(12) United States Patent (10) Patent No.: US 9.457,071 B2 Hide Et Al

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(12) United States Patent (10) Patent No.: US 9.457,071 B2 Hide Et Al US0094.57071B2 (12) United States Patent (10) Patent No.: US 9.457,071 B2 Hide et al. (45) Date of Patent: Oct. 4, 2016 (54) HISTAMINE RELEASER CONTAINED IN 2010/0311604 A1 12/2010 Takkinen et al. HUMAN SWEAT 2011/0117103 A1 5, 2011 Hide et al. 2015,0212097 A1 7/2015 Hide et al. (71) Applicant: Hiroshima University, Higashihiroshima-shi, Hiroshima (JP) FOREIGN PATENT DOCUMENTS EP O955366 A1 11, 1999 (72) Inventors: Michihiro Hide, Hiroshima (JP): EP 16O7107 12/2005 EP 1655.307 A1 5, 2006 Takaaki Hiragun, Hiroshima (JP); EP 229.2659 A1 3, 2011 Kaori Ishii, Hiroshima (JP); Shoji JP 3.642340 A 4/2005 Mihara, Hiroshima (JP); Makiko JP 2008-069 118 A 3, 2008 Hiragun, Hiroshim (JP); Jens-M JP 2010-516747 A 5, 2010 WO 03/084991 A1 10, 2003 Schroeder, Kiel (DE) WO 2005.005474 A1 1, 2005 WO 2008/092993 A1 8, 2008 (73) Assignee: Hiroshima University, Hiroshima (JP) WO 2009,133951 A1 11/2009 (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 OTHER PUBLICATIONS U.S.C. 154(b) by 0 days. Xu et al., “Malassezia globosa CBS 7966 hypothetical protein MGL 1304 partial mRNA.” Database DDBJ/EMBL/GenBank (21) Appl. No.: 14/409,730 online), XM 001731984.1 (2008). Rasool et al., “Cloning, characterization and expression of complete (22) PCT Filed: Jun. 25, 2013 coding sequences of three IgE binding Malassezia furfur allergens, Mal f7. Mal f8 and Mal f 9...” European Journal of Biochemistry, (86). PCT No.: PCT/UP2013/067396 267: 4355-4361 (2000). Lindberg et al., “Malassezia furfur mRNA coding for potential S 371 (c)(1), allergen, strain ATCC No. 42132,” Database DDBJ/EMBL/ (2) Date: Mar. 10, 2015 GenBank online), AJO 11958.1 (2000). Lindberg et al., “Malassezia sympodialis mRNA for allergen Mals (87) PCT Pub. No.: WO2014/003008 8, strain ATCC No. 42132. Database DDBJ/EMBL/GenBank PCT Pub. Date: Jan. 3, 2014 online), AJO1 1958.2 (2002). Kanbe et al., “Atopic Dermatitis and Malassezia Species: A Study (65) Prior Publication Data of Antigenic Components of Malassezia Species for Immunoglobu lin E of Patients with Atopic Dermatitis,” Japanese Journal of US 2015/O238581 A1 Aug. 27, 2015 Medical Mycology, 44: 71-75 (2003) see English abstract. Shindo et al., “Histamine release-neutralization assay for Sera of (30) Foreign Application Priority Data patients with atopic dermatitis and/or cholinergic urticaria is useful to screen type I hyperSensitivity against Sweat antigens.” Archives Jun. 28, 2012 (JP) ................................. 2012-145814 of Dermatological Research, 304: 647-654 (2012). Hiragun et al., “Fungal protein MGL 1304 in Sweat is an allergen (51) Int. Cl. for atopic dermatitis patients,” Journal of Allergy and Clinical GOIN 33/53 (2006.01) Immunology, (2013). A6 IK 39/00 (2006.01) International Search Report issued in corresponding International C07K 16/14 (2006.01) Patent Application No. PCT/JP2013/067396 dated Jul 23, 2013. Steinberger et al., “Construction of a Combinatorial IgE Library GOIN 33/68 (2006.01) from an Allergic Patient.” The Journal of Biological Chemistry, 271: C07K I4/375 (2006.01) 10967-10972 (1996). GOIN 33/569 (2006.01) Tanaka et al., “Cholinergic Urticaria Successfully Treated by A61 K 38/00 (2006.01) Immunotherapy with Partially Purified Sweat Antigen.” Allergy, 56: (52) U.S. Cl. 54-57 (2007) (see English abstract on p. 57). CPC ......... A61K 39/0002 (2013.01); C07K 14/375 (Continued) (2013.01); C07K 16/14 (2013.01); G0IN 33/56961 (2013.01); G0IN 33/6854 (2013.01); A6 IK 38/00 (2013.01); C07K 2317/76 Primary Examiner — Jennifer Graser (2013.01); C07K 2319/30 (2013.01); G0IN (74) Attorney, Agent, or Firm — Morgan, Lewis & 2800/202 (2013.01); G0IN 2800/24 (2013.01) Bockius LLP (58) Field of Classification Search None (57) ABSTRACT See application file for complete search history. Provided are a Sweat allergy antigen, an antibody capable of binding to the antigen specifically, and others, which are (56) References Cited produced utilizing a microorganism-originated protein that U.S. PATENT DOCUMENTS exists in Sweat allergy patient in a dissolved state or a partial peptide of the protein. 