Patent application EP17000245A (EP), filed 2017-02-15
Publication number: EP3244212A1
Title: AN IMPROVED ASSAY FOR THE DIAGNOSIS OF PEANUT ALLERGY
Abstract: The present invention relates to a diagnostically useful carrier comprising a means for specifically capturing an antibody to Ara h 7 isotype 7.0201 in a sample from a subject; a method comprising the step detecting in a sample from a subject the presence or absence of an antibody to Ara h 7 isotype 7.0201 and a pharmaceutical composition comprising Ara h 7 isotype 7.0201 or a variant thereof.
IPC codes: A61K  39/    35            A I
C07K  14/   415            A I
G01N  33/    68            A I
Claims: number: 1
text: A diagnostically useful carrier comprising a means for specifically capturing an antibody to Ara h 7 isotype 7.0201, preferably SEQ ID NO 6, more preferably to a sequence from the group comprising SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, most preferably to SEQ ID NO8, in a sample from a subject,
wherein the carrier is preferably selected from the group comprising a bead, a test strip, a microtiter plate, a blot, preferably from the group comprising western blot, line blot and dot blot, a glass surface, a slide, a biochip and a membrane, and is most preferably a microtiter plate or a line blot.
number: 2
text: The diagnostically useful carrier according to claim 1, wherein the carrier further comprises a means for specifically capturing an antibody to one or more further antigens from the group comprising Ara h 2, Ara h 6, Ara h 1, Ara h 3, Ara h 9, Ara h 8 and Ara h 5, more preferably from the group comprising Ara h 2, Ara h 6, Ara h 1, Ara h 3, Ara h 9, more preferably an antibody to Ara h 2 and/or an antibody to Ara h 6, most preferably an antibody to Ara h 2
number: 3
text: A kit comprising the diagnostically useful carrier according to any of claims 1 to 2, optionally as well as a means for specifically detecting a captured antibody.
number: 4
text: The kit according to claim 3,
wherein the diagnostically useful carrier comprises a means for specifically capturing an antibody to one or more further antigens from the group Ara h 2, Ara h 6, Ara h 1, Ara h 3, Ara h 9, Ara h 8 and Ara h 5,
wherein the means for specifically capturing an antibody to isotype 7.0201, preferably SEQ ID NO 6, more preferably to a sequence from the group comprising SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, most preferably SEQ ID NO8, and the means for specifically capturing an antibody to one or more further antigens are on separate carriers
or
wherein the means for specifically capturing an antibody to Ara h 7 isotype 7.0201, preferably SEQ ID NO 6, more preferably to a sequence from the group comprising SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, most preferably SEQ ID NO8, and the means for specifically capturing an antibody to one or more further antigens are on one, preferably covalently linked to one carrier.
number: 5
text: A method comprising the step detecting in a sample from a subject the presence of an antibody to Ara h 7 isotype 7.0201, preferably to SEQ ID NO 6, more preferably to a sequence from the group comprising SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, most preferably SEQ ID NO8.
number: 6
text: The method according to claim 5, further comprising the step detecting in a sample from a subject the presence of an antibody to one or more further antigens; preferably selected from the group comprising Ara h 2, Ara h 6, Ara h 1, Ara h 3, Ara h 9, Ara h 8 and Ara h 5, more preferably from the group comprising Ara h 2, Ara h 6, Ara h 1, Ara h 3 and Ara h 9, most preferably Ara h 2 and/or Ara h 6.
number: 7
text: The method according to any of claims 5 to 6, wherein the presence or absence of an antibody to Ara h 7 isotype 7.0201 and the presence of an antibody to one or more further antigens, preferably Ara h 2 and/or Ara h 6, is detected simultaneously.
number: 8
text: The method according to any of claims 5 to 7, wherein the presence or absence of an antibody to Ara h 7 isotype 7.0201, preferably SEQ ID NO8 and the presence of an antibody to one or more further antigens is detected in spatially separate binding reactions.
number: 9
text: The method according to any of claims 5 to 8, wherein the presence of an antibody Ara h 7 isotype 7.0201 and the presence of an antibody to one or more further antigens is detected in a one-pot reaction.
number: 10
text: The carrier, kit or method according to any of claims 1 to 9, wherein the antibody to isotype 7.0201 is an antibody monospecific to Ara h 7, preferably to isotype 7.0201, preferably SEQ ID NO 6, more preferably a sequence from the group comprising SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, most preferably SEQ ID NO8.
number: 11
text: A pharmaceutical composition comprising a polypeptide comprising SEQ ID NO 8, more preferably a sequence from the group comprising SEQ ID NO6, SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, more preferably SEQ ID NO6, most preferably Ara h 7 isotype 7.0201 or a variant thereof and preferably one or more further antigens from the group comprising Ara h 2, Ara h 6, Ara h 1, Ara h 3, Ara h 9, Ara h 8 and Ara h 5 and a variant thereof, more preferably from the group comprising Ara h 2, Ara h 6, Ara h 1, Ara h 3, Ara h 9 and a variant thereof, most preferably Ara h 2 and/or Ara h 6.
