Cell capable of expressing exogenous GITR ligand

• US 8,586,023 B2
• Filed: 09/11/2009
• Issued: 11/19/2013
• Est. Priority Date: 09/12/2008
• Status: Active Grant

• Current Assignee: MIE University, Takara Bio Incorporated (Ningbo Junsheng Investment Group Co., Ltd.)
• Original Assignee: MIE University, Takara Bio Incorporated (Ningbo Junsheng Investment Group Co., Ltd.)
• Inventors: Shiku, Hiroshi, Mineno, Junichi, Kato, Ikunoshin, Ikeda, Hiroaki, Mitsui, Jun, Takenaka, Yuki
• Primary Examiner(s): Allen, Marianne P
• Application Number:
  US13/062,999
• Publication Number:
  US 20110250230A1
• Time in Patent Office: 1,530 Days
• Field of Search: None
• US Class Current: 424/93.2
• CPC Class Codes: A61K 2039/5152 Tumor cells
• CPC Class Codes: A61K 2239/31 characterized by the route of administration
• CPC Class Codes: A61K 2239/38 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• 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 38/191 Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
• CPC Class Codes: A61K 39/0005 Vertebrate antigens from snakes A61K39/38
• CPC Class Codes: A61K 39/001117 Receptors for tumor necrosis factors [TNF], e.g. lymphotoxin receptor [LTR] or CD30
• CPC Class Codes: A61K 39/4611 T-cells, e.g. tumor infiltrating lymphocytes [TIL], lymphokine-activated killer cells [LAK] or regulatory T cells [Treg]
• CPC Class Codes: A61K 39/4644 Cancer antigens
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/04 Immunostimulants
• CPC Class Codes: C07K 14/70575 NGF/TNF-superfamily, e.g. CD70, CD95L, CD153, CD154 NGF C07K14/48, TNF C07K14/525
• CPC Class Codes: C07K 2319/30 Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
• CPC Class Codes: C12N 2799/022 : where the vector is derived from an adenovirus
• CPC Class Codes: C12N 2799/027 : where the vector is derived from a retrovirus

Abstract

Disclosed are: a cell capable of expressing an exogenous GITRL or an exogenous GITRL derivative; a method for producing the cell; a therapeutic or prophylactic agent comprising the cell as an active ingredient; use of the cell in the manufacture of a therapeutic or prophylactic agent; a method comprising a step of administering the cell to a subject; a viral vector carrying a gene encoding a GITRL or a GITRL derivative; a therapeutic or prophylactic agent comprising the viral vector as an active ingredient; use of the viral vector in the manufacture of a therapeutic or prophylactic agent; and a method comprising a step of administering the viral vector to a subject.

Claims

1. A pharmaceutical composition comprising an excipient and an immune cell capable of expressing an exogenous Glucocorticoid-Induced Tumor necrosis factor Receptor Ligand (GITRL) derivative, wherein said GITRL derivative is a fusion protein consisting of amino acids 50-177 of SEQ ID NO:

6 fused to an Fc fragment of an immunoglobulin, wherein the composition comprises 1×

10³ to 1×

10¹¹ cells/mL of said immune cell.

2. The pharmaceutical composition of claim 1 wherein said immunoglobulin is IgG2.

3. The pharmaceutical composition of claim 1 wherein said composition comprises 1×

10⁴ to 1×

10¹⁰ cells/mL of said immune cell.

4. The pharmaceutical composition of claim 1 wherein said composition comprises 1×

10⁵ to 1×

10⁹ cells/mL of said immune cell.

5. A pharmaceutical composition comprising an excipient and an inactivated tumor cell capable of expressing an exogenous Glucocorticoid-Induced Tumor necrosis factor Receptor Ligand (GITRL) derivative, wherein said GITRL derivative is a fusion protein consisting of amino acids 50-177 of SEQ ID NO:

6 fused to an Fc fragment of an immunoglobulin, wherein the composition comprises 1×

10³ to 1×

10¹¹ cells/mL of said inactivated tumor cell.

6. The pharmaceutical composition of claim 5 wherein said immunoglobulin is IgG2.

7. The pharmaceutical composition of claim 5 wherein said composition comprises 1×

10⁴ to 1×

10¹⁰ cells/mL of said inactivated tumor cell.

8. The pharmaceutical composition of claim 5 wherein said composition comprises 1×

10⁵ to 1×

10⁹ cells/mL of said inactivated tumor cell.