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US 2019/0169286 A1Published application
Composition for prophylaxis or treatment of il-8 related diseases
AssigneesChugai Seiyaku Kabushiki Kaisha, Jichi Medical University, National Institutes of Biomedical Innovation, Health and Nutrition
InventorsAyako KAKIUCHI, Atsuhiko KATO, Shuji HAYASHI, Izumi YANAGISAWA, Ryo KONNO, Sachiho NETSU, Tadashi SANKAI
Life of this patent
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Abstract
For example, therapeutic methods and the like for novel IL-8-related diseases using an IL-8 signal inhibitor are provided. Alternatively, for example, therapeutic methods and the like for known or novel IL-8-related diseases using a novel anti-IL-8 antibody are provided.
Claims15
A composition for treating or preventing an IL-8-related disease, which comprises as an active ingredient an isolated anti-IL-8 antibody that binds to human IL-8, wherein the IL-8-related disease is selected from the group consisting of:
- endometriosis;
- adenomyosis;
- dysmenorrhea;
- adhesion;
- fibrotic diseases;
- pain in endometriosis, adenomyosis, or dysmenorrhea;
- infertility;
- and pain resulting from adhesion, fibrosis, or inflammation;
- wherein the anti-IL-8 antibody is selected from the group consisting of:
- (1) an anti-IL-8 antibody which binds to IL-8 in a pH-dependent manner, and comprises at least one amino acid substitution in at least one of:
- (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 23,
- (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 24,
- (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 25,
- (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 26,
- (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 27, and
- (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 28;
- (2) an anti-IL-8 antibody which binds to IL-8 in a pH-dependent manner, and comprises at least one amino acid substitution in at least one of:
- (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 23,
- (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 24,
- (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 25,
- (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 26,
- (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 27, and
- (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 28,
- wherein the anti-IL-8 antibody at least comprises amino acid substitutions of:
- tyrosine at position 3 in the amino acid sequence of SEQ ID NO:
- 25, asparagine at position 1 and leucine at position 5 in the amino acid sequence of SEQ ID NO:
- 27, and glutamine at position 1 in the amino acid sequence of SEQ ID NO:
- 28;
- (3) an anti-IL-8 antibody which binds to IL-8 in a pH-dependent manner, and comprises at least one amino acid substitution in at least one of:
- (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 23,
- (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 24,
- (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 25,
- (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 26,
- (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 27, and
- (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 28,
- wherein the anti-IL-8 antibody at least comprises amino acid substitutions of:
- tyrosine at position 9 and arginine at position 11 in the amino acid sequence of SEQ ID NO:
- 24, and tyrosine at position 3 in the amino acid sequence of SEQ ID NO:
- 25;
- (4) an anti-IL-8 antibody which binds to IL-8 in a pH-dependent manner, and comprises at least one amino acid substitution in at least one of:
- (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 23,
- (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 24,
- (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 25,
- (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 26,
- (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 27, and
- (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 28,
- wherein the anti-IL-8 antibody at least comprises amino acid substitutions of:
- alanine at position 6, glycine at position 8, tyrosine at position 9, and arginine at position 11 in the amino acid sequence of SEQ ID NO:
- 24, and
- tyrosine at position 3 in the amino acid sequence of SEQ ID NO:
- 25;
- (5) an anti-IL-8 antibody which binds to IL-8 in a pH-dependent manner, and comprises at least one amino acid substitution in at least one of:
- (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 23,
