Her-2 binding antagonists

Details Her-2 binding antagonists Her-2 binding antagonists

C - Chemistry, Metallurgy

12

N

C12N 15/12 (2006.01) A61K 38/17 (2006.01) A61P 35/00 (2006.01) C07K 14/47 (2006.01) C07K 16/00 (2006.01) C07K 16/32 (2006.01) G01N 33/567 (2006.01) G01N 33/574 (2006.01)

Patent

CA 2400473

There is disclosed a pharmaceutical composition for treating solid tumors that overexpress HER-2, comprising an agent selected from the group consisting of (a) an isolated polypeptide having from about 50 to 79 amino acids taken from the sequence of SEQ ID NO. 1 or SEQ ID NO:12, wherein the polypeptide binds to the extracellular domain ECD of HER-2 at an affinity of at least 108, (b) an isolated and glycosylated polypeptide having from about 300 to 419 amino acids taken from the sequence of SEQ ID NO:2 or SEQ ID NO:13, wherein the C terminal 79 amino acids are present, and wherein at least three N-linked glycosylation sites are present, (c) a monoclonal antibody that binds to the ECD of HER-2, and (d) combinations thereof, with the proviso that the agent cannot be the monoclonal antibody alone, and pharmaceutically acceptable carrier. Also disclosed are prognostic and diagnostic assays.

La présente invention concerne une composition pharmaceutique permettant de traiter des tumeurs solides qui surexpriment HER-2. Cette composition comprend un agent sélectionné dans le groupe constitué de (a) un polypeptide isolé possédant environ de 50 à 79 acides aminés pris dans la séquence de SEQ ID NO. 1 ou de SEQ ID NO:12, ce polypeptide se fixant au domaine extracellulaire (ECD) de HER-2 à une affinité d'au moins 10?8¿, (b) un polypeptide isolé et glycosylé possédant environ de 300 à 419 acides aminés pris dans la séquence de SEQ ID NO:2 ou SEQ ID NO:13, dans lequel les 79 acides aminés de C-terminal sont présents, (c) un anticorps monoclonal qui se fixe au ECD de HER-2, et (d) une combinaison de ceux-ci, sous réserve que cet agent ne peut être l'anticorps monoclonal seul, et le porteur pharmaceutiquement acceptable. Cette invention concerne aussi des dosages biologiques de diagnostic et pronostique.

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