WO2012082573A1 - Procédés prédictifs et procédés de traitement de l'arthrite en utilisant des antagonistes de l'il-17 - Google Patents
Procédés prédictifs et procédés de traitement de l'arthrite en utilisant des antagonistes de l'il-17 Download PDFInfo
- Publication number
- WO2012082573A1 WO2012082573A1 PCT/US2011/064307 US2011064307W WO2012082573A1 WO 2012082573 A1 WO2012082573 A1 WO 2012082573A1 US 2011064307 W US2011064307 W US 2011064307W WO 2012082573 A1 WO2012082573 A1 WO 2012082573A1
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- WO
- WIPO (PCT)
- Prior art keywords
- patient
- allele
- antagonist
- hla
- treatment
- Prior art date
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/244—Interleukins [IL]
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/156—Polymorphic or mutational markers
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
Definitions
- the IL-17 antagonist is selected from the group consisting of: a) secukinumab; b) an IL-17 antibody that binds to an epitope of IL-17 comprising Leu74, Tyr85, His86, Met87, Asn88, Val l24, Thrl25, Prol26, Ilel27, Vall28, Hisl29; c) an IL- 17 antibody that binds to an epitope of IL-17 comprising Tyr43, Tyr44, Arg46, Ala79, Asp80; d) an IL-17 antibody that binds to an epitope of an IL-17 homodimer having two mature IL-17 protein chains, said epitope comprising Leu74, Tyr85, His86, Met87, Asn88, Val l24, Thrl 25, Prol26, Ilel27, Vall28, His l29 on one chain and Tyr43, Tyr44, Arg46, Ala79, Asp80 on the other chain; e) an IL- 17 antibody
- active rheumatoid arthritis or “active RA” is used to mean RA with visible signs and symptoms (e.g., swelling, difficulty in flexion, etc.).
- a set of parameters may be the Blosum 62 scoring matrix with a gap penalty of 12, a gap extend penalty of 4, and a frameshift gap penalty of 5.
- the percent identity between two amino acid or nucleotide sequences can also be determined using the algorithm of E. Meyers and W. Miller ((1989) CABIOS, 4:1 1-17) which has been incorporated into the ALIGN program (version 2.0), using a PAM120 weight residue table, a gap length penalty of 12 and a gap penalty of 4.
- ACR/EULAR criteria (found in Aletaha et al. (2010) Ann. Rheum. Dis. 69:1580-1588) may be used to classify a patient as having RA.
- Secukinumab (see, e.g., WO2006/013107 and WO2007/1 17749) has a very high affinity for IL- 17, i.e., a KD of about 100-200 pM and an IC 50 for in vitro neutralization of the biological activity of about 0.67 nM human IL-17A of about 0.4 nM.
- secukinumab inhibits antigen at a molar ratio of about 1 :1.
- This high binding affinity makes the secukinumab antibody particularly suitable for therapeutic applications.
- secukinumab has a very long half life, i.e., about 4 weeks, which allows for prolonged periods between administration, an exceptional property when treating chronic life-long disorders, such as rheumatiod arthritis (RA).
- RA chronic life-long disorders
- Direct labels include fluorescent or luminescent tags, metals, dyes, radionucleides, and the like, attached to the antibody.
- Indirect labels include various enzymes well known in the art, such as alkaline phosphatase, hydrogen peroxidase and the like.
- polypeptide products of HLA-DRB1 *04 and/or HLA-DRB1 *SE alleles are immobilized and incubated with a labeled antibody.
- the labeled antibody binds to the immobilized target molecule. After washing to remove unbound molecules, the sample is assayed for the presence of the label.
- IL-17 antagonists for use in treating RA, characterized in that: a) a biological sample from an RA patient is assayed for the presence or absence of a SE; and b) a therapeutically effective amount of an IL-17 antagonist is administered to the RA patient if the biological sample has the presence of the at least one allele.
- PG pharmacogenetic
- Table 7 shows the DAS28 CRP score change and percent of patients reaching ACR20, or ACR50 at week 12 and week 16 by carrier/non-carrier and treatment (placebo, 25 mg, 75 mg, 150 mg or 300 mg secukinumab) in patients who had not previously been treated with secukinumab.
