Process for manufacture of a modified collagen-induced...

C - Chemistry – Metallurgy – 12 – N

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C12N 15/12 (2006.01) A61K 38/17 (2006.01) C07K 1/16 (2006.01) C07K 14/435 (2006.01) C12N 15/62 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2199719

The invention provides a process for manufacture of a recombinant protein called Asp-Pallidipin. Asp-Pallidipin inhibits the collagen-induced platelet aggregation of mammalian platelets. The Asp-Pallidipin comprises: (i) a protein (Pallidipin) selected from the group of Pallipin proteins, and (ii) the amino acid aspartic acid, wherein the aspartic acid is connected by a peptide bond with the N-terminal end of Pallidipin. The process comprises the steps aa) transfecting at least one bacterium with an appropriate vector, wherein the vector comprises: (i) a DNA or cDNA coding for the recombinant Asp- Pallidipin, (ii) a suitable signal peptide sequence which signal sequence is cleaved so that the amino acid aspartic acid is in the position +1 of the amino acid sequence seen from the position of the Pallidipin and (iii) a suitable promoter; bb) expressing the preprotein comprising Asp-Pallidipin and the signal sequence; cc) transporting the Asp-Pallidipin from the cytoplasm of the bacterium to the periplasm, cleavage of the preprotein by at least one protease during the transport, producing the Asp-Pallidipin, dd) isolating the Asp-Pallidipin by extracting the periplasm, and ee) purifying the Asp- Pallidipin. The protein is used as a medicament for inhibiting of collagen- induced human platelet aggregation or of cancer with metastatic tumor cells.

On décrit un procédé de préparation d'une protéine recombinée dénommée Asp-Pallidipine qui inhibe l'agrégation plaquettaire induite par le collagène chez les mammifères et comprend: (i) une protéine (Pallidipine) choisie parmi le groupe de protéines de Pallidipine, et (ii) l'acide aspartique d'acides aminés cet acide aspartique étant raccordé par une liaison peptide à l'extrémité N-terminale de Pallidipine. Ce procédé comprend les étapes consistant: aa) à transfecter au moins une bactérie à l'aide d'un vecteur approprié comportant: (i) un ADN ou ADNc codant Asp-Pallidipine recombinée, (ii) une séquence-peptide-signal appropriée, clivée de manière que l'acide aspartique d'acides aminés soit dans la position +1 de la séquence d'acides aminés vue de la position de Pallidipine, ainsi que (iii) un promoteur approprié; bb) à exprimer la préprotéine comprenant Asp-Pallidipine ainsi que la séquence-signal; cc) à transporter Asp-Pallidipine du cytoplasme de la bactérie vers le périplasme, à cliver, lors de ce transport, la préprotéine produisant Asp-Pallidipine à l'aide d'au moins une protéase; dd) à isoler Asp-Pallidipine en extrayant le périplasme et ee) à purifier Asp-Pallidipine. On utilise cette protéine en tant que médicament destiné à inhiber chez l'homme l'agrégation plaquettaire induite par le collagène ou un cancer possédant des cellules tumorales métastatiques.

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