WO 2017/035412 Al 2 March 2017 (02.03.2017) P O P C T
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(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 2017/035412 Al 2 March 2017 (02.03.2017) P O P C T (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, A61K 31/715 (2006.01) A61K 45/06 (2006.01) BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A61K 31/716 (2006.01) A61K 31/702 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, A61P 31/04 (2006.01) A61K 31/733 (2006.01) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, (21) International Application Number: MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PCT/US20 16/048794 PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (22) International Filing Date: SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 25 August 2016 (25.08.2016) TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (26) Publication Language: English GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (30) Priority Data: TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 62/209,618 25 August 2015 (25.08.2015) US TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 62/209,629 25 August 2015 (25.08.2015) US DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, 62/209,626 25 August 2015 (25.08.2015) US LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, (71) Applicant: KALEIDO BIOSCIENCES, INC. [US/US]; GW, KM, ML, MR, NE, SN, TD, TG). 47 Moulton St, Cambridge, MA 02 138 (US). Declarations under Rule 4.17 : (72) Inventors: VON MALTZAHN, Geoffrey, A.; 42 Myrtle — as to applicant's entitlement to apply for and be granted a St Apt Bl, Somerville, MA 02145 (US). YAMANAKA, patent (Rule 4.1 7(H)) Yvonne, J.; 9 1 Sidney St, #207, Cambridge, MA 02139 (US). — as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.1 7(in)) (74) Agents: COLLAZO, Diana M. et al; Lando & Anastasi, LLP, Riverfront Office Park, One Main Street, Suite 1100, Published: Cambridge, MA 02142 (US). — with international search report (Art. 21(3)) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, (54) Title: GLYCAN COMPOSITIONS AND USES THEREOF (57) Abstract: Compositions comprising glycan preparations suitable for local administration to non-gut sites containing mucosal tissue, e.g., oral cavity, nasal cavity and vagina are provided. Further provided are methods of using said glycan preparations. GLYCAN COMPOSITIONS AND USES THEREOF CLAIM OF PRIORITY This application claims priority to U.S. Application No. 62/209,618; U.S. Application No. 62/209,626; and U.S. Application No. 62/209,629, each of which was filed on August 25, 2015. The disclosure of each of the foregoing applications is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION Maintaining or restoring human health faces a large number of challenges many of which result from the lack of effective treatment options. There is a continued need for novel therapies and treatment regimens. SUMMARY OF THE INVENTION Aspects of the invention relate to glycan preparations, pharmaceutical compositions, dosage forms, and methods of locally using the glycan preparations at non-gut body sites that contain mucosal tissues. In one aspect, the present invention features methods of modulating the abundance of a bacterial taxa in a non-gut body site. In some embodiments, the method comprises modulating the abundance of a bacterial taxa in a non-gut body site containing mucosal tissue of a human subject, comprising: locally administering to the non-gut body site a pharmaceutical composition comprising a glycan preparation in an amount effective to modulate the bacterial taxa in the non-gut body site containing mucosal tissue of the human subject, wherein the glycan preparation has at least one of the following properties: i) the glycan preparation comprises branched glycans that comprise glucose, galactose, arabinose, mannose, fructose, xylose, fucose, or rhamnose glycan units, ii) the average degree of branching (DB) of the branched glycans in the glycan preparation is between about 0.01 and about 0.6, iii) at least 50% of the glycans in the glycan preparation have a degree of polymerization (DP) of at least 3 and less than 30 glycan units, iv) the average DP of the glycan preparation is between about DP3 and about DP18, v) the ratio of alpha- to beta-glycosidic bonds present in the glycans of the glycan preparation is between about 0.8:1 and about 5:1, and/or optionally vi) the glycan preparation has a final solubility limit in water of at least about 60 Brix at 23 °C. In some embodiments, the non-gut body