WO2016022468A1 - Antagonistic anti-ox40l antibodies and methods of their use - Google Patents

Antagonistic anti-ox40l antibodies and methods of their use Download PDF

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Publication number
WO2016022468A1
WO2016022468A1 PCT/US2015/043408 US2015043408W WO2016022468A1 WO 2016022468 A1 WO2016022468 A1 WO 2016022468A1 US 2015043408 W US2015043408 W US 2015043408W WO 2016022468 A1 WO2016022468 A1 WO 2016022468A1
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WO
WIPO (PCT)
Prior art keywords
antibody
seq
ox40l
cells
amino acid
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.)
Ceased
Application number
PCT/US2015/043408
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English (en)
French (fr)
Inventor
Yong-Jun Liu
Sandra Zurawski
Sangkon Oh
Shino Hanabuchi
Haruyuki FUJITA
Hide Ueno
Patrick Blanco
HyeMee JOO
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Baylor Research Institute
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Baylor Research Institute
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Filing date
Publication date
Application filed by Baylor Research Institute filed Critical Baylor Research Institute
Priority to AU2015301338A priority Critical patent/AU2015301338C1/en
Priority to JP2017506286A priority patent/JP6628787B2/ja
Priority to CN201580052180.0A priority patent/CN107074951B/zh
Priority to US15/501,526 priority patent/US10167339B2/en
Priority to EP15829426.4A priority patent/EP3194445A4/en
Priority to CA2957314A priority patent/CA2957314C/en
Publication of WO2016022468A1 publication Critical patent/WO2016022468A1/en
Priority to IL250428A priority patent/IL250428B/en
Anticipated expiration legal-status Critical
Priority to US16/210,188 priority patent/US10570208B2/en
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • 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
    • 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
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular 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
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • 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
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/56—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

Definitions

  • the anti-OX40L antibody or antigen-binding fragment thereof comprises a sequence at least or at most 70%, 75%, 80%, 85%. 90%, 95%, or 99% (or any range derivable therein) identical to the VH or VL domain of the 19A3, 5C6, and 44F3 monoclonal antibodies.
  • the anti-OX40L antibody or antigen-binding fragment thereof comprises the VH domain from the 19A3, 5C6, or 44F3 monoclonal antibody and/or the VL domain the 19A3, 5C6, or 44F3 monoclonal antibody.
  • inflammatory Th2 cell responses for increasing IL-10 production and/or for reducing TNF-a production in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an OX40L inhibitor.
  • the inflammatory Th2 cell responses comprise IL-10 low/TNF-a hight producing inflammatory Th2 cells.
  • Chimeric, humanized or primatized antibodies of the present invention can be prepared based on the sequence of a reference monoclonal antibody prepared using standard molecular biology techniques.
  • DNA encoding the heavy and light chain immunoglobulins can be obtained from the hybridoma of interest and engineered to contain non-reference (e.g., human) immunoglobulin sequences using standard molecular biology techniques.
  • the murine variable regions can be linked to human constant regions using methods known in the art (U.S. Pat. No. 4,816,567).
  • the murine CDR regions can be inserted into a human framework using methods known in the art (U.S. Pat. No.
  • the functional nucleic acid molecules may act as effectors, inhibitors, modulators, and stimulators of a specific activity possessed by a target molecule, or the functional nucleic acid molecules may possess a de novo activity independent of any other molecules.
  • the conjugated agents can be linked to the antibody directly or indirectly, using any of a large number of available methods.
  • the antibodies of the invention may also be attached to solid supports, which are particularly useful for immunoassays or purification of the target antigen.
  • solid supports include, but are not limited to, glass, cellulose, polyacrylamide, nylon, polystyrene, polyvinyl chloride or polypropylene.
  • a siRNA directed to a gene or the mRNA of a gene may also be a siRNA that recognizes the mRNA and inhibits translation of the mRNA.
  • a siRNA may be chemically modified to increase its stability and safety. See, e.g. Dykxhoom & Lieberman, 2006 and U.S. Patent Application Publication No.: 2008/0249055.
  • modified oligonucleotides may be produced, including oligonucleotides having a peptide-nucleic acid (PNA) backbone (Nielsen et al., 1991) or incorporating 2'-0-methyl ribonucleotides, phosphorothioate nucleotides, methyl phosphonate nucleotides, phosphotriester nucleotides, phosphorothioate nucleotides, phosphoramidates.
  • PNA peptide-nucleic acid
  • Another example of the modification is replacement of a non-bridging phosphoryl oxygen atom with a sulfur atom which increases resistance to nuclease digestion.
  • the present invention includes methods and compositions for inhibiting OX40T in a subject in need thereof.
  • Administration of the compositions according to the present invention will typically be via any common route. This includes, but is not limited to parenteral, orthotopic, intradermal, subcutaneous, intramuscular, intraperitoneal, intranasal, or intravenous injection.
  • a vaccine composition may be inhaled (e.g., U.S. Pat. No. 6,651 ,655, which is specifically incorporated by reference). Additional formulations which are suitable for other modes of administration include oral formulations.
  • Oral formulations include such normally employed excipients as, for example, pharmaceutical grades of mannitol, lactose, starch, magnesium stearate, sodium saccharine, cellulose, magnesium carbonate and the like. These compositions take the form of solutions, suspensions, tablets, pills, capsules, sustained release formulations or powders and contain about 10% to about 95% of active ingredient, preferably about 25% to about 70%.
  • mDCs were cultured in RPMI+GlutaMAX (gibco), l OmM HEPES (gibco), Penicillin/Streptmycin/L-Glutamine (gibco), ImM Sodium Pyruvate (SIGMA) and MEM Non-Essential Amino Acids Solution (Hyclone) containing 10% human AB serum (GemCell#100-512).
  • Cells were seeded at a density of l-2xl 0 5 /200ul medium in flat- bottomed 96-well plate in the presence of 20 ng/ml recombinant human TSLP.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Obesity (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Endocrinology (AREA)
PCT/US2015/043408 2014-08-04 2015-08-03 Antagonistic anti-ox40l antibodies and methods of their use Ceased WO2016022468A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
AU2015301338A AU2015301338C1 (en) 2014-08-04 2015-08-03 Antagonistic anti-OX40L antibodies and methods of their use
JP2017506286A JP6628787B2 (ja) 2014-08-04 2015-08-03 拮抗性抗ｏｘ４０ｌ抗体およびそれらの使用方法
CN201580052180.0A CN107074951B (zh) 2014-08-04 2015-08-03 拮抗性抗-ox40l抗体及其使用方法
US15/501,526 US10167339B2 (en) 2014-08-04 2015-08-03 Antagonistic anti-OX40L antibodies and methods of their use
EP15829426.4A EP3194445A4 (en) 2014-08-04 2015-08-03 Antagonistic anti-ox40l antibodies and methods of their use
CA2957314A CA2957314C (en) 2014-08-04 2015-08-03 Antagonistic anti-ox40l antibodies and methods of their use
IL250428A IL250428B (en) 2014-08-04 2017-02-02 Anti-ox40l antagonist antibodies and methods of using them
US16/210,188 US10570208B2 (en) 2014-08-04 2018-12-05 Antagonistic anti-OX40L antibodies and methods of their use

