# US 12,109,237 B2 · S309 chimeric antigen receptors and methods of use

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- Number: US 12,109,237 B2
- Document ID: US12109237B2
- Status: Granted
- Kind: B2
- Application number: 17/551,006
- Filed: 2021-12-14
- Published: 2022-06-16
- Granted: 2024-10-08
- Earliest claimed: 2020-12-15
- Assignees: Rutgers, The State University of New Jersey
- Applicants: Rutgers, The State University of New Jersey
- Inventors: Dongfang Liu; Minh Ma; Saiaditya Badeti
- Web page: https://patentgrep.com/patent/US12109237B2

## CPC

- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- A61K 35/17: Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00)
- A61K 39/12: Viral antigens
- A61K 40/15: Natural-killer [NK] cells; Natural-killer T [NKT] cells
- A61K 40/31: Chimeric antigen receptors [CAR]
- A61K 40/46: Viral antigens
- A61P 31/14: for RNA viruses
- C07K 14/5443: {IL-15}
- C07K 14/70521: {CD28, CD152}
- C07K 14/7151: {for tumor necrosis factor [TNF], for lymphotoxin [LT]}
- C07K 16/10: RNA viruses
- C07K 16/104: Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2]
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K 2239/28: Expressing multiple CARs, TCRs or antigens
- C07K 14/70578: {NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95 (NGF-receptor C07K14/71, TNF-receptor C07K14/7151)}
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2319/03: containing a transmembrane segment
- C12N 2770/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Chimeric antigen receptors (CARs) including an scFv binding to coronavirus spike protein (S309 scFv), nucleic acids encoding the CARs, vectors including nucleic acids encoding the CARs, and cells expressing the CARs are provided. Methods of treating a subject with coronavirus are also provided, including administering to the subject a modified immune cell expressing a disclosed CAR.

## Claims

### Claim 1

A method of treating a subject having or suspected of having a coronavirus infection, comprising administering to the subject an effective amount of a modified immune cell comprising a chimeric antigen receptor comprising at least 93% sequence identity to the amino acid sequence of SEQ ID NO: 1, wherein the chimeric antigen receptor comprises an antigen binding domain comprising the variable heavy chain (VH) domain complementarity determining region 1 (CDR1), CDR2 and CDR3 amino acid sequences of amino acid positions 47-54, 72-79, and 118-137 of SEQ ID NO: 1, respectively, and the variable light chain (VL) domain CDR1, CDR2 and CDR3 amino acid sequences of amino acid positions 195-201, 219-221, and 258-265 of SEQ ID NO: 1, respectively.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is infected with SARS-COV or SARS-COV-2.

### Claim 3

A method of treating a subject having or suspected of having a coronavirus infection, comprising administering to the subject an effective amount of a composition comprising: (i) a modified immune cell comprising a chimeric antigen receptor comprising at least 93% sequence identity to the amino acid sequence of SEQ ID NO: 1, wherein the chimeric antigen receptor comprises an antigen binding domain comprising the variable heavy chain (VH) domain complementarity determining region 1 (CDR1), CDR2 and CDR3 amino acid sequences of amino acid positions 47-54, 72-79, and 118-137 of SEQ ID NO: 1, respectively, and the variable light chain (VL) domain CDR1, CDR2 and CDR3 amino acid sequences of amino acid positions 195-201, 219-221, and 258-265 of SEQ ID NO: 1, respectively; and (ii) a pharmaceutically acceptable carrier.

### Claim 4 (depends on 1)

The method of claim 1, wherein the antigen binding domain has at least 90% sequence identity to amino acids 22-275 of SEQ ID NO: 1, or comprises or consists of the amino acid sequence of amino acids 22-275 of SEQ ID NO: 1.

### Claim 5 (depends on 1)

The method of claim 1, wherein the chimeric antigen receptor comprises the amino acid sequence of SEQ ID NO: 1.

### Claim 6 (depends on 1)

The method of claim 1, wherein the chimeric antigen receptor further comprises a signal peptide, an interleukin-15 domain, or both.

### Claim 7 (depends on 6)

The method of claim 6, wherein the chimeric antigen receptor has at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 4 .

### Claim 8 (depends on 7)

The method of claim 7, wherein the chimeric antigen receptor comprises the amino acid sequence of SEQ ID NO: 4.

### Claim 9 (depends on 1)

The method of claim 1, wherein the chimeric antigen receptor consists of the amino acid sequence of SEQ ID NO: 1.

### Claim 10 (depends on 3)

The method of claim 3, wherein the antigen binding domain has at least 90% sequence identity to amino acids 22-275 of SEQ ID NO: 1, or comprises or consists of the amino acid sequence of amino acids 22-275 of SEQ ID NO: 1.

### Claim 11 (depends on 3)

The method of claim 3, wherein the chimeric antigen receptor comprises the amino acid sequence of SEQ ID NO: 1.

### Claim 12 (depends on 3)

The method of claim 3, wherein the chimeric antigen receptor further comprises a signal peptide, an interleukin-15 domain, or both.

### Claim 13 (depends on 12)

The method of claim 12, wherein the chimeric antigen receptor has at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 4.

### Claim 14 (depends on 13)

The method of claim 13, wherein the chimeric antigen receptor comprises the amino acid sequence of SEQ ID NO: 4.

### Claim 15 (depends on 3)

The method of claim 3, wherein the chimeric antigen receptor consists of the amino acid sequence of SEQ ID NO: 1.

### Claim 16 (depends on 3)

The method of claim 3, wherein the subject is infected with SARS-COV or SARS-COV-2.