site (e.g., containing mucosal tissue) of a human subject is the nasal cavity. In some embodiments, the abundance of a bacterial taxa of the genus Corynebacterium, Alloiococcus, or Staphylococcus is modulated in the nasal cavity. In some embodiments, the abundance of a bacterial taxa of the genus Corynebacterium or Staphylococcus is modulated in the nasal cavity. In some embodiments, the abundance of a bacterial taxa of the genus Corynebacterium and Staphylococcus is modulated in the nasal cavity. In some embodiments, the abundance of a bacterial taxa of the species Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus aureus, or Propionibacterium acnes is modulated in the nasal cavity. In some embodiments, the abundance of at least two bacterial taxa of the species Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus aureus, or Propionibacterium acnes are modulated in the nasal cavity. In some embodiments, the abundance of at least three bacterial taxa of the species Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus aureus, or Propionibacterium acnes are modulated in the nasal cavity. In some embodiments, the non-gut body site (e.g., containing mucosal tissue) of a human subject is the oral cavity. In some embodiments, the abundance of a bacterial taxa of the genus Prevotella, Oribacterium, Bifidobacterium, or Moryella is modulated in the oral cavity. In some embodiments, the abundance of a bacterial taxa of the genus Bifidobacterium, Abiotrophia, Clostridiales, Catonella, Moryella, Leptotrichia, Eikenella, Aggregatibacter, Prevotella, Oribacterium, Neisseria or Haemophilus is modulated in the oral cavity. In some embodiments, the abundance of a bacterial taxa of the genus Prevotella, Oribacterium, Neisseria or Haemophilus is modulated in the oral cavity. In some embodiments, the abundance of at least two bacterial taxa of the genera Prevotella, Oribacterium, Neisseria or Haemophilus are modulated in the oral cavity. In some embodiments, the abundance of at least three bacterial taxa of the genera Prevotella, Oribacterium, Neisseria or Haemophilus are modulated in the oral cavity. In some embodiments, the abundance of a bacterial taxa of the species Neisseria subflava or Streptococcus oralis is modulated in the oral cavity. In some embodiments, the abundance of a bacterial taxa of the species Neisseria subflava and Streptococcus oralis is modulated in the oral cavity. In some embodiments, the non-gut body site (e.g., containing mucosal tissue) of a human subject is the vagina. In some embodiments, the abundance of a bacterial taxa of the genus lactobacillus is modulated in the vagina. In some embodiments, the abundance of a bacterial taxa of the species Lactobacillus crispatus, Lactobacillus gasseri, or Lactobacillus iners is modulated in the vagina. In some embodiments, the abundance of at least two bacterial taxa of the species Lactobacillus crispatus, Lactobacillus gasseri, or Lactobacillus iners are modulated in the vagina. In some embodiments, modulating comprises increasing the abundance of the bacterial taxa (e.g., by at least 5%, 10%, 25% 50%, 75%, 100%, 250%, 500%, 750%, or by at least 1000%). In some embodiments, modulating comprises decreasing the abundance of the bacterial taxa (e.g., by at least 5%, 10%, 25% 50%, 75%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, or by at least 99.9%). In some embodiments, modulating comprises increasing or decreasing the relative abundance of the bacterial taxa by at least 5%, 10% or by at least 20%. In some embodiments, modulating comprises increasing or decreasing the abundance of the bacterial taxa in the non-gut body site relative to the bacterial community in the non-gut body site. In some embodiments, modulating comprises increasing or decreasing the abundance of the bacterial taxa: i) relative to the abundance of a second bacterial taxa at the non-gut body site, or ii) relative to a reference value (e.g., a numerical or non-numerical value), optionally, i) wherein the reference value is a function of the abundance of the bacterial taxa at the non-gut body site prior to administration of the glycan preparation to the non-gut body site (e.g., in the absence of a glycan preparation), ii) wherein the reference value is a function of the abundance of the bacterial taxa at the non-gut body site in a subject having a dysbiosis of or in the non-gut body site, iii) wherein the reference value is a function of the abundance of the bacterial taxa for one or more individuals having a disease, disorder, or pathological condition (e.g.