US 11,813,310 B2
Long-acting G-CSF for preventing neutropenia or reducing duration of neutropenia
Senem Ertan-Ahmed, Pendik-Istanbul (TR); Adem Sahin, Pendik-Istanbul (TR); Hatice Oncel, Sancaktepe-Istanbul (TR); Onur Pinarbasli, Cankaya-Ankara (TR); and Nagehan Sarracoglu, Cankaya-Ankara (AR)
Assigned to ILKOGEN ILAÇ SANAYI VE TICARET A.S., Istanbul (TR)
Filed by ILKOGEN ILAÇ SANAYI VE TICARET A.S., Istanbul (TR)
Filed on Jan. 21, 2020, as Appl. No. 16/748,057.
Claims priority of provisional application 62/804,988, filed on Feb. 13, 2019.
Prior Publication US 2020/0255842 A1, Aug. 13, 2020
Int. Cl. A61K 38/19 (2006.01); A61K 47/68 (2017.01); A61P 7/00 (2006.01); C07K 1/14 (2006.01); C07K 19/00 (2006.01); A61P 35/00 (2006.01); A61K 38/00 (2006.01); C07K 14/47 (2006.01); C12N 15/62 (2006.01); C07K 14/53 (2006.01)
CPC A61K 38/193 (2013.01) [A61K 47/68 (2017.08); A61P 7/00 (2018.01); A61K 38/00 (2013.01); C07K 14/47 (2013.01); C07K 14/53 (2013.01); C07K 19/00 (2013.01); C07K 2317/524 (2013.01); C07K 2317/53 (2013.01); C07K 2317/60 (2013.01); C07K 2319/30 (2013.01); C12N 15/62 (2013.01)] 16 Claims
 
1. A method of preventing neutropenia or reducing the duration of neutropenia of a subject in need thereof, wherein the subject has received or is received an anti-cancer chemotherapy, and wherein the method comprises administering a hybrid Fc fusion G-CSF of the following Formula (I) to the subject at a dose range between about 200 μg/kg and about 400 μg/kg administered 24 hours after the anti-cancer chemotherapy:
N′-G-Y-Z2-Z3-Z4-C′  Formula (I)
wherein
G is a G-CSF;
N′ is the N-terminal of a polypeptide and C′ is the C-terminal of a polypeptide;
Y is an amino acid sequence having 5 to 64 consecutive amino acid residues from the amino acid residue at position 162 toward the N-terminal, among the amino acid residues at positions from 99 to 162 of SEQ ID NO: 2;
Z2 is an amino acid sequence having 4 to 37 consecutive amino acid residues from the amino acid residue at position 163 toward the C-terminus, among the amino acid residues at positions from 163 to 199 of SEQ ID NO: 2;
Z3 is an amino acid sequence having 71 to 106 consecutive amino acid residues from the amino acid residue at position 220 toward the N-terminus, among the amino acid residues at positions from 115 to 220 of SEQ ID NO: 3; and
Z4 is an amino acid sequence having 80 to 107 consecutive amino acid residues from the amino acid residue at position 221 toward the C-terminus, among the amino acid residues at positions from 221 to 327 of SEQ ID NO: 3.