ES2601149T3 - Productos génicos de expresión diferencial en tumores y su uso - Google Patents

Productos génicos de expresión diferencial en tumores y su uso Download PDF

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Publication number
ES2601149T3
ES2601149T3 ES05745559.4T ES05745559T ES2601149T3 ES 2601149 T3 ES2601149 T3 ES 2601149T3 ES 05745559 T ES05745559 T ES 05745559T ES 2601149 T3 ES2601149 T3 ES 2601149T3
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Prior art keywords
tumors
expression
gene products
differential expression
associated antigen
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Expired - Lifetime
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ES05745559.4T
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English (en)
Inventor
Özlem TÜRECI
Ugur Sahin
Michael Koslowski
Stefan Fritz
Harald-Gerhard Geppert
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Ganymed Pharmaceuticals GmbH
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Ganymed Pharmaceuticals GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • 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
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • 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
    • 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
    • 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
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/303—Liver or Pancreas
    • 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
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3046—Stomach, Intestines
    • 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
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/44—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/88—Lyases (4.)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y406/00—Phosphorus-oxygen lyases (4.6)
    • C12Y406/01—Phosphorus-oxygen lyases (4.6.1)
    • C12Y406/01002—Guanylate cyclase (4.6.1.2)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/575—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/5758—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites
    • G01N33/57595—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites involving intracellular compounds
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • 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
    • 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
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • C07K2317/75—Agonist effect on antigen

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Physics & Mathematics (AREA)
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  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
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Abstract

Composición farmacéutica para su uso en un tratamiento de un adenocarcinoma del estómago que se distingue por la expresión de un antígeno asociado a un tumor, en la que la composición farmacéutica comprende un anticuerpo que se une de forma específica al antígeno asociado al tumor, en la que el antígeno asociado al tumor presenta una secuencia de aminoácidos que es codificada por una secuencia de ácido nucleico según la SEQ ID NO: 7 u 8.

Description

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Tabla 1A. Expresión de la claudina 18A2 en tejidos normales y tumorales
Tejido normal
Expresión
Cerebro
-
Cerebelo
-
Miocardio
-
Músculo esquelético
-
Endometrio
-
Estómago
+++
Colon
-
Páncreas
-
Riñón
-
Hígado
-
Testículo (teste)
+
Timo
-
Mama
-
Ovario
-
Útero
-
Piel
-
Pulmón
-
Glándula tiroides
-
Ganglio linfático
-
Bazo
-
PBMC
-
Esófago
-
Tipo de tumor
Expresión
Colon
-
Páncreas
++
Esófago
++
Estómago
+++
Pulmón
++
Mama
-
Ovario
-
Endometrio
n. a.
CCC
++
Riñón
-
Próstata
-
32
Tabla 1B. Expresión de la claudina 18A1 en tejidos normales y tumorales
Tejido normal
Expresión
Cerebro
-
Cerebelo
-
Miocardio
-
Músculo
-
Endometrio
-
Estómago
+++
Colon
-
Páncreas
-
Riñón
-
Hígado
-
Testículo
+
Timo
-
Mama
-
Ovario
-
Útero
-
Piel
-
Pulmón
+++
Glándula tiroides
-
Ganglio linfático
-
Bazo
-
PBMC
-
Esófago
-
Tipo de tumor
Expresión
Colon
-
Páncreas
++
Esófago
++
Estómago
+++
Pulmón
++
Mama
+
Ovario
n. a.
Endometrio
n. a.
CCC
++
Riñón
-
Próstata
++
La PCR convencional como análisis de control independiente también confirmó los resultados de la PCR cuantitativa. Para ello se utilizaron oligonucleótidos (SEQ ID NO: 39, 40) que permiten una amplificación específica de la variante de corte y empalme A2. Se mostró que la mayoría de los tumores gástricos y la mitad de los tumores 5 de páncreas analizados presentan una fuerte expresión de estas variantes de corte y empalme (Fig. 1). Por el contrario, no se puede detectar una expresión en otros tejidos con la PCR convencional. Particularmente, no se encuentra ninguna expresión en los tejidos normales importantes, como pulmón, hígado, sangre, ganglios linfáticos, mama y riñón (Tabla 1). En este aspecto, las variantes de corte y empalme representan marcadores moleculares altamente específicos de tumores del tracto gastrointestinal superior, así como tumores de pulmón, 10 tumores de cabeza y cuello, tumores de próstata y sus metástasis. Estos marcadores moleculares se pueden usar según la invención para detectar células tumorales. La detección de los tumores se puede efectuar con los
33
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Claims (1)

  1. imagen1
ES05745559.4T 2004-05-18 2005-05-18 Productos génicos de expresión diferencial en tumores y su uso Expired - Lifetime ES2601149T3 (es)

