IP Library › Granted Patent US 12704517

Granted Patent B2

US 12704517 · App. 18/037,591 · Granted Aug 11, 2026

Anti-severe acute respiratory syndrome coronavirus antibodies

Inventors: Christine Andrea Goetz (Blaine, MN); Jody Bonnevier (Chanhassen, MN); Christopher David Hammerbeck (Shoreview, MN); Ernesto Rubin Resnik (Minneapolis, MN); Cyrus B. Munshi (Blaine, MN); Enqing Tan (Lexington, MA)

Assignee: Bio-Techne Corporation

G01N33/56983 C07K16/104 G01N33/54388 G01N33/573 C07K2317/24 C07K2317/33 C07K2317/76 C07K2317/92 G01N2333/948 G01N2469/10

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Quick Facts

Patent No.: US 12704517
App. No.: 18/037,591
Filed: May 18, 2023
Granted: Aug 11, 2026
Kind: B2
Examiner: CHESTNUT, BARRY A
Art Unit: 1672
USPC: 435/5

External Links

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Abstract

Anti-SARS-CoV-specific monoclonal antibodies, methods of making and characterizing those antibodies, and methods of using those antibodies are described herein. In some embodiments, the antibodies may bind to both SARS-CoV-1 and SARS-CoV-2. In some embodiments, the antibodies bind to S 1 of the spike protein of SARS-CoV-2 including, for example, to the receptor binding domain (RBD) of S 1 . In some embodiments, the antibodies may block the binding of SARS-CoV-1 and/or SARS-CoV-2 to ACE-2. Such antibodies are useful as diagnostic and therapeutic agents.

Claims (107)

1 . An anti-SARS-CoV antibody or antigen binding fragment thereof, wherein the anti-SARS-CoV antibody or antigen binding fragment thereof comprises:

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 32, a CDR2 comprising SEQ ID NO: 33, and a CDR3 comprising SEQ ID NO: 34 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 69, a CDR2 comprising SEQ ID NO: 70, and a CDR3 comprising SEQ ID NO: 71; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 35, a CDR2 comprising SEQ ID NO: 36, and a CDR3 comprising SEQ ID NO: 37 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 72, a CDR2 comprising SEQ ID NO: 73, and a CDR3 comprising SEQ ID NO: 74; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 32, a CDR2 comprising SEQ ID NO: 33, and a CDR3 comprising SEQ ID NO: 34 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 75, a CDR2 comprising SEQ ID NO: 70, and a CDR3 comprising SEQ ID NO: 71; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 47, a CDR2 comprising SEQ ID NO: 39, and a CDR3 comprising SEQ ID NO: 48 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 76, a CDR2 comprising SEQ ID NO: 85, and a CDR3 comprising SEQ ID NO: 86; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 38, a CDR2 comprising SEQ ID NO: 39, and a CDR3 comprising SEQ ID NO: 40 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 76, a CDR2 comprising SEQ ID NO: 77 and a CDR3 comprising SEQ ID NO: 78; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 41, a CDR2 comprising SEQ ID NO: 42, and a CDR3 comprising SEQ ID NO: 43 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 79, a CDR2 comprising SEQ ID NO: 80, and a CDR3 comprising SEQ ID NO: 81; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 44, a CDR2 comprising SEQ ID NO: 45, and a CDR3 comprising SEQ ID NO: 46 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 82, a CDR2 comprising SEQ ID NO: 83, and a CDR3 comprising SEQ ID NO: 84; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 49, a CDR2 comprising SEQ ID NO: 50, and a CDR3 comprising SEQ ID NO: 51 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 87, a CDR2 comprising SEQ ID NO: 88, and a CDR3 comprising SEQ ID NO: 89; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 52, a CDR2 comprising SEQ ID NO: 53, and a CDR3 comprising SEQ ID NO: 54 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 90, a CDR2 comprising SEQ ID NO: 91, and a CDR3 comprising SEQ ID NO: 92; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 55, a CDR2 comprising SEQ ID NO: 56, and a CDR3 comprising SEQ ID NO: 57 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 90, a CDR2 comprising SEQ ID NO: 93, and a CDR3 comprising SEQ ID NO: 92; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 58, a CDR2 comprising SEQ ID NO: 59, and a CDR3 comprising SEQ ID NO: 34 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 94, a CDR2 comprising SEQ ID NO: 95, and a CDR3 comprising SEQ ID NO: 96; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 60, a CDR2 comprising SEQ ID NO: 61, and a CDR3 comprising SEQ ID NO: 34 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 94, a CDR2 comprising SEQ ID NO: 95 and a CDR3 comprising SEQ ID NO: 96; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 62, a CDR2 comprising SEQ ID NO: 63, and a CDR3 comprising SEQ ID NO: 64 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO:97, a CDR2 comprising SEQ ID NO: 98, and a CDR3 comprising SEQ ID NO: 99; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 65, a CDR2 comprising SEQ ID NO: 66, and a CDR3 comprising SEQ ID NO: 67 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 100, a CDR2 comprising SEQ ID NO: 101, and a CDR3 comprising SEQ ID NO: 102; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 35, a CDR2 comprising SEQ ID NO: 36, and a CDR3 comprising SEQ ID NO: 37 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 100, a CDR2 comprising SEQ ID NO: 73, and a CDR3 comprising SEQ ID NO: 103; or

