EP3849572A4 - METHOD OF TREATMENT OF IMMUNOTHERAPY-RELATED TOXICITY USING A GM-CSF ANTAGONIST - Google Patents

METHOD OF TREATMENT OF IMMUNOTHERAPY-RELATED TOXICITY USING A GM-CSF ANTAGONIST Download PDF

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Publication number
EP3849572A4
EP3849572A4 EP19860890.3A EP19860890A EP3849572A4 EP 3849572 A4 EP3849572 A4 EP 3849572A4 EP 19860890 A EP19860890 A EP 19860890A EP 3849572 A4 EP3849572 A4 EP 3849572A4
Authority
EP
European Patent Office
Prior art keywords
methods
related toxicity
csf antagonist
immunotherapy
treating
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19860890.3A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3849572A2 (en
Inventor
Cameron DURRANT
Dale CHAPPELL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Humanigen Inc
Original Assignee
Humanigen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/149,346 external-priority patent/US10870703B2/en
Priority claimed from US16/204,220 external-priority patent/US10899831B2/en
Priority claimed from US16/248,762 external-priority patent/US10927168B2/en
Priority claimed from US16/283,694 external-priority patent/US11130805B2/en
Application filed by Humanigen Inc filed Critical Humanigen Inc
Publication of EP3849572A2 publication Critical patent/EP3849572A2/en
Publication of EP3849572A4 publication Critical patent/EP3849572A4/en
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/17—Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K39/0005—Vertebrate antigens
    • A61K39/0011—Cancer antigens
    • A61K39/001102—Receptors, cell surface antigens or cell surface determinants
    • A61K39/001111—Immunoglobulin superfamily
    • A61K39/001112—CD19 or B4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/10—Cellular immunotherapy characterised by the cell type used
    • A61K40/11—T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/30—Cellular immunotherapy characterised by the recombinant expression of specific molecules in the cells of the immune system
    • A61K40/31—Chimeric antigen receptors [CAR]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
    • A61K40/41—Vertebrate antigens
    • A61K40/42—Cancer antigens
    • A61K40/4202—Receptors, cell surface antigens or cell surface determinants
    • A61K40/4203—Receptors for growth factors
    • A61K40/4205—Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ ErbB4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
    • A61K40/41—Vertebrate antigens
    • A61K40/42—Cancer antigens
    • A61K40/4202—Receptors, cell surface antigens or cell surface determinants
    • A61K40/421—Immunoglobulin superfamily
    • A61K40/4211—CD19 or B4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
    • A61K40/41—Vertebrate antigens
    • A61K40/42—Cancer antigens
    • A61K40/4202—Receptors, cell surface antigens or cell surface determinants
    • A61K40/4224—Molecules with a "CD" designation not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/005—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243—Colony Stimulating Factors
    • 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
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55516—Proteins; Peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/31—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterized by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/38—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the cancer treated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the cancer treated
    • A61K2239/48—Blood cells, e.g. leukemia or lymphoma
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Virology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Biomedical Technology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
EP19860890.3A 2018-09-10 2019-09-10 METHOD OF TREATMENT OF IMMUNOTHERAPY-RELATED TOXICITY USING A GM-CSF ANTAGONIST Pending EP3849572A4 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201862729043P 2018-09-10 2018-09-10
US16/149,346 US10870703B2 (en) 2017-10-02 2018-10-02 Methods of treating immunotherapy-related toxicity using a GM-CSF antagonist
PCT/US2018/053933 WO2019070680A2 (en) 2017-10-02 2018-10-02 METHODS OF TREATING IMMUNOTHERAPY-RELATED TOXICITY USING GM-CSF ANTAGONIST
US16/204,220 US10899831B2 (en) 2017-10-02 2018-11-29 Method of reducing the level of non-GM-CSF cytokines/chemokines in immunotherapy-related toxicity
US16/248,762 US10927168B2 (en) 2017-10-02 2019-01-15 Method of reducing tumor relapse rate in immunotherapy by administration of lenzilumab
US16/283,694 US11130805B2 (en) 2017-10-02 2019-02-22 Methods of treating CART-T cell therapy-induced neuroinflammation using a GM-CSF antagonist
PCT/US2019/050494 WO2020055932A2 (en) 2018-09-10 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist

Publications (2)

Publication Number Publication Date
EP3849572A2 EP3849572A2 (en) 2021-07-21
EP3849572A4 true EP3849572A4 (en) 2022-07-13

Family

ID=69778357

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19860890.3A Pending EP3849572A4 (en) 2018-09-10 2019-09-10 METHOD OF TREATMENT OF IMMUNOTHERAPY-RELATED TOXICITY USING A GM-CSF ANTAGONIST

Country Status (11)

