Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection

11897,943

17/397915

August 09, 2021

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.

ADMA Biologics, Inc. (Ramsey, NJ, US)

ADMA BIOMANUFACTURING, LLC (Boca Raton, FL, US)

1. A method of treating an upper respiratory tract infection, the method comprising: administering to a subject a therapeutically effective amount of an immunotherapeutic composition comprising immune globulin prepared from pooled plasma samples from healthy adult human plasma donors vaccinated with a primary and a secondary anti-pneumococcal vaccine, wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group consisting of S. pneumonia serotypes 1, 2, 3, 4, 5, 6A, 6B, 7A, 7B, 7C, 7D, 7E, 7F, 8, 9A-9V, 12, 14, 18C, 19A-19F, 23A-23F, and 25, wherein the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes are each at least 3-fold higher than the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes present in a control sample, wherein the control sample is immune globulin prepared from plasma pooled from 500 or more random human plasma donors that have not been vaccinated with an anti-pneumococcal vaccine.

2. The method of claim 1 , wherein the method comprises therapeutically treating the upper respiratory tract infection.

3. The method of claim 1 , wherein the method comprises prophylactically treating the upper respiratory tract infection.

4. The method of claim 1 , wherein the method further comprises administrating one or more biologically active agents.

5. The method of claim 4 , wherein the one or more biologically active agents is selected from the group consisting of antibodies, anti-toxin material, anti-inflammatory agents, anti-cancer agents, antimicrobial agents, therapeutic agents, antihistamines, cytokines, chemokines, and vitamins.

6. The method of claim 1 , wherein the immunotherapeutic composition further comprises a mono-specific, bi-specific or multi-specific antibody with specificity toward a bacterial or fungal toxin.

7. The method of claim 6 , 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.

8. The method of claim 1 , wherein the immunotherapeutic composition comprises neutralizing antibodies specific for one or more of Corynebacterium diphtheria , measles virus, polio virus, and Haemophilus influenza.

9. 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.

10. The method of claim 1 , wherein the subject has a primary immunodeficiency disease (PIDD).

11. The method of claim 1 , wherein the immunogenic composition treats or prevents the upper respiratory tract infection in the subject.

12. The method of claim 1 , wherein the upper respiratory tract infection is caused by S. pneumonia.

13. The method of claim 1 , wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group of S. pneumonia serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

14. The method of claim 13 , wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group of S. pneumonia serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, wherein the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes are each at least 5-fold higher than the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes present in the control sample.

15. The method of claim 13 , wherein the pooled plasma contains opsonophagocytic antibody titers specific for at least 7 or more S. pneumonia serotypes selected from the group of S. pneumonia serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, wherein the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes are each at least 10-fold higher than the opsonophagocytic antibody titers specific for the 7 or more S. pneumonia serotypes present in the control sample.

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