Claims for Patent: 6,248,332

Summary for Patent: 6,248,332

Title:	Targeted immunostimulation with bispecific reagents
Abstract:	Disclosed are methods of stimulating in a subject an immune response to an antigen to which the immune response is targeted. This method includes the step of administering to the subject a binding agent which binds a surface receptor of an antigen-presenting cell, in some instances without being blocked substantially by the natural ligand for the surface receptor, and an antigen to which the immune response is targeted, in a physiologically acceptable medium to the subject. Also disclosed are molecular complexes including the binding agent coupled to an antigen.
Inventor(s):	Romet-Lemonne; Jean Loup (Gif-sur-Yvette, FR), Fanger; Michael W. (Lebanon, NH), Guyre; Paul M. (Hanover, NH), Gosselin; Edmund J. (North Haverhill, NH)
Assignee:	Medarex, Inc. (Princeton, NJ)
Application Number:	08/249,669
Patent Claims:	1. A composition comprising: a pharmaceutically acceptable medium and a preformed molecular complex comprising: (a) an antigen; and (b) a binding agent having a first binding specificity which binds to said antigen and a second binding specificity which binds to Fc.gamma.RI on an antigen-presenting cell without being blocked by human immunoglobulin G. 2. The composition of claim 1, wherein the bispecific binding agent is a bispecific antibody. 3. The composition of claim 1, wherein the bispecific binding agent is chemically coupled to the antigen. 4. The composition of claim 1, wherein the antigen is selected from the group consisting of a virus, a bacterium, a parasite, an allergen, a venom and a tumor-associated antigen. 5. The composition of claim 4, wherein the antigen is a human immunodeficiency virus (HIV) antigen. 6. The composition of claim 4, wherein the antigen is a tumor associated antigen. 7. The composition of claim 4, wherein the antigen is a hepatitis virus antigen. 8. The composition of claim 1, wherein the antigen-presenting cell is a macrophage. 9. The composition of claim 1, wherein the binding agent comprises an antibody fragment. 10. The composition of claim 9, wherein the antibody fragment is selected from the group consisting of an Fab, an Fab', and an Fv fragment. 11. The composition of claim 9, wherein the binding agent comprises an Fab--Fab heteroantibody. 12. The composition of claim 1, wherein the molecular complex is produced recombinantly. 13. A composition comprising: (a) a binding agent, which binds to Fc.gamma.RI on an antigen-presenting cell without being blocked by human immunoglobulin, linked to (b) an antigen, wherein said composition is administered in a pharmacologically acceptable medium. 14. The composition of claim 13, wherein the antigen is covalently crosslinked to the binding agent. 15. The composition of claim 13, wherein the binding agent is an antibody, or an antigen binding fragment thereof. 16. The composition of claim 13, wherein the binding agent is a bispecific binding agent, having a binding affinity for the Fc receptor and for the antigen. 17. The composition of claim 16, wherein the binding agent is selected from the group consisting of a heteroantibody and a bispecific antibody. 18. The composition of claim 16, wherein the binding agent comprises: (i) a first antibody, or fragment thereof, which specifically binds the Fc receptor for immunoglobulin G (IgG) on the macrophage surface without being blocked by IgG; and (ii) a second antibody, or fragment thereof, which specifically binds the antigen. 19. The composition of claim 18, wherein the binding agent is selected from the group consisting of a heteroantibody and a bispecific antibody. 20. The composition of claim 16, wherein the binding agent comprises an Fab--Fab conjugate. 21. The composition of claim 13, wherein the antigen is selected from the group consisting of a viral antigen, a bacterial antigen, a parasitic antigen, an allergen, a venom, and a tumor-associated antigen. 22. The composition of claim 21, wherein the antigen is a surface antigen of a hepatitis virus. 23. The composition of claim 22, wherein the antigen is an envelope glycoprotein of the human immunodeficiency virus (HIV). 24. The composition of claim 22, wherein the antigen is a tumor cell antigen. 25. The composition of claim 13, wherein the antigen-presenting cell is a macrophage, a monocyte or a dendritic cell. 26. The composition of claim 13, wherein the complex comprises a fusion protein comprising the binding agent and the antigen. 27. The composition of claim 13, wherein the complex is produced recombinantly.

Details for Patent 6,248,332

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	07/27/2000		2018-06-19
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		2018-06-19
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		2018-06-19
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	02/07/2013		2018-06-19
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	09/17/2009		2018-06-19
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	02/06/2017		2018-06-19
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	03/04/2010		2018-06-19