AU2009243184B2 - Antibodies to granulocyte-macrophage colony-stimulating factor - Google Patents

Antibodies to granulocyte-macrophage colony-stimulating factor Download PDF

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Publication number
AU2009243184B2
AU2009243184B2 AU2009243184A AU2009243184A AU2009243184B2 AU 2009243184 B2 AU2009243184 B2 AU 2009243184B2 AU 2009243184 A AU2009243184 A AU 2009243184A AU 2009243184 A AU2009243184 A AU 2009243184A AU 2009243184 B2 AU2009243184 B2 AU 2009243184B2
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Australia
Prior art keywords
antibody
seq
sequence
region
csf
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AU2009243184A
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English (en)
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AU2009243184A1 (en
Inventor
Christopher R. Bebbington
Kenneth Luehrsen
Geoffrey T. Yarranton
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Humanigen Inc
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Humanigen Inc
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Assigned to HUMANIGEN, INC. reassignment HUMANIGEN, INC. Request to Amend Deed and Register Assignors: KALOBIOS PHARMACEUTICALS, INC.
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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • 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
    • A61P17/04—Antipruritics
    • 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
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • 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
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • 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
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • C07K2317/50—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]
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Pulmonology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Transplantation (AREA)
  • Ophthalmology & Optometry (AREA)
  • Psychiatry (AREA)
  • Obesity (AREA)
AU2009243184A 2008-04-28 2009-04-28 Antibodies to granulocyte-macrophage colony-stimulating factor Active AU2009243184B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US4852208P 2008-04-28 2008-04-28
US61/048,522 2008-04-28
PCT/US2009/041981 WO2009134805A2 (en) 2008-04-28 2009-04-28 Antibodies to granulocyte-macrophage colony-stimulating factor

Publications (2)

Publication Number Publication Date
AU2009243184A1 AU2009243184A1 (en) 2009-11-05
AU2009243184B2 true AU2009243184B2 (en) 2015-06-04

Family

ID=41255734

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2009243184A Active AU2009243184B2 (en) 2008-04-28 2009-04-28 Antibodies to granulocyte-macrophage colony-stimulating factor

Country Status (17)

Country Link
US (3) US8168183B2 (enExample)
EP (2) EP3449941A1 (enExample)
JP (1) JP5688363B2 (enExample)
KR (2) KR101824512B1 (enExample)
CN (1) CN102037016B (enExample)
AU (1) AU2009243184B2 (enExample)
BR (1) BRPI0911902A2 (enExample)
CA (1) CA2722137C (enExample)
CO (1) CO6311004A2 (enExample)
DK (1) DK2280732T3 (enExample)
EA (1) EA201001691A1 (enExample)
ES (1) ES2704835T3 (enExample)
IL (1) IL208980A (enExample)
MX (1) MX2010011761A (enExample)
NZ (1) NZ588850A (enExample)
WO (1) WO2009134805A2 (enExample)
ZA (1) ZA201008028B (enExample)

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EP2064325B1 (en) 2006-09-01 2011-12-07 Therapeutic Human Polyclonals, Inc. Enhanced expression of human or humanized immunoglobulin in non-human transgenic animals
TW200918553A (en) 2007-09-18 2009-05-01 Amgen Inc Human GM-CSF antigen binding proteins
KR101824512B1 (ko) 2008-04-28 2018-02-02 휴머니건, 아이엔씨. 과립구-대식세포 콜로니 자극 인자에 대한 항체
EP3381471B1 (en) 2008-12-22 2024-03-20 The University of Melbourne Pain treatment
DK2376121T4 (da) 2008-12-22 2021-08-16 Univ Melbourne Slidgigtbehandling
US8512950B2 (en) 2010-07-21 2013-08-20 Saint Louis University Biolayer interferometry measurement of biological targets
BR112013033944A2 (pt) 2011-07-06 2017-12-19 Morphosys Ag combinação sinérgica
US9400600B2 (en) * 2011-12-16 2016-07-26 Samsung Electronics Co., Ltd. Method, apparatus, and graphical user interface for providing visual effects on a touchscreen display
WO2013090989A1 (en) 2011-12-22 2013-06-27 Csl Limited Method of treating inflammatory bowel disease
US9833410B2 (en) 2012-10-31 2017-12-05 Takeda Gmbh Lyophilized formulation comprising GM-CSF neutralizing compound
AR093297A1 (es) 2012-10-31 2015-05-27 Amgen Res Munich Gmbh Formulacion liquida que comprende un compuesto neutralizante de gm-csf
RU2714919C2 (ru) * 2013-08-30 2020-02-21 Такеда Гмбх Антитела, нейтрализующие gm-csf, для применения в лечении ревматоидного артрита или в качестве анальгетиков
US11173208B2 (en) 2014-05-07 2021-11-16 Takeda Gmbh Liquid formulation comprising GM-CSF neutralizing compound
HK1258306A1 (zh) * 2015-10-29 2019-11-08 F. Hoffmann-La Roche Ag 具有共同轻链的转基因兔
US11130805B2 (en) 2017-10-02 2021-09-28 Humanigen, Inc. Methods of treating CART-T cell therapy-induced neuroinflammation using a GM-CSF antagonist
CN111757744A (zh) * 2017-10-02 2020-10-09 人源股份有限公司 使用gm-csf拮抗剂治疗免疫疗法相关毒性的方法
EP3849572A4 (en) * 2018-09-10 2022-07-13 Humanigen, Inc. METHOD OF TREATMENT OF IMMUNOTHERAPY-RELATED TOXICITY USING A GM-CSF ANTAGONIST
US12624086B2 (en) 2018-10-31 2026-05-12 Mayo Foundation For Medical Education And Research Materials and methods for treating cancer
EP4054602A4 (en) 2019-11-08 2023-12-06 Mayo Foundation for Medical Education and Research EPHA3 TARGETED CAR-T CELLS FOR TREATING TUMORS
CN118561999B (zh) * 2024-06-26 2025-03-14 武汉爱博泰克生物科技有限公司 抗人粒细胞-巨噬细胞集落刺激因子抗体、抗体对及其应用