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 68, a CDR2 comprising SEQ ID NO: 50, and a CDR3 comprising SEQ ID NO: 51 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 87, a CDR2 comprising SEQ ID NO: 104, and a CDR3 comprising SEQ ID NO: 89.

2 . An anti-SARS-CoV antibody or antigen binding fragment thereof of claim 1 , wherein the anti-SARS-CoV antibody or antigen binding fragment thereof comprises:

a heavy chain variable region (VH) with an amino acid sequence selected from SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 27, SEQ ID NO:28, SEQ ID NO: 29, SEQ ID NO: 30, and SEQ ID NO: 31; or

a light chain variable region (VL) with an amino acid sequence selected from SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, and SEQ ID NO: 16; or

a VH with amino acid sequence SEQ ID NO: 17 and a VL with amino acid sequence SEQ ID NO: 1, or

a VH with amino acid sequence SEQ ID NO: 18 and a VL with amino acid sequence SEQ ID NO: 2, or

a VH with amino acid sequence SEQ ID NO: 19 and a VL with amino acid sequence SEQ ID NO: 3, or

a VH with amino acid sequence SEQ ID NO: 20 and a VL with amino acid sequence SEQ ID NO: 4, or

a VH with amino acid sequence SEQ ID NO: 21 and a VL with amino acid sequence SEQ ID NO: 5, or

a VH with amino acid sequence SEQ ID NO: 22 and a VL with amino acid sequence SEQ ID NO: 6, or

a VH with amino acid sequence SEQ ID NO: 23 and a VL with amino acid sequence SEQ ID NO: 7, or

a VH with amino acid sequence SEQ ID NO: 24 and a VL with amino acid sequence SEQ ID NO: 8, or

a VH with amino acid sequence SEQ ID NO: 25 and a VL with amino acid sequence SEQ ID NO: 9, or

a VH with amino acid sequence SEQ ID NO: 26 and a VL with amino acid sequence SEQ ID NO: 10, or

a VH with amino acid sequence SEQ ID NO:27 and a VL with amino acid sequence SEQ ID NO: 11, or

a VH with amino acid sequence SEQ ID NO: 27 and a VL with amino acid sequence SEQ ID NO: 12, or

a VH with amino acid sequence SEQ ID NO: 28 and a VL with amino acid sequence SEQ ID NO: 13, or

a VH with amino acid sequence SEQ ID NO: 29 and a VL with amino acid sequence SEQ ID NO: 14, or

a VH with amino acid sequence SEQ ID NO: 30 and a VL with amino acid sequence SEQ ID NO: 15, or

a VH with amino acid sequence SEQ ID NO: 31 and a VL with amino acid sequence SEQ ID NO: 16.

3 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody specifically binds to the receptor binding domain (RBD) of the SARS-CoV spike(S) protein.

