# US 12,595,293 B2 · Anti-follicle stimulating hormone receptor antibodies

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- Number: US 12,595,293 B2
- Document ID: US12595293B2
- Status: Granted
- Kind: B2
- Application number: 17/267,331
- Filed: 2019-08-09
- Published: 2021-11-04
- Granted: 2026-04-07
- Earliest claimed: 2018-08-09
- Assignees: The Wistar Institute
- Applicants: The Wistar Institute
- Inventors: Alfredo Perales-Puchalt; David B. Weiner
- Web page: https://patentgrep.com/patent/US12595293B2

## CPC

- C07K 14/72: for hormones {(for neuromediators C07K14/70571)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/6849: {the antibody targeting a receptor, a cell surface antigen or a cell surface determinant}
- A61P 35/00: Antineoplastic agents
- C07K 16/2869: {against hormone receptors (for antibodies against neuromediator receptors C07K16/286)}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/54: {characterised by the route of administration}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- 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 relates to an isolated antibody or antigen binding fragment thereof that bind specifically to the Follicle Stimulating Hormone Receptor (FSHR). Also provided are methods for treating a disease in a subject comprising administering to the subject an isolated antibody or antibody fragment thereof that binds FSHR.

## Claims

### Claim 1

An isolated antibody or antigen binding fragment thereof that binds Follicle Stimulating Hormone Receptor (FSHR), wherein the isolated antibody or antigen binding fragment thereof comprises:
A) a heavy chain comprising:
(i) a heavy chain CDR1 having the sequence of SEQ ID NO: 6;
(ii) a heavy chain CDR2 having the sequence of SEQ ID NO: 7; and
(iii) a heavy chain CDR3 having the sequence of SEQ ID NO: 8; and
B) a light chain comprising:
(i) a light chain CDR1 having the sequence of SEQ ID NO: 2;
(ii) a light chain CDR2 having the sequence of SEQ ID NO: 3; and
(iii) a light chain CDR3 having the sequence of SEQ ID NO: 4.

### Claim 2 (depends on 1)

The isolated antibody or antigen binding fragment thereof of claim 1, wherein said antibody or antigen binding fragment thereof comprises a heavy chain comprising SEQ ID NO: 5 and a light chain comprising SEQ ID NO: 1.

### Claim 3 (depends on 1)

The isolated antibody or antigen binding fragment thereof of claim 1, wherein said antibody or antigen binding fragment thereof is humanized.

### Claim 4 (depends on 1)

The isolated humanized antibody or antigen binding fragment thereof of claim 1, wherein said antibody or antigen binding fragment thereof comprises a heavy chain comprising SEQ ID NO: 10 and a light chain comprising SEQ ID NO: 9.

### Claim 5 (depends on 1)

The isolated antibody or antigen binding fragment thereof of claim 1, wherein said antibody or antigen binding fragment thereof is chimeric.

### Claim 6 (depends on 1)

A recombinant nucleic acid encoding the antibody or antigen binding fragment thereof of claim 1.

### Claim 7 (depends on 1)

An antibody-drug conjugate comprising the antibody or antigen binding fragment of claim 1.

### Claim 8 (depends on 7)

The antibody-drug conjugate of claim 7, wherein the drug is monomethyl auristatin (EMMAE), ozogamicin, emtansine, amanitin, pyrrolobenzodiazepine (PBD) dimer toxin, a chalichaemicin, a cytotoxic maytansinoid, carboplatin, cisplatin, paclitaxel, vedotin, or diphtheria toxin.

### Claim 9 (depends on 1)

A pharmaceutical composition comprising the isolated antibody or antigen binding fragment of claim 1 and a pharmaceutically acceptable carrier.

### Claim 10 (depends on 1)

A method of treating a cancer that expresses FSHR in a subject in need thereof, comprising administering to the subject an effective amount of a pharmaceutical composition comprising the isolated antibody or antigen-binding fragment of claim 1, wherein the cancer is ovarian, prostate, breast, colon, pancreas, urinary bladder, kidney, lung, liver, stomach or testis cancer.

### Claim 11 (depends on 10)

The method of claim 10, wherein the antibody or antigen binding fragment is administered intravenously, intra-articularly, intraperitoneally, intrathecally, intraventricularly, intrasternally, intracranially, intra-muscularly, subcutaneously, orally or intranasally.

### Claim 12 (depends on 10)

The method of claim 10, further comprising administering a second agent to the subject.

### Claim 13 (depends on 12)

The method of claim 12, wherein the second agent is at least one of carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, bevacizumab, olaparib, rucaparib, niraparib, cyclophosphamide, abiraterone, flutamide, bicalutamide, leuprolide, goserelin, buserelin, triptorelin, degarelix, Enzalutamide, Apalutamide, Sipuleucel-T, Cabazitaxel, Radium-223, trastuzumab, pertuzumab, lapatinib, tamoxifen, oxaliplatin, capecitabine, leucovorin, Irinotecan, Cetuximab, panitumumab, aflibercept, Regorafenib, Trifluridine-tipiracil, immune checkpoint inhibitors, cabozantinib, sunitinib, pazopanib, axitinib, interleukin-2, interferon alpha, mitomycin C, epirubicin, BCG, bleomycin, etoposide, sorafenib, regorafenib, lenvatinib, pemetrexed and/or vinorelbine.

### Claim 14 (depends on 10)

The method of claim 10, wherein the cancer is metastatic.