number: 12
text: A polypeptide comprising SEQ ID NO 8, more preferably a sequence from the group comprising SEQ ID NO6, SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, more preferably SEQ ID NO6, most preferably Ara h 7 isotype 7.0201 or a variant thereof, wherein the polypeptide is recombinant, immobilized purified or a fusion protein, preferably purified and recombinant and immobilized.
number: 13
text: A use of the polypeptide according to claim 12, the carrier according to any of claims 1 to 2 or the kit according to any of claims 3 to 4 for the diagnosis of peanut allergy, wherein preferably the sensitivity of the diagnosis is increased.
number: 14
text: A use of the polypeptide according to claim 12 for the manufacture of a kit for the diagnosis of peanut allergy, wherein preferably the sensitivity of the diagnosis is increased.
number: 15
text: The pharmaceutical composition according to claim 11, the polypeptide according to claim 12 or the use according to any of claims 13 to 14, wherein the polypeptide comprising SEQ ID NO 8, more preferably a sequence from the group comprising SEQ ID NO6, SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, more preferably SEQ ID NO6, most preferably Ara h 7 isotype 7.0201 or a variant thereof is a composition comprising said polypeptide and Ara h 2 and/or Ara h 6 or a variant thereof.
number: 16
text: An antibody, preferably IgE class antibody, binding specifically to Ara h 7 isotype 7.0201, preferably SEQ ID NO6, more preferably a sequence from the group comprising SEQ ID NO7, SEQ ID NO8, SEQ ID NO9 and SEQ ID NO10, most preferably to SEQ ID NO8, which antibody is preferably isolated.
Office action: search_report, dated 2017-11-15
Rejection reasons: novelty_epc_54
inventive_step_epc_56
Prior art cited: ref_id: WO2013041540A1
ref_type: patent
severity: background
ref_id: - FLINTERMAN, A. E.; VAN HOFFEN, E.; DEN HARTOG, JAGER C. F.; KOPPELMAN, S.; PASMANS, S. G.; HOEKSTRA, M. O.; BRUIJNZEEL-KOOMEN, C.: "Children with peanut allergy recognize predominantly Ara h 2 and Ara h 6, which remains stable over time", CLIN EXP ALLERGY, vol. 37, 2007, pages 1221 - 1228, XP002545064, DOI: doi:10.1111/J1365-2222.2007.02764.X
ref_type: npl
severity: background
ref_id: - DE LEON, M, P.; DREW, A. C; GLASPOLE, I. N.; SUPHIOGLU, C.; O'HEHIR, R. E.; ROLLAND, J. M.: "IgE cross-reactivity between the major peanut allergen Ara h 2 and tree nut allergens", MOL IMMUNOL, vol. 44, 2007, pages 463 - 471, XP005622927, DOI: doi:10.1016/j.molimm.2006.02.016
ref_type: npl
severity: background
ref_id: - SCHMIDT, H.; KRAUSE, S.; GELHAUS, C.; PETERSEN, A.; JANSSEN, O.; BECKER, W. M.: "Detection and structural characterization of natural Ara h 7, the third peanut allergen of the 2S albumin family", J PROTEOME RES, vol. 9, 2010, pages 3701 - 709, XP055237195, DOI: doi:10.1021/pr1002406
ref_type: npl
severity: background
ref_id: - SCHMIDT ET AL.: "Detection and Structural Characterization of Natural Ara h 7", THIRD PEANUT ALLGERGEN OF THE 2S ALBUMIN FAMILY, 2008
ref_type: npl
severity: background
ref_id: - PEETERS, K. A.; KOPPELMAN, S. J.; VAN HOFFEN, E.; VAN DER TAS, C. W.; DEN HARTOG, JAGER C. F.; PENNINKS, A. H.; HEFLE, S. L; BRUIJ: "Does skin prick test reactivity to purified allergens correlate with clinical severity of peanut allergy?", CLIN EXP ALLERGY., vol. 37, no. 1, January 2007 (2007-01-01), pages 108 - 15
ref_type: npl
severity: background
ref_id: - CODREANU, F.; COLLIGNON, O.; ROITEL, 0.; THOUVENOT, B.; SAUVAGE, C.; VILAIN, A. C.; COUSIN, M. O; DECOSTER, A.; RENAUDIN, JM.; AST: "A novel immunoassay using recombinant allergens simplifies peanut allergy diagnosis", INT ARCH ALLERGY IMMUNOL, vol. 154, no. 3, 2011, pages 216 - 26, XP009187761, DOI: doi:10.1159/000321108
ref_type: npl
severity: background
ref_id: - RAOULT, D.; DASCH, G. A.: "The line blot: an immunoassay for monoclonal and other antibodies. Its application to the serotyplng of gram-negative bacteria", J. IMMUNOL. METHODS, vol. 125, no. 1-2, 1989, pages 57 - 65, XP023653127, DOI: doi:10.1016/0022-1759(89)90078-1