- Table 11 shows the percent of secukinumab-treated patients reaching a given endpoint (ACR20, ACR50, ACR70).
- HLA-DRB 1 *04- patients with no HLA-DRB 1 *04 allele;
- HLA-DRB 1 *04 + patients with at least one HLA- DRB 1 *04 allele.
- the data provided herein supports an association between HLA-DRB 1 *04 and/or HLA-DRB1 *SE status and RA patient's response to secukinumab, as measured by DAS28 and ACR scores.
- This finding is currently undergoing validation in prospective clinical trials.
- the SE does not predict response to biological agents, particularly to anti-TNF factor treatments such as etanercept and infliximab (Potter et al. (2009) Ann. Rheum. Dis. 68:69-74). Potter et al showed that there was no association between anti-TNF response and carriage of risk alleles for either of the two well established RA susceptibility factors, SE or PTPN22.
- our determination that there is a significant association between HLA-DRB 1 *04 and/or HLA-DRB l *SE status and RA patient's response to secukinumab is surprising.
Abstract
L'invention concerne des procédés prédictifs innovants et des thérapies personnalisées pour traiter l'arthrite rhumatoïde (RA). Spécifiquement, l'invention consiste à prédire la probabilité qu'un patient atteint de RA répondra cliniquement à un traitement avec une molécule liant l'IL-17, par ex. un anticorps contre l'IL-17 comme le secukinumab.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US42252110P | 2010-12-13 | 2010-12-13 | |
US61/422,521 | 2010-12-13 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2012082573A1 true WO2012082573A1 (fr) | 2012-06-21 |
Family
ID=45390221
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2011/064307 WO2012082573A1 (fr) | 2010-12-13 | 2011-12-12 | Procédés prédictifs et procédés de traitement de l'arthrite en utilisant des antagonistes de l'il-17 |
Country Status (3)
Country | Link |
---|---|
AR (1) | AR084234A1 (fr) |
TW (1) | TW201307845A (fr) |
WO (1) | WO2012082573A1 (fr) |
Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2013077907A1 (fr) * | 2011-11-21 | 2013-05-30 | Novartis Ag | Procédés de traitement du rhumatisme psoriasique (psa) utilisant des antagonistes d'il-17 et des allèles répondeurs ou non répondeurs à psa |
EP2635303A2 (fr) * | 2010-11-05 | 2013-09-11 | Novartis AG | Méthodes de traitement de la polyarthrite rhumatoïde au moyen d'antagonistes d'il-17 |
WO2014036357A1 (fr) * | 2012-08-31 | 2014-03-06 | Five Prime Therapeutics, Inc. | Méthodes de traitement de pathologies par des anticorps qui se lient au récepteur du facteur stimulant les colonies 1 (csf1r) |
US8747845B2 (en) | 2010-05-04 | 2014-06-10 | Five Prime Therapeutics, Inc. | Methods of treatment by administering antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
WO2014155278A2 (fr) | 2013-03-26 | 2014-10-02 | Novartis Ag | Méthodes de traitement de maladies auto-immunes à l'aide d'antagonistes de l'il -17 |
US9284283B2 (en) | 2012-02-02 | 2016-03-15 | Ensemble Therapeutics Corporation | Macrocyclic compounds for modulating IL-17 |
WO2016038538A1 (fr) * | 2014-09-10 | 2016-03-17 | Novartis Ag | Utilisation d'antagonistes d'il-17 pour inhiber la progression d'une lésion structurelle chez des patients atteints d'une polyarthrite psoriasique |
US9765147B2 (en) | 2014-10-29 | 2017-09-19 | Five Prime Therapeutics, Inc. | Anti-CSFR1 antibody and anti PD-1 antibody combination therapy for cancer |
US10040858B2 (en) | 2014-12-22 | 2018-08-07 | Five Prime Therapeutics, Inc. | Anti-CSF1R antibodies for treating PVNS |