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Application Number Priority Date Filing Date Title
DE102004024617 2004-05-18
DE102004024617A DE102004024617A1 (de) 2004-05-18 2004-05-18 Differentiell in Tumoren exprimierte Genprodukte und deren Verwendung
PCT/EP2005/005410 WO2005113587A2 (de) 2004-05-18 2005-05-18 Differentiell in tumoren exprimierte genprodukte und deren verwendung

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ES2601149T3 true ES2601149T3 (es) 2017-02-14

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ES18167570T Expired - Lifetime ES2847025T3 (es) 2004-05-18 2005-05-18 Productos génicos de expresión diferencial en tumores y su uso
ES11002017.9T Expired - Lifetime ES2627962T3 (es) 2004-05-18 2005-05-18 Productos génicos de expresión diferencial en tumores y su uso
ES05745559.4T Expired - Lifetime ES2601149T3 (es) 2004-05-18 2005-05-18 Productos génicos de expresión diferencial en tumores y su uso
ES11002013.8T Expired - Lifetime ES2675558T3 (es) 2004-05-18 2005-05-18 Productos génicos de expresión diferencial en tumores y su uso

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US (4) US9044382B2 (es)
EP (7) EP2383288A3 (es)
JP (5) JP5242160B2 (es)
AU (1) AU2005245593B2 (es)
CA (2) CA2563666C (es)
CY (4) CY1118271T1 (es)
DE (1) DE102004024617A1 (es)
DK (4) DK1749027T3 (es)
ES (4) ES2847025T3 (es)
HR (4) HRP20161449T1 (es)
HU (4) HUE035289T2 (es)
LT (4) LT1749027T (es)
ME (2) ME02653B (es)
PL (4) PL3401327T3 (es)
PT (4) PT2380903T (es)
RS (4) RS61395B1 (es)
SI (4) SI2380903T1 (es)
TR (1) TR201809165T4 (es)
WO (1) WO2005113587A2 (es)

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DE102004024617A1 (de) 2004-05-18 2005-12-29 Ganymed Pharmaceuticals Ag Differentiell in Tumoren exprimierte Genprodukte und deren Verwendung
EP1790664A1 (en) 2005-11-24 2007-05-30 Ganymed Pharmaceuticals AG Monoclonal antibodies against claudin-18 for treatment of cancer
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EP2060583A1 (en) 2007-10-23 2009-05-20 Ganymed Pharmaceuticals AG Identification of tumor-associated markers for diagnosis and therapy
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WO2013167153A1 (en) 2012-05-09 2013-11-14 Ganymed Pharmaceuticals Ag Antibodies useful in cancer diagnosis
WO2013174404A1 (en) 2012-05-23 2013-11-28 Ganymed Pharmaceuticals Ag Combination therapy involving antibodies against claudin 18.2 for treatment of cancer
CN105073776B (zh) 2012-11-13 2019-04-12 拜恩科技股份公司 用于治疗表达紧密连接蛋白的癌症疾病的制剂
WO2014127785A1 (en) 2013-02-20 2014-08-28 Ganymed Pharmaceuticals Ag Combination therapy involving antibodies against claudin 18.2 for treatment of cancer
WO2014146672A1 (en) 2013-03-18 2014-09-25 Ganymed Pharmaceuticals Ag Therapy involving antibodies against claudin 18.2 for treatment of cancer
CN120329449A (zh) * 2014-07-17 2025-07-18 恺兴生命科技(上海)有限公司 靶向cld18a2的t淋巴细胞及其制备方法和应用
WO2016165762A1 (en) * 2015-04-15 2016-10-20 Ganymed Pharmaceuticals Ag Drug conjugates comprising antibodies against claudin 18.2
WO2016180468A1 (en) * 2015-05-11 2016-11-17 Biontech Cell & Gene Therapies Gmbh Claudin-18.2-specific immunoreceptors and t cell epitopes
KR20210013013A (ko) 2018-03-09 2021-02-03 카르스젠 테라퓨틱스 리미티드 종양 치료 방법 및 조성물
JP7458399B2 (ja) * 2018-12-07 2024-03-29 ゼットリップ ホールディング リミテッド 抗クローディン抗体及びそれらの使用
SG11202108398YA (en) 2019-02-01 2021-08-30 Novarock Biotherapeutics Ltd Anti-claudin 18 antibodies and methods of use thereof
EP4069738A1 (en) 2019-12-06 2022-10-12 SOTIO Biotech a.s. Humanized cldn18.2 antibodies
AU2020410998A1 (en) 2019-12-23 2022-06-16 Sotio Biotech A.S. Tumor-specific Claudin 18.2 antibodies
WO2022122709A1 (en) 2020-12-07 2022-06-16 Sotio Biotech A.S. Antibody-drug conjugates based on humanized cldn18.2 antibodies
CN116635085A (zh) 2020-12-23 2023-08-22 斯迪安生物技术公司 肿瘤特异性密蛋白18.2抗体-药物缀合物

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