvor behandlingen består af op til 12 cyklusser.
- 5. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-4, hvor anti-PD-l-antistoffet er beregnet til at blive administreret på dag 1, 15, 29 og 43 af hver cyklus.
- 6. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-5, hvor anti-KIR-antistoffet er beregnet til at blive administreret på dag 1 og 29 af hver cyklus; eventuelt (a) hvor anti-PD-l-antistoffet er beregnet til at blive administreret før administration af anti-KIR-antistoffet på dag 1 og 29, eller (b) hvor anti-PD-l-antistoffet er beregnet til at blive administreret før administration af anti-KIR-antistoffet på dag 1 og 29 og anti-KIR-antistoffet er beregnet til at blive administreret inden 30 minutter efter anti-PD-l-antistoffet.
- 7. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-6, hvor behandlingen frembringer mindst én terapeutisk effekt, der er udvalgt fra en størrelsesreduktion af en tumor, antalsreduktion af metastaserende læsioner over tid, komplet respons, delvist respons og stabil sygdom.
- 8. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor canceren er en solid tumor, eller navnlig en fremskredet refraktær solid tumor og eventuelt er udvalgt fra cancer i hoved eller hals, ikke-småcellet lungecancer (NSCLC), renalcellekarcinom (RCC), melanom, kolorektal cancer og serøst ovariekarcinom.
- 9. Antistoffer til anvendelse ifølge krav 8, hvor canceren er cancer i hoved eller hals.
- 10. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor canceren er en hæmatologisk ondartethed og eventuelt er udvalgt fra multipelt myelom, Hodgkins lymfom, follikulært lymfom, diffust storcellet B-cellelymfom og T-cellelymfom.
- 11. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-10, hvor anti-KIR-antistoffet omfatter (a) en variabel tungkæderegion CDR1 med sekvensen ifølge SEQ ID NO: 7, (b) en variabel tungkæderegion CDR2 med sekvensen ifølge SEQ ID NO: 8, (c) en variabel tungkæderegion CDR3 med sekvensen ifølge SEQ ID NO: 9, (d) en variabel letkæderegion CDR1 med sekvensen ifølge SEQ ID NO: 10, (e) en variabel letkæderegion CDR2 med sekvensen ifølge SEQ ID NO: 11, og (f) en variabel letkæderegion CDR3 med sekvensen ifølge SEQ ID NO: 12; og/eller hvor anti-PD-l-antistoffet omfatter (a) en variabel tungkæderegion CDR1 med sekvensen ifølge SEQ ID NO: 23, (b) en variabel tungkæderegion CDR2 med sekvensen ifølge SEQ ID NO: 24, (c) en variabel tungkæderegion CDR3 med sekvensen ifølge SEQ ID NO: 25, (d) en variabel letkæderegion CDR1 med sekvensen ifølge SEQ ID NO: 26, (e) en variabel letkæderegion CDR2 med sekvensen ifølge SEQ ID NO: 27 og (f) en variabel letkæderegion CDR3 med sekvensen ifølge SEQ ID NO: 28.
- 12. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-11, hvor anti-KIR-antistoffet omfatter variable tung- og letkæderegioner med sekvenserne ifølge henholdsvis SEQ ID NO: 3 og 5; og/eller hvor anti-PD-l-antistoffet omfatter variable tung- og letkæderegioner med sekvenserne ifølge henholdsvis SEQ ID NO: 19 og 21.
- 13. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-12, hvor anti-KIR-antistoffet omfatter tung- og letkæder med sekvenserne ifølge henholdsvis SEQ ID NO: 1 og 2; og/eller hvor anti-PD-l-antistoffet omfatter tung- og letkæder med sekvenserne ifølge henholdsvis SEQ ID NO: 17 og 18.
- 14. Antistoffer til anvendelse ifølge et hvilket som helst af kravene 1-13, hvor: (a) anti-KIR-antistoffet og anti-PD-l-antistoffet er beregnet til at blive administreret samtidig i en enkelt formulering; eller (b) anti-KIR-antistoffet og anti-PD-l-antistoffet er formuleret til separat administration; eller (c) anti-KIR-antistoffet og anti-PD-l-antistoffet er beregnet til at blive administreret samtidig; eller (d) anti-KIR-antistoffet og anti-PD-1-antistoffet er beregnet til at blive administreret sekventielt; eller (e) anti-PD-l-antistoffet er beregnet til at blive administreret første efterfulgt af administration af anti-KIR-antistoffet; eller (f) anti-KIR-antistoffet er beregnet til at blive administreret første efterfulgt af administration af anti-PD-l-antistoffet.
