Combination of blys inhibition and anti-cd 20 agents for...

A - Human Necessities – 61 – K

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A61K 38/17 (2006.01) A61K 39/395 (2006.01) A61P 37/00 (2006.01) C07K 16/28 (2006.01) C07K 19/00 (2006.01)

Patent

CA 2701329

The invention relates to novel combination therapies involving BLyS or BLyS/APRIL inhibition and anti-CD20 agents for the treatment of autoimmune diseases. One preferred method is where the BLyS antagonist is a Fc-fusion protein which can be a TACI-Fc-fusion protein comprising the extracellular domain of TACI or a functional fragment thereof, a BAFF-R-Fc-fusion protein comprising the extracellular domain of BAFF-R or a functional fragment thereof, or a BCMA-Fc-fusion protein comprising the extracellular domain of BCMA or a functional fragment thereof. In the methods of the present invention some of anti-CD20 agents contemplated include RITUXAN®, ocrelizumab, ofatumumab (HuMax- CD20®), TRU-015, and DXL625, although any agent that binds to CD 20 may be suitable. The methods of the present invention reduce the levels of B cells in patients in need of such reduction, such as those suffering from autoimmune diseases.

L'invention porte sur de nouvelles polythérapies mettant en jeu des agents d'inhibition de BLyS ou BLyS/APRIL et des agents anti-CD 20, pour le traitement de maladies auto-immunes. Un procédé préféré est celui où l'antagoniste de BLyS est une protéine de fusion à Fc qui peut être une protéine de fusion TACI-Fc incluant le domaine extracellulaire de TACI ou un fragment fonctionnel de celui-ci, une protéine de fusion BAFF-R-Fc incluant le domaine extracellulaire de BAFF-R ou un fragment fonctionnel de celui-ci, ou une protéine de fusion BCMA-Fc incluant le domaine extracellulaire de BCMA ou un fragment fonctionnel de celui-ci. Dans les procédés de la présente invention, certains des agents anti-CD 20 envisagés incluent RITUXAN®, ocrelizumab, oftatumumab (HuMax-CD20®), TRU-015, et DXL625, bien que tout agent qui se lie à CD 20 puisse être approprié. Les procédés de la présente invention réduisent les taux de lymphocytes B chez des patients ayant besoin d'une telle réduction, tels que des patients souffrant de maladies auto-immunes.

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