ES2665317T3 - Anticuerpos humanizados dirigidos contra el dominio EC1 de la cadherina-11 y composiciones y procedimientos relacionados - Google Patents
Anticuerpos humanizados dirigidos contra el dominio EC1 de la cadherina-11 y composiciones y procedimientos relacionados Download PDFInfo
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- ES2665317T3 ES2665317T3 ES11741717.0T ES11741717T ES2665317T3 ES 2665317 T3 ES2665317 T3 ES 2665317T3 ES 11741717 T ES11741717 T ES 11741717T ES 2665317 T3 ES2665317 T3 ES 2665317T3
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/461—Igs containing Ig-regions, -domains or -residues form different species
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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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
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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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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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
- 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
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- C07K14/461—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from fish
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- 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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- 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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- 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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/74—Inducing cell proliferation
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- C—CHEMISTRY; METALLURGY
- 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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Abstract
Un anticuerpo humanizado que se une especificamente a un dominio EC1 de una proteina cadherina-11 de mamifero y antagoniza dicha proteina cadherina-11 de mamifero, que comprende una region variable de la cadena pesada de anticuerpo que comprende la SEQ ID NO: 69 y una region variable de la cadena ligera de anticuerpo que comprende la SEQ ID NO: 71.
Description
La CI50 relativa se calculó dividiendo el valor para el anticuerpo de ensayo por el de SYN0012. Los niveles de expresión de anticuerpos dados son para cultivos estáticos en matraces T. Se calculan los PI.
5 En la selección inicial de los anticuerpos anti-cad-11 humanizados contra el antígeno cad-11 y los antígenos cad-7, 8, -9, -11, -18, -20, -24 a un revestimiento de 500 ng/ml ( Figura 41A), SDP051 demostró una unión mucho mayor a cad-11 que cualquier otra cadherina. El mayor grado de reactividad cruzada se observó con el antígeno de cad-8. Este ensayo se repitió con los antígenos de cad-11, cad-8 y cad-18 con una concentración de revestimiento de antígeno inferior de 50 ng/ml y una serie de dilución más amplia del anticuerpo SDP051 (Figura 41B). En este
10 ensayo, SDP051 tenía una CE50 de 6,8 ng/ml para cad-11 y una CE50 de 1421 ng/ml de cad-8, un diferencial de unión de más de 200 veces. No se pudo establecer una CE50 para ad-18 debido al bajo nivel de unión observado. Estos resultados confirmaron que SDP051 era altamente específico para cad-11. Una búsqueda BLAST con la secuencia del dominio EC1 de cad-11 indicó que las coincidencias más cercanas estaban entre los antígenos cad-7, -8, -9, -11, -18, -20 y -24. Una búsqueda BLAST con el epítopo de unión a hexapéptido SDP051 dilucidado en el
15 dominio EC1 de cad-11 indicó que ninguna otra proteína humana conocida poseía esta secuencia.
SDP051 tenía afinidad subnanomolar por la proteína rhCad-11 con una constante de disociación en el equilibrio (KD) de 0,37 nM (Tabla 4).
20 Tabla 4: Propiedades físicas de SDP051. mAb SDP051
ka1 (1/Ms) 6,13x105 kd1 (1/s) 0,004301 ka2 (1/s) 0,01160 kd2 (1/s) 6,618 x104 KD (M) 3,787 x1010 Chi2 0,194
Los experimentos de caracterización y control para la superficie del chip sugirieron que la rhCad-11 inmovilizada en la densidad única era adecuada para determinar los valores cinéticos de las interacciones del anticuerpo anti-cad-11.
25 Para el análisis cinético, se usó un modelo de reacción de 2 estados (Ecuación 1, Figura 42) basándose en los resultados del control de reacción de unión, que indicaba que se producía otro suceso dependiente del tiempo una vez que el antígeno se había unido al anticuerpo. Dado que rhCad-11 es homodimérica y, por lo tanto, contiene dos epítopos de unión idénticos, es probable que las moléculas de mAb individuales se unan secuencialmente a través de un primer sitio de unión y luego a ambos sitios de unión.
30
Ecuación 1: Reacción de dos estados
En los ensayos de unión a células, SDP051 y SDP071 demostraron una unión dependiente de la dosis a las células que expresan cad-11 y no se unen a la línea celular parental negativa para cad-11 (Figura 43).
35 Una forma alternativa de determinar la especificidad de SDP051 para cad-11 es medir la capacidad de diferentes cadherinas para bloquear la unión de SDP051 a células que expresan cad-11. Esto se realizó para cada una de las cadherinas-7, -8, -9, -18, -20, -24 o -MN. Solo el péptido cad-11 bloqueó significativamente la unión de SDP051 a las células cad-11+. Los resultados del análisis se muestran en las figuras 44A-C.