4 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody decreases binding of SARS-CoV-1 or SARS-CoV-2 or both SARS-CoV-1 and SARS-CoV-2 to ACE-2 by at least 10 percent (%), at least 15%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, or at least 98%.

5 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody specifically binds SARS-CoV-2.

6 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody specifically binds SARS-CoV-1.

7 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody specifically binds to a SARS-CoV-2 variant selected from:

the alpha variant (the United Kingdom variant (UK), B.1.1.7 lineage, RBD with N501Y);

the beta variant (South African variant (SA), B.1.3512 lineage, RBD with K417N, E484K, and N501Y);

the gamma variant (Brazilian variant P.1 (BR P.1), B.1.1.28.1 lineage, RBD with K417T, E484K, and N501Y);

the delta variant (Indian variant 2 (IN v2), B.1.617.2 lineage, RBD with L452R and T478K);

the epsilon variant (California variant (CA), B.1.427/9 lineage, RBD with L452R);

the kappa variant (Indian variant 1 (IN v1), B.1.617.1 lineage, RBD with L452R and E484Q);

the zeta variant (Brazilian variant P.2 (BR P.2), B.1.1.28.2 lineage, RBD with E484K);

the K417E RBD (R319-F541 with K417E);

the T478K RBD (R319-F541 with T478K);

the iota variant (New York variant (NY), B.1.526 lineage, RBD with a single mutation E484K);

the eta variant (Nigeria variant, B.1.525 lineage);

the lambda variant (Peru variant, C.37 lineage, RBD with L452Q and F490S);

the theta variant (Philippine variant, P.3 lineage, RBD with E484K and N501Y); and/or

the Denmark mink variant (B.1.1.298 lineage, DM, RBD with Y453).

8 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody has an NC 50 of about 0.3 μg/ul to about 1.5 μg/ul, and wherein NC 50 is the concentration of antibody in μg/mL that yields a 50% inhibition of the maximal binding capacity of recombinant RBD and recombinant ACE2 as measured by lateral flow immunoassay.

9 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody comprises a humanized antibody.

10 . The anti-SARS-CoV antibody of claim 1 , wherein the anti-SARS-CoV antibody is labeled with one or more detectable markers.

11 . A composition comprising the anti-SARS-CoV antibody of claim 1 .

12 . The composition of claim 11 further comprising one or more additional anti-SARS-CoV antibodies.

13 . A composition comprising two or more anti-SARS-CoV antibodies of claim 1 .

14 . The composition of claim 13 , wherein one anti-SARS-CoV antibody binds to a bin A epitope of RBD and one anti-SARS-CoV antibody binds to a bin B epitope of RBD:

wherein an anti-SARS-CoV antibody binding to a bin A epitope of RBD comprises:

an antibody comprising a light chain variable region comprising a CDR1 comprising SEQ ID NO: 49, a CDR2 comprising SEQ ID NO: 50, and a CDR3 comprising SEQ ID NO: 51 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 87, a CDR2 comprising SEQ ID NO: 88, and a CDR3 comprising SEQ ID NO: 89, or

an antibody comprising a light chain variable region comprising a CDR1 comprising SEQ ID NO: 68, a CDR2 comprising SEQ ID NO: 50, and a CDR3 comprising SEQ ID NO: 51 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 87, a CDR2 comprising SEQ ID NO: 104, and a CDR3 comprising SEQ ID NO: 89; and

wherein an anti-SARS-CoV antibody binding to a bin B epitope of RBD comprises:

an antibody comprising a light chain variable region comprising a CDR1 comprising SEQ ID NO: 55, a CDR2 comprising SEQ ID NO: 56, and a CDR3 comprising SEQ ID NO: 57 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 90, a CDR2 comprising SEQ ID NO: 93, and a CDR3 comprising SEQ ID NO: 92, or

an antibody comprising a light chain variable region comprising a CDR1 comprising SEQ ID NO: 38, a CDR2 comprising SEQ ID NO: 39, and a CDR3 comprising SEQ ID NO: 40 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 76, a CDR2 comprising SEQ ID NO: 77, and a CDR3 comprising SEQ ID NO: 78.