- (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 24,
- (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 25,
- (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 26,
- (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 27, and
- (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 28,
- wherein the anti-IL-8 antibody at least comprises amino acid substitutions of:
- asparagine at position 1 and leucine at position 5 in the amino acid sequence of SEQ ID NO:
- 27, and glutamine at position 1 in the amino acid sequence of SEQ ID NO:
- 28;
- (6) an anti-IL-8 antibody which binds to IL-8 in a pH-dependent manner, and comprises at least one amino acid substitution in at least one of:
- (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 23,
- (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 24,
- (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 25,
- (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 26,
- (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 27, and
- (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 28,
- wherein the anti-IL-8 antibody at least comprises amino acid substitutions of:
- tyrosine at position 9 and arginine at position 11 in the amino acid sequence of SEQ ID NO:
- 24, tyrosine at position 3 in the amino acid sequence of SEQ ID NO:
- 25, asparagine at position 1 and leucine at position 5 in the amino acid sequence of SEQ ID NO:
- 27, and glutamine at position 1 in the amino acid sequence of SEQ ID NO:
- 28;
- and
- (7) an anti-IL-8 antibody which binds to IL-8 in a pH-dependent manner, and comprises at least one amino acid substitution in at least one of:
- (a) HVR-H1 comprising the amino acid sequence of SEQ ID NO:
- 23,
- (b) HVR-H2 comprising the amino acid sequence of SEQ ID NO:
- 24,
- (c) HVR-H3 comprising the amino acid sequence of SEQ ID NO:
- 25,
- (d) HVR-L1 comprising the amino acid sequence of SEQ ID NO:
- 26,
- (e) HVR-L2 comprising the amino acid sequence of SEQ ID NO:
- 27, and
- (f) HVR-L3 comprising the amino acid sequence of SEQ ID NO:
- 28,
- wherein the anti-IL-8 antibody at least comprises amino acid substitutions of:
- alanine at position 6, glycine at position 8, tyrosine at position 9, and arginine at position 11 in the amino acid sequence of SEQ ID NO:
- 24, tyrosine at position 3 in the amino acid sequence of SEQ ID NO:
- 25, asparagine at position 1 and leucine at position 5 in the amino acid sequence of SEQ ID NO:
- 27, and glutamine at position 1 in the amino acid sequence of SEQ ID NO:
- 28.
128 more elements
A composition for treating or preventing an IL-8-related disease, which comprises as an active ingredient an isolated anti-IL-8 antibody that binds to human IL-8, wherein the IL-8-related disease is selected from the group consisting of:
- endometriosis;
- adenomyosis;
- dysmenorrhea;
- adhesion;
- fibrotic diseases;
- pain in endometriosis, adenomyosis, or dysmenorrhea;
- infertility;
- and pain resulting from adhesion, fibrosis, or inflammation, and
- wherein the anti-IL-8 antibody is selected from the group consisting of:
- (I) an anti-IL-8 antibody which comprises an Fc region comprising amino acid substitution at one or more positions selected from the group consisting of positions 235, 236, 239, 327, 330, 331, 428, 434, 436, 438, and 440 according to EU numbering;
- (II) an anti-IL-8 antibody which comprises an Fc region comprising amino acid substitution at all positions selected from the group consisting of positions 434, 438, and 440 according to EU numbering;
- (III) an anti-IL-8 antibody which comprises an Fc region comprising all of amino acid substitution with Ala at position 434;
- amino acid substitution with Glu, Arg, Ser, or Lys at position 438;
- and amino acid substitution with Glu, Asp, or Gln at position 440, according to EU numbering;
- (IV) an anti-IL-8 antibody which comprises an Fc region comprising all of amino acid substitution with Ala at position 434;
- amino acid substitution with Glu, Arg, Ser, or Lys at position 438;
- and amino acid substitution with Glu, Asp, or Gln at position 440, and further comprising Ile or Leu at position 428, and/or Ile, Leu, Val, Thr, or Phe at position 436, according to EU numbering;
- (V) an anti-IL-8 antibody which comprises an Fc region comprising one or more amino acid substitutions selected from the group consisting of L235R, G236R, S239K, A327G, A330S, P331S, M428L, N434A, Y436T, Q438R, and S440E according to EU numbering;
