公开(公告)号：US20230340147A1

公开(公告)日：2023-10-26

申请号：US18187502

申请日：2023-03-21

Applicant: Roche Diagnostics Operations, Inc.

Inventor： Magdalena Swiatek-de Lange ,  Joanna Siebenhaar ,  Carol Jones ,  Thomas Pritchett ,  Andrea Muranyi ,  Caroline Dorothea Hojer ,  Michael Gerg ,  Lars Hillringhaus ,  Gloria Tabares ,  Christian Roessler ,  Michael Schraeml ,  Shalini Singh ,  Theresa Kott

IPC: C07K16/30 ,  G01N33/574 ,  G01N1/30

CPC classification number: C07K16/3069 ,  G01N33/57434 ,  G01N1/30 ,  C07K2317/41 ,  G01N2001/302 ,  C07K2317/33 ,  C07K2317/92

Abstract: The present invention relates to an antibody or an antigen binding fragment thereof that specifically binds to α-1,6-core-fucosylated prostate specific antigen (PSA) and partial sequences thereof comprising the α-1,6-core-fucose residue. The antibodies and antigen binding fragments significantly discriminate between core-fucosylated PSA or core-fucosylated PSA partial sequences and other glycosylated PSA species and partial sequences thereof lacking the core-fucose residue, including aglycosylated PSA, as well as core-fucosylated glycan in other contexts. The present invention further relates to nucleic acid molecules encoding the light chain variable region or the heavy chain variable region of the antibody of the invention, as well as vectors comprising said nucleic acid molecules. The invention also relates to a host cell comprising the vector(s) of the invention, as well as to methods for the production of an antibody or antigen binding fragment of the invention comprising culturing the host cell of the invention under suitable conditions and isolating the antibody produced. Furthermore, the present invention relates to an antibody obtainable by the method of the invention, to a composition comprising at least one of the antibody or antigen binding fragment of the invention, the nucleic acid molecule of the invention, the vector of the invention, the host cell of the invention or the antibody produced by the method of the invention. The present invention also relates to the use of an antibody or antigen binding fragment of the invention for detecting and discriminating core-fucosylated PSA or core-fucosylated partial sequences thereof in biological samples.