WO2018156367A1 - Anticorps anti-il31 à usage vétérinaire - Google Patents

Anticorps anti-il31 à usage vétérinaire Download PDF

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Publication number
WO2018156367A1
WO2018156367A1 PCT/US2018/017623 US2018017623W WO2018156367A1 WO 2018156367 A1 WO2018156367 A1 WO 2018156367A1 US 2018017623 W US2018017623 W US 2018017623W WO 2018156367 A1 WO2018156367 A1 WO 2018156367A1
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WO
WIPO (PCT)
Prior art keywords
antibody
seq
amino acid
sequence
acid sequence
Prior art date
Application number
PCT/US2018/017623
Other languages
English (en)
Inventor
Shyr Jiann Li
Lam Nguyen
Hangjun Zhan
Original Assignee
Kindred Biosciences, 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 PCT/US2017/023788 external-priority patent/WO2018156180A1/fr
Priority to AU2018224711A priority Critical patent/AU2018224711A1/en
Priority to KR1020197025631A priority patent/KR20190127703A/ko
Priority to CA3053525A priority patent/CA3053525A1/fr
Priority to CN202311589839.9A priority patent/CN117603350A/zh
Priority to BR112019017308A priority patent/BR112019017308A2/pt
Application filed by Kindred Biosciences, Inc. filed Critical Kindred Biosciences, Inc.
Priority to EP18756690.6A priority patent/EP3585429A4/fr
Priority to US16/488,045 priority patent/US11673946B2/en
Priority to JP2019545292A priority patent/JP7277370B2/ja
Priority to RU2019129618A priority patent/RU2795485C2/ru
Priority to CN201880026436.4A priority patent/CN110769851B/zh
Publication of WO2018156367A1 publication Critical patent/WO2018156367A1/fr
Priority to US18/311,777 priority patent/US20240101660A1/en
Priority to JP2023076588A priority patent/JP2023109811A/ja

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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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • C07K2317/76—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
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Definitions

