# US 10,865,245 B2 · Anti-B7H3 binding compounds and uses thereof

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- Number: US 10,865,245 B2
- Document ID: US10865245B2
- Status: Granted
- Kind: B2
- Application number: 15/967,858
- Filed: 2018-05-01
- Published: 2019-11-07
- Granted: 2020-12-15
- Earliest claimed: 2014-12-23
- Assignees: Full Spectrum Genetics, Inc.
- Applicants: Full Spectrum Genetics, Inc.
- Inventors: Robert DuBridge; Veronica Juan
- Web page: https://patentgrep.com/patent/US10865245B2

## CPC

- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C07K 2317/31: multispecific
- C07K 2317/55: Fab or Fab'
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/567: Framework region [FR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2319/00: Fusion polypeptide
- 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)

## Abstract

The invention is directed to novel antibody binding compounds specific for the human B7H3 and uses of such compounds for diagnostic and therapeutic purposes.

## Claims

### Claim 1

An antibody binding compound specific for the human B7H3 comprising a heavy chain of the following form:
f1-HC1-f2-HC2-f3-HC3-f4
and light chain of the following form:
g1-LC1-g2-LC2-g3-LC3-g4
wherein f1, f2, f3 and f4 are human heavy chain framework residues; g1, g2, g3 and g4 are human light chain framework residues; and HC1, HC2, HC3, LC1, LC2 and LC3 are complementarity determining regions (CDRs) defined by the following amino acid sequences:
HC1:
(SEQ ID NO: 1)
N-Y-D-I-N;
HC2:
(SEQ ID NO: 9)
W-I-F-P-G-D-G-S-T-Q-Y-N-G-K-F-K-G;
HC3:
(SEQ ID NO: 10)
Q-T-T-G-T-W-F-A-Y;
LC1:
(SEQ ID NO: 11)
R-A-S-Q-S-I-S-P-Y-L-H;
LC2:
(SEQ ID NO: 12)
Y-A-S-Q-S-W-S;
and
LC3:
(SEQ ID NO: 6)
Q-N-G-H-S-F-P-L-T.

### Claim 2 (depends on 1)

The antibody binding compound of claim 1 wherein said antibody binding compound has an affinity for human B7H3 that is characterized by an equilibrium binding constant of 100 nM or less.

### Claim 3 (depends on 2)

The antibody binding compound of claim 2 having a bispecific antibody format, or an antibody binding compound-drug conjugate format, or a format selected from the group consisting of IgG, Fab, single chain Fv, and chimeric antigen receptor compound.

### Claim 4

An antibody binding compound specific for the human B7H3 comprising a heavy chain of the following form:
f1-HC1-f2-HC2-f3-HC3-f4
and light chain of the following form:
g1-LC1-g2-LC2-g3-LC3-g4
wherein f1, f2, f3 and f4 are human heavy chain framework residues; g1, g2, g3 and g4 are human light chain framework residues; and HC1, HC2, HC3, LC1, LC2 and LC3 are complementarity determining regions (CDRs) defined by the following amino acid sequences:
HC1:
(SEQ ID NO: 1)
N-Y-D-I-N;
HC2:
(SEQ ID NO: 15)
W-I-F-P-G-D-G-S-T-Q-Y-N-E-T-F-K-G;
HC3:
(SEQ ID NO: 10)
Q-T-T-G-T-W-F-A-Y;
LC1:
(SEQ ID NO: 16)
R-A-S-Q-S-I-S-K-Y-L-H;
LC2:
(SEQ ID NO: 17)
Y-A-N-Q-S-I-R;
and
LC3:
(SEQ ID NO: 6)
Q-N-G-H-S-F-P-L-T.

### Claim 5 (depends on 4)

The antibody binding compound of claim 4 wherein said antibody binding compound has an affinity for human B7H3 that is characterized by an equilibrium binding constant of 100 nM or less.

### Claim 6 (depends on 5)

The antibody binding compound of claim 5 having a bispecific antibody format, or an antibody binding compound-drug conjugate format, or a format selected from the group consisting of IgG, Fab, single chain Fv, and chimeric antigen receptor compound.