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462032959P 2014-08-04 2014-08-04
US62/032,959 2014-08-04

Related Child Applications (2)

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US15/501,526 A-371-Of-International US10167339B2 (en) 2014-08-04 2015-08-03 Antagonistic anti-OX40L antibodies and methods of their use
US16/210,188 Division US10570208B2 (en) 2014-08-04 2018-12-05 Antagonistic anti-OX40L antibodies and methods of their use

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US (2) US10167339B2 (enExample)
EP (1) EP3194445A4 (enExample)
JP (1) JP6628787B2 (enExample)
CN (1) CN107074951B (enExample)
AU (1) AU2015301338C1 (enExample)
IL (1) IL250428B (enExample)
WO (1) WO2016022468A1 (enExample)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9434785B1 (en) 2015-04-30 2016-09-06 Kymab Limited Anti-human OX40L antibodies and methods of treating graft versus host disease with the same
US9512229B2 (en) 2015-03-03 2016-12-06 Kymab Limited Synergistic combinations of OX40L antibodies for the treatment of GVHD
US9587030B2 (en) 2014-03-04 2017-03-07 Kymab Limited Anti-hOX40L antibodies, uses, and methods
WO2018170764A1 (zh) * 2017-03-22 2018-09-27 深圳市博奥康生物科技有限公司 一种用于 RNAi 的载体及其应用
WO2023017252A1 (en) * 2021-08-10 2023-02-16 Kymab Limited Treatment of atopic dermatitis
US11779604B2 (en) 2016-11-03 2023-10-10 Kymab Limited Antibodies, combinations comprising antibodies, biomarkers, uses and methods
EP4261222A4 (en) * 2020-12-09 2024-12-25 HK inno.N Corporation ANTI-OX40L ANTIBODY, BISPECIFIC ANTI-OX40L/ANTI-TNFALPHA ANTIBODY AND USES THEREOF
US12209128B2 (en) 2016-06-20 2025-01-28 Kymab Limited Anti-PD-L1 antibodies