Citations (2)

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WO2003068920A2 (en) * 2002-02-13 2003-08-21 Ludwig Institute For Cancer Research Humanized gm-csf antibodies
WO2009126659A1 (en) * 2008-04-07 2009-10-15 Kalobios Pharmaceuticals, Inc. Neutralization of gm-csf for the treatment of heart failure

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CN1678634A (zh) * 2002-06-28 2005-10-05 多曼蒂斯有限公司 免疫球蛋白单个变体抗原结合区及其特异性构建体
WO2004065417A2 (en) * 2003-01-23 2004-08-05 Genentech, Inc. Methods for producing humanized antibodies and improving yield of antibodies or antigen binding fragments in cell culture
GB0303337D0 (en) * 2003-02-13 2003-03-19 Celltech R&D Ltd Biological products
US7981843B2 (en) 2004-01-20 2011-07-19 Kalobios Pharmaceuticals, Inc. Antibody specificity transfer using minimal essential binding determinants
PL2343380T3 (pl) * 2004-11-16 2020-03-31 Humanigen, Inc. Wymiana kasety dla regionu zmiennego immunoglobuliny
US7381802B2 (en) * 2005-04-15 2008-06-03 Universidad Nacional Autónoma De México (UNAM) Human antibodies that specifically recognize the toxin Cn2 from Centruroides noxius scorpion venom
MX2007012569A (es) * 2005-04-18 2007-12-06 Micromet Ag Neutralizadores de anticuerpos del factor estimulante de la colonia de macrofagos-granulocitos humanos.
ES2918209T3 (es) * 2005-05-18 2022-07-14 Morphosys Ag Anticuerpos anti-GM-CSF y usos a partir de los mismos
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WO2007019620A1 (en) * 2005-08-15 2007-02-22 Arana Therapeutics Limited Engineered antibodies with new world primate framework regions
KR101395515B1 (ko) * 2006-02-08 2014-05-14 모르포테크, 인크. 항원성 ｇｍ-ｃｓｆ 펩티드 및 ｇｍ-ｃｓｆ에 대한 항체
US8398972B2 (en) * 2006-11-21 2013-03-19 Kalobios Pharmaceuticals, Inc. Methods of treating dementia using a GM-CSF antagonist
US20080206241A1 (en) * 2006-11-21 2008-08-28 Kalobios Pharmaceuticals Inc. Methods of Treating Chronic Inflammatory Diseases Using a GM-CSF Antagonist
TW200918553A (en) 2007-09-18 2009-05-01 Amgen Inc Human GM-CSF antigen binding proteins
KR101824512B1 (ko) 2008-04-28 2018-02-02 휴머니건, 아이엔씨. 과립구-대식세포 콜로니 자극 인자에 대한 항체

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
WO2003068920A2 (en) * 2002-02-13 2003-08-21 Ludwig Institute For Cancer Research Humanized gm-csf antibodies
WO2009126659A1 (en) * 2008-04-07 2009-10-15 Kalobios Pharmaceuticals, Inc. Neutralization of gm-csf for the treatment of heart failure

Also Published As

Publication number Publication date
KR101852915B1 (ko) 2018-04-27
KR20110011638A (ko) 2011-02-08
NZ588850A (en) 2012-12-21
CA2722137C (en) 2019-03-19
IL208980A (en) 2015-06-30
AU2009243184A1 (en) 2009-11-05
CA2722137A1 (en) 2009-11-05
EA201001691A1 (ru) 2011-10-31
ZA201008028B (en) 2012-04-25
IL208980A0 (en) 2011-01-31
EP3449941A1 (en) 2019-03-06
US20120213776A1 (en) 2012-08-23
EP2280732A2 (en) 2011-02-09
CN102037016B (zh) 2015-06-03
JP2011518886A (ja) 2011-06-30
WO2009134805A2 (en) 2009-11-05
US20150344565A1 (en) 2015-12-03
CO6311004A2 (es) 2011-08-22
US8168183B2 (en) 2012-05-01
MX2010011761A (es) 2010-11-30
EP2280732B1 (en) 2018-10-17
EP2280732A4 (en) 2012-11-14
JP5688363B2 (ja) 2015-03-25
WO2009134805A3 (en) 2010-06-03
KR101824512B1 (ko) 2018-02-02
US9017674B2 (en) 2015-04-28
US20090274706A1 (en) 2009-11-05
BRPI0911902A2 (pt) 2015-10-13
CN102037016A (zh) 2011-04-27
DK2280732T3 (en) 2019-01-28
ES2704835T3 (es) 2019-03-20
KR20170126458A (ko) 2017-11-17

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Owner name: HUMANIGEN, INC.

Free format text: FORMER NAME(S): KALOBIOS PHARMACEUTICALS, INC.