### Claim 7

An antibody binding compound specific for the human B7H3 comprising a heavy chain of the following form:
f1-HC1-f2-HC2-f3-HC3-f4
and light chain of the following form:
g1-LC1-g2-LC2-g3-LC3-g4
wherein f1, f2, f3 and f4 are human heavy chain framework residues: g1, g2, g3 and g4 are human light chain framework residues; and HC1, HC2, HC3, LC1, LC2 and LC3 are complementarity determining regions (CDRs) defined by the following amino acid sequences:
HC1:
(SEQ ID NO: 1)
N-Y-D-I-N;
HC2:
(SEQ ID NO: 20)
W-I-F-P-G-D-G-S-T-Q-Y-N-P-K-F-K-G;
HC3:
(SEQ ID NO: 10)
Q-T-T-G-T-W-F-A-Y;
LC1:
(SEQ ID NO: 21)
R-A-S-Q-S-I-S-T-Y-L-H;
LC2:
(SEQ ID NO: 22)
E-A-S-Q-S-I-S;
and
LC3:
(SEQ ID NO: 6)
Q-N-G-H-S-F-P-L-T.

### Claim 8 (depends on 7)

The antibody binding compound of claim 7 wherein said antibody binding compound has an affinity for human B7H3 that is characterized by an equilibrium binding constant of 100 nM or less.

### Claim 9 (depends on 8)

The antibody binding compound of claim 8 having a bispecific antibody format, or an antibody binding compound-drug conjugate format, or a format selected from the group consisting of IgG, Fab, single chain Fv, and chimeric antigen receptor compound.

### Claim 10

An antibody binding compound specific for the human B7H3 comprising a heavy chain of the following form:
f1-HC1-f2-HC2-f3-HC3-f4
and light chain of the following form:
g1-LC1-g2-LC2-g3-LC3-g4
wherein f1, f2, f3 and f4 are human heavy chain framework residues; g1, g2, g3 and g4 are human light chain framework residues; and HC1, HC2, HC3, LC1, LC2 and LC3 are complementarity determining regions (CDRs) defined by the following amino acid sequences:
HC1:
(SEQ ID NO: 1)
N-Y-D-I-N;
HC2:
(SEQ ID NO: 25)
W-I-F-P-G-D-G-S-T-Q-Y-N-E-K-F-K-G;
HC3:
(SEQ ID NO: 10)
Q-T-T-G-T-W-F-A-Y;
LC1:
(SEQ ID NO: 26)
R-A-S-Q-S-I-S-H-Y-L-H;
LC2:
(SEQ ID NO: 27)
Y-A-S-Q-S-L-S;
and
LC3:
(SEQ ID NO: 6)
Q-N-G-H-S-F-P-L-T.

### Claim 11 (depends on 10)

The antibody binding compound of claim 10 wherein said antibody binding compound has an affinity for human B7H3 that is characterized by an equilibrium binding constant of 100 nM or less.

### Claim 12 (depends on 11)

The antibody binding compound of claim 11 having a bispecific antibody format, or an antibody binding compound-drug conjugate format, or a format selected from the group consisting of IgG, Fab, single chain Fv, and chimeric antigen receptor compound.

### Claim 13

An antibody binding compound specific for the human B7H3 comprising a heavy chain of the following form:
f1-HC1-f2-HC2-f3-HC3-f4
and light chain of the following form:
g1-LC1-g2-LC2-g3-LC3-g4
wherein f1, f2, f3 and f4 are human heavy chain framework residues; g1, g2, g3 and g4 are human light chain framework residues; and HC1, HC2, HC3, LC1, LC2 and LC3 are complementarity determining regions (CDRs) defined by the following amino acid sequences:
HC1:
(SEQ ID NO: 1)
N-Y-D-I-N;
HC2:
(SEQ ID NO: 25)
W-I-F-P-G-D-G-S-T-Q-Y-N-E-K-F-K-G;
HC3:
(SEQ ID NO: 10)
Q-T-T-G-T-W-F-A-Y;
LC1:
(SEQ ID NO: 11)
R-A-S-Q-S-I-S-P-Y-L-H;
LC2:
(SEQ ID NO: 30)
H-A-S-Q-S-I-S;
and
LC3:
(SEQ ID NO: 6)
Q-N-G-H-S-F-P-L-T.