US10975153B2 (en) | 2014-06-23 | 2021-04-13 | Five Prime Therapeutics, Inc. | Methods of treating conditions with antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
US10982001B2 (en) | 2012-05-11 | 2021-04-20 | Five Prime Therapeutics, Inc. | Methods of treating conditions with antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
CN114249826A (zh) * | 2014-12-22 | 2022-03-29 | 诺华股份有限公司 | Il-17抗体中半胱氨酸残基的选择性还原 |
US11421034B2 (en) | 2017-09-13 | 2022-08-23 | Five Prime Therapeutics, Inc. | Combination anti-CSF1R and anti-PD-1 antibody combination therapy for pancreatic cancer |
US11559583B2 (en) | 2015-04-13 | 2023-01-24 | Five Prime Therapeutics, Inc. | Anti-CSF1R antibody and agonistic anti-CD40 antibody combination therapy for cancer |
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WO2006013107A1 (fr) | 2004-08-05 | 2006-02-09 | Novartis Ag | Anticorps antagonistes de il-17 |
WO2007117749A2 (fr) | 2006-01-31 | 2007-10-18 | Novartis Ag | Anticorps antagonistes il-17 |
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-
2011
- 2011-12-12 WO PCT/US2011/064307 patent/WO2012082573A1/fr active Application Filing
- 2011-12-12 TW TW100145816A patent/TW201307845A/zh unknown
- 2011-12-12 AR ARP110104621A patent/AR084234A1/es not_active Application Discontinuation
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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US6974701B2 (en) | 2003-03-21 | 2005-12-13 | Hemovations, Llc | Erythrocyte sedimentation rate (ESR) test measurement instrument of unitary design and method of using the same |
WO2006013107A1 (fr) | 2004-08-05 | 2006-02-09 | Novartis Ag | Anticorps antagonistes de il-17 |
WO2007117749A2 (fr) | 2006-01-31 | 2007-10-18 | Novartis Ag | Anticorps antagonistes il-17 |
WO2010034443A1 (fr) * | 2008-09-29 | 2010-04-01 | F. Hoffmann-La Roche Ag | Anticorps contre l'il 17 humaine et utilisations associees |
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US9200075B2 (en) | 2010-05-04 | 2015-12-01 | Five Prime Therapeutics, Inc. | Nucleic acids encoding antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
US10562970B2 (en) | 2010-05-04 | 2020-02-18 | Five Prime Therapeutics, Inc. | Antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
US8747845B2 (en) | 2010-05-04 | 2014-06-10 | Five Prime Therapeutics, Inc. | Methods of treatment by administering antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
US9957327B2 (en) | 2010-05-04 | 2018-05-01 | Five Prime Therapeutics, Inc. | Antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
US9695243B2 (en) | 2010-05-04 | 2017-07-04 | Five Prime Therapeutics, Inc. | Antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
US11186646B2 (en) | 2010-05-04 | 2021-11-30 | Five Prime Therapeutics, Inc. | Antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
EP2635303A2 (fr) * | 2010-11-05 | 2013-09-11 | Novartis AG | Méthodes de traitement de la polyarthrite rhumatoïde au moyen d'antagonistes d'il-17 |
US10363307B2 (en) | 2010-11-05 | 2019-07-30 | Novartis Ag | Methods of treating psoriatic arthritis using IL-17 antagonists |
US11534491B2 (en) | 2010-11-05 | 2022-12-27 | Novartis Ag | Methods of treating ankylosing spondylitis using IL-17 antagonists |
US9744234B2 (en) | 2010-11-05 | 2017-08-29 | Novartis Ag | Methods of treating ankylosing spondylitis using IL-17 antagonists |
WO2013077907A1 (fr) * | 2011-11-21 | 2013-05-30 | Novartis Ag | Procédés de traitement du rhumatisme psoriasique (psa) utilisant des antagonistes d'il-17 et des allèles répondeurs ou non répondeurs à psa |
