Erythropoietin fusion protein

C - Chemistry – Metallurgy – 12 – N

Patent

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Details

C12N 15/62 (2006.01) A61K 38/18 (2006.01) C07K 14/505 (2006.01)

Patent

CA 2678986

The present invention relates to recombinant fusion proteins wherein erythropoietin (EPO) is linked via its C-terminus to an Fc fragment, and wherein said recombinant fusion proteins are further carbamoylated at the primary amines of the fusion protein. More specifically the invention relates to carbamoylated EPO-Fc fusion proteins, wherein at least one, preferably two or more, lysine amine residues and/or the N-terminal amino acid of said fusion protein are carbamoylated. The carbamoylated EPO-Fc fusion proteins of the present invention having a reduced hematopoietic activity whereas the tissue regenerative activity, i.e. the nerval cell regenerative activity remains unaltered or is even enhanced as compared to unmodified EPO-Fc fusion proteins. The invention further relates to a process for the manufacture of such fusion proteins and to pharmaceutical compositions containing them, as well as to the use of such fusion proteins and pharmaceutical compositions for medical therapy.

La présente invention concerne des protéines de fusion recombinées dans lesquelles de l'érythropoïétine (EPO) est liée par l'intermédiaire de son extrémité C à un fragment Fc, et qui sont également carbamoylées au niveau de leurs amines primaires. Plus particulièrement, l'invention concerne des protéines de fusion EPO-Fc carbamoylées, dans lesquelles au moins un, de préférence deux ou plus, résidus d'amine lysine et/ou l'acide aminé N-terminal de ladite protéine de fusion sont carbamoylés. Les protéines de fusion EPO-Fc carbamoylées de l'invention présentent une activité hématopoïétique réduite alors que leur activité de régénération tissulaire, c'est-à-dire l'activité de régénération des cellules nerveuses demeure inaltérée ou est même augmentée par comparaison avec des protéines de fusion EPO-Fc non modifiées. L'invention concerne en outre un procédé de production desdites protéines de fusion et des compositions pharmaceutiques les contenant, ainsi que l'utilisation desdites protéines de fusion et compositions pharmaceutiques pour un traitement médical.

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