# US 2022/0031822 A1 · Chimeric antigen receptors comprising bcma-specific fibronectin type iii domains and uses thereof

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- Number: US 2022/0031822 A1
- Document ID: US20220031822A1
- Status: Published application
- Kind: A1
- Application number: 17/396,517
- Filed: 2021-08-06
- Published: 2022-02-03
- Earliest claimed: 2016-09-14
- Assignees: Janssen Biotech, Inc.
- Applicants: Janssen Biotech, Inc.
- Inventors: Chen Ni CHIN; John LEE; Timothy MCCABE; Jill MOONEY; Michael NASO; William STROHL
- Web page: https://patentgrep.com/patent/US20220031822A1

## CPC

- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 40/31: Chimeric antigen receptors [CAR]
- A61K 40/4211: {CD19 or B4}
- A61K 40/4215: {Receptors for tumor necrosis factors [TNF], e.g. lymphotoxin receptor [LTR], CD30}
- A61P 35/00: Antineoplastic agents
- C07K 14/525: Tumour necrosis factor [TNF]
- C07K 14/705: Receptors; Cell surface antigens; Cell surface determinants {(tumour specific antigens C07K14/4748)}
- C07K 14/75: Fibrinogen
- C07K 14/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
- C12N 5/0636: {T lymphocytes}
- C12N 15/8257: {for the production of primary gene products, e.g. pharmaceutical products, interferon}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/50: characterized by immunoglobulin fragments
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2319/03: containing a transmembrane segment
- C07K 2319/033: containing a motif for targeting to the internal surface of the plasma membrane, e.g. containing a myristoylation motif
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/31: fusions, other than Fc, for prolonged plasma life, e.g. albumin
- 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

BCMA-specific fibronectin type III (FN3) domains, BCMA-targeting chimeric antigen receptors (CARs) comprising the FN3 domains, and engineered BCMA-targeting immune cells expressing the CARs are described. Also described are nucleic acids and expression vectors encoding the FN3 domains and the CARs, recombinant cells containing the vectors, and compositions comprising the engineered immune cells. Methods of making the FN3 domains, CARs, and engineered immune cells, and methods of using the engineered immune cells to treat diseases including cancer are also described.

## Claims

### Claim at position 1

1-13. (canceled)

### Claim 14

An isolated polynucleotide encoding a chimeric antigen receptor (CAR) comprising:
an extracellular domain having an FN3 domain that binds to BCMA;
a transmembrane domain; and
an intracellular signaling domain.

### Claim 15 (depends on 14)

The isolated polynucleotide of claim 14, wherein the FN3 domain comprises an amino acid sequence that is at least 80% identical to SEQ ID NO: 1; and wherein the FN3 domain binds to a human BCMA with a KD less than 1×10−6 M as determined by using surface plasmon resonance.

### Claim 16 (depends on 14)

The isolated polynucleotide of claim 14, wherein the FN3 domain comprises the amino acid sequence of SEQ ID NO: 7.

### Claim 17 (depends on 14)

The isolated polynucleotide of claim 14, wherein the FN3 domain comprises an amino acid sequence that is at least 90% identical to any one of SEQ ID NOs: 8-44 and 58-145.

### Claim 18 (depends on 14)

The isolated polynucleotide of claim 14, wherein the FN3 domain comprises the amino acid sequence of any one of SEQ ID NOs: 8-44 and 58-145.

### Claim 19 (depends on 14)

The isolated polynucleotide of claim 14, wherein the CAR further comprises a signal peptide at the amino terminus.

### Claim 20 (depends on 19)

The isolated polynucleotide of claim 19, wherein the CAR further comprises a hinge region connecting the extracellular domain and the transmembrane domain.

### Claim 21 (depends on 20)

The isolated polynucleotide of claim 20, wherein the hinge region comprises an amino acid sequence that is at least 90% identical to SEQ ID NO: 3.

### Claim 22 (depends on 21)

The isolated polynucleotide of claim 21, wherein the hinge region comprises the amino acid sequence of SEQ. ID NO: 3.

### Claim 23 (depends on 14)

The isolated polynucleotide of claim 14, wherein the transmembrane domain comprises an amino acid sequence that is at least 90% identical to SEQ ID NO: 4.

### Claim 24 (depends on 23)

The isolated polynucleotide of claim 23, wherein the transmembrane domain comprises the amino acid sequence of SEQ ID NO: 4.

### Claim 25 (depends on 14)

The isolated polynucleotide of claim 14, wherein the intracellular signaling domain comprises a co-stimulatory domain having an amino acid sequence that is at least 90% identical to SEQ ID NO: 5, and a primary signaling domain having an amino acid sequence that is at least 90% identical to SEQ ID NO: 6.

### Claim 26 (depends on 25)

The isolated polynucleotide of claim 25, wherein the intracellular signaling domain comprises a co-stimulatory domain comprising the amino acid sequence of SEQ ID NO: 5, and a primary signaling domain comprising the amino acid sequence of SEQ ID NO: 6.

### Claim 27 (depends on 14)

The isolated polynucleotide of claim 14, comprising:
the extracellular domain comprising the amino acid sequence of one of SEQ ID NOs: 8-44 and 58-145;
a hinge region comprising the amino acid sequence of SEQ ID NO: 3;
the transmembrane domain comprising the amino acid sequence of SEQ ID NO: 4; and
the intracellular signaling domain comprising the amino acid sequence of SEQ ID NO: 5 and the amino acid sequence of SEQ ID NO: 6.

### Claim 28 (depends on 14)

A vector comprising the polynucleotide of claim 14.

### Claim 29 (depends on 14)

A host cell comprising the polynucleotide of claim 14.

### Claim 30 (depends on 14)

A polypeptide encoded by the polynucleotide of claim 14.