- (VI) an anti-IL-8 antibody which comprises an Fc region comprising a combination of amino acid substitutions selected from the group consisting of:
- N434A/Q438R/S440E;
- N434A/Q438R/S440D;
- N434A/Q438K/S440E;
- N434A/Q438K/S440D;
- N434A/Y436T/Q438R/S440E;
- N434A/Y436T/Q438R/S440D;
- N434A/Y436T/Q438K/S440E;
- N434A/Y436T/Q438K/S440D;
- N434A/Y436V/Q438R/S440E;
- N434A/Y436V/Q438R/S440D;
- N434A/Y436V/Q438K/S440E;
- N434A/Y436V/Q438K/S440D;
- N434A/R435H/F436T/Q438R/S440E;
- N434A/R435H/F436T/Q438R/S440D;
- N434A/R435H/F436T/Q438K/S440E;
- N434A/R435H/F436T/Q438K/S440D;
- N434A/R435H/F436V/Q438R/S440E;
- N434A/R435H/F436V/Q438R/S440D;
- N434A/R435H/F436V/Q438K/S440E;
- N434A/R435H/F436V/Q438K/S440D;
- M428L/N434A/Q438R/S440E;
- M428L/N434A/Q438R/S440D;
- M428L/N434A/Q438K/S440E;
- M428L/N434A/Q438K/S440D;
- M428L/N434A/Y436T/Q438R/S440E;
- M428L/N434A/Y436T/Q438R/S440D;
- M428L/N434A/Y436T/Q438K/S440E;
- M428L/N434A/Y436T/Q438K/S440D;
- M428L/N434A/Y436V/Q438R/S440E;
- M428L/N434A/Y436V/Q438R/S440D;
- M428L/N434A/Y436V/Q438K/S440E;
- and
- M428L/N434A/Y436V/Q438K/S440D
- according to EU numbering;
- (VII) an anti-IL-8 antibody which comprises an Fc region comprising a combination of amino acid substitutions:
- L235R/G236R/S239K/M428L/N434A/Y436T/Q438R/S440E;
- or
- L235R/G236R/A327G/A330S/P331S/M428L/N434A/Y436T/Q438R/S440E,
- according to EU numbering;
- and
- (VIII) an anti-IL-8 antibody comprising the Fc region of any one of (I) to (VII) above, wherein the Fc region has at least one property selected from the group consisting of (a) to (e) below:
- (a) the FcRn-binding affinity of the Fc region at an acidic pH has been increased relative to the FcRn-binding affinity of a native Fc region;
- (b) the binding affinity of the Fc region for a pre-existing ADA has been reduced relative to the binding affinity of a native Fc region for the pre-existing ADA;
- (c) the plasma half-life of the Fc region has been increased relative to the plasma half-life of a native Fc region;
- (d) the plasma clearance of the Fc region has been reduced relative to the plasma clearance of a native Fc region;
- and
- (e) the binding affinity of the Fc region for an effector receptor has been reduced relative to the binding affinity of a native Fc region for the effector receptor.
63 more elements
A composition for treating of preventing an IL-8-related disease, which comprises as an active ingredient an isolated anti-IL-8 antibody that binds to human IL-8, wherein the IL-8-related disease is selected from the group consisting of:
- endometriosis;
- adenomyosis;
- dysmenorrhea;
- adhesion;
- fibrotic diseases;
- pain in endometriosis, adenomyosis, or dysmenorrhea;
- infertility;
- and pain resulting from adhesion, fibrosis, or inflammation, and
- wherein the anti-IL-8 antibody is selected from the group consisting of:
- (A) an anti-IL-8 antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 36 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 38;
- (B) an anti-IL-8 antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 37 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 38;
- (C) an anti-IL-8 antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 106 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 44;
- (D) an anti-IL-8 antibody comprising heavy and light chains which have at least 80% sequence identity with a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 36 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 38, respectively;
- (E) an anti-IL-8 antibody comprising heavy and light chains which have at least 80% sequence identity to a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 37 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 38, respectively;
- and
- (F) an anti-IL-8 antibody comprising heavy and light chains which have at least 80% sequence identity with a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 106 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 44, respectively.
25 more elements
A composition for treating or preventing an IL-8-related disease, which comprises an IL-8 signal inhibitor as an active ingredient, wherein the IL-8-related disease is selected from the group consisting of human endometriosis;
- adenomyosis;
- dysmenorrhea;
- adhesion;
- pain in human endometriosis, adenomyosis, or dysmenorrhea;
- infertility;
- and pain resulting from adhesion, fibrosis, or inflammation.
3 more elements
Dependencies are inferred from the claim text.