US 12,410,239 B2Granted

Anti-hepatitis B virus antibody and uses thereof

AssigneesXiamen University, Yang Sheng Tang Company, Ltd.

InventorsWenxin Luo, Can Wen, Xinchu Xiang, Jixian Tang, Yangtao Wu, Tianying Zhang, Quan Yuan, Ningshao Xia

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Abstract

Disclosed are antibodies to anti-hepatitis B surface antigen (HBsAg) (especially humanized antibodies), nucleic acid molecules encoding same, methods for preparing same, and pharmaceutical compositions containing same. The antibodies have higher affinity for HBsAg at neutral pH than at acidic pH, thereby significantly enhancing the virus clearance efficiency and prolonging the virus inhibition time. The antibodies and the pharmaceutical compositions can be used for preventing and/or treating HBV infections or diseases related to HBV infections (e.g., hepatitis B), for neutralizing the virulence of HBV in a subject (e.g., a human), for reducing the serum level of HBV DNA and/or HBsAg in the body of the subject, or for activating the humoral immune response of the subject (e.g., a chronic HBV infected or chronic hepatitis B patient) against HBV.

An antibody or antigen-binding fragment thereof capable of specifically binding to HBsAg, wherein the antibody or antigen-binding fragment thereof binds to HBsAg with higher affinity at neutral pH than at acidic pH, and the antibody or antigen-binding fragment thereof comprises:

(1) a VH comprising three CDRs:
HCDR1 consisting of the amino acid sequence of SEQ ID NO:8,
HCDR2 consisting of the amino acid sequence of SEQ ID NO:
9, and
HCDR3 consisting of the amino acid sequence of SEQ ID NO:
10;
and
a VL comprising three CDRs:
LCDR1 consisting of the amino acid sequence of SEQ ID NO:
11,
LCDR2 consisting of the amino acid sequence of SEQ ID NO:
12, and
LCDR3 consisting of the amino acid sequence of SEQ ID NO:
13;
(2) a VH comprising three CDRs:
HCDR1 consisting of the amino acid sequence of SEQ ID NO:
14,
HCDR2 consisting of the amino acid sequence of SEQ ID NO:
15, and
HCDR3 consisting of the amino acid sequence of SEQ ID NO:
16;
and
a VL comprising three CDRs:
LCDR1 consisting of the amino acid sequence of SEQ ID NO:
11,
LCDR2 consisting of the amino acid sequence of SEQ ID NO:
12, and
LCDR3 consisting of the amino acid sequence of SEQ ID NO:
13;
(3) a VH comprising three CDRs:
HCDR1 consisting of the amino acid sequence of SEQ ID NO:
20,
HCDR2 consisting of the amino acid sequence of SEQ ID NO:
21, and
HCDR3 consisting of the amino acid sequence of SEQ ID NO:
22;
and
a VL comprising three CDRs:
LCDR1 consisting of the amino acid sequence of SEQ ID NO:
23,
LCDR2 consisting of the amino acid sequence of SEQ ID NO:
12, and
LCDR3 consisting of the amino acid sequence of SEQ ID NO:
13;
or
(4) a VH comprising three 3 CDRs:
HCDR1 consisting of the amino acid sequence of SEQ ID NO:
17,
HCDR2 consisting of the amino acid sequence of SEQ ID NO:
18, and
HCDR3 consisting of the amino acid sequence of SEQ ID NO:
10;
and
a VL comprising three CDRs:
LCDR1 consisting of the amino acid sequence of SEQ ID NO:
19,
LCDR2 consisting of the amino acid sequence of SEQ ID NO:
12, and
LCDR3 consisting of the amino acid sequence of SEQ ID NO:
13.

57 more elements

Facts

Application

17/613,322Filed 22 May 2020

Priority

CN 201910432602.723 May 2019

Published

US 2022/0235117 A128 Jul 2022

Granted

9 Sep 2025

Term ends

Not estimatedThe source records don’t support an estimate.

Classification23 codes

A61P 1/16
Drugs for disorders of the alimentary tract or the digestive system: for liver or gallbladder disorders, e.g. hepatoprotective agents,…
C07K 16/082
DNA viruses: hepadnaviridae , e.g. hepatitis B virus
A61P 31/20
Antivirals: for DNA viruses
C12P 21/02
Preparation of peptides or proteins: having a known sequence of two or more amino acids, e.g. glutathione

Abstract

Claims17