### Claim 14 (depends on 13)

The antibody binding compound of claim 13 wherein said antibody binding compound has an affinity for human B7H3 that is characterized by an equilibrium binding constant of 100 nM or less.

### Claim 15 (depends on 14)

The antibody binding compound of claim 14 having a bispecific antibody format, or an antibody binding compound-drug conjugate format, or a format selected from the group consisting of IgG, Fab, single chain Fv, and chimeric antigen receptor compound.

### Claim 16

An antibody binding compound specific for the human B7H3 comprising a heavy chain of the following form:
f1-HC1-f2-HC2-f3-HC3-f4
and light chain of the following form:
g1-LC1-g2-LC2-g3-LC3-g4
wherein f1, f2, f3 and f4 are human heavy chain framework residues; g1, g2, g3 and g4 are human light chain framework residues; and HC1, HC2, HC3, LC1, LC2 and LC3 are complementarity determining regions (CDRs) defined by the following amino acid sequences:
HC1:
(SEQ ID NO: 1)
N-Y-D-I-N;
HC2:
(SEQ ID NO: 25)
W-I-F-P-G-D-G-S-T-Q-Y-N-E-K-F-K-G;
HC3:
(SEQ ID NO: 33)
Q-T-T-S-T-W-F-A-Y;
LC1:
(SEQ ID NO: 34)
R-A-S-Q-I-I-S-D-Y-L-H;
LC2:
(SEQ ID NO: 35)
Y-A-S-Q-L-I-S;
and
LC3:
(SEQ ID NO: 6)
Q-N-G-H-S-F-P-L-T.

### Claim 17 (depends on 16)

The antibody binding compound of claim 16 wherein said antibody binding compound has an affinity for human B7H3 that is characterized by an equilibrium binding constant of 100 nM or less.

### Claim 18 (depends on 17)

The antibody binding compound of claim 17 having a bispecific antibody format, or an antibody binding compound-drug conjugate format, or a format selected from the group consisting of IgG, Fab, single chain Fv, and chimeric antigen receptor compound.

### Claim 19

An antibody binding compound specific for the human B7H3 comprising a heavy chain of the following form:
f1-HC1-f2-HC2-f3-HC3-f4
and light chain of the following form:
g1-LC1-g2-LC2-g3-LC3-g4
wherein f1, f2, f3 and f4 are human heavy chain framework residues; g1, g2, g3 and g4 are human light chain framework residues; and HC1, HC2, HC3, LC1, LC2 and LC3 are complementarity determining regions (CDRs) defined by the following amino acid sequences:
HC1:
(SEQ ID NO: 1)
N-Y-D-I-N;
HC2:
(SEQ ID NO: 25)
W-I-F-P-G-D-G-S-T-Q-Y-N-E-K-F-K-G;
HC3:
(SEQ ID NO: 10)
Q-T-T-G-T-W-F-A-Y;
LC1:
(SEQ ID NO: 38)
R-A-S-Q-S-I-S-E-Y-L-H;
LC2:
(SEQ ID NO: 30)
H-A-S-Q-S-I-S;
and
LC3:
(SEQ ID NO: 6)
Q-N-G-H-S-F-P-L-T.

### Claim 20 (depends on 19)

The antibody binding compound of claim 19 wherein said antibody binding compound has an affinity for human B7H3 that is characterized by an equilibrium binding constant of 100 nM or less.

### Claim 21 (depends on 20)

The antibody binding compound of claim 20 having a bispecific antibody format, or an antibody binding compound-drug conjugate format, or a format selected from the group consisting of IgG, Fab, single chain Fv, and chimeric antigen receptor compound.