15 . A method comprising administering the anti-SARS-CoV antibody of claim 1 to a subject.

16 . The method of claim 15 , wherein the subject is suspected of having, has been diagnosed with, or has been exposed to a SARS-CoV-2 variant selected from:

the alpha variant (the United Kingdom variant (UK), B.1.1.7 lineage, RBD with N501Y);

the beta variant (South African variant (SA), B.1.3512 lineage, RBD with K417N, E484K, and N501Y);

the gamma variant (Brazilian variant P.1 (BR P.1), B.1.1.28.1 lineage, RBD with K417T, E484K, and N501Y);

the delta variant (Indian variant 2 (IN v2), B.1.617.2 lineage, RBD with L452R and T478K);

the epsilon variant (California variant (CA), B.1.427/9 lineage, RBD with L452R);

the kappa variant (Indian variant 1 (IN v1), B.1.617.1 lineage, RBD with L452R and E484Q);

the zeta variant (Brazilian variant P.2 (BR P.2), B.1.1.28.2 lineage, RBD with E484K);

the K417E RBD (R319-F541 with K417E);

the T478K RBD (R319-F541 with T478K);

the iota variant (New York variant (NY), B.1.526 lineage, RBD with a single mutation E484K);

the eta variant (Nigeria variant, B.1.525 lineage);

the lambda variant (Peru variant, C.37 lineage, RBD with L452Q and F490S);

the theta variant (Philippine variant, P.3 lineage, RBD with E484K and N501Y); and/or

the Denmark mink variant (B.1.1.298 lineage, DM, RBD with Y453).

17 . An immunoassay device, the immunoassay device comprising one or more of the anti-SARS-CoV antibodies of claim 1 .

18 . A lateral flow immunoassay device, the lateral flow immunoassay device comprising one or more of the anti-SARS-CoV antibodies of claim 1 .

19 . A method of identifying a SARS-CoV-2 receptor binding domain (RBD) variant in a sample, the method comprising contacting the biosample with an antibody of claim 1 .

20 . The method of claim 15 , wherein the subject is suspected of having, has been diagnosed with, or has been exposed to a SARS-CoV-2 to SARS-CoV-1 or SARS-CoV-2.

21 . A method comprising administering the composition of claim 13 to a subject, wherein the subject is suspected of having, has been diagnosed with, or has been exposed to SARS-CoV-1 or SARS-CoV-2.

22 . A method comprising administering the composition of claim 14 to a subject, wherein the subject is suspected of having, has been diagnosed with, or has been exposed to SARS-CoV-1 or SARS-CoV-2.

23 . The composition of claim 13 , wherein one anti-SARS-CoV antibody binds to a bin A epitope of RBD and one anti-SARS-CoV antibody binds to a bin C epitope of RBD;

wherein an anti-SARS-CoV antibody binding to a bin A epitope of RBD comprises:

wherein an anti-SARS-CoV antibody binding to a bin C epitope of RBD comprises:

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 32, a CDR2 comprising SEQ ID NO: 33, and a CDR3 comprising SEQ ID NO: 34 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 75, a CDR2 comprising SEQ ID NO: 70, and a CDR3 comprising SEQ ID NO: 71.

24 . The composition of claim 13 , wherein one anti-SARS-CoV antibody binds to a bin B epitope of RBD and one anti-SARS-CoV antibody binds to a bin C epitope of RBD;

wherein an anti-SARS-CoV antibody binding to a bin B epitope of RBD comprises:

wherein an anti-SARS-CoV antibody binding to a bin C epitope of RBD comprises:

a light chain variable region comprising a CDR1 comprising SEQ ID NO: 32, a CDR2 comprising SEQ ID NO: 33, and a CDR3 comprising SEQ ID NO: 34 and a heavy chain variable region comprising a CDR1 comprising SEQ ID NO: 75, a CDR2 comprising SEQ ID NO: 70, and a CDR3 comprising SEQ ID NO: 71.

25 . A method of diagnosing a subject with SARS-CoV-1 or SARS-CoV-2, the method comprising contacting a biosample from the subject with an antibody of claim 1 .