Patent SG-11201908573Q-A (SG)
Title: Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection
Inventor: MOND JAMES
IPC: A61K39/09
Filed: 2018-03-15
Abstract: 1 N t:T N O N 1-1 00 1-1 O N C (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 20 September 2018 (20.09.2018) WIP0 I PCT mu °million °nolo olomoliolommommo oimIE (10) International Publication Number WO 2018/170297 Al (51) International Patent Classification: A61K 35/00 (2006.01) A61K 39/09 (2006.01) A61K 35/16 (2015.01) A61K 39/155 (2006.01) A61K 39/00 (2006.01) A61K 39/395 (2006.01) (21) International Application Number: PCT/US2018/022701 (22) International Filing Date: 15 March 2018 (15.03.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 15/460,147 15 March 2017 (15.03.2017) US (71) Applicant: ADMA BIOLOGICS, INC. [US/US]; 465 Route 17 South, Ramsey, New Jersey 07446 (US). (72) Inventors: MOND, James; 465 Route 17 South, Ram- sey, New Jersey 07446 (US). GROSSMAN, Adam S.; 465 Route 17 South, Ramsey, New Jersey 07446 (US). (74) Agent: SISK, Tyler J.; Casimir Jones, S.C., 2275 Deming Way, Suite 310, Middleton, Wisconsin 53562 (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. (54) Title: ANTI-PNEUMOCOCCAL HYPERIMMUNE GLOBULIN FOR THE TREATMENT AND PREVENTION OF PNEU- MOCOCCAL INFECTION FIG. I Pneumococcal serotype specific IgG Concentrations in individual donor sera drawn at different time points Donor ID Time Point Sample ID Seroty c specific 1gG concentration (µg/mL) 1 3 4 5 613 7F 9V 14 18C 190 19F 23F Donor #34440 Pre 1010183980 2.14 0.13 0.19 0.57 0.15 0.81 0.04 0.65 0.57 0.25 1.10 1.29 Week 4 1010187977 1086.8 2.12 28 50 3.24 4.56 12.82 10.27 056 10.12 23.76 166.82 56.74 Week 8 1010191870 683.56 1.04 18.37 1.72 2.57 8.75 7.14 0.39 5.55 14.62 99.79 35.07 Week 10 1010193841 894.33 2.85 27.24 2.74 2.80 12.26 8.92 0.66 7.88 18.69 118.51 51.77 Week 12 1010195848 814.20 2.30 22 37 2.58 2.60 12.29 8.07 0.65 7.30 16.70 143 87 45.81 Week 16 1010199412 632.08 1.90 19.35 2.32 2.21 10.83 6.47 0.81 6.71 15.16 103.09 39.97 Donor #7942 Pre 1010184203 0.52 0.32 LOD 0.39 0.24 0.14 0.03 CLOD <LOD 0.18 <LOD 0.36 Week 4 1010187944 36.04 15.06 5.49 2.54 0.28 4.95 9.76 3.14 23.07 3.40 0.17 1.43 Wcck8 1010191587 33 01 10 17 3.92 2.35 0.27 2.85 8.91 3.23 19 45 2.11 0.24 1.63 Week 10 1010193786 3143 10 72 6.50 2.78 0.49 2.66 7.64 3.29 15.90 5.54 0.35 157 Week 12 1010195777 26.03 8.66 5.42 2.82 0.48 2.22 6.99 3.18 14.71 6.26 0.30 1.62 Week 16 1010200569 18.36 5.78 3.98 2.72 0.56 1.69 5.70 2.96 11.31 6.72 0.54 1.83 Donor #20003 Prc 1010184756 0.44 1 00 <LOD 13 52 3.90 1 26 0.68 2.38 1.17 6.54 17.69 2.85 Week 4 1010188381 0.72 3.12 1.16 90 54 10.40 16.61 0.93 5.47 39 95 8.65 23.85 8.03 Week 8 1010192000 0.76 2.48 1.06 84.87 8.83 9.42 0.78 4.34 27.09 9.24 23.12 7.03 Week 10 1010193932 1.05 3.18 1.85 216.25 8.50 8.98 1.04 4.13 30.70 8.41 17.11 7.26 Week 12 1010195963 1.08 2.49 1.49 251.97 6.82 5.63 0.99 3.37 20.26 6.96 14.72 5,80 Week 16 1010200033 1.03 2.34 1.24 268.43 6.96 3.93 1.05 3.18 14 30 6.92 13.96 4.38 Donor #1892 Pre 1010184804 0.13 LOD <LOD 0.19 <LOD 0.04 <LOD <LOD <LOD <LOD 0.06 <LOD Week 4 1010188291 22.30 1.98 0.59 0.52 0.37 41.00 1.25 049 18.30 3.92 1.50 1.98 Wcck8 1010192199 9.75 0.93 0.21 0.50 0.10 19.40 0.59 0.15 6.91 2.52 0.37 1.27 (57) : The present invention relates to compositions and methods for the treatment of infection caused by Streptococcus pneu- monia. In particular, the invention provides human hyperimmune globulin and compositions thereof for preventing or treating pneu- mococcal infection. The invention provides methods of producing hyperimmune globulin containing high titers of opsonophagocytic anti-pneumococcal antibodies, compositions containing same, and methods of using the compositions for the prevention and treatment of pneumococcal infection. The invention further provides methods of preventing or treating pneumococcal infection (e.g., upper res- piratory infections (e.g., bronchitis, otitis, sinusitis, etc.)) in immunocompromised subjects via administration of hyperimmune globulin compositions of the invention (e.g., containing a high titer of opsonophagocytic anti-pneumococcal antibodies) to immunocompromised subjects. [Continued on next page] WO 2018/170297 Al IMEDIMOMMIONE10130101110101HOEUVOIMIE (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, 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: 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))