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WO 2019/094700 Al 16 May 2019 (16.05.2019) W 1P O PCT

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WO 2019/094700 Al 16 May 2019 (16.05.2019) W 1P O PCT (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 2019/094700 Al 16 May 2019 (16.05.2019) W 1P O PCT (51) International Patent Classification: (72) Inventors: SANTOS, Michael; One Kendall Square, C07K 14/435 (2006.01) A01K 67/04 (2006.01) Building 200, Cambridge, Massachusetts 02139 (US). A01K 67/00 (2006.01) C07K 14/00 (2006.01) DELISLE, Scott; One Kendall Square, Building 200, Cam¬ A01K 67/033 (2006.01) bridge, Massachusetts 02139 (US). TWEED-KENT, Ailis; One Kendall Square, Building 200, Cambridge, Massa¬ (21) International Application Number: chusetts 02139 (US). EASTHON, Lindsey; One Kendall PCT/US20 18/059996 Square, Building 200, Cambridge, Massachusetts 02139 (22) International Filing Date: (US). PATTNI, Bhushan S.; 15 Evergreen Circle, Canton, 09 November 2018 (09. 11.2018) Massachusetts 02021 (US). (25) Filing Language: English (74) Agent: WARD, Donna T. et al; DT Ward, P.C., 142A Main Street, Groton, Massachusetts 01450 (US). (26) Publication Language: English (81) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of national protection available): AE, AG, AL, AM, 62/584,153 10 November 2017 (10. 11.2017) US AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/659,213 18 April 2018 (18.04.2018) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/659,209 18 April 2018 (18.04.2018) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/680,386 04 June 2018 (04.06.2018) US HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/680,371 04 June 2018 (04.06.2018) US KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (71) Applicant: COCOON BIOTECH INC. [US/US]; One MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, Kendall Square, Building 200, Cambridge, Massachusetts OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 02139 (US). SC, 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. (54) Title: SILK-BASED PRODUCTS AND METHODS OF USE o - ©OS (57) Abstract: Embodiments of the present disclosure include silk-based products and related methods of use in a variety of applications. o Included are applications in the fields of medicine, veterinary medicine, agriculture, and material science. o [Continued on nextpage] W O 2019/094700 A l I lllll II lllll lllll lllll llll I II III lllll lllll lllll lllll Hill llll llll llll llll (84) Designated States (unless otherwise indicated, for every kind of regional protection available) : ARIPO (BW, GH, GM, KE, LR, LS, MW, ML, 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). Published: SILK-BASED PRODUCTS AND METHODS OF USE CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to 62/584,153 filed on November 1 , 2017 entitled Manufacture and Uses of Silk Fibroin, 62/659,213 filed April 18, 2018 entitled Silk-Based Products and Methods of Use, 62/659,209 filed April 18, 20 8 entitled Ocular Silk-Based Products and Methods of Use, 62/680,386 filed June 4, 2018 entitled Silk-Based Products and Methods of Use, and 62/680,371 filed June 4, 2018 entitled Ocular Silk-Based Products and Methods of Use, the contents of each of which are herein incorporated by reference in their entirety. FIELD OF THE INVENTION [0002] The present invention relates to formulations and methods of using silk in therapeutic, agricultural, and materials applications. Specifically provided are silk-based product formulations. BACKGROUND OF THE INVENTION [0003] Silk is a naturally occurring polymer. Most silk fibers are derived from silkworm moth (Bombyx mori) cocoons and include silk fibroin and sericin proteins. Silk fibroin is a fibrous material that forms a polymeric matrix bonded together with sericin. In nature, silk is formed from a concentrated solution of these proteins that are extruded through silkworm spinnerets to produce a highly insoluble fiber. These fibers have been used for centuries to form threads used in garments and other textiles. [0004] Many properties of silk make it an attractive candidate for products serving a variety of industries. Polymer strength and flexibility has supported classical uses of silk in textiles and materials, while silk biocompatibility has gained attention more recently for applications in the fields of medicine and agriculture. Additional uses for silk in applications related to material science are being explored as technologies for producing and processing silk advance. [0005] Although a