  • the heavy chain comprises a CDR-H1 sequence having at least 85% sequence identity, at least 90% sequence identity, at least 95% sequence identity, or at least 98% sequence identity to the amino acid sequence of SEQ ID NO: 1; a CDR-H2 sequence having at least 85% sequence identity, at least 90% sequence identity, at least 95% sequence identity, or at least 98% sequence identity to the amino acid sequence of SEQ ID NO: 2, 62, 89, or 87; and a CDR-H3 sequence having at least 85% sequence identity, at least 90% sequence identity, at least 95% sequence identity, or at least 98% sequence identity to the amino acid sequence of SEQ ID NO: 3, and b.
  • the antibody comprises a heavy chain comprising (a) a
  • the antibody comprises one or more of (a) a variable region heavy chain framework 1 (HC-FR1) sequence of SEQ ID NO: 4, 70, or 79, (b) a HC-FR2 sequence of SEQ ID NO: 5, 71, or 80, (c) a HC-FR3 sequence of SEQ ID NO: 6, 72, 73, or 81, (d) a HC- FR4 sequence of SEQ ID NO: 7, 74, or 82, (e) a variable region light chain framework 1 (LC-FR1) sequence of SEQ ID NO: 11, 75, or 83, (f) an LC-FR2 sequence of SEQ ID NO: 12, 76, or 84, (g) an LC-FR3 sequence of SEQ ID NO: 13, 77, or 85, or (h) an LC-FR4 sequence of SEQ ID NO: 14, 78, or 86.
  • HC-FR1 variable region heavy chain framework 1
  • the antibody comprises:
  • the pharmaceutical composition has a sodium chloride concentration of from 80 to 200 mM, from 100 to 175 mM, from 120 to 150 mM, or 140 mM.
  • FIG. 1A is an alignment of variable light sequences of M14, M18, M19, and M87 mouse monoclonal antibody clones.
  • FIG. IB is an alignment of variable heavy sequences of M14, Ml 8, Ml 9, and M87 mouse monoclonal antibody clones.
  • FIG. 2A and FIG. 2B are graphs of canine IL31 binding analysis with varying concentrations of chimeric M14 antibody.
  • FIG. 8 shows immunoblot analysis of fine epitope mapping and alanine scanning of mature canine IL31 epitope using anti-canine IL31 antibody (top panel) and anti-GST antibody (bottom panel).
  • EVQLVESGPSLVKPGGSLRLTCSVTGDSITSGYWNWI Caninized heavy chain RKFPGNKLEYMGYISYSGITDYNPSLKSRITISRDTS sequence from mouse antibody clone Ml 4 and canine IgG-C K QYYLQLNSVTTEDTATYYCARYGNYGYAMDYWGQG TLVTVSSASTTAPSVFPLAPSCGSQSGSTVALACLVS GYIPEPVTVSWNSVSLTSGVHTFPSVLQSSGLYSLSS MVTVPSSRWPSETFTCNVAHPATNTKVDKPVAKECEC KCNCNNCPCPGCGLLGGPSVFIFPPKPKDILVTARTP TVTCVVVDLDPENPEVQISWFVDSKQVQTANTQPREE QSNGTYRVVSVLPIGHQDWLSGKQFKCKVNNKALPSP IEEIISKTPGQAHQPNVYVLPPSRDEMSKNTVTLTCL VKDFFPPEIDVEWQS
  • Kd is calculated based upon scientific measurements and, thus, are subject to appropriate measurement error. In some instances, a numerical term may include numerical values that are rounded to the nearest significant figure.
  • variable heavy chain CDRs SEQ ID NOs: 1-3; SEQ ID NO: 89 is an alternate definition for CDR-H2
  • variable light chain CDRs SEQ ID NOs: 8-10
  • variable region heavy chain framework sequences SEQ ID NOs: 4-7)
  • variable region light chain framework sequences SEQ ID NOs: 11-14
  • amino acid sequences of the variable light chain, light chain, variable heavy chain, and variable and hinge heavy chain of monoclonal antibody M14 are provided (SEQ ID NOs: 24, 36, 25, and 40, respectively).
  • antibody includes, but is not limited to, fragments that are capable of binding to an antigen, such as Fv, single-chain Fv (scFv), Fab, Fab', di-scFv, sdAb (single domain antibody) and (Fab')2 (including a chemically linked F(ab')2).
  • an antigen such as Fv, single-chain Fv (scFv), Fab, Fab', di-scFv, sdAb (single domain antibody) and (Fab')2 (including a chemically linked F(ab')2).
  • Papain digestion of antibodies produces two identical antigen-binding fragments, called “Fab” fragments, each with a single antigen-binding site, and a residual "Fc” fragment, whose name reflects its ability to crystallize readily.
  • Pepsin treatment yields an F(ab')2 fragment that has two antigen combining sites and is still capable of cross-linking antigen.
  • a CDR-H1 comprising the amino acid sequence of SEQ ID NO: 1
  • a CDR-H2 comprising the amino acid sequence of SEQ ID NO: 62 or 87
  • a CDR-H3 comprising the amino acid sequence of SEQ ID NO: 3
  • a light chain comprising (a) a CDR-L1 comprising the amino acid sequence of SEQ ID NO: 8 or 63, (b) a CDR-L2 comprising the amino acid sequence of SEQ ID NO: 9, and (c) a CDR-L3 comprising the amino acid sequence of SEQ ID NO: 10.
  • an anti-IL31 antibody comprises a chimeric antibody comprising:
  • an anti-IL31 antibody comprises a canine heavy chain constant region selected from an IgG-A, IgG-B, IgG-C, and IgG-D constant region.
  • an anti-IL31 antibody is a canine IgG-A, IgG-B, IgG-C, or IgG-D antibody.
