Claims for Patent: 10,259,865

Summary for Patent: 10,259,865

Title:	Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection
Abstract:	The present invention relates to compositions and methods for the treatment of infection caused by Streptococcus pneumonia. In particular, the invention provides human hyperimmune globulin and compositions thereof for preventing or treating pneumococcal infection. The invention provides methods of producing hyperimmune globulin containing high titers of opsonophagocytic anti-pneumococcal antibodies, compositions containing same, and methods of using the compositions for the prevention and treatment of pneumococcal infection. The invention further provides methods of preventing or treating pneumococcal infection (e.g., upper respiratory infections (e.g., bronchitis, otitis, sinusitis, etc.)) in immunocompromised subjects via administration of hyperimmune globulin compositions of the invention (e.g., containing a high titer of opsonophagocytic anti-pneumococcal antibodies) to immunocompromised subjects.
Inventor(s):	Mond; James (Silver Spring, MD), Grossman; Adam S. (Saddle River, NJ)
Assignee:	ADMA Biologics, Inc. (Ramsey, NJ)
Application Number:	15/460,147
Patent Claims:	1. A method for preparing an immune globulin having elevated opsonophagocytic antibody titers for 50% or more Streptococcus pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F comprising the steps of: (a) immunizing healthy adult human plasma donors between the ages of 18-60 with a primary immunization with a multivalent S. pneumonia conjugate vaccine followed by a secondary immunization with a multivalent S. pneumonia polysaccharide vaccine; (b) harvesting plasma from the immunized plasma donors subsequent to the secondary immunization; (c) pooling the plasma harvested according to step (b) in order to obtain a pooled plasma containing elevated opsonophagocytic antibody titers specific for 50% or more S. pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, wherein each of the elevated opsonophagocytic antibody titers is three-fold or higher than the opsonophagocytic antibody titer specific for each S. pneumonia serotype present in a control sample, wherein the control sample is immune globulin prepared from plasma pooled from 500 or more random non-immunized human plasma donors; and (d) preparing immune globulin from the plasma pooled according to step (c). 2. The method of claim 1, further comprising the step (e) rendering the immune globulin obtained according to step (d) intravenously injectable. 3. The method of claim 2, wherein the immune globulin is provided in solution and the pH and ionic strength of the solution is adjusted so as to render it intravenously injectable. 4. An immune globulin prepared according to the method of claim 1. 5. A method of treating S. pneumonia infection in a subject comprising administering to the subject a therapeutically effective amount of an immune globulin prepared according to the method of claim 1. 6. A method of providing immunotherapy to a subject comprising administering to the subject a therapeutically effective amount of an immune globulin prepared according to the method of claim 1. 7. The method of claim 1, wherein the pooled plasma of step (c) contains elevated opsonophagocytic antibody titers specific for 50% or more S. pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F that are five-fold or higher than the opsonophagocytic antibody titer specific for each S. pneumonia serotype present in the control sample. 8. The method of claim 1, wherein the pooled plasma of step (c) contains elevated opsonophagocytic antibody titers specific for 50% or more S. pneumonia serotypes selected from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F that are ten-fold or higher than the opsonophagocytic antibody titer specific for each S. pneumonia serotype present in the control sample.

Details for Patent 10,259,865

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	05/21/2004		2040-01-30
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	03/26/2007		2040-01-30
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	07/11/2014		2040-01-30