Patent SG-11201909572Q-A (SG)
Title: Methods for the treatment of subjects having a hepatitis b virus (hbv) infection
Inventor: SEPP-LORENZINO LAURA
IPC: A61K39/00
Filed: 2018-04-18
Abstract: International Patent Classification: A61K 39/12 (2006.01) Cl 2N 15/86 (2006.01) A61K 31/713 (2006.01) A61P 31/20 (2006.01) C12N 15/113 (2010.01) A61K 39/00 (2006.01) (21) International Application Number: PCT/US2018/028116 (22) International Filing Date: 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). (25) Filing Language: (26) Publication Language: (30) Priority Data: 18 April 2018 (18.04.2018) English English Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(ii)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) 62/486,618 18 April 2017 (18.04.2017) US Published: 62/553,358 01 September 2017 (01.09.2017) US with international search report (Art. 21(3)) 62/646,978 23 March 2018 (23.03.2018) US with sequence listing part of description (Rule 5.2(a)) (71) Applicants: ALNYLAM PHARMACEUTICALS, INC. [US/US]; 300 Third Street, 3rd Floor, Cambridge, MA 02142 (US). TECHNISCHE UNIVERSITAT MUNCHEN [DE/DE]; Arcisstrasse 21, 80333 Munich (DE). (72) Inventors: SEPP-LORENZINO, Laura; 300 Third Street, 3rd Floor, Cambridge, MA 02142 (US). PROTZER, Ulrike; Trogerstrasse 30, 81675 Munich (DE). MICHLER, Thomas; Trogerstrasse 30, 81675 Munich (DE). (74) Agent: ZACHARAKIS, Maria Laccotripe et al.; Mc- Carter & English, LLP, 265 Franklin Street, Boston, MA 02110 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 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, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 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, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 25 October 2018 (25.10.2018) WIPO I PCT 0111111010 0111 °nolo mu Em mil Imo oimIE (10) International Publication Number WO 2018/195165 Al (54) Title: METHODS FOR THE TREATMENT OF SUBJECTS HAVING A HEPATITIS B VIRUS (HBV) INFECTION (57) : The present invention provides methods for the treatment of a subject having a Hepatitis B virus (HBV) infection, e.g., a chronic HBV infection, using a combination of an RNAi agent that targets HBV and an HBV vaccine. It is disclosed a RNAi agent and an HBV vaccine for use in treatment of HBV infection, comprising sequentially administering to the subject having an HBV infection: a) an RNAi agent that inhibits expression of at least three HBV transcripts, wherein the RNAi agent forms a double stranded region; b) a protein-based vaccine comprising a first HBV core antigen (HBcAg) polypeptide, and a first HBV surface antigen (HBsAg) polypeptide; and c) a nucleic acid-based vaccine comprising an expression vector construct encoding a second HBcAg polypeptide, and/or a second HBsAg polypeptide, wherein the second HBcAg polypeptide, and/or the second HBsAg polypeptide, shares at least one epitope with at least one of the first HBcAg polypeptide, and/or the first HBsAg polypeptide.