Methods for producing a depsipeptide

• US 10,414,800 B2
• Filed: 06/15/2016
• Issued: 09/17/2019
• Est. Priority Date: 12/03/2012
• Status: Active Grant

• Current Assignee: NovoBiotic Pharmaceuticals, LLC
• Original Assignee: NovoBiotic Pharmaceuticals, LLC
• Inventors: Peoples, Aaron J., Hughes, Dallas, Ling, Losee Lucy, Millett, William, Nitti, Anthony, Spoering, Amy, Steadman, Victoria Alexandra, Chiva, Jean-Yves Christophe, Lazarides, Linos, Jones, Michael Kenyon, Poullennec, Karine Gaelle, Lewis, Kim, Epstein, Slava
• Primary Examiner(s): Heard, Thomas S
• Application Number:
  US15/183,031
• Publication Number:
  US 20170121372A1
• Time in Patent Office: 1,189 Days
• Field of Search: None
• CPC Class Codes: 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
• CPC Class Codes: A61K 38/15 Depsipeptides; Derivatives thereof
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/06 for tuberculosis
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 31/20 for DNA viruses
• CPC Class Codes: A61P 31/22 for herpes viruses
• CPC Class Codes: A61P 33/02 Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
• CPC Class Codes: A61P 33/04 Amoebicides
• CPC Class Codes: A61P 33/06 Antimalarials
• CPC Class Codes: A61P 33/10 Anthelmintics
• CPC Class Codes: A61P 33/12 Schistosomicides
• CPC Class Codes: C07K 11/02 cyclic, e.g. valinomycins ; Derivatives thereof
• CPC Class Codes: C07K 7/56 the cyclisation not occurring through 2,4-diamino-butanoic acid
• CPC Class Codes: C12N 1/205 Bacterial isolates
• CPC Class Codes: C12P 17/14 Nitrogen or oxygen as hetero atom and at least one other diverse hetero ring atom in the same ring
• CPC Class Codes: C12P 21/02 : having a known sequence of two or more amino acids, e.g. glutathione
• CPC Class Codes: C12R 2001/01 : Bacteria or Actinomycetales ; using bacteria or Actinomycetales
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention relates generally to novel depsipeptides, to methods for the preparation of these novel depsipeptides, to pharmaceutical compositions comprising the novel depsipeptides; and to methods of using the novel depsipeptides to treat or inhibit various disorders.

Claims

1. A method for producing a pharmaceutical composition comprising a compound of Formula (II):

2. The method of claim 1, wherein cultivating a bacterial isolate ISO18629 comprises the following steps:

(a) growing the bacterial isolate ISO18629 on an appropriate support, thereby producing a bacterial colony;

(b) homogenizing the bacterial colony produced in step (a) and using it to inoculate a seed broth;

(c) fermenting the seed broth, thereby producing a seed culture; and

(d) using the seed culture to inoculate a production broth.

3. The method of claim 2, further comprising the following steps:

(e) fermenting the production broth of step (d); and

(f) harvesting the compound of Formula (II) from the production broth.

4. The method of claim 3, wherein harvesting the compound of Formula (II) from the production broth comprises centrifuging the production broth to produce a pellet and a supernatant.

5. The method of claim 4, further comprising adsorbing said supernatant onto a reversed-phase column.

6. The method of claim 5, further comprising eluting the compound of Formula (II) from the reversed-phase column.

7. The method of claim 1, wherein the pharmaceutically-acceptable carrier is a cellulose selected from the group consisting of sodium carboxymethyl cellulose, ethyl cellulose, and cellulose acetate.

8. The method of claim 1, wherein the pharmaceutically-acceptable carrier is an oil selected from the group consisting of peanut oil, cottonseed oil, groundnut oil, corn oil, germ oil, olive oil, castor oil, sesame oil, safflower oil, and soybean oil.

9. The method of claim 1, wherein the pharmaceutically-acceptable carrier is a glycol selected from the group consisting of propylene glycol, polyethylene glycol and 1,3-butylene glycol.

10. The method of claim 1, wherein the pharmaceutical composition is in a form selected from the group consisting of a capsule, a tablet, a pill, a dragee, a powder, a spray, an ointment, a paste, a cream, a lotion, a gel, a drop, a patch, and an inhalant.

11. The method of claim 1, wherein the pharmaceutical composition comprises about 1 mg to about 10 g of the compound of Formula (II).

12. The method of claim 1, wherein the pharmaceutical composition is in a pre-filled syringe.