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CN-120137010-B - Antibodies that specifically bind HPV

CN120137010BCN 120137010 BCN120137010 BCN 120137010BCN-120137010-B

Abstract

The present invention provides a set of antibodies or antigen binding fragments thereof that specifically bind HPV. The invention also provides polynucleotides encoding the antibodies or antigen binding fragments thereof, vectors comprising the polynucleotides, host cells comprising the vectors, methods of producing the antibodies, and compositions comprising the antibodies.

Inventors

  • XU LINGJIE
  • XU XIAOYU
  • HUANG WEIJIN
  • HU JINPAN
  • WANG MENG

Assignees

  • 南京诺唯赞生物科技股份有限公司
  • 中国食品药品检定研究院

Dates

Publication Date
20260512
Application Date
20240913
Priority Date
20231204

Claims (12)

  1. 1. An antibody or antigen-binding fragment thereof that specifically binds HPV comprising: (1) CDR-H1 as shown in SEQ ID NO.1, CDR-H2 as shown in SEQ ID NO.2, CDR-H3 as shown in SEQ ID NO.3, CDR-L1 as shown in SEQ ID NO.4, CDR-L2 as shown in SEQ ID NO. 5, and CDR-L3 as shown in SEQ ID NO. 6; (2) CDR-H1 as shown in SEQ ID NO. 7, CDR-H2 as shown in SEQ ID NO. 8, CDR-H3 as shown in SEQ ID NO. 9, CDR-L1 as shown in SEQ ID NO. 10, CDR-L2 as shown in SEQ ID NO. 11, and CDR-L3 as shown in SEQ ID NO. 12; (3) CDR-H1 as shown in SEQ ID NO. 13, CDR-H2 as shown in SEQ ID NO. 14, CDR-H3 as shown in SEQ ID NO. 15, CDR-L1 as shown in SEQ ID NO. 16, CDR-L2 as shown in SEQ ID NO. 17, and CDR-L3 as shown in SEQ ID NO. 18; (4) CDR-H1 as shown in SEQ ID NO. 19, CDR-H2 as shown in SEQ ID NO. 20, CDR-H3 as shown in SEQ ID NO. 21, CDR-L1 as shown in SEQ ID NO. 22, CDR-L2 as shown in SEQ ID NO. 23, and CDR-L3 as shown in SEQ ID NO. 24, or (5) CDR-H1 as shown in SEQ ID NO. 25, CDR-H2 as shown in SEQ ID NO. 26, CDR-H3 as shown in SEQ ID NO. 27, CDR-L1 as shown in SEQ ID NO. 28, CDR-L2 as shown in SEQ ID NO. 29, and CDR-L3 as shown in SEQ ID NO. 30.
  2. 2. The antibody or antigen-binding fragment thereof of claim 1, comprising: (1) A VH shown as SEQ ID NO. 31 and a VL shown as SEQ ID NO. 32; (2) A VH shown as SEQ ID NO. 33 and a VL shown as SEQ ID NO. 34; (3) A VH shown as SEQ ID NO. 35 and a VL shown as SEQ ID NO. 36; (4) VH shown as SEQ ID NO. 37 and VL shown as SEQ ID NO. 38, or (5) VH shown as SEQ ID NO. 39 and VL shown as SEQ ID NO. 40.
  3. 3. The antibody or antigen-binding fragment thereof of claim 1, comprising: (1) A heavy chain constant region as shown in SEQ ID NO. 53, and (2) The light chain constant region is shown as any one of SEQ ID NO. 51 and SEQ ID NO. 52.
  4. 4. A polynucleotide encoding the antibody or antigen-binding fragment thereof of any one of claims 1-3.
  5. 5. The polynucleotide of claim 4, comprising: (1) SEQ ID NOS 41 and 42; (2) SEQ ID NOS 43 and 44; (3) SEQ ID NOS 45 and 46; (4) SEQ ID NOS 47 and 48, or (5) SEQ ID NOS.49 and 50.
  6. 6. A vector comprising the polynucleotide of claim 4 or 5.
  7. 7. A host cell comprising the polynucleotide of claim 4 or 5 or the vector of claim 6.
  8. 8. The host cell of claim 7, which is a CHO cell.
  9. 9. A method of producing an antibody or antigen-binding fragment thereof, comprising: (a) Culturing the host cell according to claim 7 or 8 under conditions suitable for expression of the antibody or antigen binding fragment thereof, and (B) Optionally, recovering the antibody or antigen binding fragment thereof.
  10. 10. A composition comprising the antibody or antigen-binding fragment thereof of any one of claims 1-3.
  11. 11. Use of an antibody or antigen-binding fragment thereof according to any one of claims 1-3 or a composition according to claim 10 in the preparation of an agent for detecting HPV in a sample.
  12. 12. Use of an antibody or antigen-binding fragment thereof according to any one of claims 1-3 or a composition according to claim 10 in an identification assay for HPV vaccines.