- 15. Kit til anvendelse i en fremgangsmåde til behandling af cancer hos en human patient, hvilket kit omfatter: (a) en dosis af et anti-KIR-antistof, der omfatter CDR1-, CDR2- og CDR3-domæneme i en variabel tungkæderegion med sekvensen ifølge SEQ ID NO: 3, og CDR1-, CDR2- og CDR3-domænerne i en variabel letkæderegion med sekvensen ifølge SEQ ID NO: 5; (b) en dosis af et anti-PD-l-antistof, der omfatter CDR1-, CDR2- og CDR3-domænerne i en variabel tungkæderegion med sekvensen ifølge SEQ ID NO: 19, og CDR1-, CDR2- og CDR3-domænerne i en variabel letkæderegion med sekvensen ifølge SEQ ID NO: 21; og (c) instruktioner om anvendelse af anti-KIR-antistoffet og anti-PD-l-antistoffet ifølge et hvilket som helst af kravene 1-14.
- 16. Anti-KIR-antistof, der omfatter CDR1-, CDR2- og CDR3-domænerne i en variabel tungkæderegion med sekvensen ifølge SEQ ID NO: 3, og CDR1-, CDR2- og CDR3-domænerne i en variabel letkæderegion med sekvensen ifølge SEQ ID NO: 5, til anvendelse i behandling af en person, hvor anti-KIR-antistoffet er beregnet til coadministration med et anti-PD-l-antistof, der omfatter CDR1-, CDR2-og CDR3-domæneme i en variabel tungkæderegion med sekvensen ifølge SEQ ID NO: 19, og CDR1-, CDR2- og CDR3-domænerne i en variabel letkæderegion med sekvensen ifølge SEQ ID NO: 21, i mindst én cyklus, hvor for hver cyklus to doser af anti-KIR-antistoffet administreres ved en dosis på 0,1, 0,3, 1, 3, 6 eller 10 mg/kg og fire doser af anti-PD-l-antistoffet administreres ved en dosis på 3 mg/kg.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261708784P | 2012-10-02 | 2012-10-02 | |
PCT/US2013/063068 WO2014055648A1 (en) | 2012-10-02 | 2013-10-02 | Combination of anti-kir antibodies and anti-pd-1 antibodies to treat cancer |
Publications (1)
Publication Number | Publication Date |
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DK2904011T3 true DK2904011T3 (da) | 2017-12-04 |
Family
ID=49326890
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK13774596.4T DK2904011T3 (da) | 2012-10-02 | 2013-10-02 | Kombination af anti-kir-antistoffer og anti-pd-1-antistoffer til behandling af cancer |
Country Status (26)
Country | Link |
---|---|
US (2) | US20150290316A1 (da) |
EP (2) | EP2904011B1 (da) |
JP (3) | JP6239628B2 (da) |
KR (1) | KR102130865B1 (da) |
CN (1) | CN104837868B (da) |
AU (1) | AU2013327116C1 (da) |
BR (1) | BR112015007184A2 (da) |
CA (1) | CA2887027C (da) |
CY (1) | CY1119799T1 (da) |
DK (1) | DK2904011T3 (da) |
EA (1) | EA038920B1 (da) |
ES (1) | ES2643887T3 (da) |
HK (1) | HK1210786A1 (da) |
HR (1) | HRP20171788T1 (da) |
HU (1) | HUE035503T2 (da) |
IL (1) | IL237960B (da) |
LT (1) | LT2904011T (da) |
MX (2) | MX367042B (da) |
NO (1) | NO2787245T3 (da) |
NZ (1) | NZ631405A (da) |
PL (1) | PL2904011T3 (da) |
PT (1) | PT2904011T (da) |
RS (1) | RS56624B1 (da) |
SG (2) | SG10201702421TA (da) |
SI (1) | SI2904011T1 (da) |
WO (1) | WO2014055648A1 (da) |
Families Citing this family (146)
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MX346912B (es) | 2009-12-07 | 2017-04-05 | Univ Leland Stanford Junior | Metodos para mejorar terapia con anticuerpos antitumor. |
EP3444363B1 (en) | 2011-06-03 | 2020-11-25 | Eisai R&D Management Co., Ltd. | Biomarkers for prediciting and assessing responsiveness of thyroid and kidney cancer subjects to lenvatinib compounds |
