Antibody specific to spike protein of SARS-CoV-2 and uses thereof

Patent metadata

Field	Value
Publication number	US-11866485-B2
Application number	US-202217937744-A
Country	US
Kind code	B2
Filing date	Oct 3, 2022
Priority date	Oct 1, 2021
Publication date	Jan 9, 2024
Grant date	Jan 9, 2024

Abstract

The present disclosure relates to an antibody or antigen-binding fragment thereof that specifically binds to a spike protein of SARS-CoV-2. The present disclosure also relates to a pharmaceutical composition, a method for treating and/or preventing diseases and/or disorders caused by a coronavirus in a subject in need thereof, and a method for detecting a coronavirus in a sample.

First claim

What is claimed is:

1. An antibody or antigen-binding fragment thereof that is specific for an epitope in a spike protein of a CoV; wherein the epitope comprises a part locating in 419 to 433 amino acid residues or 471 to 482 amino acid residues of SEQ ID NO: 8,
wherein the antibody or antigen-binding fragment thereof comprises complementarity determining regions (CDRs) of a heavy chain variable region and complementarity determining regions of a light chain variable region, wherein the complementarity determining regions of the heavy chain variable region comprise CDRH1, CDRH2, and CDRH3 regions, and the complementarity determining regions of the light chain variable region comprise CDRL1, CDRL2, and CDRL3 regions,
wherein the CDRH1 region comprises the amino acid sequence of SEQ ID NO: 1; the CDRH2 region comprises the amino acid sequence of SEQ ID NO: 2; the CDRH3 region comprises the amino acid sequence of SEQ ID NO: 3; and
the CDRL1 region comprises the amino acid sequence of SEQ ID NO: 4; the CDRL2 region comprises the amino acid sequence of WAS; the CDRL3 region comprises the amino acid sequence of SEQ ID NO: 5.

2. The antibody or antigen-binding fragment thereof of claim 1 , wherein the spike protein is fully glycosylated.

3. The antibody or antigen-binding fragment thereof of claim 1 , wherein the antibody or antigen-binding fragment thereof comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 6; and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 7.

4. The antibody or antigen-binding fragment thereof of claim 1 , wherein the antibody is a monoclonal antibody, chimeric antibody, humanized antibody or human antibody.

5. The antibody or antigen-binding fragment thereof of claim 1 , wherein the antibody is multispecific.

6. The antibody or antigen-binding fragment thereof of claim 1 , wherein the CoV is alpha-CoV, beta-CoV, gamma-CoV, and delta-CoV2.

7. The antibody or antigen-binding fragment thereof of claim 1 , wherein the CoV is SARS-CoV, MERS-CoV or SARS-CoV-2.

8. A genetically engineered cell containing a vector, wherein the vector encoding the antibody or antigen-binding fragment thereof claim 1 .

9. A genetically engineered cell expressing the antibody or antigen-binding fragment thereof of claim 1 .

10. A method for manufacturing the antibody or antigen-binding fragment thereof of a claim 1 , comprising: (a) introducing into a host cell one or more polynucleotides encoding said antibody or antigen-binding fragment; (b) culturing the host cell under conditions favorable to expression of the one or more polynucleotides; and (c) optionally, isolating the antibody or antigen-binding fragment from the host cell and/or a medium in which the host cell is grown.

11. A pharmaceutical composition comprising the antibody or antigen-binding fragment thereof of claim 1 and pharmaceutically acceptable carrier and, optionally, a further therapeutic agent.

12. The pharmaceutical composition of claim 11 , wherein the therapeutic agent is an antiviral agent.

13. The pharmaceutical composition of claim 11 , wherein the therapeutic agent is an anti-inflammatory agent or an antibody or antigen-binding fragment thereof that specifically binds to a spike protein of SARS-CoV-2.

14. A vessel or injection device comprising the antibody or antigen-binding fragment thereof of claim 1 .

15. A method for detecting a coronavirus in a sample comprising contacting the sample with the antibody or antigen-binding fragment thereof of claim 1 .

16. A kit for detecting a coronavirus in a sample, wherein the kit comprises the antibody or antigen-binding fragment thereof of claim 1 .

Assignees

• Academia Sinica

Inventors

• Lin Kuo-I
• Ma Che
• Wong Chi-Huey
• Wang Szu-Wen
• Chang Yi-Hsuan
• Chen Xiaorui
• Huang han-yi

Classifications

• A61K39/42

  viral · CPC title

• C07K16/104 Primary

  Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2] · CPC title

• C07K16/10 Primary

  RNA viruses · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• C07K2317/14

  Specific host cells or culture conditions, e.g. components, pH or temperature · CPC title