Description

Antibodies that specifically bind HPV Technical Field The present invention provides a set of antibodies or antigen binding fragments thereof that specifically bind HPV. The invention also provides polynucleotides encoding the antibodies or antigen binding fragments thereof, vectors comprising the polynucleotides, host cells comprising the vectors, methods of producing the antibodies, and compositions comprising the antibodies. Background Cervical cancer and precancerous lesions are serious threats to women's health worldwide, and clinical, molecular biological and epidemiological surveys have demonstrated that human papillomaviruses (human papillomavirus, HPV) are the major causative agents of cervical cancer and cervical dysplasia. HPV is a group of spherical, tiny and non-enveloped circular double-stranded DNA viruses belonging to the genus papillomavirus of the family papovaviridae, the capsid of the HPV is an icosahedral structure consisting of 72 main capsid proteins L protein pentamers, and 1 virus particle contains 360L protein monomers, so that the HPV can mainly cause hyperplasia lesions of human skin and mucous membrane, 200 subtypes are found, and the high-risk types (including HPV16, 18, 31, 33, 35, 39, 45 and the like) and the low-risk types (including HPV6, 11 and the like) are classified according to pathogenicity. There are several cervical cancer vaccines approved by China at present, including HPV 2 vaccine Cervarix (subtype HPV 16, 18) from the company Gelanin Smith (GSK) and HPV4 vaccine from the company moesadongAnd 9-valent vaccine9 (Subtypes HPV 6, 11, 16, 18, 31, 33, 45, 52, 58), bivalent HPV vaccine by vantai organism, bivalent HPV vaccine by watson organism Wo Zehui. Since most of the 9 subtypes are currently marketed, more and more companies are continuously developing more multivalent (e.g., 15-valent) HPV vaccines. In vaccine research, monoclonal antibodies are an important tool for quality control of vaccine antigens, and antibody levels are the criteria for evaluating vaccine effects, so various types of antibodies specifically recognizing HPV are required to be able to better judge the produced vaccine and vaccine protection effects, and to be used for diagnosis, treatment and prevention of HPV. Disclosure of Invention In one aspect, the invention provides an antibody or antigen-binding fragment thereof that specifically binds HPV comprising: (1) CDR-H1 as shown in SEQ ID NO. 1, CDR-H2 as shown in SEQ ID NO. 2, CDR-H3 as shown in SEQ ID NO. 3, CDR-L1 as shown in SEQ ID NO. 4, CDR-L2 as shown in SEQ ID NO. 5, and CDR-L3 as shown in SEQ ID NO. 6; (2) CDR-H1 as shown in SEQ ID NO. 7, CDR-H2 as shown in SEQ ID NO. 8, CDR-H3 as shown in SEQ ID NO. 9, CDR-L1 as shown in SEQ ID NO. 10, CDR-L2 as shown in SEQ ID NO. 11, and CDR-L3 as shown in SEQ ID NO. 12; (3) CDR-H1 as shown in SEQ ID NO. 13, CDR-H2 as shown in SEQ ID NO. 14, CDR-H3 as shown in SEQ ID NO. 15, CDR-L1 as shown in SEQ ID NO. 16, CDR-L2 as shown in SEQ ID NO. 17, and CDR-L3 as shown in SEQ ID NO. 18; (4) CDR-H1 as shown in SEQ ID NO. 19, CDR-H2 as shown in SEQ ID NO. 20, CDR-H3 as shown in SEQ ID NO. 21, CDR-L1 as shown in SEQ ID NO. 22, CDR-L2 as shown in SEQ ID NO. 23, and CDR-L3 as shown in SEQ ID NO. 24, or (5) CDR-H1 as shown in SEQ ID NO. 25, CDR-H2 as shown in SEQ ID NO. 26, CDR-H3 as shown in SEQ ID NO. 27, CDR-L1 as shown in SEQ ID NO. 28, CDR-L2 as shown in SEQ ID NO. 29, and CDR-L3 as shown in SEQ ID NO. 30. In one embodiment, an antibody or antigen binding fragment thereof of the invention comprises: (1) A VH shown as SEQ ID NO. 31 and a VL shown as SEQ ID NO. 32; (2) A VH shown as SEQ ID NO. 33 and a VL shown as SEQ ID NO. 34; (3) A VH shown as SEQ ID NO. 35 and a VL shown as SEQ ID NO. 36; (4) VH shown as SEQ ID NO. 37 and VL shown as SEQ ID NO. 38, or (5) VH shown as SEQ ID NO. 39 and VL shown as SEQ ID NO. 40. In one embodiment, an antibody or antigen binding fragment thereof of the invention comprises: (1) A heavy chain constant region as shown in SEQ ID NO. 53, and (2) The light chain constant region is shown as any one of SEQ ID NO. 51 and SEQ ID NO. 52. In one embodiment, an antibody or antigen binding fragment thereof of the invention comprises an alpha heavy chain, delta heavy chain, epsilon heavy chain, gamma heavy chain, or mu heavy chain. In one embodiment, the antibody or antigen binding fragment thereof of the invention belongs to the subclass IgG1, igG2, igG3, or IgG 4. In one embodiment, an antibody or antigen binding fragment thereof of the invention comprises a lambda light chain or a kappa light chain. In one embodiment, the antibody or antigen binding fragment thereof of the invention is a full length antibody. In one embodiment, the antibody or antigen binding fragment thereof of the invention is an antibody fragment selected from Fv, scFv, fab, fab ', F (ab') 2 and xFab. In one embodiment, the antibody or antigen-binding fragment thereof of the invention is a chimeric antibody or a h