US9284283B2 (en) | 2012-02-02 | 2016-03-15 | Ensemble Therapeutics Corporation | Macrocyclic compounds for modulating IL-17 |
US10982001B2 (en) | 2012-05-11 | 2021-04-20 | Five Prime Therapeutics, Inc. | Methods of treating conditions with antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
CN104684582A (zh) * | 2012-08-31 | 2015-06-03 | 戊瑞治疗有限公司 | 用结合群落刺激因子1受体(csf1r)的抗体治疗病状的方法 |
RU2718751C2 (ru) * | 2012-08-31 | 2020-04-14 | Файв Прайм Терапьютикс, Инк. | Способы лечения патологических состояний антителами, которые связываются с рецептором колониестимулирующего фактора 1 (csf1r) |
US10221243B2 (en) | 2012-08-31 | 2019-03-05 | Five Prime Therapeutics, Inc. | Methods of treating conditions with antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
WO2014036357A1 (fr) * | 2012-08-31 | 2014-03-06 | Five Prime Therapeutics, Inc. | Méthodes de traitement de pathologies par des anticorps qui se lient au récepteur du facteur stimulant les colonies 1 (csf1r) |
US10822421B2 (en) | 2012-08-31 | 2020-11-03 | Five Prime Therapeutics, Inc. | Methods of treating conditions with antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
WO2014155278A2 (fr) | 2013-03-26 | 2014-10-02 | Novartis Ag | Méthodes de traitement de maladies auto-immunes à l'aide d'antagonistes de l'il -17 |
US10975153B2 (en) | 2014-06-23 | 2021-04-13 | Five Prime Therapeutics, Inc. | Methods of treating conditions with antibodies that bind colony stimulating factor 1 receptor (CSF1R) |
WO2016038538A1 (fr) * | 2014-09-10 | 2016-03-17 | Novartis Ag | Utilisation d'antagonistes d'il-17 pour inhiber la progression d'une lésion structurelle chez des patients atteints d'une polyarthrite psoriasique |
US11278618B2 (en) | 2014-09-10 | 2022-03-22 | Novartis Ag | Use of IL-17 antagonists to inhibit the progression of structural damage in psoriatic arthritis patients |
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US10618967B2 (en) | 2014-10-29 | 2020-04-14 | Five Prime Therapeutics, Inc. | Anti-CSF1R antibody and anti PD-1 antibody combination therapy for cancer |
US10221244B2 (en) | 2014-10-29 | 2019-03-05 | Five Prime Therapeutics, Inc. | Anti-CSF1R antibody and anti PD-1 antibody combination therapy for cancer |
US9765147B2 (en) | 2014-10-29 | 2017-09-19 | Five Prime Therapeutics, Inc. | Anti-CSFR1 antibody and anti PD-1 antibody combination therapy for cancer |
US11566076B2 (en) | 2014-10-29 | 2023-01-31 | Five Prime Therapeutics, Inc. | Anti-CSF1R antibody and anti-PD-1 antibody combination therapy for selected cancers |
US10730949B2 (en) | 2014-12-22 | 2020-08-04 | Five Prime Therapeutics, Inc. | Method of treating PVNS with anti-CSF1R antibodies |
US10040858B2 (en) | 2014-12-22 | 2018-08-07 | Five Prime Therapeutics, Inc. | Anti-CSF1R antibodies for treating PVNS |
CN114249826A (zh) * | 2014-12-22 | 2022-03-29 | 诺华股份有限公司 | Il-17抗体中半胱氨酸残基的选择性还原 |
CN114249826B (zh) * | 2014-12-22 | 2024-02-02 | 诺华股份有限公司 | Il-17抗体中半胱氨酸残基的选择性还原 |
US11559583B2 (en) | 2015-04-13 | 2023-01-24 | Five Prime Therapeutics, Inc. | Anti-CSF1R antibody and agonistic anti-CD40 antibody combination therapy for cancer |
US11421034B2 (en) | 2017-09-13 | 2022-08-23 | Five Prime Therapeutics, Inc. | Combination anti-CSF1R and anti-PD-1 antibody combination therapy for pancreatic cancer |
Also Published As
Publication number | Publication date |
---|---|
TW201307845A (zh) | 2013-02-16 |
AR084234A1 (es) | 2013-05-02 |
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