Patent SG-11201811831S-A (SG)
Title: Compositions and methods for stabilizing flaviviruses with improved formulations
Inventor: LIVENGOOD JILL
IPC: A61K39/12
Filed: 2017-08-03
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) --„, (19) World Intellectual Property 11111111111111111111111111111111111111110111111111111111111111111111111111111111 Organization International Bureau (10) International Publication Number (43) International Publication Date .......'\"' WO 2018/027075 Al 08 February 2018 (08.02.2018) WIP0 I PCT (51) International Patent Classification: chusetts 01701 (US). ERB, Steven, Michael; 2207 Tangle- A611 f 39/12 (2006.01) A61K 39/00 (2006.01) wood Drive, Fort Collins, Colorado 80525 (US). (21) International Application Number: (74) Agent: HANSON, Roberta et al.; 2200 Wells Fargo PCT/US2017/045375 Center, 90 South Seventh St., Minneapolis, Minnesota 55402-3901 (US). (22) International Filing Date: 03 August 2017 (03.08.2017) (81) Designated States (unless otherwise indicated, for every (25) Filing Language: English kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, (26) Publication Language: English CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, (30) Priority Data: DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/370,611 03 August 2016 (03.08.2016) US HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (71) Applicant: TAKEDA VACCINES, INC. [US/US]; One MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, Takeda Parkway, Deerfield, Illinois 60015 (US). OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, (72) Inventors: LWENGOOD, Jill, Ann; 2348 Hampshire TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. Court, Fort Collins, Colorado 80526 (US). STRANGE, Linda, Marie; 65 Hemenway Road, Framingham, Massa- (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, = (54) Title: COMPOSITIONS AND METHODS FOR STABILIZING = Potency Loss after 5 weeks at 25°C ion in 1 i itol Sucrose BB+Meth e+MSG+A an ne+Urea+Mann FLAVIVIRUSES WITH IMPROVED FORMULATIONS IM 1 Trehalose BB+Methionine+MSG+Alanine+Urea+Mannitol = Sucrose BB+Methionine+Urea 1 Alanine: 10 tuM Mannitol: 5% = Trehalose BB+Mannitol Methionine: 2.5 inM Monosodium Glutamate: 10mM = Sucrose BB+Alanine+Urea Urea: 0.25% = Sucrose BB+Arginine+Urea Trehalose BB+ A rgi n ne+Urea i = = Trehalose BB+MSG+Urea , 1 Sucrose BB+Methionine+MSG+Alanine+Urea = Sucrose BB+Urea Trehalose BB+ Methionine+Urea . 0 = = • = Trehalose BB+Methionine+MSG+Alanine+Urea Log Los of _ Trehalose BB+Urea = Trehalose BB+Alanine+Urea Sucrose BB+Methionine+MSG+Alanine = Sucrose BB MSG + (10mM) +Urea (0.25%) Sucrose BB+Mannitol Control/Reference Formulation FIG. 1 -030 If) IN c ::: :) (57) : Embodiments herein relate to compositions and IN sitions and methods disclosed herein concern stabilizing live, e •1 0 ments relate to compositions and methods for reducing degradation —. relate to improved formulations for prolonging stabilization of 0 1-1 0 age ' accelerated storage and transport. Yet other embodiments relate to uses of compositions disclosed herein in kits for transportable © applications and methods. ei -0.20 -0.10 methods for stabilizing Flaviviruses. In certain embodiments, compo- attenuated or unattenuated (e.g. live whole) flaviviruses. Other embodi- of live, attenuated or unattenuated flaviviruses. live attenuated 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 Titer Loss (log i „ PFU/dose) or unattenuated Flaviviruses during manufacturing, stor- Other embodiments O [Continued on next page] WO 2018/027075 Al MIDEDIMOMOIDEIRDERIONIONOBIENBUDIMI GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, 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, 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, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: — as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(U)) Published: — with international search report (Art. 21(3))