# US 2023/0056782 A1 · Antibodies, pharmaceutical compositions and uses thereof

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- Number: US 2023/0056782 A1
- Document ID: US20230056782A1
- Status: Published application
- Kind: A1
- Application number: 17/789,796
- Filed: 2020-12-30
- Published: 2023-02-23
- Earliest claimed: 2019-12-30
- Assignees: Obi Pharma, Inc.
- Applicants: Obi Pharma, Inc.
- Inventors: MING-TAIN LAI; JIANN-SHIUN LAI; CHIU-CHUN LIN; I-JU CHEN; WOAN-ENG CHAN
- Web page: https://patentgrep.com/patent/US20230056782A1

## CPC

- C07K 16/18: against material from animals or humans
- A61K 39/001169: {Tumor associated carbohydrates}
- A61K 39/00118: {from embryonic or fetal origin}
- A61P 35/00: Antineoplastic agents
- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/5156: {expressing foreign proteins}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/31: multispecific
- C07K 2317/55: Fab or Fab'
- C07K 2317/622: Single chain antibody (scFv)
- 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

The present invention provides antibodies or the antigen-binding portion thereof, that bind to stage-specific embryonic antigen 3 (SSEA-3) antigen. Also disclosed herein are pharmaceutical compositions and methods for the inhibition of cancer cells in a subject in need thereof. The pharmaceutical compositions include an antibody or an antigen-binding portion thereof and at least one pharmaceutically acceptable carrier.

## Claims

### Claim 1

An antibody, or an antigen-binding portion thereof, comprising:
a heavy chain variable domain comprising an amino acid sequence with 80-100% identity to SEQ ID NO: 3; and
a light chain variable domain comprising an amino acid sequence with 80-100% identity to SEQ ID NO: 4.

### Claim 2 (depends on 1)

The antibody, or an antigen-binding portion thereof of claim 1, further comprising:
a first heavy chain complementarity determining region (HCDR1) having an amino acid sequence with 90-100% identity to SEQ ID NO: 5;
a second heavy chain complementarity determining region (HCDR2) having an amino acid sequence with 90-100% identity to SEQ ID NO: 6;
a third heavy chain complementarity determining region (HCDR3) having an amino acid sequence with 90-100% identity to SEQ ID NO: 7;
a first light chain complementarity determining region (LCDR1) having an amino acid sequence with 90-100% identity to SEQ ID NO: 8;
a second light chain complementarity determining region (LCDR2) having an amino acid sequence with 90-100% identity to SEQ ID NO: 9; and
a third light chain complementarity determining region (LCDR3) having an amino acid sequence with 90-100% identity to SEQ ID NO: 10.

### Claim 3

An antibody, or an antigen-binding portion thereof, produced by a hybridoma designated as 1E12b deposited under ATCC Accession Number PTA-126149.

### Claim 4 (depends on 1)

The antibody or antigen-binding portion thereof of claim 1, wherein the variable domain is capable of binding a carbohydrate antigen.

### Claim 5 (depends on 4)

The antibody or antigen-binding portion thereof of claim 4, wherein the carbohydrate antigen is a stage-specific embryonic antigen 3 (SSEA-3) or a stage-specific embryonic antigen 4 (SSEA-4).

### Claim 6 (depends on 1)

The antibody or antigen-binding portion thereof of claim 1, wherein the antibody or antigen-binding portion thereof is selected from the group consisting of a whole immunoglobulin molecule, an scFv, a Fab fragment, an F(ab′)2, and a disulfide linked Fv.

### Claim 7 (depends on 1)

The antibody, or an antigen-binding portion thereof of claim 1, wherein the antibody is a humanized antibody.

### Claim 8 (depends on 7)

The antibody, or an antigen-binding portion thereof of claim 7, wherein the antibody is an IgG or an IgM.

### Claim 9 (depends on 7)

The antibody, or an antigen-binding portion thereof of claim 7, wherein the antibody further comprises a chimeric antigen receptor (CAR) domain specific for SSEA-3.

### Claim 10 (depends on 9)

The antibody, or an antigen-binding portion thereof of claim 9, wherein the CAR domain comprises a transmembrane domain and a intracellular signaling domain, wherein the transmembrane domain comprises a transmembrane domains of CD8 and/or CD28, and the intracellular signaling domain comprises an intracellular signaling domains selected from the groups consisting of CD27, CD28, CD137, OX40, ICOS, CD3zeta and any combination thereof.

### Claim 11 (depends on 1)

A bi-specific antibody or antigen-binding portion thereof, comprising:
the antibody, or the antigen-binding portion thereof of claim 1, wherein the antibody, or the antigen-binding portion thereof further comprises a first binding domain that specifically binds to Globo series antigens and a second binding domain that specifically binds to T cell surface antigens.

### Claim 12 (depends on 11)

The bi-specific antibody or antigen-binding portion of claim 11, wherein the Globo series antigens comprising Globo H, SSEA-3 or SSEA-4.

### Claim 13 (depends on 11)

The bi-specific antibody or antigen-binding portion of claim 11, wherein the T cell surface antigens comprise CD2, CD3, CD4, CD5, CD6, CD8, CD28, CD40 L, CD44, CD47, CD137, OX40 or TGFβ.

### Claim 14 (depends on 1)

A pharmaceutical composition, comprising:
the antibody or the antigen-binding portion thereof of claim 1; and
at least one pharmaceutically acceptable carrier.

### Claim 15 (depends on 14)

The pharmaceutical composition of claim 14, further comprises an additional therapeutic agent.

### Claim 16 (depends on 1)

A method of treating a cancer in a human, comprising: using the antibody, or an antigen-binding portion thereof of claim 1.

### Claim 17 (depends on 16)

The method of claim 16, wherein the cancer comprises breast cancer, lung cancer, prostate cancer, pancreatic cancer, gastric cancer, ovarian cancer and endometrial cancer and colon cancer, liver cancer, nasopharyngeal cancer, skin cancer, oral cancer, renal cancer, brain cancer, cervical cancer and bladder cancer.

### Claim 18 (depends on 1)

A method of treating cancer in a human, comprising:
administering to a subject in need thereof an effective amount of the pharmaceutical composition comprising the antibody or the antigen-binding portion thereof of claim 1, and/or a combination of a chemotherapeutic agent, a photodynamic therapeutic agent or a biological agent.

### Claim 19 (depends on 18)

The method of claim 18, wherein the combination provides a synergistic effect in inducing or enhancing immune reaction.

### Claim 20

A hybridoma designated as 1E12b deposited under ATCC Accession Number PTA-126149.

### Claim 21

(canceled)

### Claim 22

(canceled)
