	US 12,290,549 B2
	Method of reducing titers of antibodies specific for a therapeutic agent
Priya S. Kishnani, Durham, NC (US); Suhrad G. Banugaria, Durham, NC (US); Dwight D. Koeberl, Durham, NC (US); and Sean N. Prater, Durham, NC (US)
Assigned to Duke University, Durham, NC (US)
Filed by Duke University, Durham, NC (US)
Filed on Dec. 17, 2020, as Appl. No. 17/125,885.
Application 17/125,885 is a division of application No. 15/796,137, filed on Oct. 27, 2017, granted, now 10,869,906.
Application 15/796,137 is a division of application No. 15/438,375, filed on Feb. 21, 2017, granted, now 10,028,993, issued on Jul. 24, 2018.
Application 15/438,375 is a division of application No. 14/454,137, filed on Aug. 7, 2014, granted, now 9,592,247, issued on Mar. 14, 2017.
Application 14/454,137 is a division of application No. 13/696,388, granted, now 8,809,282, issued on Aug. 19, 2014, previously published as PCT/US2011/000800, filed on May 6, 2011.
Claims priority of provisional application 61/332,148, filed on May 6, 2010.
Prior Publication US 2021/0177928 A1, Jun. 17, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/05 (2006.01); A61K 31/00 (2006.01); A61K 31/519 (2006.01); A61K 31/69 (2006.01); A61K 38/17 (2006.01); A61K 39/395 (2006.01); C07K 16/28 (2006.01); A61K 39/00 (2006.01)

CPC A61K 38/05 (2013.01) [A61K 31/00 (2013.01); A61K 31/519 (2013.01); A61K 31/69 (2013.01); A61K 38/1722 (2013.01); A61K 39/3955 (2013.01); C07K 16/2887 (2013.01); A61K 2039/505 (2013.01); A61K 2039/545 (2013.01); C07K 2317/24 (2013.01)]

16 Claims

1. A method of improving the efficacy of gene replacement therapy, the method comprising:

administering to a treatment-naive patient having glycogen storage disease type II (GSD II) a viral vector encoding human acid glucosidase alfa (rhGAA); and

administering to the patient a therapeutically effective amount of bortezomib,

wherein, following the administering of the bortezomib, the titer of antibodies specific for the viral vector, the encoded rhGAA, or both is reduced, thereby improving the efficacy of the gene replacement therapy.

9. A method of reducing the risk of developing high sustained antibody titers (HSAT), the method comprising:

administering to a treatment-naive patient having glycogen storage disease type II (GSD II) gene replacement therapy comprising a viral vector encoding human acid glucosidase alfa (rhGAA); and

administering to the patient a therapeutically effective amount of bortezomib,

wherein, following the administering of the bortezomib, the patient's risk of developing HSAT to the viral vector, the encoded rhGAA, or both is reduced.