Claims for Patent: 9,969,793

Summary for Patent: 9,969,793

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), Mond; James (Silver Spring, MD), Grossman; Jerrold B. (Saddle River, NJ), Goldstein; Dov A. (New York, NY)
Assignee:	ADMA Biologics, Inc. (Ramsey, NJ)
Application Number:	15/811,486
Patent Claims:	1. A method of treating a respiratory infection in 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 respiratory syncytial virus (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, coronavirus 229E, influenza A virus, influenza B virus, and metapneumovirus 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 respiratory infection is an upper respiratory tract infection. 3. The method of claim 1, wherein the respiratory infection is a lower respiratory tract infection. 4. The method of claim 1, wherein the respiratory infection is caused by RSV. 5. The method of claim 1, wherein the treating reduces viral load in the subject. 6. The method of claim 5, wherein the treating reduces the viral load in the lungs of the subject. 7. The method of claim 1, wherein the treating 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 subject has an immunodeficiency. 10. The method of claim 1, wherein the immunotherapeutic composition comprises neutralizing antibodies specific for Haemophilus influenza. 11. The method of claim 1, wherein the subject has a primary immunodeficiency disease (PIDD). 12. 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. 13. The method of claim 1, wherein the immunotherapeutic composition further comprises a recombinant monoclonal and/or polyclonal antibody specific for a respiratory pathogen. 14. The method of claim 13, wherein the respiratory pathogen is selected from the group consisting of respiratory syncytial virus, influenza A virus, influenza B virus, influenza C virus, parainfluenza virus type 1, parainfluenza virus type 2, rhinovirus, metapneumovirus, coronavirus, S. pneumonia, H. influenza, L. pneumophila, group A Streptococcus, Streptococcus mutans, B. gingivalis, S. pyogenes (group A), S. pneumoniae, K. pneumoniae, P. aeruginosa, S. aureus, M. pneumoniae.

Details for Patent 9,969,793

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		2037-11-13
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	March 26, 2007		2037-11-13
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	July 11, 2014		2037-11-13

International Patent Family for US Patent 9,969,793

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