# US 10,501,775 B2 · Antigen binding molecules and methods of use thereof

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- Number: US 10,501,775 B2
- Document ID: US10501775B2
- Status: Granted
- Kind: B2
- Application number: 15/646,817
- Filed: 2017-07-11
- Published: 2018-01-18
- Granted: 2019-12-10
- Earliest claimed: 2016-07-12
- Assignees: Kite Pharma, Inc.
- Applicants: Kite Pharma, Inc.
- Inventors: Jed Wiltzius; Stuart Sievers; Arianne Perez Garcia
- Web page: https://patentgrep.com/patent/US10501775B2

## CPC

- A61P 35/00: Antineoplastic agents
- C12Q 1/68: involving nucleic acids
- A61K 39/0011: {Cancer antigens}
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 1/14: Extraction; Separation; Purification
- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- C07K 16/24: against cytokines, lymphokines or interferons
- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- C07K 16/46: Hybrid immunoglobulins (hybrids of an immunoglobulin with a peptide not being an immunoglobulin C07K19/00)
- C12N 15/70: Vectors or expression systems specially adapted for E. coli
- A61K 35/00: Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- 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 2039/505: {comprising antibodies}
- A61K 2039/5156: {expressing foreign proteins}
- A61K 2039/5158: {Antigen-pulsed cells, e.g. T-cells}
- C07K 16/2809: {against the T-cell receptor (TcR)-CD3 complex}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/626: Diabody or triabody
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/75: Agonist effect on antigen
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2319/03: containing a transmembrane segment
- C07K 2319/33: fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
- C12P 21/00: Preparation of peptides or proteins (single cell protein C12N1/00)
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- 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)
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12P: FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE {(brewing of beer C12C; producing vinegar C12J; producing specific peptides or proteins C07K; producing enzymes C12N9/00; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification C12N15/00; measuring or testing processes involving enzymes or microorganisms C12Q; measuring or testing processes involving nucleic acid amplification reactions C12Q1/6844; fermentation processes to form a food composition, A21 or A23; compounds in general, see the relevant compound class, e.g. C01, C07)}
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Isolated antigen binding molecules that specifically binds to a molecule comprising an amino acid sequence selected from the group consisting of GSTSGSGKPGSGEGSTKG (SEQ ID NO: 1), GSGKPGSGEG (SEQ ID NO: 2), GKPGSGEG (SEQ ID NO: 3), SGKPGSGE (SEQ ID NO: 499) and KPGSG (SEQ ID NO: 500) are provided. The antigen binding molecules can be used in the methods provided herein.

## Claims

### Claim 1

An isolated antigen binding molecule that specifically binds to a molecule comprising an amino acid sequence selected from the group consisting of GSTSGSGKPGSGEGSTKG (SEQ ID NO: 1), GSGKPGSGEG (SEQ ID NO: 2), GKPGSGEG (SEQ ID NO: 3), SGKPGSGE (SEQ ID NO: 499), and KPGSG (SEQ ID NO: 500), wherein the antigen binding molecule comprises
(a) a VH CDR1 region comprising the amino acid sequence of SEQ ID NO: 7;
(b) a VH CDR2 region comprising the amino acid sequence of SEQ ID NO: 8;
(c) a VH CDR3 region comprising the amino acid sequence of SEQ ID NO: 9;
(d) a VL CDR1 region comprising the amino acid sequence of SEQ ID NO: 13;
(e) a VL CDR2 region comprising the amino acid sequence of SEQ ID NO: 14; and
(f) a VL CDR3 region comprising the amino acid sequence of SEQ ID NO: 15.

