Combination therapies employing GITR binding molecules

• US 8,591,886 B2
• Filed: 07/11/2008
• Issued: 11/26/2013
• Est. Priority Date: 07/12/2007
• Status: Active Grant

• Current Assignee: GITR, Inc.
• Original Assignee: GITR, Inc.
• Inventors: Ponath, Paul, Rosenzweig, Michael, Ponte, Jose F.
• Primary Examiner(s): Huff, Sheela J
• Application Number:
  US12/218,187
• Publication Number:
  US 20090136494A1
• Time in Patent Office: 1,964 Days
• Field of Search: None
• US Class Current: 424/130.1
• CPC Class Codes: A61K 2039/507 Comprising a combination of two or more separate antibodies
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/513 having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/664 Amides of phosphorus acids
• CPC Class Codes: A61K 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 31/7068 having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
• CPC Class Codes: A61K 39/39541 against normal tissues, cells
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 39/39558 against tumor tissues, cells, antigens
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 1/18 for pancreatic disorders, e.g. pancreatic enzymes
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 17/00 : Drugs for dermatological disorders
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 : for peripheral neuropathies
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 35/02 : specific for leukemia
• CPC Class Codes: A61P 35/04 : specific for metastasis
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/2818 : against CD28 or CD152
• CPC Class Codes: C07K 16/2878 : against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
• CPC Class Codes: C07K 2317/24 : containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
• CPC Class Codes: C07K 2317/51 : Complete heavy chain or Fd fragment, i.e. VH + CH1
• CPC Class Codes: C07K 2317/515 : Complete light chain, i.e. VL + CL
• CPC Class Codes: C07K 2317/565 : Complementarity determining region [CDR]
• CPC Class Codes: C07K 2317/567 : Framework region [FR]
• CPC Class Codes: C07K 2317/75 : Agonist effect on antigen

Abstract

The present invention provides combination therapies that employ a GITR binding molecule in combination with one or more additional agents.

Claims

1. A method for treating a subject having a tumor, the method comprising administering a GITR-binding antibody, or an antigen-binding fragment thereof, and a therapy, to the subject,

wherein the GITR-binding antibody or the antigen-binding fragment acts as a GITR agonist, and the therapy is administered at a separate time from the GITR-binding antibody or the antigen-binding fragment at least once, and

wherein the therapy is cytotoxic or exerts an anti-proliferative effect on cells.

2. The method of claim 1, wherein the method results in inhibition of tumor growth.

3. The method of claim 1, wherein the method results in reduction in tumor size.

4. The method of claim 1, wherein the method results in reduction in the number of tumors.

5. The method of claim 1, wherein the method decreases tumor burden in the subject.

6. The method of claim 1, wherein the method prolongs survival of the subject.

7. The method of any one of claims 1-6, wherein the separate in time administration comprises administration of the therapy to the subject prior to administration of the GITR-binding antibody or the antigen-binding fragment.

8. The method of any one of claims 1-6, wherein the GITR-binding antibody or the antigen-binding fragment acts synergistically with the therapy.

9. The method of claim 8, wherein the separate in time administration comprises administration of the therapy to the subject prior to administration of the GITR-binding antibody or the antigen-binding fragment.

10. The method of claim 1, wherein the GITR agonist activity of the GITR-binding antibody or the antigen-binding fragment comprises increasing T cell effector responses.