2006, OO88926 A1 4/2006 Ozawa et al. 2006/01347.06 A1 6, 2006 Hide et al. 12 Claims, 11 Drawing Sheets US 9.457,071 B2 Page 2 (56) References Cited Xu et al., “hypothetical protein MGL 1304 Malassezia globosa CBS 7966).” RefSeq, online), XP 001732036.1 (2008). OTHER PUBLICATIONS Extended European Search Report issued in corresponding Euro pean Patent Application No. 13809354.7 dated Feb. 10, 2016. Tanaka et al., “Semi-purification of the immunoglobulin E-Sweat Valenta et al., “Autoallergy: A pathogenetic factor in atopic derma antigen acting on mast cells and basophils in atopic dermatitis.” titis?” Journal of Allergy and Clinical Immunology, 105: 432-437 Experimental Dermatology, 15: 283-290 (2006). (2000). Fairley et al., “A Pathogenic Role for IgE in Autoimmunity: Bullous Vilhelmsson, “Structural and functional studies of malassezia Pemphigoid IgE Reproduces the Early Phase of Lesion Develop sympodialis-derived allergens.” Department of Medicine Solna, ment in Human Skin Grafted to nu/nu Mice,” Journal of Investi Clinical Allergy Research Unit, Karolinska Institutet, XP55234699 gative Dermatology, 127: 2605-2611 (2007). Human IgE (non-Immune), BIOPORTO Diagnostics (2011). (2008). International Preliminary Report on Patentability issued in related Partial Supplementary European Search Report issued in related International Patent Application No. PCT/JP2013/071715 dated European Patent Application No. 13879589.3 dated Apr. 20, 2016. Feb. 26, 2015. Ishii et al., “A human monoclonal IgE antibody that binds to International Preliminary Report on Patentability issued in corre MGL 1304, a major allergen in human Sweat, without activation of sponding International Patent Application No. PCT/JP2013/067396 mast cells and basophils.” Biochemical and Biophysical Research dated Dec. 28, 2014. Communications, 468: 99-104 (2015). International Search Report issued in related International Patent “Product Catalog 2010 Bioporto Diagnostics,” XP055257898, Application No. PCT/JP2013/071715 dated Nov. 12, 2013. http://www.ngal.cz/files/bioporto-katalog-2010-en.pdf (2010). U.S. Patent Oct. 4, 2016 Sheet 1 of 11 US 9,457,071 B2 Fig, A B HKMSWGSESPGNVR 0.4 2 15 2 0.3 N N s 1.0 3 0.2 at s s i 0.5 i 0. , 0. 30 35 40 45 50 SS 5 20 25 30 Retension time (min) Retension time (min) as s gits it ge FractioS Fractions Fig.2 C38 stair: anti-his-tag A ser:Fr. U.S. Patent Oct. 4, 2016 Sheet 2 of 11 US 9,457,071 B2 Fig. 3 s 60 mom AD s 50 as AD 2 s 40 ava AD 3 9 30 ara HC 20 : 10 0 a -10 10 100 1000 10000 rMG 1304 (ng/ml) Fig. 4 Ai) sefa A sara Biot A Sea a. rhigi. 304 QRX U.S. Patent Oct. 4, 2016 Sheet 3 of 11 US 9,457,071 B2 Fig.5 -MG 1304 20 U.S. Patent Oct. 4, 2016 Sheet S of 11 US 9,457,071 B2 Fig. 7 5 -25kDa -20kDa in 15kDa "10kba U.S. Patent Oct. 4, 2016 Sheet 6 of 11 US 9,457,071 B2 Fig.9 {x3 Skia Sika 3x33 2Sika ska 28&a 2k}a Sixa ska ka ik}3 Fig. 30 Sit-2 U.S. Patent Oct. 4, 2016 Sheet 7 of 11 US 9,457,071 B2 A. s s 8. s $8 race.823 20 px. 8: s x: staaite release sets 388-8ye-tag ity (R Fig. 2 Difference of reactivity of each MGL-Ab to fragmented rw CL S-3 D3 3-3 A. 3 M E33-3 d E-3 N 33-33 2M g 3 2 Es 3N 2 U.S. Patent Oct. 4, 2016 Sheet 8 of 11 US 9,457,071 B2 Fig. 3 Primary antibody:8-2fantigen: QRX 8x8 x bos Fig. 4 Primary antibody:8-2fantigen:MGL 8.8 88 8. : o: 3. ... 3.3 Fig. 5 Primary antibody:Smith2|antigen:MGL 8 : U.S. Patent Oct. 4, 2016 Sheet 9 of 11 US 9,457,071 B2 Fig. 6 Coating with MGL antibody (6-3) QRX-IgE measurements Dilution of Serur Fig. 7 Coating with MGL antibody (8-2) QRX-lgE measurements . i...................................... ............................ tra-83. Dilution of Serum U.S. Patent Oct. 4, 2016 Sheet 10 of 11 US 9,457,071 B2 Fig.20 MiG-igE x :s 8s Fig.2 : U.S. Patent Oct. 4, 2016 Sheet 11 of 11 US 9,457,071 B2 Fig.22 MGL product ion in M.globosa culture using buffer A ::::::::: Incubation period (min) US 9,457,071 B2 1. 2 HISTAMINE RELEASER CONTAINED IN In one aspect, the present invention provides a composi HUMAN SWEAT tion or kit for detecting an antibody binding to a Sweat allergy antigen, or a composition or kit for measuring an A computer readable text file, entitled “SequenceLis amount of a antigen binding to a Sweat allergy antigen, ting..txt, created on or about Mar. 10, 2015 with a file size comprising a Sweat allergy antigen protein that is a protein of about 15 kb contains the sequence listing for this appli derived from a microorganism or a MGL 1304 partial cation and is hereby incorporated by reference in its entirety. peptide. In one aspect, the present invention provides a composi TECHNICAL FIELD tion or kit for diagnosing a Sweat allergy or a disease related 10 to a Sweat allergy antigen, comprising: This application claims priority to Japanese Patent Appli (i) a Sweat allergy antigen protein that is a protein derived cation No. 2012-145814, filed Jun.
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