US 12,121,569 B2
Methods and compositions for CNS delivery of iduronate-2-sulfatase
Gaozhong Zhu, Weston, MA (US); Kris Lowe, Boston, MA (US); Zahra Shahrokh, Weston, MA (US); James Christian, Grafton, MA (US); Richard Fahrner, Boxford, MA (US); Jing Pan, Boxborough, MA (US); Teresa Leah Wright, Lexington, MA (US); and Pericles Calias, Melrose, MA (US)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on Jan. 18, 2022, as Appl. No. 17/578,119.
Application 14/938,824 is a division of application No. 13/974,457, filed on Aug. 23, 2013, granted, now 9,220,677, issued on Dec. 29, 2015.
Application 17/578,119 is a continuation of application No. 16/515,568, filed on Jul. 18, 2019, granted, now 11,260,112.
Application 16/515,568 is a continuation of application No. 14/938,824, filed on Nov. 11, 2015, abandoned.
Application 13/974,457 is a continuation of application No. 13/168,966, filed on Jun. 25, 2011, granted, now 8,545,837, issued on Oct. 1, 2013.
Claims priority of provisional application 61/495,268, filed on Jun. 9, 2011.
Claims priority of provisional application 61/476,210, filed on Apr. 15, 2011.
Claims priority of provisional application 61/442,115, filed on Feb. 11, 2011.
Claims priority of provisional application 61/435,710, filed on Jan. 24, 2011.
Claims priority of provisional application 61/387,862, filed on Sep. 29, 2010.
Claims priority of provisional application 61/360,786, filed on Jul. 1, 2010.
Claims priority of provisional application 61/358,857, filed on Jun. 25, 2010.
Prior Publication US 2023/0026836 A1, Jan. 26, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/47 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 35/76 (2015.01); A61K 35/761 (2015.01); A61K 38/46 (2006.01); A61K 47/02 (2006.01); A61K 47/26 (2006.01); C07K 14/65 (2006.01); C12N 9/24 (2006.01); C12N 9/42 (2006.01)
CPC A61K 38/47 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0085 (2013.01); A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 35/76 (2013.01); A61K 35/761 (2013.01); A61K 38/46 (2013.01); A61K 38/465 (2013.01); A61K 47/02 (2013.01); A61K 47/26 (2013.01); C07K 14/65 (2013.01); C12N 9/2402 (2013.01); C12N 9/2437 (2013.01); C12Y 301/06008 (2013.01); C12Y 301/06013 (2013.01); C12Y 302/01045 (2013.01); C12Y 302/01046 (2013.01); C12Y 302/0105 (2013.01); C12Y 310/01001 (2013.01)] 15 Claims
OG exemplary drawing
 
1. A stable formulation for CNS delivery comprising a recombinant iduronate-2-sulfatase (I2S) protein at a concentration of at least 5 mg/ml, a polysorbate surfactant at a concentration of approximately 0.001-0.5%, and no greater than 5 mM phosphate.