IP Library Granted Patent US 8,911,722
Granted Patent B2
US 8,911,722 · App. 13/395,965 · Granted Dec 16, 2014

Modulation of yeast-based immunotherapy products and responses

Inventors: Donald Bellgrau (Highlands Ranch, CO); Beth Tamburini (Denver, CO)
Assignee: The Regents of the University of Colorado, a body corporate
A61K39/39541A61K2039/523A61K2039/57A61K2039/505
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Quick Facts
Patent No.
US 8,911,722
App. No.
13/395,965
Granted
Dec 16, 2014
Kind
B2
Abstract

Disclosed are methods to modulate yeast-based immunotherapy products and the immune responses, prophylactic responses, and/or therapeutic responses elicited by such products. Also disclosed are modified yeast-based immunotherapy products, kits and compositions.

Claims (19)

1. A method to inhibit the production or survival of CD4+ TH17 cells in a subject, comprising administering to a subject:

a) a yeast-based immunotherapy composition comprising a whole yeast and an antigen; and

b) an agent that inhibits the production or survival of CD4+ TH17 cells,

wherein the agent inhibits interleukin-6 (IL 6), and wherein the agent is selected from an antibody or antigen binding portion thereof, or a soluble inactive form of IL-6 or its receptor;

wherein the administration of the agent is prior to, in conjunction with, and/or following administration of the yeast-based immunotherapy composition, and wherein the production or survival of CD4+ TH17 cells is inhibited in the subject.

2. The method of claim 1 , wherein the subject, as a result of administration of the yeast-based immunotherapy composition in the absence of the agent, produces statistically significantly (p>0.05) more IL-17 and/or has more TH17 CD4+ T cells than the average level of IL-17 production or average number of TH17 cells in CD4+ T cells isolated from the same source from a population of individuals who are generally healthy or, as a group, are not experiencing a particular disease or condition.

3. The method of claim 1 , wherein T cells that have been isolated from the subject do not proliferate or proliferate weakly in response to contact with a yeast-based immunotherapy composition.

4. The method of claim 1 , wherein T cells that have been isolated from the subject have greater than normal retinoid-related orphan receptor (ROR)-γexpression and/or have greater than normal levels of IL-17 production.

5. The method of claim 1 , wherein the yeast-based immunotherapy composition is administered in one or more doses over a period of time prior to commencing the administration of the agent.

6. The method of claim 1 , wherein the agent is administered for a period of time sufficient to induce an initial immune response in the subject, followed by a period of time wherein the yeast-based immunotherapy composition is administered in the absence of the agent.

7. The method of claim 1 , wherein the whole yeast is a heat-inactivated whole yeast.

8. The method of claim 1 , wherein the whole yeast is from Saccharomyces.

9. The method of claim 1 , wherein the whole yeast is from Saccharomyces cerevisiae.

10. The method of claim 1 , wherein the agent is anti-IL-6.

11. A composition comprising:

a) a yeast-based immunotherapy composition comprising a whole yeast and an antigen; and

b) an agent that inhibits the production or survival of CD4+ TH17 cells, wherein the agent

inhibits interleukin-6 (IL 6), and wherein the agent is selected from an antibody or antigen binding portion thereof, or a soluble inactive form of IL-6 or its receptor.

12. The composition of claim 11 , wherein the agent is anti-IL-6.

Assignments (2)
CONFIRMATORY LICENSE Recorded Oct 18, 2012
From: UNIVERSITY OF COLORADO
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 029151/0023 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 1, 2012
From: BELLGRAU, DONALD; TAMBURINI, BETH
To: THE REGENTS OF THE UNIVERSITY OF COLORADO, A BODY CORPORATE
Reel/Frame 028137/0422 →
Continuity (4)
Provisional Application 61242355 · Sep 14, 2009
Provisional Application 61242353 · Sep 14, 2009
Provisional Application 61288568 · Dec 21, 2009
Related Publication 20120321664A1 · Dec 20, 2012