SG11201407190TA (en) | 2012-05-15 | 2014-12-30 | Bristol Myers Squibb Co | Cancer immunotherapy by disrupting pd-1/pd-l1 signaling |
EA038920B1 (ru) * | 2012-10-02 | 2021-11-10 | Бристол-Майерс Сквибб Компани | Комбинация антител к kir и антител к pd-1 для лечения злокачественной опухоли |
EP3757130A1 (en) | 2013-09-26 | 2020-12-30 | Costim Pharmaceuticals Inc. | Methods for treating hematologic cancers |
US9457019B2 (en) * | 2013-11-07 | 2016-10-04 | Deciphera Pharmaceuticals, Llc | Methods for inhibiting tie-2 kinase useful in the treatment of cancer |
ES2746805T3 (es) | 2013-12-12 | 2020-03-06 | Shanghai hengrui pharmaceutical co ltd | Anticuerpo de PD-1, fragmento de unión a antígeno del mismo y aplicación médica del mismo |
TWI680138B (zh) | 2014-01-23 | 2019-12-21 | 美商再生元醫藥公司 | 抗pd-l1之人類抗體 |
TWI681969B (zh) | 2014-01-23 | 2020-01-11 | 美商再生元醫藥公司 | 針對pd-1的人類抗體 |
JOP20200094A1 (ar) | 2014-01-24 | 2017-06-16 | Dana Farber Cancer Inst Inc | جزيئات جسم مضاد لـ pd-1 واستخداماتها |
JOP20200096A1 (ar) | 2014-01-31 | 2017-06-16 | Children’S Medical Center Corp | جزيئات جسم مضاد لـ tim-3 واستخداماتها |
WO2015198311A1 (en) * | 2014-06-24 | 2015-12-30 | Ccam Therapeutics Ltd. | Compositions comprising antibodies to ceacam-1 and kir for cancer therapy |
TWI693232B (zh) | 2014-06-26 | 2020-05-11 | 美商宏觀基因股份有限公司 | 與pd-1和lag-3具有免疫反應性的共價結合的雙抗體和其使用方法 |
US9982052B2 (en) | 2014-08-05 | 2018-05-29 | MabQuest, SA | Immunological reagents |
WO2016020856A2 (en) | 2014-08-05 | 2016-02-11 | MabQuest SA | Immunological reagents |
HUE059131T2 (hu) | 2014-08-11 | 2022-10-28 | Acerta Pharma Bv | BTK-inhibitor, PD-1-inhibitor és/vagy PD-L1-inhibitor terápiás kombinációja |
RU2731098C2 (ru) * | 2014-08-19 | 2020-08-28 | Нэшнл Юниверсити Корпорейшн Окаяма Юниверсити | Способ улучшения функции иммунных клеток и оценки мультифункциональности иммунных клеток |
BR112017002827B1 (pt) | 2014-08-28 | 2023-04-18 | Eisai R&D Management Co., Ltd | Derivado de quinolina altamente puro e método para produção do mesmo |
US20170281624A1 (en) | 2014-09-13 | 2017-10-05 | Novartis Ag | Combination therapies of alk inhibitors |
GB201419084D0 (en) | 2014-10-27 | 2014-12-10 | Agency Science Tech & Res | Anti-PD-1 antibodies |
US11639384B2 (en) * | 2014-10-28 | 2023-05-02 | University Children's Hospital Tübingen | Treatment of pediatric BCP-ALL patients with an anti-KIR antibody |
CN105669862A (zh) * | 2014-11-21 | 2016-06-15 | 上海中信国健药业股份有限公司 | 抗人pd-l1/kir双特异性抗体及其制备方法和应用 |
WO2016128912A1 (en) | 2015-02-12 | 2016-08-18 | Acerta Pharma B.V. | Therapeutic combinations of a btk inhibitor, a pi3k inhibitor, a jak-2 inhibitor, a pd-1 inhibitor, and/or a pd-l1 inhibitor |
MX2017010474A (es) | 2015-02-25 | 2017-11-28 | Eisai R&D Man Co Ltd | Metodo para suprimir el amargor de un derivado de quinoleina. |
CN112263677A (zh) * | 2015-02-26 | 2021-01-26 | 默克专利股份公司 | 用于治疗癌症的pd-1/pd-l1抑制剂 |
KR20240064733A (ko) * | 2015-03-04 | 2024-05-13 | 머크 샤프 앤드 돔 코포레이션 | 암을 치료하기 위한 pd-1 길항제 및 vegfr/fgfr/ret 티로신 키나제 억제제의 조합 |
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- 2013-10-02 KR KR1020157011033A patent/KR102130865B1/ko active IP Right Grant
- 2013-10-02 BR BR112015007184A patent/BR112015007184A2/pt not_active Application Discontinuation
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