  • a “caninized antibody” means an antibody in which at least one amino acid in a portion of a non-canine variable region has been replaced with the corresponding amino acid from a canine variable region.
  • a caninized antibody comprises at least one canine constant region (e.g., a ⁇ constant region, an a constant region, a ⁇ constant region, an ⁇ constant region, a ⁇ constant region, or etc.) or fragment thereof.
  • a caninized antibody is an antibody fragment, such as Fab, scFv, (Fab') 2 , etc.
  • Fv framework region (FR) residues of the feline immunoglobulin are replaced by corresponding non-feline residues.
  • the felinized antibody can comprise residues that are found neither in the recipient antibody nor in the imported CDR or framework sequences, but are included to further refine and optimize antibody performance.
  • Fv framework region (FR) residues of the equine immunoglobulin are replaced by corresponding non-equine residues.
  • the equinized antibody can comprise residues that are found neither in the recipient antibody nor in the imported CDR or framework sequences, but are included to further refine and optimize antibody performance.
  • At least one amino acid residue in a portion of a mouse variable heavy chain or a mouse variable light chain has been replaced with the corresponding amino acid from an equine variable region.
  • the modified chain is fused to an equine constant heavy chain or a canine constant light chain.
  • an anti-IL31 antibody that competes with an anti-IL31 antibody described herein (such as M14, M18, M19, or M87) for binding to IL31.
  • an antibody that competes with binding with any of the antibodies provided herein can be made or used.
  • an anti-IL31 antibody is provided that competes with monoclonal Ml 4 antibody in binding to canine IL31 or feline IL31.
  • a "host cell” refers to a cell that may be or has been a recipient of a vector or isolated polynucleotide.
  • Host cells may be prokaryotic cells or eukaryotic cells.
  • Exemplary eukaryotic cells include mammalian cells, such as primate or non-primate animal cells; fungal cells, such as yeast; plant cells; and insect cells.
  • Nonlimiting exemplary mammalian cells include, but are not limited to, NS0 cells, PER.C6® cells (Crucell), 293 cells, and CHO cells, and their derivatives, such as 293-6E, DG44, CHO-S, and CHO-K cells.
  • a DNA polynucleotide that is contained in a vector inside a host cell may be referred to as "isolated.”
  • the anti-IL31 antibody is purified using chromatography, such as size exclusion chromatography, ion exchange chromatography, protein A column chromatography, hydrophobic interaction chromatography, and CHT chromatography.
  • Immuno-blot analysis of the cell lysate using anti-phospho STAT-3 and anti-STAT-3 antibodies were used to detect the concentration of phosphorylated STAT-3 and unphosphorylated STAT-3 relative to each other and compared to a beta-actin control.
  • Methods for determining the concentration of proteins, either qualitatively or quantitatively, by immunoblot are understood by persons of skill in the art. In some embodiments, relative concentration is determined by qualitatively by visual inspection of the immunoblot.
  • Appropriate labels include, without limitation, radionuclides (for example 125 I, 131 I, 35 S, 3 H, or 32 P), enzymes (for example, alkaline phosphatase, horseradish peroxidase, luciferase, or p-glactosidase), fluorescent moieties or proteins (for example, fluorescein, rhodamine, phycoerythrin, GFP, or BFP), or luminescent moieties (for example, QdotTM nanoparticles supplied by the Quantum Dot Corporation, Palo Alto, Calif).
  • radionuclides for example 125 I, 131 I, 35 S, 3 H, or 32 P
  • enzymes for example, alkaline phosphatase, horseradish peroxidase, luciferase, or p-glactosidase
  • fluorescent moieties or proteins for example, fluorescein, rhodamine, phycoerythrin, GFP
  • Anti-beta actin antibody was from Sigma- Aldrich. As shown in Figure 4, canine IL31 signaling decreased (as evidenced by a reduction in STAT-3 phosphorylation) as the concentration of caninized M14 exposed to the cells increased (lane 1 : no anti-IL31 antibody; Lane 2: 3.3nM; Lane 3 : 6.6nM; Lane 4: 9.9 nM; and Lane 5: 13.2 nM).
  • Example 10 M14 specifically binds to IL31 of other species having the PSDX1X2KI epitope motif
  • Macaca mulatta EHH21279.1; SEQ ID NO: 56
  • 151-1901 composed of thyroglobulin, bovine ⁇ -globulin, chicken ovalbumin, equine myoglobin, and vitamin B12 (molecular weight 1,350-670,000).
  • the amount of monomeric antibody remaining in solution was determined by measuring UV absorbance at 214 nm or 280 nm and calculating the peak area under the curve.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

