Claims for Patent: 9,714,283

Summary for Patent: 9,714,283

Title:	Compositions and methods for the treatment of immunodeficiency
Abstract:	The present invention relates to compositions and methods for the treatment of immunodeficiency (e.g., primary immunodeficiency disease). In particular, the invention provides human plasma immunoglobulin compositions containing select antibody titers specific for a plurality of respiratory pathogens, methods of identifying human donors and donor samples for use in the compositions, methods of manufacturing the compositions, and methods of utilizing the compositions (e.g., for prophylactic administration and/or therapeutic treatment (e.g., passive immunization (e.g., immune-prophylaxis))).
Inventor(s):	Grossman; Adam S. (Saddle River, NJ), Grossman; Jerrold B. (Saddle River, NJ), Mond; James (Silver Spring, MD), Goldstein; Dov A. (New York, NY)
Assignee:	ADMA BIOLOGICS, INC. (Ramsey, NJ)
Application Number:	14/790,872
Patent Claims:	1. A method of providing immunotherapy to a subject comprising administering to the subject a therapeutically effective amount of an immunotherapeutic composition comprising: A) immune globulin prepared from a pooled plasma composition comprising plasma samples from 1000 or more human plasma donors, wherein the pooled plasma composition has a final RSV neutralization titer of at least 1800, and an antibody titer for one or more respiratory pathogens selected from parainfluenza virus 1, parainfluenza virus 2, coronavirus OC43 and coronavirus 229E that is at least 1.5 times greater than the antibody titer in a control sample, wherein the control sample is a mixture of plasma samples obtained from 1000 or more random human plasma donors, and wherein less than 50% of the donor plasma samples used for pooling are from donors with a final RSV neutralization titer of at least 1800; and B) a pharmaceutically acceptable carrier. 2. The method of claim 1, wherein the subject has an immunodeficiency. 3. The method of claim 1, wherein the subject has a primary immunodeficiency disease (PIDD). 4. The method of claim 1, wherein the subject is selected from the group consisting of an end stage renal disease (ESRD) patient, a patient on immunosuppressive therapy, an AIDS patient, a diabetic patient, a neonate, a transplant patient, a patient with malfunctioning immune system, an elderly person, a patient with autoimmune disease, a burn patient, a cancer patient, and a patient in an acute care setting. 5. The method of claim 1, wherein the immunotherapy reduces viral load in the lungs of the subject. 6. The method of claim 1, wherein the immunotherapy reduces lung histopathology in the subject. 7. The method of claim 1, wherein the immunotherapy reduces the level of pathogenic viral RNA in an organ of the subject. 8. The method of claim 7, wherein the organ is selected from the lungs, liver and kidneys. 9. The method of claim 1, wherein the immunotherapy is used to treat infection in the subject. 10. The method of claim 9, wherein the infection is caused by a pathogen selected from the group consisting of respiratory syncytial virus (RSV), parainfluenza virus 1, parainfluenza virus 2, coronavirus OC43, coronavirus 229E, influenza A virus, influenza B virus, and metapneumovirus. 11. The method of claim 1, wherein the immunotherapeutic composition further comprises an anti-toxin agent. 12. The method of claim 11, wherein the anti-toxin agent is a mono-specific, bi-specific or multi-specific antibody with specificity toward a bacterial or fungal toxin. 13. The method of claim 12, wherein the bacterial or fungal toxin is selected from the group consisting of Botulinum neurotoxin, Tetanus toxin, E. coli toxin, Clostridium difficile toxin, Vibrio RTX toxin, Staphylococcal toxins, Cyanobacteria toxin, and mycotoxins. 14. The method of claim 1, wherein the immunotherapeutic composition comprises neutralizing antibodies specific for Corynebacterium diphtheria. 15. The method of claim 1, wherein the immunotherapeutic composition comprises neutralizing antibodies specific for measles virus. 16. The method of claim 1, wherein the immunotherapeutic composition comprises neutralizing antibodies specific for polio virus. 17. The method of claim 1, wherein the immunotherapeutic composition comprises neutralizing antibodies specific for Haemophilus influenza. 18. The method of claim 1, wherein the immunotherapeutic composition comprises neutralizing antibodies specific for Streptococcus pneumonia. 19. The method of claim 1, wherein the immunotherapeutic composition comprises neutralizing antibodies specific for Corynebacterium diphtheria, measles virus, polio virus, Haemophilus influenza and Streptococcus pneumonia. 20. The method of claim 1, wherein only 30-45% of the donor plasma samples used for pooling are from donors with a final RSV neutralization titer of at least 1800. 21. A method of providing immunotherapy to a subject comprising administering to the subject a therapeutically effective amount of an immunotherapeutic composition comprising: A) immune globulin prepared from a pooled plasma composition comprising plasma samples from 1000 or more human plasma donors, wherein the pooled plasma composition has a final RSV neutralization titer of at least 1800, and an antibody titer for parainfluenza virus 1 and/or parainfluenza virus 2 that is at least 1.5 times greater than the antibody titer in a control sample, wherein the control sample is a mixture of plasma samples obtained from 1000 or more random human plasma donors, and wherein less than 50% of the donor plasma samples used for pooling are from donors with a final RSV neutralization titer of at least 1800; and B) a pharmaceutically acceptable carrier. 22. A method of providing immunotherapy to a subject comprising administering to the subject a therapeutically effective amount of an immunotherapeutic composition comprising: A) immune globulin prepared from a pooled plasma composition comprising plasma samples from 1000 or more human plasma donors, wherein the pooled plasma composition has a final RSV neutralization titer of at least 1800, and an antibody titer for coronavirus OC43 and/or coronavirus 229E that is at least 1.5 times greater than the antibody titer in a control sample, wherein the control sample is a mixture of plasma samples obtained from 1000 or more random human plasma donors, and wherein less than 50% of the donor plasma samples used for pooling are from donors with a final RSV neutralization titer of at least 1800; and B) a pharmaceutically acceptable carrier.

Details for Patent 9,714,283

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	May 21, 2004	9,714,283	2035-07-02
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	March 26, 2007	9,714,283	2035-07-02
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	July 11, 2014	9,714,283	2035-07-02
Adma Biologics, Inc.	BIVIGAM	immune globulin intravenous (human)	Injection	125389	December 19, 2012	9,714,283	2035-07-02

International Patent Family for US Patent 9,714,283

Country	Patent Number	Estimated Expiration
South Africa	201707303
World Intellectual Property Organization (WIPO)	2016069693
United States of America	9969793
United States of America	9815886
United States of America	9107906
United States of America	2024043503
United States of America	2022403008