variety of products and uses related to silk are being developed, there remains a need for methods of producing and processing silk and silk-based products that can meet modem demands. Additionally, there remains a need for silk-based products that can leverage silk polymer strength, flexibility, biocompatibility, and other properties to meet needs in the fields of medicine, agriculture, and material sciences. The present disclosure addresses these needs by providing methods for producing and processing silk as well as silk-based products useful in a variety of industries. SUMMARY OF THE INVENTION [0006] In some embodiments, the present disclosure provides a silk-based product (SBP) for use in a therapeutic application, an agricultural application, and/or a material science application, wherein the SBP includes processed silk that is derived from one or more of raw silk, silk fiber, silk fibroin, and a sil fibroin fragment. The SBP may be used in a therapeutic application, wherein the SBP includes or is combined with one or more of: (a) a pharmaceutical composition, the pharmaceutical composition optionally including one or more of: (i) an excipient, wherein the excipient includes one or more members including, but not limited to, any of those listed in Table 1: and (ii) a therapeutic agent, wherein the therapeutic agent includes one or more members such as, but not limited to, any of those listed in Table 3; (b) an implant, the implant optionally including one or more of: (i) an excipient, wherein the excipient includes one or more members such as, but not limited to, any of those listed in 'Table 1: (ii) a therapeutic agent, where the therapeutic agent includes one or more members such as, but not limited to, any of those listed in Table 3; (iii) a coating; (iv) a gel or hydrogel; (v) a scaffold; (vi) a particle; and (vii) a device, where the device includes one or more members such as, but not limited to, any of those listed in Table 6; (c) a coating, the coating optionally including one or more of: (i) an excipient, where the excipient includes one or more members such as, but not limited to, any of those listed in Table 1; and (ii) a therapeutic agent, where the therapeutic agent includes one or more members such as, but not limited to, any of those listed in Table 3; (d) a food or health supplement; and (e) a device, the device optionally including one or more of: (i) a synthetic material; and (ii) a therapeutic agent, wherein the therapeutic agent includes one or more members such as, but not limited to, any of those listed in Table 3. [0007] In some embodiments, the present disclosure provides an SBP for use in an agricultural application, wherein the SBP includes or is combined with one or more members such as, but not limited to, (a) an agricultural composition, where the agricultural composition optionally includes one or more members such as, but not limited to, (i) a cargo, where the cargo includes one or more members such as, but not limited to, any of those listed in Table 7; (ii) a coating; (iii) a fertilizer; (iv) a nutrient, where the nutrient includes one or more members such as, but not limited to, any of those listed in Table 7; (v) an agricultural product; (vi) a pest control agent, where the pest control agent optionally includes a pesticide such as, but not limited to, (1) a parasiticide, where the parasiticide includes one or more members such as, but not limited to, any of those listed in Table 7; (2) an insecticide, where the insecticide includes one or more members such as, but not limited to, any of those listed in Table 7; (3) an herbicide, r the herbicide includes one or more members such as, but not limited to, any of those listed in Table 7: and (4) an anti-fungal or fungicide, where the anti-fungal or fungicide includes one or more members such as, but not limited to, any of those listed in Table 7; (vii) a soil stabilizer including one or more members such as, but not limited to, any of those listed in Table 7; (viii) a biological system including at least one microbe and/or probiotic; and (ix) an agricultural therapeutic agent including one or more members such as, but not limited to, any of those listed in Table 3 and any of those listed in Table 7; and (b) an agricultural device, ere the agricultural device optionally includes one or more members such as, but not limited to, (i) an article of agricultural equipment; (ii) a crop storage device; (iii) a landscaping fabric; and (iv) a pest control device.
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