Claims for Patent: 8,999,398

Summary for Patent: 8,999,398

Title:	Polyclonal bispecific antibody compositions and method of use
Abstract:	The invention relates to compositions and methods for treating a host infected with a pathogen. The composition comprising a population of polyclonal bispecific binding molecules that can target and eliminate a host cell infected with the pathogen. Methods for activating and arming cytotoxic immune cells with the composition for use in treating a patient infected with a pathogen are also provided.
Inventor(s):	Lum; Lawrence (Harrison Township, MI), Huang; Manley (Palo Alto, CA)
Assignee:	TransTarget Inc. (Burlingame, CA) Wayne State University (Detroit, MI)
Application Number:	13/508,182
Patent Claims:	1. A method for treating a patient infected with a pathogen, the method comprising: a) obtaining a sample of blood mononuclear cells comprising T-cells from a donor; b) activating one or more of the T-cells ex vivo by stimulating the T-cells with soluble anti-CD3 antibody and culture of the T-cells in the presence of T-cell growth factors 10 IU/ml to 500 IU/ml IL-2, or in the presence of 25 to 100 ng/ml IL-7 and 25 to 100 ng/ml IL-15; c) arming the activated T-cells with a heterogeneous population of polyclonal bispecific binding molecules where each bispecific binding molecule comprises a first and a second antigen binding moiety, wherein the first antigen binding moieties specifically bind to an antigen on the surface of a cytotoxic immune cell, said first antigen binding moieties being the same or different, and wherein the second antigen binding moieties are a heterogeneous polyclonal population of antigen binding moieties against multiple different epitopes on one or more pathogenic antigens expressed or presented on the surface of a cell infected with the pathogen, said antigens being the same or different, wherein the first antigen binding moiety is fused to the second antigen binding moiety to form the bispecific binding molecule, and d) administering the armed T-cells to the patient infected with the pathogen. 2. The method of claim 1, wherein the T-cell growth factors comprise IL-2, IL-7, and IL-15, present at a concentration of 10 IU/ml to 500 IU/ml for IL-2, 25-100 ng/ml for IL-7, and 25-100 ng/ml for IL-15. 3. The method of claim 1, wherein the first binding moiety and the second binding moiety are antibodies or antigen binding fragments thereof. 4. The method of claim 1, wherein the first binding moiety is a monoclonal antibody or antigen binding fragment thereof and the second binding moiety comprises a population of polyclonal antibodies or an antigen binding fragments thereof. 5. The method of claim 4, wherein the population of polyclonal bispecific binding molecules comprises at least two different polyclonal antibodies as second antigen binding moieties with each antibody having a different antigen recognition specificity and being directed to different epitopes on the pathogen. 6. The method of claim 4, wherein the population of polyclonal antibodies is derived from an immunoglobulin enriched serum fraction. 7. The method of claim 6, wherein the IgG serum fraction is depleted of antibodies that recognize human leukocyte antigen (HLA) molecules. 8. The method of claim 4, wherein the polyclonal antibody is derived from an autologous donor. 9. The method of claim 4, wherein the polyclonal antibody is derived from an allogeneic donor or a pool of allogeneic donors. 10. The method of claim 1, wherein the activated T-cell is derived from an autologous donor. 11. The method of claim 1, wherein the activated T cell is derived from an allogeneic donor or a pool of allogeneic donors. 12. The method of claim 1, wherein the first antigen binding moiety specifically binds to a molecule selected from the group consisting of CD2, CD3, CD4, CD5, CD8, CD11b, CD14, CD16a, CD28, CD45 and CD56. 13. The method of claim 12, wherein the first binding moiety is an anti-CD3 antibody, or functional equivalent, or antigen binding fragment thereof. 14. The method of claim 13, wherein the anti-CD3 antibody is OKT3 or a functional equivalent. 15. The method of claim 1, wherein the arming dose of the population of polyclonal bispecific binding molecules is in the range of 0.001 ng to 100 ng per 10.sup.6 activated T cells. 16. The method of claim 1, wherein the pathogen is selected from the group consisting of a virus, a bacterium, a fungus, and a parasite. 17. The method of claim 1, wherein the population of second antigen binding moieties is derived from CYTOGAM.

Details for Patent 8,999,398

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Saol Therapeutics Research Limited	CYTOGAM	cytomegalovirus immune globulin intravenous (human)	Injection	103189	04/17/1990		2029-11-06