# US 12,600,784 B2 · Anti-Clec12A antibodies and uses thereof

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- Number: US 12,600,784 B2
- Document ID: US12600784B2
- Status: Granted
- Kind: B2
- Application number: 17/728,664
- Filed: 2022-04-25
- Published: 2023-04-13
- Granted: 2026-04-14
- Earliest claimed: 2021-04-26
- Assignees: Millennium Pharmaceuticals, Inc.
- Applicants: Millennium Pharmaceuticals, Inc.
- Inventors: Tomoki Yoshihara
- Web page: https://patentgrep.com/patent/US12600784B2

## CPC

- C07K 16/2851: {against the lectin superfamily, e.g. CD23, CD72}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 35/00: Antineoplastic agents
- C07K 2317/21: from primates, e.g. man
- 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 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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

## Abstract

Antibodies, fragments thereof and fusion proteins that specifically bind to Clec12A, are described, as well as methods of making and using such antibodies. Such antibodies, fusion proteins and fragments thereof are useful for the treatment and diagnosis of various autoimmune diseases and cancers, including leukemia, lymphoma, or myeloma, including, for example, acute myeloid leukemia.

## Claims

### Claim 1

An anti-Clec12A antibody or antigen-binding fragment thereof comprising:
(a) a heavy chain complementarity determining region (HCDR) 1 comprising an amino acid sequence of GGSISTYY (SEQ ID NO: 19), an HCDR2 comprising an amino acid sequence of IYYSGST (SEQ ID NO: 20), an HCDR3 comprising an amino acid sequence of AREDYYGSGSPFDY (SEQ ID NO: 21); and
a light chain complementarity determining region (LCDR) 1 comprising an amino acid sequence of QGIRYD (SEQ ID NO: 22), an LCDR2 comprising an amino acid sequence of AAS (SEQ ID NO:23), and an LCDR3 comprising an amino acid sequence of LQDYNFPRT (SEQ ID NO: 24); or
(b) an HCDR1 comprising an amino acid sequence of GFTFSSYG (SEQ ID NO: 73), an HCDR2 comprising an amino acid sequence of ISYDGSDK (SEQ ID NO: 25), and HCDR3 comprising an amino acid sequence of ARDKGYYFDY (SEQ ID NO: 26); and
an LCDR1 comprising an amino acid sequence of QSVGNRY (SEQ ID NO: 27), an LCDR2 comprising an amino acid sequence of GAS (SEQ ID NO: 28), an LCDR3 comprising an amino acid sequence of QQDYNLPLT (SEQ ID NO:29); or
(c) an HCDR1 comprising an amino acid sequence of GFTFSSYG (SEQ ID NO: 73), an HCDR2 comprising an amino acid sequence of ISYDGSDK (SEQ ID NO: 25), an HCDR3 comprising an amino acid sequence of ARDGSRYFDY (SEQ ID NO: 30); and
an LCDR1 comprising an amino acid sequence of QSVHSKY (SEQ ID NO: 31), an LCDR2 comprising an amino acid sequence of GAS (SEQ ID NO: 28), an LCDR3 comprising an amino acid sequence of QQDYNLPIT (SEQ ID NO: 32); or
(d) an HCDR1 comprising an amino acid sequence of GGSISSSTYY (SEQ ID NO: 33), an HCDR2 comprising an amino acid sequence of THYRGST (SEQ ID NO: 34), an HCDR3 comprising an amino acid sequence of ARELTGEVFDY (SEQ ID NO: 35); and
an LCDR1 comprising an amino acid sequence of QSISSY (SEQ ID NO:36), an LCDR2 comprising an amino acid sequence of AAS (SEQ ID NO: 23), an LCDR3 comprising an amino acid sequence of QQSYSTPFT (SEQ ID NO: 37); or
(e) an HCDR1 comprising an amino acid sequence of GGSISTYY (SEQ ID NO: 19), an HCDR2 comprising an amino acid sequence of IYFSGST (SEQ ID NO: 38), and HCDR3 comprising an amino acid sequence of AREDYYGSGSPFDY (SEQ ID NO:21); and
an LCDR1 comprising an amino acid sequence of QGIRND (SEQ ID NO: 39), an LCDR2 comprising an amino acid sequence of AAS (SEQ ID NO: 23), an LCDR3 comprising an amino acid sequence of LQDYNYPRT (SEQ ID NO:40); or
(f) an HCDR1 comprising an amino acid sequence of GGSISTDY (SEQ ID NO:41), an HCDR2 comprising an amino acid sequence of IYFSGST (SEQ ID NO:38), and HCDR3 comprising an amino acid sequence of AREDYYGSGSPFDY (SEQ ID NO:21); and
an LCDR1 comprising an amino acid sequence of QDIRND (SEQ ID NO:42), an LCDR2 comprising an amino acid sequence of AAS (SEQ ID NO: 23), an LCDR3 comprising an amino acid sequence of LQDYNFPRT (SEQ ID NO: 24); or
(g) an HCDR1 comprising an amino acid sequence of GFTFSSYG (SEQ ID NO: 73), an HCDR2 comprising an amino acid sequence of ISYDGSDK (SEQ ID NO:25), and HCDR3 comprising an amino acid sequence of ARDGQFYFDY (SEQ ID NO: 43); and
an LCDR1 comprising an amino acid sequence of QSVTSRY (SEQ ID NO:44), an LCDR2 comprising an amino acid sequence of GAS (SEQ ID NO:28), an LCDR3 comprising an amino acid sequence of QQDYNLPLT (SEQ ID NO:29); or
(h) an HCDR1 comprising an amino acid sequence of GFTFSNYG (SEQ ID NO: 45), an HCDR2 comprising an amino acid sequence of ISYDGSDK (SEQ ID NO: 25), and HCDR3 comprising an amino acid sequence of ARDSGRYFFDY (SEQ ID NO:46); and
an LCDR1 comprising an amino acid sequence of QSVSSRS (SEQ ID NO:47), an LCDR2 comprising an amino acid sequence of GPS (SEQ ID NO: 48), an LCDR3 comprising an amino acid sequence of HQDYNLPLT (SEQ ID NO:49); or
(i) an HCDR1 comprising an amino acid sequence of GFTFSKYG (SEQ ID NO: 50), an HCDR2 comprising an amino acid sequence of IWYDGSIK (SEQ ID NO: 51), and HCDR3 comprising an amino acid sequence of ARGSLWFGEFYFDY (SEQ ID NO: 52); and
an LCDR1 comprising an amino acid sequence of QGISSA (SEQ ID NO: 53), an LCDR2 comprising an amino acid sequence of DAS (SEQ ID NO: 54), an LCDR3 comprising an amino acid sequence of QQFNNYPRT (SEQ ID NO: 55).

