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FIG. 4A © O O Wo 2015/042110 Al III III II II III III 1 1 II III II II III III II III

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FIG. 4A © O O Wo 2015/042110 Al III III II II III III 1 1 II III II II III III II III (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date W O 2015/042110 A l 2 6 March 2015 (26.03.2015) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61P 37/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US20 14/056021 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, ΓΝ , IR, IS, JP, KE, KG, KN, KP, KR, 17 September 2014 (17.09.2014) KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (25) Filing Language: English PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (26) Publication Language: English SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/880,522 20 September 2013 (20.09.2013) (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant: CHILDREN'S MEDICAL CENTER COR¬ GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, PORATION [US/US]; 55 Shattuck Street, Boston, Mas¬ TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, sachusetts 021 15 (US). TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (72) Inventors: WINAU, Florian E.; 293 Shawmut Avenue, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, Boston, Massachusetts 021 18 (US). KIM, Ji Hyung; SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, #408, 99 Pond Avenue, Brookline, Massachusetts 02445 GW, KM, ML, MR, NE, SN, TD, TG). (US). (74) Agents: RESNICK, David S. et al; Nixon Peabody LLP, 100 Summer Street, Boston, Massachusetts 021 10 (US). [Continued on nextpage] (54) Title: TREATMENT OF INFLAMMATORY SKIN DISEASE (57) Abstract: The methods, composi¬ tions, and assays described herein are 0.25-. based, in part, on the discovery that CD l a mediates inflammation related to certain conditions such as urushiol ex¬ posure, psoriasis and other inflammat¬ 0.20- ory skin diseases. One aspect provided herein relates to a method for treating or preventing an inflammatory skin dis¬ 0.15- ease, the method comprising: adminis¬ tering a therapeutically effective amount of an inhibitor of CD l a to a 0.10- subject having an inflammatory skin disease, thereby treating or preventing the inflammatory skin diseases. 0.05- 0.00 WT CDIaTg CDIaTg +ANTI-CD1aAb © FIG. 4A © o o wo 2015/042110 Al III III II II III III 1 1 II III II II III III II III Declarations under Rule 4.17: Published: — as to applicant's entitlement to apply for and be granted — with international search report (Art. 21(3)) a patent (Rule 4.17(H)) — as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(Hi)) TREATMENT OF INFLAMMATORY SKIN DISEASE CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims benefit of U.S. Provisional Patent Application Serial No. 61/880,522, filed September 20, 2013, the contents of which are herein incorporated by reference in their entirety. TECHNICAL FIELD [0002] The technical field relates to the compositions and methods for the treatment of inflammatory skin diseases. The field also relates to screening assays for agents the treatment of inflammatory skin diseases. BACKGROUND [0003] Various skin conditions are associated with increased T cell activation and abnormal antigen presentation in the dermis and epidermis. For example, in contact allergic dermatitis, activation of intracutaneous T-cells is observed. It is known that skin from patients exhibiting atopic dermatitis contains an increased number of Langerhans cells. In psoriatic skin, there is an increased number of antigen presenting cells, composed of both Langerhans cells and non-Langerhans cell Class II MHC- bearing antigen presenting cells. [0004] T cells play a major role in the immune response by interacting with target and antigen presenting cells. For example, T cell-mediated killing of target cells is a multi-step process involving, initially, adhesion of cytolytic T cells (the effector cells) to target cells. Also, helper T cells help initiate the immune response by adhesion to antigen presenting cells. [0005] These interactions of T cells with target and antigen presenting cells are highly specific and depend on the recognition of an antigen on the surface of a target or antigen presenting cell by one of the many specific antigen receptors on the surface of T cells. [0006] One way in which T cells are activated is by binding of their antigen specific T cell receptors to peptide-MHC complexes on the surface of antigen presenting cells such as macrophages. T cell activation stimulates proliferation and differentiation of two types of functional T cells: helper cells, which promote the proliferation and