# US 9,518,094 B2 · Romidepsin solid forms and uses thereof

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- Number: US 9,518,094 B2
- Document ID: US9518094B2
- Status: Granted
- Kind: B2
- Application number: 14/615,384
- Filed: 2015-02-05
- Published: 2015-08-06
- Granted: 2016-12-13
- Earliest claimed: 2010-07-12
- Assignees: Celgene Corporation
- Applicants: Celgene Corporation
- Inventors: Jason Hanko; David Alan Engers; Eric Hagen; Valeriya Smolenskaya; Jeffrey Scott Stults
- Web page: https://patentgrep.com/patent/US9518094B2

## CPC

- C07K 11/02: cyclic, e.g. valinomycins {; Derivatives thereof}
- A61K 38/07: Tetrapeptides
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 17/00: Drugs for dermatological disorders
- A61P 31/04: Antibacterial agents
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 5/101: {the side chain containing 2 to 4 carbon atoms, e.g. Val, Ile, Leu}
- 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)
- 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 disclosure provides solid forms of a compound of formula I. In some embodiments, the present disclosure provides crystalline forms of Compound I. In some embodiments, the present disclosure provides solvate forms of Compound I. In some embodiments, the present disclosure provides amorphous Compound I.

## Claims

### Claim 1

A crystalline form of romidepsin characterized by:
XRPD characteristic peaks at about 9.0 2θ, 10.3 2θ, 11.7 2θ, and 20.4 2θ;
a differential scanning calorimetry (DSC) thermogram having endotherm at ˜255° C.; or
a thermogravimetric analysis (TGA) thermogram exhibiting a weight loss of ˜10.9%.

### Claim 2 (depends on 1)

A pharmaceutical composition comprising the crystalline form of romidepsin of claim 1 and a pharmaceutically acceptable excipient.

### Claim 3 (depends on 1)

A method of treating a hematological disorder comprising administering to a subject the crystalline form of romidepsin of claim 1, wherein the hematological disorder is cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL).

### Claim 4 (depends on 3)

The method of claim 3, wherein the hematological disorder is cutaneous T-cell lymphoma (CTCL).

### Claim 5 (depends on 3)

The method of claim 3, wherein the hematological disorder is peripheral T-cell lymphoma (PTCL).

### Claim 6 (depends on 2)

A method of treating a hematological disorder comprising administering to a subject the pharmaceutical composition of claim 2, wherein the hematological disorder is cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL).