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WO 2012/175518 Al 27 December 2012 (27.12.2012) P O P C T

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WO 2012/175518 Al 27 December 2012 (27.12.2012) P O P C T (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 WO 2012/175518 Al 27 December 2012 (27.12.2012) P O P C T (51) International Patent Classification: (72) Inventor; and A61K 39/39 (2006.01) A61K 39/205 (2006.01) (75) Inventor/Applicant (for US only): PETROVSKY, A61K 31/715 (2006.01) A61K 39/29 (2006.01) Nikolai [AU/AU]; 11 Walkley Avenue, Warradale, A d A61K 39/145 (2006.01) elaide, South Australia 5046 (AU). (21) International Application Number: (74) Agent: WRIGHT,, Andrew John; POTTER CLARKSON PCT/EP2012/061748 LLP, Park View House, 58 The Ropewalk, Nottingham Nottinghamshire NG1 5DD (GB). (22) International Filing Date: 19 June 2012 (19.06.2012) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (25) English Filing Language: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (26) Publication Language: English CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, (30) Priority Data: HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, 61/498,557 19 June 201 1 (19.06.201 1) US KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, (71) Applicant (for all designated States except US): VAXINE MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, PTY LTD [AU/AU]; Endocrinology Department, Room OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, 6D313, Flinders Medical Centre, Bedford Park, South SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, Australia 5042 (AU). TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant (for MG only): WRIGHT, Andrew [GB/GB]; (84) Designated States (unless otherwise indicated, for every Potter Clarkson LLP, Parkview House, 58 The Ropewalk, kind of regional protection available): ARIPO (BW, GH, Nottingham NG1 5DD (GB). GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, [Continued on nextpage] (54) Title: VACCINE ADJUVANT COMPOSITION COMPRISING INULIN PARTICLES (57) Abstract: The present invention provides a composi tion comprising or consisting of inulin particles for use in the reduction or inhibition of inflammation, and/or for treat ing or preventing inflammatory disease, in a subject. Also provided is a pharmaceutically acceptable composition com prising: particles of inulin; and a substance comprising or consisting of one or more pathogen-associated molecular patterns (PAMPs), or an equivalent kit of parts, and methods and uses of the composition and kit for inducing or modulat ing an immune response in a subject, such as modulating an immune response to an antigen or allergen and/or as a vac a cine. Also provided is a single-dose vaccine composition comprising inulin particles, an antigen and, optionally, an . c <J> » , ? ? antigen-binding carrier material, and methods and uses of the vaccine. < 00 , o o w o 2012/175518 Ai Iinn iiiiiii 1mil i mil il i 1 ill i inn i iurn i mill i i i UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, Published: TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, — with international search report (Art. 21(3)) EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, — before the expiration of the time limit for amending the SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, claims and to be republished in the event of receipt of GW, ML, MR, NE, SN, TD, TG). amendments (Rule 48.2(h)) Declarations under Rule 4.17: — of inventorship (Rule 4.1 7(iv)) VACCINE ADJUVANT COMPOSITION COMPRISING INULIN PARTICLES FIELD OF THE INVENTION The present invention relates to novel composition suitable for the stimulation, modulation or enhancement of an immune response. INCORPORATION BY REFERENCE The following International Patent Applications are referred to herein: - PCT/AU86/0031 (WO 87/02679) titled "Immunotherapeutic treatment", PCT/AU89/00349 (WO 90/01 949) titled "Gamma inulin compositions", and PCT/AU2005/001328 (WO 2006/024100) titled "New polymorphic form of inulin and uses thereof. PCT/AU201 0/001221 (WO 201 1/032229) titled "A novel epsilon polymorphic form of inulin and compositions comprising same" The entire content of all of these applications is hereby incorporated by reference. BACKGROUND AND OVERVIEW OF THE INVENTION AND PRIOR ART The listing or discussion of an apparently prior-published document in this specification should not necessarily be taken as an acknowledgement that the document is part of the state of the art or is common general knowledge. As known in the art, microbial-derived compounds that trigger innate immune activation also enhance the adaptive immune response to a co-administered vaccine antigen. Such compounds are now known to comprise or mimic pathogen-associated molecular patterns (PAMPs), where a PAMP is a structurally conserved motif derived from a pathogen that is immunologically distinguishable from host molecules, and is recognised by an innate immune receptor (Heine et al., 2005). PAMPs are present in certain types of protein, lipid, lipoprotein, carbohydrate, glycolipid, glycoprotein, and nucleic acids expressed by particular pathogens and include triacyl lipopeptides, porins, glycans, single and double stranded RNA, flagellin, lipotechoic acid, N-formymethionine, and bacterial or viral DNA, amongst others. PAMPs act as innate immune activators by binding to PAMP-specific innate immune receptors such as toll-like receptors (TLR), NOD-like receptors, RIG ligase receptors and C-type lectins. This leads to activation of inflammatory gene pathways in immune cells. What these PAMP compounds have in common is that they all activate the innate immune system and induce inflammatory gene pathways, in particular through activating Nuclear Factor-Kappa B (NFKB), the master transcriptional regulator of inflammatory gene activation. This inflammation in turn may lead to enhancement of an adaptive immune response to a co-administered antigen, as a by-product or downstream effect of the innate immune activation. The enhancement by a separate substance of an adaptive immune response to a co-administered antigen is known as an "adjuvant" effect. Without wishing to be restricted by theory, it is accepted by those skilled in the art that the common factor that links all compounds that possess adjuvant activity is that they induce immune "danger signals" (Matzinger, 2002) leading to activation of innate immune and thereby activation of NFKB and other inflammatory pathways. Danger signals that provide immune adjuvant effects can be generated by local tissue damage, e.g. induced by injection of inflammatory substances such as oil emulsions, or more specifically through binding of PAMPs to innate immune receptors whose role is to detect pathogen invasion and tissue damage. PAMP-associated danger signals thereby alert the innate immune system of the need to mount a defensive inflammatory response against the perceived threat. Following the activation of these danger-sensing PAMP receptors, inflammatory gene signalling pathways including the key NFKB pathway are activated leading to secretion by immune cells such as monocytes of key inflammatory effectors including tumour necrosis factor (TNF)-a, interleukin (IL)-1 , IL-6, IL-8 and IL-1 2 , amongst others. These inflammatory mediators released in response to PAMP activation are believed in the art to be critical to the ability of PAMPs to enhance antigen-specific adaptive immune responses, with high-throughput cell-based screening assays designed to identify new adjuvant compounds reliant upon their ability to induce inflammatory cytokines such as TNF-a, IFN- γ , IL-1 , IL-8 or IL1 2 as the readout of potential adjuvant activity (Buckner et al, 2008). Conceptually, two or more such innate immune activators when combined together induce even stronger danger signals, generate higher levels of inflammatory gene activation, and thereby are predicted to show increased adjuvant potency (Querec et al., 2006; Kasturi et al, 201 1) . However, as known by those skilled in the art, the problem of using PAMPs either singly or, more particularly, combined together as immune modulators or vaccine adjuvants is that the inflammatory effects are highly toxic and hence the ability to achieve enhancement of an adaptive immune response in this way is hindered by severe dose-limiting local and systemic inflammation-associated toxicity which is correspondingly magnified as the dose of the innate immune activator is increased. For example, even the combination of a partially detoxified PAMP analogue, monophosphoryl lipid A (MPL), with aluminium hydroxide ("alum") adjuvant in a hepatitis B surface antigen (HBsAg) vaccine caused significantly more local injection site reactions, fever and other systemic side effects than HBsAg with alum adjuvant alone (Tong et al., 2005). Increased vaccine reactogenicity and toxicity when two or more innate immune activators are combined in a vaccine formulation is a major barrier to regulatory approval of such adjuvant combinations, even where there might be a favourable impact on vaccine immunogenicity (Petrovsky et al, 2008). Furthermore, not all combinations of innate immune activators are favourable from an immunogenicity standpoint, such that some combinations of innate immune activators produce an adaptive immune response to a co-administered antigen that is no better than the individual innate immune activator components alone, and some innate immune activator combinations even result in lower antigen-specific responses than with each individual innate immune activator used alone. For example, humans immunized with C-terminal recombinant malaria circumsporozoite antigen with alum alone achieved higher antigen-specific antibodies than subjects receiving the combination of alum with MPL (Gordon et al., 1995). The vaccine art recognizes the use of certain substances called adjuvants to potentiate an immune response when used in conjunction with an antigen.
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