L'invention concerne divers modes de réalisation se rapportant à des anticorps anti-IL31 qui se lient à l'IL 31 canine. De tels anticorps peuvent être utilisés dans des méthodes de traitement d'états induits par IL31 chez des animaux de compagnie, tels que des canidés, des félidés et des équidés.
PCT/US2018/017623 2017-02-24 2018-02-09 Anticorps anti-il31 à usage vétérinaire WO2018156367A1 (fr)

Priority Applications (12)

Application Number Priority Date Filing Date Title
CN201880026436.4A CN110769851B (zh) 2017-02-24 2018-02-09 兽用抗il31抗体
US16/488,045 US11673946B2 (en) 2017-02-24 2018-02-09 Methods of treating a companion animal species comprising administering anti-IL31 antibodies
CA3053525A CA3053525A1 (fr) 2017-02-24 2018-02-09 Anticorps anti-il31 a usage veterinaire
CN202311589839.9A CN117603350A (zh) 2017-02-24 2018-02-09 兽用抗il31抗体
BR112019017308A BR112019017308A2 (pt) 2017-02-24 2018-02-09 anticorpos anti-il31 para uso veterinário
AU2018224711A AU2018224711A1 (en) 2017-02-24 2018-02-09 Anti-IL31 antibodies for veterinary use
EP18756690.6A EP3585429A4 (fr) 2017-02-24 2018-02-09 Anticorps anti-il31 à usage vétérinaire
KR1020197025631A KR20190127703A (ko) 2017-02-24 2018-02-09 수의학적 용도를 위한 항-il31 항체
JP2019545292A JP7277370B2 (ja) 2017-02-24 2018-02-09 獣医用抗ｉｌ－３１抗体
RU2019129618A RU2795485C2 (ru) 2017-02-24 2018-02-09 Анти-il31 антитела для применения в ветеринарии
US18/311,777 US20240101660A1 (en) 2017-02-24 2023-05-03 Anti-il31 antibodies for veterinary use
JP2023076588A JP2023109811A (ja) 2017-02-24 2023-05-08 獣医用抗ｉｌ－３１抗体

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201762463543P 2017-02-24 2017-02-24
US62/463,543 2017-02-24
USPCT/US2017/023788 2017-03-23
PCT/US2017/023788 WO2018156180A1 (fr) 2017-02-24 2017-03-23 Anticorps anti-il31 à usage vétérinaire

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US16/488,045 A-371-Of-International US11673946B2 (en) 2017-02-24 2018-02-09 Methods of treating a companion animal species comprising administering anti-IL31 antibodies
US18/311,777 Continuation US20240101660A1 (en) 2017-02-24 2023-05-03 Anti-il31 antibodies for veterinary use

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019178601A1 (fr) 2018-03-16 2019-09-19 Zoetis Services Llc Vaccins peptidiques contre l'interleukine-31
JP6845973B1 (ja) * 2019-11-20 2021-03-24 中外製薬株式会社 抗体含有製剤
CN112724256A (zh) * 2019-10-28 2021-04-30 中国农业大学 一种高稳定性的磺胺类药物抗体hAb 4D11及其应用
WO2021123092A1 (fr) * 2019-12-20 2021-06-24 Intervet International B.V. Anticorps bispécifiques caninisés pour le traitement de la dermatite atopique
JP2022513693A (ja) * 2018-11-29 2022-02-09 ハーバー・バイオメド・セラピューティクス・リミテッド 抗ｐｄ－ｌ１抗体製剤
EP4138914A1 (fr) * 2020-04-22 2023-03-01 Kindred Biosciences, Inc. Anticorps anti-il31 à action prolongée à usage vétérinaire
US11673946B2 (en) 2017-02-24 2023-06-13 Kindred Biosciences, Inc. Methods of treating a companion animal species comprising administering anti-IL31 antibodies
US11773173B2 (en) 2015-04-14 2023-10-03 Chugai Seiyaku Kabushiki Kaisha Pharmaceutical composition for prevention and/or treatment of atopic dermatitis comprising IL-31 antagonist as active ingredient

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US20110318343A1 (en) * 2001-11-08 2011-12-29 Abbott Biotherapeutics Corp. Stable Liquid Pharmaceutical Formulation Of IgG Antibodies
US20130022616A1 (en) * 2011-07-21 2013-01-24 Pfizer Inc. Interleukin-31 Monoclonal Antibody

Patent Citations (2)

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US20110318343A1 (en) * 2001-11-08 2011-12-29 Abbott Biotherapeutics Corp. Stable Liquid Pharmaceutical Formulation Of IgG Antibodies
US20130022616A1 (en) * 2011-07-21 2013-01-24 Pfizer Inc. Interleukin-31 Monoclonal Antibody

Non-Patent Citations (3)

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Title
"IL -31 Antibody", AVIVA SYSTEMS BIOLOGY, Retrieved from the Internet <URL:https://www.google.com/search?q=IL31+Antibody+-+N-termina)+region+%28OAAB05980%29+from+Aviva+Systems+Biotogy&r)z=1C1GGRV_enUS769US769&source=lnt&tbs=cdr%3A1%2Ccd_min%3A%2Ccd_max%3A2.24.2017&tbm=> [retrieved on 20180424] *
ANONYMOUS: "IL31 Antibody - N-terminal region (OAAB05980)", AVIVA SYSTEMS BIOLOGY, 11 October 2016 (2016-10-11), XP009517720, Retrieved from the Internet <URL:https://www.avivasysbio.com/en/il31-antibody-n-terminal-region-oaab05980.html> [retrieved on 20180424] *
See also references of EP3585429A4 *

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11773173B2 (en) 2015-04-14 2023-10-03 Chugai Seiyaku Kabushiki Kaisha Pharmaceutical composition for prevention and/or treatment of atopic dermatitis comprising IL-31 antagonist as active ingredient
US11697683B2 (en) 2017-02-24 2023-07-11 Kindred Biosciences, Inc. Anti-IL31 antibodies for veterinary use
US11673946B2 (en) 2017-02-24 2023-06-13 Kindred Biosciences, Inc. Methods of treating a companion animal species comprising administering anti-IL31 antibodies
US11433139B2 (en) 2018-03-16 2022-09-06 Zoetis Services Llc Peptide vaccines against interleukin-31
WO2019178601A1 (fr) 2018-03-16 2019-09-19 Zoetis Services Llc Vaccins peptidiques contre l'interleukine-31
JP2022513693A (ja) * 2018-11-29 2022-02-09 ハーバー・バイオメド・セラピューティクス・リミテッド 抗ｐｄ－ｌ１抗体製剤
CN112724256A (zh) * 2019-10-28 2021-04-30 中国农业大学 一种高稳定性的磺胺类药物抗体hAb 4D11及其应用
WO2021100794A1 (fr) * 2019-11-20 2021-05-27 中外製薬株式会社 Préparation pharmaceutique comprenant un anticorps
US11260125B2 (en) 2019-11-20 2022-03-01 Chugai Seiyaku Kabushiki Kaisha Anti-IL31RA antibody-containing formulations
US11723976B2 (en) 2019-11-20 2023-08-15 Chugai Seiyaku Kabushiki Kaisha Methods of administering anti-IL31A antibody-containing formulations
JP6845973B1 (ja) * 2019-11-20 2021-03-24 中外製薬株式会社 抗体含有製剤
WO2021123094A1 (fr) * 2019-12-20 2021-06-24 Intervet International B.V. Anticorps bispécifiques caninisés et partenaires de liaison bispécifiques pour le traitement de la dermatite atopique
WO2021123092A1 (fr) * 2019-12-20 2021-06-24 Intervet International B.V. Anticorps bispécifiques caninisés pour le traitement de la dermatite atopique
EP4138914A1 (fr) * 2020-04-22 2023-03-01 Kindred Biosciences, Inc. Anticorps anti-il31 à action prolongée à usage vétérinaire
EP4138914A4 (fr) * 2020-04-22 2024-05-22 Elanco Us Inc Anticorps anti-il31 à action prolongée à usage vétérinaire

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