Monoclonal antibody capable of binding to specific discontinuous epitope occurring in AD1 region of human cytomegalovirus GB glycoprotein, and antigen-binding fragment thereof
View Patent ↗The present invention provides a pharmaceutical composition for human cytomegalovirus HCMV causative of various disease states, the composition comprising a monoclonal antibody and an antigen-binding fragment thereof that specifically binds to the AD1 region of glycoprotein gB and that has excellent neutralizing capacity. The present invention provides: a monoclonal antibody and an antigen-binding fragment thereof having an excellent neutralizing capacity and cell-to-cell infection blocking capacity and specifically binding to a discontinuous sequence occurring in the HCMV AD1 region; a pharmaceutical composition comprising the antibody or the fragment thereof; and the like.
1. A monoclonal antibody or an antigen-binding fragment thereof that specifically binds to the AD1 region of human cytomegalovirus (HCMV) glycoprotein gB, comprising:
(i)
(a) a heavy chain CDR1 comprising the amino acid sequence of SEQ ID NO: 13;
(b) a heavy chain CDR2 comprising the amino acid sequence of SEQ ID NO: 14; and
(c) a heavy chain CDR3 comprising the amino acid sequence of SEQ ID NO: 15, and
(ii)
(a) a light chain CDR I comprising the amino acid sequence of SEQ ID NO: 16;
(b) a light chain CDR2 comprising the amino acid sequence of SEQ ID NO: 17; and
(c) a light chain CDR3 comprising the amino acid sequence of SEQ ID NO: 18.
2. The antibody or an antigen-binding fragment thereof according to claim 1 , comprising:
(a) a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO: 10; and
(b) a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO: 12.
3. The antibody or an antigen-binding fragment thereof according to claim 1 , comprising:
(a) a heavy chain (H-chain) comprising the amino acid sequence of SEQ ID NO: 6; and
(b) a light chain (L-chain) comprising the amino acid sequence of SEQ ID NO: 8.
4. The antibody or the antigen-binding fragment according to claim 1 , wherein the class/subclass of the antibody is IgG1/λ.
5. A pharmaceutical composition comprising the antibody or the antigen-binding fragment according to claim 1 and a pharmaceutically acceptable carrier.
6. A method of treating a human cytomegalovirus (HCMV) infection, comprising:
administering a pharmaceutical composition to a subject in need thereof, the composition comprising the antibody or the antigen-binding fragment according to claim 1 and a pharmaceutically acceptable carrier.
7. The method of claim 6 , wherein the HCMV infection is congenital cytomegalovirus (CMV) infection.