ANTIBODY WHICH IS CAPABLE OF NEUTRALIZING A SUBSTANCE HAVING AN ACTIVITY OF AN ALTERNATIVE COAGULATION FACTOR FUNCTION VIII (FVIII) Russian patent published in 2020 - IPC C07K16/36 C07K16/42 C12N15/09 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions relates to a composition and a solution for measuring reactivity of VIII (FVIII) coagulation factor in the presence of a compound having functional substitution activity on coagulation factor VIII. Disclosed is a composition comprising an antibody which neutralizes a substance having functional activity with respect to functional substitution of the coagulation factor VIII, wherein substance possessing activity with respect to functional substitution of coagulation factor VIII, is a bispecific antibody, which binds to coagulation factor IX and/or activated coagulation factor IX and coagulation factor X and/or activated coagulation factor X. This neutralizing antibody is an antibody which binds Fab containing an antigen-binding site, which binds to the coagulation factor IX and/or the activated coagulation factor IX, and which contains a variable heavy chain region containing CDR1 consisting of SEQ ID NO: 12, CDR2 consisting of SEQ ID NO: 13, and CDR3 consisting of SEQ ID NO: 14; and a light chain variable region comprising CDR1 consisting of SEQ ID NO: 18, CDR2 consisting of SEQ ID NO: 19, and CDR3 consisting of SEQ ID NO: 20. Also, said composition contains an antibody which neutralises a compound having functional substitution of coagulation factor VIII, where the compound having the blood coagulation factor VIII functional substitution activity is a bispecific antibody, which binds to blood coagulation factor IX and/or activated blood coagulation factor IX and coagulation factor X and/or activated coagulation factor X. This neutralizing antibody is an antibody which binds Fab containing an antigen-binding site, which binds to coagulation factor X and/or activated coagulation factor X, and which includes a variable heavy chain region containing CDR1 consisting of SEQ ID NO: 24, CDR2 consisting of SEQ ID NO: 25, and CDR3 consisting of SEQ ID NO: 26; and a light chain variable region comprising CDR1 consisting of SEQ ID NO: 30, CDR2 consisting of SEQ ID NO: 31, and CDR3 consisting of SEQ ID NO: 32. Also disclosed is a solution for measuring reactivity of coagulation factor VIII (FVIII) in the presence of a compound having functional substitution of the coagulation factor VIII, including said antibodies.

EFFECT: group of inventions provides using the antibodies to measure FVIII activity and the FVIII inhibitor titre, avoiding the effect of activity of the substance exhibiting FVIII-substituting activity.

6 cl, 4 dwg, 4 tbl, 6 ex