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US20220372153A1 (en) * 2015-03-03 2022-11-24 Kymab Limited Synergistic combinations of ox40l antibodies for the treatment of gvhd
EA202090974A1 (ru) * 2017-10-18 2020-08-05 Элпайн Иммьюн Сайенсиз, Инк. Вариантные иммуномодулирующие белки лиганда icos и сопутствующие композиции и способы
CN108458964A (zh) * 2017-10-31 2018-08-28 天津协和华美医学诊断技术有限公司 一种抗体组合物及其在淋巴浆细胞性淋巴瘤微小残留检测中的应用
MX2021010766A (es) * 2019-03-12 2021-12-10 Univ Health Network Anticuerpos que se unen a la proteína del gen 6 inducible por el factor de necrosis tumoral (tsg-6) y usos de estos.
IL293554A (en) * 2019-12-06 2022-08-01 Ablynx Nv Polypeptides comprising an immunoglobulin with one variable domain that target tnfa and ox40l
KR20230005268A (ko) * 2020-04-24 2023-01-09 밀레니엄 파머슈티컬스 인코퍼레이티드 항-cd19 항체 및 이의 용도
KR102705172B1 (ko) * 2020-12-09 2024-09-11 에이치케이이노엔 주식회사 항 OX40L 항체, 항 OX40L 및 항 TNFα 이중 특이성 항체 및 이들의 용도
TW202521577A (zh) * 2023-08-04 2025-06-01 大陸商信達生物製藥（蘇州）有限公司 抗ｏｘ４０ｌ抗體以及其用途

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Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10654935B2 (en) 2014-03-04 2020-05-19 Kymab Limited Methods of treating SLE with anti-OX40L antibodies
US11773175B2 (en) 2014-03-04 2023-10-03 Kymab Limited Antibodies, uses and methods
US9587030B2 (en) 2014-03-04 2017-03-07 Kymab Limited Anti-hOX40L antibodies, uses, and methods
US11753479B2 (en) 2014-03-04 2023-09-12 Kymab Limited Nucleic acids encoding anti-OX40L antibodies
US11396550B2 (en) 2014-03-04 2022-07-26 Kymab Limited Methods of treating comprising administering anti-OX40L antibodies
US10669342B2 (en) 2014-03-04 2020-06-02 Kymab Limited Anti-OX40L antibodies and methods of treating graft versus host disease
US9868789B2 (en) 2015-03-03 2018-01-16 Kymab Limited Synergistic combinations of OX40L antibodies for the treatment of GvHD
US9868790B2 (en) 2015-03-03 2018-01-16 Kymab Limited Synergistic combinations of OX40L antibodies for the treatment of GvHD
US9512229B2 (en) 2015-03-03 2016-12-06 Kymab Limited Synergistic combinations of OX40L antibodies for the treatment of GVHD
US9434785B1 (en) 2015-04-30 2016-09-06 Kymab Limited Anti-human OX40L antibodies and methods of treating graft versus host disease with the same
US12209128B2 (en) 2016-06-20 2025-01-28 Kymab Limited Anti-PD-L1 antibodies
US11779604B2 (en) 2016-11-03 2023-10-10 Kymab Limited Antibodies, combinations comprising antibodies, biomarkers, uses and methods
WO2018170764A1 (zh) * 2017-03-22 2018-09-27 深圳市博奥康生物科技有限公司 一种用于 RNAi 的载体及其应用
EP4261222A4 (en) * 2020-12-09 2024-12-25 HK inno.N Corporation ANTI-OX40L ANTIBODY, BISPECIFIC ANTI-OX40L/ANTI-TNFALPHA ANTIBODY AND USES THEREOF
WO2023017252A1 (en) * 2021-08-10 2023-02-16 Kymab Limited Treatment of atopic dermatitis

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AU2015301338C1 (en) 2021-07-22
US10570208B2 (en) 2020-02-25
US10167339B2 (en) 2019-01-01
JP6628787B2 (ja) 2020-01-15
IL250428B (en) 2021-03-25
IL250428A0 (en) 2017-03-30
US20170349661A1 (en) 2017-12-07
CN107074951B (zh) 2021-08-03
CA2957314A1 (en) 2016-02-11
AU2015301338A1 (en) 2017-02-23
AU2015301338B2 (en) 2021-03-25
CN107074951A (zh) 2017-08-18
EP3194445A4 (en) 2018-05-23
EP3194445A1 (en) 2017-07-26
JP2017523984A (ja) 2017-08-24
US20190092869A1 (en) 2019-03-28

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