Country Link
EP (1) EP3849572A4 (https=)
JP (1) JP2022517461A (https=)
KR (1) KR20210075090A (https=)
CN (1) CN113164520A (https=)
AU (1) AU2019340662A1 (https=)
BR (1) BR112021004489A2 (https=)
CA (1) CA3111804A1 (https=)
IL (1) IL281243A (https=)
MX (1) MX2021002856A (https=)
SG (1) SG11202102317PA (https=)
WO (1) WO2020055932A2 (https=)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240158467A1 (en) * 2018-10-31 2024-05-16 Humanigen, Inc. Materials and methods for treating cancer
AU2020232691B2 (en) 2019-03-05 2023-06-29 Nkarta, Inc. CD19-directed chimeric antigen receptors and uses thereof in immunotherapy
CN118949031A (zh) * 2019-06-03 2024-11-15 基尼克萨制药股份有限公司 用gm-csf拮抗剂治疗癌症
WO2021204649A1 (en) * 2020-04-06 2021-10-14 Glaxosmithkline Intellectual Property Development Limited Gm-csf antagonists for use in the treatment of severe pulmonary covid-19, cytokine release syndrome and/or acute respiratory distress syndrome
CN113402620B (zh) * 2021-07-30 2021-12-10 中山大学 细胞因子联合嵌合抗原受体的融合蛋白及其应用
CN116887856A (zh) * 2022-01-20 2023-10-13 舒泰神（北京）生物制药股份有限公司 一种特异性地识别粒细胞-巨噬细胞集落刺激因子受体的抗体制剂及其应用
CN114606237B (zh) * 2022-05-11 2025-10-28 上海优替济生生物医药有限公司 Gm-csf抑制剂及其用途
CN119144563B (zh) * 2023-11-24 2025-11-25 成都赛恩吉诺生物科技有限公司 表达gm-csf截短功能区片段的免疫工程细胞及应用

Citations (3)

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WO2009134805A2 (en) * 2008-04-28 2009-11-05 Kalobios Pharmaceuticals, Inc. Antibodies to granulocyte-macrophage colony-stimulating factor
WO2014011984A1 (en) * 2012-07-13 2014-01-16 The Trustees Of The University Of Pennsylvania Toxicity management for anti-tumor activity of cars
WO2015066262A1 (en) * 2013-11-04 2015-05-07 Trustees Of Dartmouth College Methods for preventing toxicity of adoptive cell therapy

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US8398972B2 (en) * 2006-11-21 2013-03-19 Kalobios Pharmaceuticals, Inc. Methods of treating dementia using a GM-CSF antagonist
US20160024200A1 (en) * 2013-03-14 2016-01-28 John Schrader Human monoclonal antibodies that neutralize bioactivity of granulocyte macrophage colony-stimulating factor and methods and uses thereof
US20190292246A1 (en) * 2016-11-03 2019-09-26 Juno Therapeutics, Inc. Combination therapy of a cell based therapy and a microglia imhibitor
EP3691663A4 (en) * 2017-10-02 2021-08-18 Humanigen, Inc. METHODS OF TREATMENT OF TOXICITY ASSOCIATED WITH IMMUNOTHERAPIES USING A GM-CSF ANTAGONIST
US10899831B2 (en) * 2017-10-02 2021-01-26 Humanigen, Inc. Method of reducing the level of non-GM-CSF cytokines/chemokines in immunotherapy-related toxicity
JP7411578B2 (ja) * 2018-06-01 2024-01-11 マヨ ファウンデーション フォー メディカル エデュケーション アンド リサーチ 癌を治療するための物質及び方法

Patent Citations (3)

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WO2009134805A2 (en) * 2008-04-28 2009-11-05 Kalobios Pharmaceuticals, Inc. Antibodies to granulocyte-macrophage colony-stimulating factor
WO2014011984A1 (en) * 2012-07-13 2014-01-16 The Trustees Of The University Of Pennsylvania Toxicity management for anti-tumor activity of cars
WO2015066262A1 (en) * 2013-11-04 2015-05-07 Trustees Of Dartmouth College Methods for preventing toxicity of adoptive cell therapy

Non-Patent Citations (4)

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Title
D. W. LEE ET AL: "Current concepts in the diagnosis and management of cytokine release syndrome", BLOOD, vol. 124, no. 2, 29 May 2014 (2014-05-29), US, pages 188 - 195, XP055313556, ISSN: 0006-4971, DOI: 10.1182/blood-2014-05-552729 *
JULIANE GUST ET AL: "Endothelial Activation and Blood?Brain Barrier Disruption in Neurotoxicity after Adoptive Immunotherapy with CD19 CAR-T Cells", CANCER DISCOVERY, vol. 7, no. 12, 26 March 2018 (2018-03-26), US, pages 1404 - 1419, XP055462614, ISSN: 2159-8274, DOI: 10.1158/2159-8290.CD-17-0698 *
SATTVA S. NEELAPU ET AL: "Chimeric antigen receptor T-cell therapy - assessment and management of toxicities", NATURE REVIEWS CLINICAL ONCOLOGY, vol. 15, no. 1, 19 September 2017 (2017-09-19), NY, US, pages 47 - 62, XP055541211, ISSN: 1759-4774, DOI: 10.1038/nrclinonc.2017.148 *
SENTMAN MARIE-LOUISE ET AL: "Mechanisms of Acute Toxicity in NKG2D Chimeric Antigen Receptor T Cell-Treated Mice", THE JOURNAL OF IMMUNOLOGY (1950), 15 December 2016 (2016-12-15), United States, pages 4674 - 4685, XP055823799, Retrieved from the Internet <URL:https://www.jimmunol.org/content/jimmunol/early/2016/11/12/jimmunol.1600769.full.pdf?with-ds=yes> [retrieved on 20210713], DOI: 10.4049/jimmunol.1600769 *

Also Published As

Publication number Publication date
EP3849572A2 (en) 2021-07-21
MX2021002856A (es) 2021-05-28
IL281243A (en) 2021-04-29
BR112021004489A2 (pt) 2021-07-20
CA3111804A1 (en) 2020-03-19
WO2020055932A2 (en) 2020-03-19
CN113164520A (zh) 2021-07-23
AU2019340662A1 (en) 2021-05-06
WO2020055932A9 (en) 2020-07-09
SG11202102317PA (en) 2021-04-29
WO2020055932A3 (en) 2020-05-22
KR20210075090A (ko) 2021-06-22
JP2022517461A (ja) 2022-03-09

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