US 11,655,289 B2
Pharmaceutical compositions containing anti-beta amyloid antibodies
Steven Andrew Lantz, Jamaica Plain, MA (US); Kapil Gupta, Concord, MA (US); Shantanu Sule, Arlington, MA (US); and Adnan Zunic, Cambridge, MA (US)
Assigned to Biogen MA Inc., Cambridge, MA (US)
Appl. No. 16/639,338
Filed by Biogen MA Inc., Cambridge, MA (US)
PCT Filed Aug. 22, 2018, PCT No. PCT/US2018/047508
§ 371(c)(1), (2) Date Feb. 14, 2020,
PCT Pub. No. WO2019/040612, PCT Pub. Date Feb. 28, 2019.
Claims priority of provisional application 62/548,583, filed on Aug. 22, 2017.
Prior Publication US 2021/0188954 A1, Jun. 24, 2021
Int. Cl. A61K 39/395 (2006.01); C07K 16/18 (2006.01); A61K 47/18 (2017.01); A61K 47/20 (2006.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/18 (2013.01) [A61K 39/3955 (2013.01); A61K 39/39591 (2013.01); A61K 47/183 (2013.01); A61K 47/20 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); A61K 2039/505 (2013.01); C07K 2317/565 (2013.01); C07K 2317/94 (2013.01)] 18 Claims
 
1. A pharmaceutical composition comprising:
(i) an anti-beta amyloid (Aβ) antibody or Aβ-binding fragment thereof at a concentration of 100 mg/ml to 200 mg/ml;
(ii) arginine hydrochloride (Arg.HC1) at a concentration of 75 mM to 175 mM;
(iii) methionine at a concentration of 5 mM to 15 mM;
(iv) histidine at a concentration of 10 mM to 30 mM;
(v) polysorbate-80 (PS80) at a concentration (w/v) of 0.03% to 0.08%; and
(vi) a thiol-containing antioxidant selected from the group consisting of GSH, GSSG, the combination of GSH and GSSG, cystine, cysteine, and the combination of cystine and cysteine, wherein the thiol-containing antioxidant is at a concentration of 0.02 mM to 4 mM, wherein the anti-Aβ antibody or Aβ-binding fragment thereof comprises an immunoglobulin heavy chain variable domain (VH) and an immunoglobulin light chain variable domain (VL), wherein
(a) the VH comprises
a VH-CDR1 that consists of the amino acid sequence set forth in SEQ ID NO:1;
a VH-CDR2 that consists of the amino acid sequence set forth in SEQ ID NO:2; and
a VH-CDR3 that consists of the amino acid sequence set forth in SEQ ID NO:3; and
(b) the VL comprises
a VL-CDR1 that consists of the amino acid sequence set forth in SEQ ID NO:4;
a VL-CDR2 that consists of the amino acid sequence set forth in SEQ ID NO:5; and
a VL-CDR3 that consists of the amino acid sequence set forth in SEQ ID NO:6, and
wherein the composition has a pH of 5.2 to 6.2.