Claims for Patent: 9,815,886

Summary for Patent: 9,815,886

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:	14/592,727
Patent Claims:	1. An immunotherapeutic composition comprising: A) immune globulin prepared from a pooled plasma composition comprising plasma samples obtained 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, 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 immunotherapeutic composition of claim 1, wherein the pooled plasma composition comprises antibody titers for two 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 are each at least 1.5 times greater than the antibody titers in the control sample. 3. The immunotherapeutic composition of claim 1, wherein the pooled plasma composition comprises neutralizing antibodies specific for Corynebacterium diphtheria, measles virus, and polio virus. 4. The immunotherapeutic composition of claim 1, wherein the pooled plasma composition comprises plasma samples obtained from 1000-1100 human plasma donors. 5. The immunotherapeutic composition of claim 1, wherein the pooled plasma composition possesses a protective antibody titer for one or more of measles, polio and diphtheria. 6. The immunotherapeutic composition of claim 1, further comprising C) an anti-toxin agent. 7. The immunotherapeutic composition of claim 6, wherein the anti-toxin agent is a mono-specific, bi-specific or multi-specific antibody with specificity toward a bacterial or fungal toxin. 8. The immunotherapeutic composition of claim 7, 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. 9. 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. 10. The immunotherapeutic composition of claim 9, wherein the pooled plasma composition comprises neutralizing antibodies specific for Corynebacterium diphtheria, measles virus, and polio virus. 11. The immunotherapeutic composition of claim 9, wherein the pooled plasma composition possesses a protective antibody titer for one or more of measles, polio and diphtheria. 12. The immunotherapeutic composition of claim 9, further comprising C) an anti-toxin agent. 13. The immunotherapeutic composition of claim 12, wherein the anti-toxin agent is a mono-specific, bi-specific or multi-specific antibody with specificity toward a bacterial or fungal toxin. 14. The immunotherapeutic composition of claim 13, 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. 15. 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. 16. The immunotherapeutic composition of claim 15, wherein the pooled plasma composition comprises neutralizing antibodies specific for Corynebacterium diphtheria, measles virus, and polio virus. 17. The immunotherapeutic composition of claim 15, wherein the pooled plasma composition possesses a protective antibody titer for one or more of measles, polio and diphtheria. 18. The immunotherapeutic composition of claim 15, further comprising C) an anti-toxin agent. 19. The immunotherapeutic composition of claim 18, wherein the anti-toxin agent is a mono-specific, bi-specific or multi-specific antibody with specificity toward a bacterial or fungal toxin. 20. The immunotherapeutic composition of claim 19, 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.

Details for Patent 9,815,886

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Adma Biologics, Inc.	NABI-HB	hepatitis b immune globulin (human)	Injection	103945	October 23, 2001		2035-01-08
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	May 21, 2004		2035-01-08
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	March 26, 2007		2035-01-08
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	July 11, 2014		2035-01-08

International Patent Family for US Patent 9,815,886

Country	Patent Number	Estimated Expiration
South Africa	201707303
World Intellectual Property Organization (WIPO)	2016069693
United States of America	9969793
United States of America	9714283