Abstract: The present invention relates to the field of therapeutic proteins, in particular, to recombinant coagulation factors. It provides a recombinant Factor VIII (FVIII) protein comprising specific point mutations at defined positions, which serve to reduce the immunogenicity of said FVIII protein, wherein the Factor VIII protein substantially retains its coagulant activity. It further provides nucleic acids encoding said de-immunized protein, cell lines and methods of recombinant preparation as well as pharmaceutical compositions comprising the recombinant FVIII of the invention, which are advantageous for use in treatment of patients with Hemophilia A, particularly those who have not yet been treated with a FVIII product. Additionally, it can be a safe alternative for previously treated patients and even for patients who have developed an immune-response to FVIII, e.g., for immune-tolerance-induction therapy (ITI/ITT) or rescue ITI.

Abstract: The present invention relates to the field of immunology, in particular, to the field of modulation of immune responses, in particular, suppression of immune responses and/or induction of tolerance. It provides a tregitope (regulatory T cell activating epitope) carrying polypeptide based on sequences derived from the Fc part of human IgG, wherein said TCP comprises at least one tregitope heterologous to human IgG that is located within at least one of three specific sequence frames. The invention provides such polypeptides for multiple purposes, e.g., in monomeric or dimeric form, wherein both are optionally be linked to an agent, e.g., to which an immune response is to be modulated or suppressed, or co-administered to such an agent, or for use as a stand-alone therapeutic. Nucleic acids encoding the TCP of the invention, pharmaceutic compositions and uses of said TCP are also provided.

Abstract: The present invention relates to a recombinant Factor VIII protein comprising, in a single chain, a heavy chain portion comprising an A1 and an A2 domain and a light chain portion comprising an A3, C1 and C2 domain of Factor VIII, wherein the B-domain is partially deleted in two deletions, the first leading to the presence of a defined processing sequence cleavable by thrombin, and the second leading to absence of the furin cleavage recognition site at position R1664-R1667. An internal fragment of the B-domain is maintained Nucleic acids encoding said protein, host cells and methods of preparing the protein are also provided, as well as a pharmaceutical composition comprising the protein, nucleic acid or host cell, which may be used for treatment of hemophilia A.

Abstract: A process for preparing a powder, which includes one or more human coagulation factor proteins and a lactic acid polymer, involves mixing and dispersing a lactic acid polymer with a particle size d50 in the range 0.1-2 ?m and the one or more human coagulation factor proteins in water. The dispersion is dried, and the resulting dried mass is compressed. The resulting compressed dried mass is comminuted to a powder with a particle size d50 in the range of more than 0.5 and up to 5 ?m.

Abstract: A process for preparing a powder, which includes one or more human coagulation factor proteins and a lactic acid polymer, involves mixing and dispersing a lactic acid polymer with a particle size d50 in the range 0.1-2 ?m and the one or more human coagulation factor proteins in water. The dispersion is dried, and the resulting dried mass is compressed. The resulting compressed dried mass is comminuted to a powder with a particle size d50 in the range of more than 0.5 and up to 5 ?m.