WO2018013855A3 - Il-15/il-15 receptor alpha treatment regimens and use with therapeutic vaccines - Google Patents

Il-15/il-15 receptor alpha treatment regimens and use with therapeutic vaccines Download PDF

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Publication number
WO2018013855A3
WO2018013855A3 PCT/US2017/042002 US2017042002W WO2018013855A3 WO 2018013855 A3 WO2018013855 A3 WO 2018013855A3 US 2017042002 W US2017042002 W US 2017042002W WO 2018013855 A3 WO2018013855 A3 WO 2018013855A3
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WO
WIPO (PCT)
Prior art keywords
treatment regimens
receptor alpha
therapeutic vaccines
alpha treatment
patient
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PCT/US2017/042002
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French (fr)
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WO2018013855A2 (en
Inventor
Barbara K. Felber
George N. Pavlakis
Antonio Valentin
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The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services
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Application filed by The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services filed Critical The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services
Publication of WO2018013855A2 publication Critical patent/WO2018013855A2/en
Publication of WO2018013855A3 publication Critical patent/WO2018013855A3/en

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    • 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
    • A61K38/20—Interleukins [IL]
    • A61K38/2086—IL-13 to IL-16
    • 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
    • A61K39/12—Viral antigens
    • 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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • 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
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5011—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics for testing antineoplastic activity
    • 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
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G01N33/57492—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds localized on the membrane of tumor or cancer cells
    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • G01N33/6869—Interleukin
    • 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
    • A61K2039/55522—Cytokines; Lymphokines; Interferons
    • A61K2039/55527—Interleukins
    • 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
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/15011—Lentivirus, not HIV, e.g. FIV, SIV
    • C12N2740/15034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • C12N2740/00—Reverse transcribing RNA viruses
    • C12N2740/00011—Details
    • C12N2740/10011—Retroviridae
    • C12N2740/16011—Human Immunodeficiency Virus, HIV
    • C12N2740/16211—Human Immunodeficiency Virus, HIV concerning HIV gagpol
    • C12N2740/16234—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/521—Chemokines
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/5443—IL-15
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/55—IL-2

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Virology (AREA)
  • Microbiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oncology (AREA)
  • Pathology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biotechnology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Organic Chemistry (AREA)
  • Mycology (AREA)
  • Communicable Diseases (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Zoology (AREA)
  • AIDS & HIV (AREA)
  • Gastroenterology & Hepatology (AREA)

Abstract

The invention provides dose escalation regimens for administering IL-15/IL-15Ra in a Fibonacci series to a patient suffering from lymphocytopenia, cancer, or an infectious disease. The inventionfurther provides methods for monitoring treatment of a patient with IL-15.
PCT/US2017/042002 2016-07-14 2017-07-13 Il-15/il-15 receptor alpha treatment regimens and use with therapeutic vaccines WO2018013855A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662362223P 2016-07-14 2016-07-14
US62/362,223 2016-07-14

Publications (2)

Publication Number Publication Date
WO2018013855A2 WO2018013855A2 (en) 2018-01-18
WO2018013855A3 true WO2018013855A3 (en) 2018-02-15

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PCT/US2017/042002 WO2018013855A2 (en) 2016-07-14 2017-07-13 Il-15/il-15 receptor alpha treatment regimens and use with therapeutic vaccines

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Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3024509A1 (en) 2016-05-18 2017-11-23 Modernatx, Inc. Mrna combination therapy for the treatment of cancer
WO2023086772A1 (en) 2021-11-12 2023-05-19 Xencor, Inc. Bispecific antibodies that bind to b7h3 and nkg2d
WO2024102636A1 (en) 2022-11-07 2024-05-16 Xencor, Inc. Bispecific antibodies that bind to b7h3 and mica/b

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090238791A1 (en) * 2005-10-20 2009-09-24 Institut National De La Sante Et De La Recherche Medicale Il-15ralpha sushi domain as a selective and potent enhancer of il-15 action through il-15beta/gamma, and hyperagonist (il-15ralpha sushi - il-15) fusion proteins
WO2011020047A1 (en) * 2009-08-14 2011-02-17 The Government Of The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Use of il-15 to increase thymic output and to treat lymphopenia
US20150359853A1 (en) * 2012-10-24 2015-12-17 Admune Therapeutics Llc Il-15r alpha forms, cells expressing il-15r alpha forms, and therapeutic uses of il-15r alpha and il-15/il-15r alpha complexes
WO2016018920A1 (en) * 2014-07-29 2016-02-04 Admune Therapeutics Llc Il-15 and il-15ralpha heterodimer dose escalation regimens for treating conditions

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US6174666B1 (en) 1992-03-27 2001-01-16 The United States Of America As Represented By The Department Of Health And Human Services Method of eliminating inhibitory/instability regions from mRNA
US9068234B2 (en) 2003-01-21 2015-06-30 Ptc Therapeutics, Inc. Methods and agents for screening for compounds capable of modulating gene expression
NZ569541A (en) 2006-01-13 2012-05-25 Us Gov Health & Human Serv Codon optimized IL-15 and IL-15R-alpha genes for expression in mammalian cells
CN108948177B (en) 2007-05-11 2022-04-22 阿尔托生物科学有限公司 Fusion molecules and IL-15 variants
KR101577849B1 (en) 2008-08-22 2015-12-15 마그나 시팅 인크. Disc recliner with reduced backlash
WO2013131099A1 (en) 2012-03-02 2013-09-06 The Government Of The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Method of altering the immundominance hierarchy of hiv gag by dna vaccine expressing conserved regions

Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
US20090238791A1 (en) * 2005-10-20 2009-09-24 Institut National De La Sante Et De La Recherche Medicale Il-15ralpha sushi domain as a selective and potent enhancer of il-15 action through il-15beta/gamma, and hyperagonist (il-15ralpha sushi - il-15) fusion proteins
WO2011020047A1 (en) * 2009-08-14 2011-02-17 The Government Of The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Use of il-15 to increase thymic output and to treat lymphopenia
US20150359853A1 (en) * 2012-10-24 2015-12-17 Admune Therapeutics Llc Il-15r alpha forms, cells expressing il-15r alpha forms, and therapeutic uses of il-15r alpha and il-15/il-15r alpha complexes
WO2016018920A1 (en) * 2014-07-29 2016-02-04 Admune Therapeutics Llc Il-15 and il-15ralpha heterodimer dose escalation regimens for treating conditions

Non-Patent Citations (2)

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Title
MORTIER ERWAN ET AL: "Soluble interleukin-15 receptor alpha (IL-15R alpha)-sushi as a selective and potent agonist of IL-15 action through IL-15R beta/gamma. Hyperagonist IL-15 x IL-15R alpha fusion proteins", JOURNAL OF BIOLOGICAL CHEMISTRY, AMERICAN SOCIETY FOR BIOCHEMISTRY AND MOLECULAR BIOLOGY, US, vol. 281, no. 3, 20 January 2006 (2006-01-20), pages 1612 - 1619, XP002394330, ISSN: 0021-9258, DOI: 10.1074/JBC.M508624200 *
NICOLAS PENEL ET AL: "What does a modified-Fibonacci dose-escalation actually correspond to?", BMC MEDICAL RESEARCH METHODOLOGY, BIOMED CENTRAL, LONDON, GB, vol. 12, no. 1, 23 July 2012 (2012-07-23), pages 103, XP021135004, ISSN: 1471-2288, DOI: 10.1186/1471-2288-12-103 *

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