### Claim 2 (depends on 1)

The anti-Clec12A antibody or antigen-binding fragment thereof of claim 1, wherein the anti-Clec12A antibody or fragment thereof is a monoclonal antibody or a single-chain variable fragment (scFv).

### Claim 3 (depends on 2)

The anti-Clec12A antibody or antibody-binding fragment thereof of claim 2, wherein the scFv comprises a heavy chain variable sequence, a GS-Linker, and a light chain variable sequence.

### Claim 4 (depends on 3)

The anti-Clec12A antibody or antigen-binding fragment thereof of claim 3, wherein the scFv comprises a sequence having at least 80% identity to:
(d) SEQ ID NO: 56;
(e) SEQ ID NO: 57;
(f) SEQ ID NO: 58; or
(g) SEQ ID NO: 59.

### Claim 5 (depends on 4)

The anti-Clec 12A antibody or antigen-binding fragment thereof of claim 4, wherein the scFv comprises a sequence selected from:
(a) SEQ ID NO: 56;
(b) SEQ ID NO: 57;
(c) SEQ ID NO: 58; and
(d) SEQ ID NO: 59.

### Claim 6 (depends on 1)

The anti-Clec12A antibody or antigen-binding fragment thereof of claim 1, wherein the anti-Clec12A antibody is an antibody comprising an IgG constant region.

### Claim 7 (depends on 1)

A nucleic acid sequence encoding the amino acid sequence of the anti-Clec12A antibody or antigen-binding fragment thereof of claim 1.

### Claim 8 (depends on 7)

A vector comprising the nucleic acid sequence of claim 7.

### Claim 9 (depends on 8)

A cell comprising the vector of claim 8.

### Claim 10 (depends on 1)

The anti-Clec12A antibody or antigen-binding fragment thereof according to claim 1, comprising:
(a) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 1, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 2; or
(b) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 3, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 4; or
(c) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 5, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 6; or
(d) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 7, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 8; or
(e) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 9, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 10; or
(f) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 11, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 12; or
(g) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 13, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 14; or
(h) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 15, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 16; or
(i) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 17, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence that is at least 80% identical to SEQ ID NO: 18.

### Claim 11 (depends on 10)

The anti-Clec12A antibody or antigen-binding fragment thereof according to claim 10, comprising:
(a) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 1, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence of SEQ ID NO: 2; or
(b) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 3, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence of SEQ ID NO: 4; or
(c) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 5, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence of SEQ ID NO: 6; or
(d) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 7, and
an immunoglobulin light chain variable (VL) region comprising an amino acid sequence of SEQ ID NO: 8; or
(e) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 9, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence of SEQ ID NO: 10; or
(f) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 11, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence of SEQ ID NO: 12; or
(g) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 13, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence of SEQ ID NO: 14; or
(h) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 15, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence of SEQ ID NO: 16; or
(i) an immunoglobulin heavy chain variable (VH) region comprising an amino acid sequence of SEQ ID NO: 17, and
an immunoglobulin light variable (VL) region comprising an amino acid sequence of SEQ ID NO: 18.