maturation of antibody-producing B lymphocytes, and killer cells, which lyse target cells. [0007] CD1 proteins are a family of transmembrane glycoproteins that mediate the presentation of lipid and glycolipid antigens of self or microbial origin to T cells in a manner similar to MHC Class I molecules. CDl a molecules are found primarily on Langerhans cells, which are the major dendritic antigen-presenting cells in the skin. SUMMARY [0008] The methods, compositions, and assays described herein are based, in part, on the discovery that CDl a mediates inflammation related to certain conditions such as urushiol exposure (e.g., poison oak, poison ivy, and poison sumac), psoriasis and atopic dermatitis. Further, the inventors have discovered that inhibitors of CD l a are effective to therapeutically treat or prevent these and other inflammatory skin diseases. [0009] One aspect provided herein relates to a method for treating or preventing an inflammatory skin disease, the method comprising: administering a therapeutically effective amount of an inhibitor of CD l a to a subject having an inflammatory skin disease, thereby treating or preventing the inflammatory skin diseases. [0010] In one embodiment of this aspect and all other aspects described herein, the inhibitor of CD l a inhibits CD l a expression and/or activity. [0011] In another embodiment of this aspect and all other aspects described herein, the inhibitor of CD l a expression is an RNA interference molecule or a small molecule. [0012] In another embodiment of this aspect and all other aspects described herein, the inhibitor of CD l a activity is a small molecule, an antibody or fragment thereof, or a peptide. [0013] In one embodiment of this aspect and all other aspects described herein, the inhibitor of CD l a is a human binding molecule against CDl a as described in U.S. Patent No. 7,968,092, the contents are incorporated here in reference in its entirety. [0014] In another embodiment of this aspect and all other aspects described herein, the inflammatory skin disease is a T-cell mediated skin disease or disorder. [0015] In another embodiment of this aspect and all other aspects described herein, the inflammatory skin disease is urushiol-induced contact dermatitis. [0016] In another embodiment of this aspect and all other aspects described herein, the inflammatory skin disease is psoriasis and/or atopic dermatitis. [0017] In another embodiment of this aspect and all other aspects described herein, the inhibitor of CD l a activity inhibits binding of a ligand to CDl a or CD la-mediated antigen presenting activity. [0018] In another embodiment of this aspect and all other aspects described herein, the ligand is urushiol. [0019] In another embodiment of this aspect and all other aspects described herein, the inhibitor of CD l a activity inhibits antigen-presenting activity of a Langerhans cell. [0020] Also provided herein in another aspect is a pharmaceutical composition for treating an inflammatory skin disease, the composition comprising a therapeutically effective amount of an inhibitor of CD l a and a pharmaceutically acceptable carrier. [0021] In another embodiment of this aspect and all other aspects described herein, the inhibitor of CD l a is selected from the group consisting of: an RNA interference molecule, a small molecule, a peptide, and an antibody or fragment thereof. [0022] In one embodiment of this aspect and all other aspects described herein, the composition comprises an inhibitor of CD l a that is a human binding molecule against CD l a as described in U.S. Patent No. 7,968,092, the contents are incorporated here in reference in its entirety. [0023] In another embodiment of this aspect and all other aspects described herein, the composition is formulated for systemic delivery. [0024] In another embodiment of this aspect and all other aspects described herein, the composition is formulated for topical delivery. [0025] Another aspect provided herein relates to a method for screening a candidate agent for treating an inflammatory skin disease, the method comprising: (a) contacting a Langerhans cell or population of Langerhans cells with an agent, (b) measuring expression and/or activity of CDl a in the cell or population of cells, wherein a decrease in expression and/or activity of CD l a indicates that the agent is a candidate agent for the treatment of an inflammatory skin disease. [0026] In one embodiment of this aspect and all other aspects described herein, the candidate agent is selected from the group consisting of: an RNA interference molecule, a small molecule, a peptide, and an antibody or fragment thereof.
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