Patent SG-11201909941Q-A (SG)
Title: Stable formulations of anti-tigit antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
Inventor: DE ARNAB
IPC: A61P35/00
Filed: 2018-05-01
Abstract: International Publication Number WO 2018/204405 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) PCT (19) World Intellectual Property Organization International Bureau (43) International Publication Date 08 November 2018 (08.11.2018) W I P I (51) International Patent Classification: A61K 39/00 (2006.01) A61P 31/12 (2006.01) A61K 39/395 (2006.01) A61P 35/00 (2006.01) (21) International Application Number: PCT/US2018/030516 (22) International Filing Date: 01 May 2018 (01.05.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/500,278 02 May 2017 (02.05.2017) US (71) Applicant: MERCK SHARP & DOHME CORP. [US/US]; 126 East Lincoln Avenue, Rahway, New Jersey 07065-0907 (US). (72) Inventors; and (71) Applicants US only): DE, Arnab [IN/US]; 2000 Gal- loping Hill Road, Kenilworth, New Jersey 07033 (US). NARASIMHAN, Chakravarthy Nachu [US/US]; 2000 Galloping Hill Road, Kenilworth, New Jersey 07033 (US). (74) Common Representative: MERCK SHARP & DOHME CORP.; 126 East Lincoln Avenue, Rahway, New Jersey 07065-0907 (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, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, (54) Title: STABLE FORMULATIONS OF ANTI-TIGIT ANTIBODIES ALONE AND IN COMBINATION WITH PRO- GRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF pH Stability of anti—TIGIT antibody formulation 6.4 6.2 6.0 = 5.8 • • A— 5C —A— 25C 40C Upper Limit 5.6 5.4 5.2 5.0 0 00 O C 3 6 9 12 Time on stability (Months) FIG.1 (57) : The present invention relates to stable formulations of antibodies against T cell immunoreceptor with Ig and ITIM do- mains (TIGIT), optionally further containing an anti-human programmed death receptor 1 (PD-1) antibody or antigen binding fragment thereof. Also provided are methods of treating various cancers and chronic infections with the formulations of the invention. [Continued on next page] WO 2018/204405 Al 1#110figinigE1010010101HOHOIREBER 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(11)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) with sequence listing part of description (Rule 5.2(a))