ref_type: npl
severity: background
ref_id: - ARTHUR LESK: "Introduction to bioinformatics", 2008, OXFORD UNIVERSITY PRESS
ref_type: npl
severity: background
ref_id: - LARKIN, M. A.; BLACKSHIELDS, G.; BROWN, N. P.; CHENNA, R.; MCGETTIGAN, P. A.; MCWILLIAM, H.; VALENTIN, F.; WALLACE, 1. M.; WILM, A: "Clustal W and Clustal X version 2.0", BIOINFORMATICS, vol. 23, 2007, pages 2947 - 2948
ref_type: npl
severity: background
ref_id: - SAMBROOK, J.; FRITSCH, E. F.; MANIATIS, T.: "Molecular Cloning", 1989, CSH
ref_type: npl
severity: background
ref_id: - BROWN T. A.: "Gene Cloning - an introduction", 1986, CHAPMAN & HALL
ref_type: npl
severity: background
ref_id: - "Handbooks ..Strategies for Protein Purification", GE HEALTHCARE LIFE SCIENCES, article "Antibody Purification"
ref_type: npl
severity: background
ref_id: - BURGESS, R. R; DEUTSCHER, M. P.: "Guide to Protein Purification", 2009
ref_type: npl
severity: background
ref_id: - ZANE, H. D.: "Immunology - Theoretical & Practical Concepts in Laboratory Medicine", 2001, W. B. SAUNDERS COMPANY
ref_type: npl
severity: background
ref_id: - HAUSMANN, O. V.; GENTINETTA, T.; BRIDTS, C. H.; EBO, E. G.: "The Basophil Activation Test in Immediate-Type Drug Allergy", IMMUNOL. ALLERGY CLIN. N. AM., vol. 29, 2009, pages 555 - 566
ref_type: npl
severity: background
ref_id: - SITARU C; DSHNRICH C; PROBST C; KOMOROWSKI L; BLOCKER I; SCHMIDT E; SCHLUMBERGER W; ROSE C; STACKER W; ZILLIKENS D: "Enzyme-linked immunosorbent assay using multimers of the 16th non-collagenous domain of the BP180 antigen for sensitive and specific detection of pemphigoid autoantibodies", EXP DERMATOL., vol. 16, no. 9, September 2007 (2007-09-01), pages 770 - 7
ref_type: npl
severity: background
ref_id: - TAYLOR SL; HEFLE SL; BINDSLEV-JENSEN C; ATKINS FM; ANDRE C; BRUIJNZEEL-KOOMEN C ET AL.: "A consensus protocol for the determination of the threshold doses for allergenic foods: How much is too much?", CLIN EXP ALLERGY, vol. 34, 2004, pages 689 - 95
ref_type: npl
severity: background
ref_id: - PEETERS KABM; KOPPELMAN SJ; VAN HOFFEN E; VAN DER TAS CWH; DEN HARTOG JAGER CF; PENNLNKS AH ET AL.: "Does skin prick test reactivity to purified allergens correlate with clinical severity of peanut allergy?", CLIN EXP ALLERGY, vol. 37, 2007, pages 108 - 15
ref_type: npl
severity: background
ref_id: - WILLIAMS PB; BARNES JH; SZEINBACH SL; SULLIVAN TJ: "Analytic precision and accuracy of commercial immunoassays for specific IgE: Establishing a standard", J ALLERGY CLIN IMMUNOL, vol. 105, 2000, pages 1221 - 30, XP027420951, DOI: doi:10.1067/mai.2000.105219
ref_type: npl
severity: background
ref_id: - "SPSS Statistics 21", IBM CORPORATION, ARMONK, NY, USA
ref_type: npl
severity: background
ref_id: WO2016172511A1
ref_type: patent
severity: background
ref_id: WO2016131000A2
ref_type: patent
severity: background
ref_id: WO2014182932A1
ref_type: patent
severity: background
ref_id: WO2012129246A2
ref_type: patent
severity: background
ref_id: [XDY]     - SCHMIDT H. ET AL.: "Detection and structural characterization of natural Ara h 7, the third peanut allergen of the 2S albumin family", J. PROTEOME RES., vol. 9, no. 7, 2 July 2010 (2010-07-02), pages 3701 - 3709, XP055237195
ref_type: npl
severity: background
ref_id: WO2012129246
ref_type: patent
severity: background
ref_id: WO2014182932
ref_type: patent
severity: obviousness
ref_id: WO2016131000
ref_type: patent
severity: novelty_destroying
ref_id: WO2016172511
ref_type: patent
severity: novelty_destroying
ref_id: - SCHMIDT H. ET AL., "Detection and structural characterization of natural Ara h 7, the third peanut allergen of the 2S albumin family", J. PROTEOME RES., (20100702), vol. 9, no. 7, pages 3701 - 3709, XP055237195 [XD] 12,16 * abstract * * figure 2 * * page  3705, column  2, paragraph  2 * * page  3707, column  2, paragraph  l  - page  3708, column  1, paragraph  1 * [Y] 1-10,13,14
ref_type: npl
severity: novelty_destroying
Final disposition: pending (2017-11-15)