### Claim 2 (depends on 1)

The isolated antigen binding molecule of claim 1, wherein the antigen binding molecule is selected from the group consisting of an antibody, an scFv, a Fab, a Fab′, a Fv, a F(ab′)2, a dAb, a human antibody, a humanized antibody, a chimeric antibody, a monoclonal antibody, a polyclonal antibody, a recombinant antibody, an IgE antibody, an IgD antibody, an IgM antibody, an IgG1 antibody, an IgG1 antibody having at least one mutation in the hinge region, an IgG2 antibody, an IgG2 antibody having at least one mutation in the hinge region, an IgG3 antibody, an IgG3 antibody having at least one mutation in the hinge region, an IgG4 antibody, and an IgG4 and antibody having at least one mutation in the hinge region.

### Claim 3 (depends on 2)

The isolated antigen binding molecule of claim 2, wherein the antigen binding molecule is a humanized antibody.

### Claim 4 (depends on 1)

The isolated antigen binding molecule of claim 1, comprising
(a) a heavy chain variable region (VH) amino acid sequence that is at least about 95% identical to the amino acid sequence of SEQ ID NO: 5; and
(b) a light chain variable region (VL) amino acid sequence that is at least about 95% identical to the amino acid sequence of SEQ ID NO: 11.

### Claim 5 (depends on 4)

The isolated antigen binding molecule of claim 4, comprising
(a) a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 5; and
(b) a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 11.

### Claim 6 (depends on 1)

The isolated antigen binding molecule of claim 1 comprising
(a) a heavy chain comprising an amino acid sequence that is at least 95%, 96%, 97%, 98% or 99% identical to the amino acid sequence of SEQ ID NO: 6; and
(b) a light chain comprising an amino acid sequence that is 95%, 96%, 97%, 98% or 99% identical to the amino acid sequence of SEQ ID NO: 12.

### Claim 7 (depends on 6)

The isolated antigen binding molecule of claim 6 comprising at least one of
(a) a heavy chain comprising the amino acid sequence of SEQ ID NO: 6; and
(b) a light chain comprising the amino acid sequence of SEQ ID NO: 12.

### Claim 8 (depends on 6)

The isolated antigen binding molecule of claim 6 comprising
(a) a heavy chain comprising the amino acid sequence of SEQ ID NO: 6; and
(b) a light chain comprising the amino acid sequence of SEQ ID NO: 12.

### Claim 9

An isolated antigen binding molecule that specifically binds to a molecule comprising an amino acid sequence selected from the group consisting of GSTSGSGKPGSGEGSTKG (SEQ ID NO: 1), GSGKPGSGEG (SEQ ID NO: 2), GKPGSGEG (SEQ ID NO: 3), SGKPGSGE (SEQ ID NO: 499), and KPGSG (SEQ ID NO: 500), wherein the antigen binding molecule comprises:
(a) a VH CDR1 region comprising the amino acid sequence of SEQ ID NO: 19;
(b) a VH CDR2 region comprising the amino acid sequence of SEQ ID NO: 20;
(c) a VH CDR3 region comprising the amino acid sequence of SEQ ID NO: 21;
(d) a VL CDR1 region comprising the amino acid sequence of SEQ ID NO: 25;
(e) a VL CDR2 region comprising the amino acid sequence of SEQ ID NO: 26; and
(f) a VL CDR3 region comprising the amino acid sequence of SEQ ID NO: 27.

### Claim 10 (depends on 9)

The isolated antigen binding molecule of claim 9, wherein the antigen binding molecule is selected from the group consisting of an antibody, an scFv, a Fab, a Fab′, a Fv, a F(ab′)2, a dAb, a human antibody, a humanized antibody, a chimeric antibody, a monoclonal antibody, a polyclonal antibody, a recombinant antibody, an IgE antibody, an IgD antibody, an IgM antibody, an IgG1 antibody, an IgG1 antibody having at least one mutation in the hinge region, an IgG2 antibody, an IgG2 antibody having at least one mutation in the hinge region, an IgG3 antibody, an IgG3 antibody having at least one mutation in the hinge region, an IgG4 antibody, and an IgG4 and antibody having at least one mutation in the hinge region.

### Claim 11 (depends on 10)

The isolated antigen binding molecule of claim 10, wherein the antigen binding molecule is a humanized antibody.