40
Ejemplo 15: SDP051, un anticuerpo humanizado Anti EC1 de cad11, exhibe baja inmunogenicidad en ensayos que usan células humanas
Materiales y procedimientos 45 Purificación de anticuerpos
SDP051 se purificó a partir de cultivos de 5 l de células que expresaban anticuerpos que crecían hasta la saturación. Los sobrenadantes se separaron de las células y los desechos, se ajustaron a pH 7,4, se esterilizaron por filtración y 50 se procesaron a través de columnas de afinidad de proteína A Hi-Trap Mab Select Sure de 5 ml (GE Healthcare, Amersham, Reino Unido), previamente desinfectadas con NaOH 0,5 M, a un caudal de 5 ml/min. La columna se lavó con 100 ml de PBS a pH 7,4. El anticuerpo se eluyó en fracciones de 5 ml con citrato de sodio 0,1M a pH 3,0 y cada fracción se neutralizó inmediatamente con 0,25 ml de Tris-HCl 1M. El contenido de proteína de cada fracción se controló por absorción de UV a 280 nm y las fracciones que contenían proteína se juntaron, se cambió el tampón en
25
Claims (1)
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Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US36469810P | 2010-07-15 | 2010-07-15 | |
| US364698P | 2010-07-15 | ||
| PCT/US2011/044172 WO2012009631A1 (en) | 2010-07-15 | 2011-07-15 | Humanized antibodies targeting the ec1 domain of cadherin-11 and related compositions and methods |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2665317T3 true ES2665317T3 (es) | 2018-04-25 |
Family
ID=44630044
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES11741717.0T Active ES2665317T3 (es) | 2010-07-15 | 2011-07-15 | Anticuerpos humanizados dirigidos contra el dominio EC1 de la cadherina-11 y composiciones y procedimientos relacionados |
Country Status (21)
| Country | Link |
|---|---|
| US (2) | US8940300B2 (es) |
| EP (2) | EP2593128B1 (es) |
| JP (2) | JP5886283B2 (es) |
| KR (1) | KR101695056B1 (es) |
| CN (2) | CN103153331B (es) |
| AU (1) | AU2011279044B2 (es) |
| BR (1) | BR112013001062A2 (es) |
| CA (1) | CA2805112A1 (es) |
| DK (1) | DK2593128T3 (es) |
| ES (1) | ES2665317T3 (es) |
| HR (1) | HRP20180563T1 (es) |
| HU (1) | HUE038000T2 (es) |
| IL (2) | IL224186A (es) |
| LT (1) | LT2593128T (es) |
| MX (1) | MX343376B (es) |
| NO (1) | NO2593128T3 (es) |
| PT (1) | PT2593128T (es) |
| RS (1) | RS57215B1 (es) |
| SG (1) | SG187097A1 (es) |
| SI (1) | SI2593128T1 (es) |
| WO (1) | WO2012009631A1 (es) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2711394A1 (en) | 2008-01-11 | 2009-07-16 | Synovex Corporation | Cadherin-11 antagonists and methods for the treatment of inflammatory joint disorders |
| RS57215B1 (sr) | 2010-07-15 | 2018-07-31 | Adheron Therapeutics Inc | Humanizovana antitela koja ciljaju ec1 domen kadherina-11 i kompozicije i postupci koji su u vezi sa njima |
| RS63930B1 (sr) | 2011-10-28 | 2023-02-28 | Prothena Biosciences Ltd | Humanizovana antitela koja prepoznaju alfa-sinuklein |
| DK2807188T3 (da) | 2012-01-27 | 2019-10-07 | Prothena Biosciences Ltd | Humaniserede antistoffer, der genkender alpha-synuclein |
| EP2830659A1 (en) * | 2012-03-27 | 2015-02-04 | Novartis AG | Treatment of fibrosis |
| UA118441C2 (uk) | 2012-10-08 | 2019-01-25 | Протена Біосаєнсиз Лімітед | Антитіло, що розпізнає альфа-синуклеїн |
| MX2015012563A (es) * | 2013-03-15 | 2016-10-26 | Abbvie Biotechnology Ltd | Anticuerpos anti-cd25 y sus usos. |
| HK1220470A1 (zh) * | 2013-03-15 | 2017-05-05 | Abbvie Biotechnology Ltd. | 抗cd25抗体及其用途 |
| US10513555B2 (en) | 2013-07-04 | 2019-12-24 | Prothena Biosciences Limited | Antibody formulations and methods |
| US11097005B2 (en) * | 2014-12-15 | 2021-08-24 | The Brigham And Women's Hospital, Inc. | Use of cadherin-11 antagonists to treat metabolic disorders and/or increase insulin sensitivity |
| CN113817059B (zh) * | 2016-01-09 | 2024-03-08 | 嘉立医疗科技(广州)有限公司 | 用于癌症治疗的钙粘蛋白-17特异性抗体和细胞毒性细胞 |
| MX2021001268A (es) * | 2018-08-01 | 2021-09-08 | Imcheck Therapeutics Sas | Anticuerpos anti-btn3a y su uso en el tratamiento del cáncer o trastornos infecciosos. |
| CN113072633B (zh) * | 2021-04-21 | 2022-11-15 | 湖北医药学院 | Cdh11截短型变体及其应用 |
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