### Claim 12 (depends on 9)

The isolated antigen binding molecule of claim 9, comprising
(a) a heavy chain variable region (VH) amino acid sequence that is at least about 95% identical to the amino acid sequence of SEQ ID NO: 17; and
(b) a light chain variable region (VL) amino acid sequence that is at least about 95% identical to the amino acid sequence of SEQ ID NO: 23.

### Claim 13 (depends on 10)

The isolated antigen binding molecule of claim 10, comprising
(a) a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 17; and
(b) a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 23.

### Claim 14 (depends on 13)

The isolated antigen binding molecule of claim 13 comprising
(a) a heavy chain comprising an amino acid sequence that is at least 95%, 96%, 97%, 98% or 99% identical to the amino acid sequence of SEQ ID NO: 18; and
(b) a light chain comprising an amino acid sequence that is at least 95%, 96%, 97%, 98% or 99% identical to the amino acid sequence of SEQ ID NO: 24.

### Claim 15 (depends on 14)

The isolated antigen binding molecule of claim 14 comprising at least one of
(a) a heavy chain comprising the amino acid sequence of SEQ ID NO: 18; and
(b) a light chain comprising the amino acid sequence of SEQ ID NO: 24.

### Claim 16 (depends on 14)

The isolated antigen binding molecule of claim 14 comprising
(a) a heavy chain comprising the amino acid sequence of SEQ ID NO: 18; and
(b) a light chain comprising the amino acid sequence of SEQ ID NO: 24.

### Claim 17 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)

The antigen binding molecule of any of claims 1-16, wherein the antigen binding molecule further comprises a detectable label.

### Claim 18 (depends on 17)

The antigen binding molecule of claim 17, wherein the detectable label is selected from the group consisting of a fluorescent label, a photochromic compound, a proteinaceous fluorescent label, a magnetic label, a radiolabel, and a hapten.

### Claim 19 (depends on 18)

The antigen binding molecule of claim 18, comprising a fluorescent label selected from the group consisting of an Atto dye, an Alexafluor dye, quantum dots, Hydroxycoumarin, Aminocouramin, Methoxycourmarin, Cascade Blue, Pacific Blue, Pacific Orange, Lucifer Yellow, NBD, R-Phycoerythrin (PE), PE-Cy5 conjugates, PE-Cy7 conjugates, Red 613, PerCP, TruRed, FluorX, Fluorescein, BODIPY-FL, Cy2, Cy3, Cy3B, Cy3.5, Cy5, Cy5.5, Cy7, TRITC, X-Rhodamine, Lissamine Rhocamine B, Texas Red, Allophycocyanin (APC), APC-Cy7 conjugates, Indo-1, Fluo-3, Fluo-4, DCFH, DHR, SNARF, GFP (Y66H mutation), GFP (Y66F mutation), EBFP, EBFP2, Azurite, GFPuv, T-Sapphire, Cerulean, mCFP, mTurquoise2, ECFP, CyPet, GFP (Y66W mutation), mKeima-Red, TagCFP, AmCyan1, mTFP1, GFP (S65A mutation), Midorishi Cyan, Wild Type GFP, GFP (S65C mutation), TurboGFP, TagGFP, GFP (S65L mutation), Emerald, GFP (S65T mutation), EGFP, Azami Green, ZsGreen1, TagYFP, EYFP, Topaz, Venus, mCitrine, YPet, TurboYFP, ZsYellow1, Kusabira Orange, mOrange, Allophycocyanin (APC), mKO, TurboRFP, tdTomato, TagRFP, DsRed monomer, DsRed2 (“RFP”), mStrawberry, TurboFP602, AsRed2, mRFP1, J-Red, R-phycoerythrin (RPE), B-phycoerythrin (BPE), mCherry, HcRed1, Katusha, P3, Peridinin Chlorophyll (PerCP), mKate (TagFP635), TurboFP635, mPlum, and mRaspberry.

### Claim 20 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)

A composition comprising the antigen binding molecule of any one of claims 1-19.