Granted Patent
B2
US 12,612,450 · App. 18/438,693 · Granted Apr 28, 2026
Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection
Assignee:
ADMA BIOMANUFACTURING, LLC
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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.
Claims (21)
1 . A method of treating pneumococcal infection in a subject comprising administering to the subject a therapeutically effective amount of an immunotherapeutic composition comprising:
A) 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 samples are screened for one or more pathogens, and 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; and
B) a pharmaceutically acceptable carrier.
2 . The method of claim 1 , wherein the samples are screened for the one or more pathogens prior to pooling.
3 . The method of claim 1 , wherein the samples are screened for the one or more pathogens after pooling of the samples.
4 . The method of claim 1 , wherein the treating pneumococcal infection comprises therapeutically treating the pneumococcal infection.
5 . The method of claim 1 , wherein the treating pneumococcal infection comprises prophylactically treating the pneumococcal infection.
6 . The method of claim 1 , wherein the samples are screened for the one or more pathogens using nucleic acid testing.
7 . The method of claim 1 , wherein the samples are screened for the one or more pathogens using a serological test.
8 . The method of claim 1 , wherein the immunotherapeutic composition is administered to the subject via intravenous administration.
9 . The method of claim 1 , wherein the immunotherapeutic composition further comprises neutralizing antibodies specific for one or more of Corynebacterium diphtheria , measles virus, polio virus, and Haemophilus influenza.
10 . The method of claim 9 , wherein the immunotherapeutic composition is used to treat infection caused by S. pneumonia, Corynebacterium diphtheria , measles virus, and/or polio virus.
11 . 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.
12 . The method of claim 11 , 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.
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, 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.
14 . The method of claim 1 , wherein the immunotherapeutic composition further comprises a recombinant antibody, synthetic antibody, monoclonal antibody, polyclonal antibody, bi-specific antibody, or multi-specific antibody.
15 . The method of claim 14 , wherein the mono-specific, bi-specific or multi-specific antibody has specificity toward a bacterial or fungal toxin 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.
16 . 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.
17 . The method of claim 1 , wherein the subject has a primary immunodeficiency disease.
18 . The method of claim 1 , wherein the method further comprises administrating one or more biologically active agents.
19 . The method of claim 18 , 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.
Assignments (3)
SECURITY INTEREST
Recorded Aug 5, 2025
From: ADMA BIOMANUFACTURING, LLC; ADMA BIOLOGICS, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 071930/0600 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 28, 2024
From: MOND, JAMES; GROSSMAN, ADAM S.
To: ADMA BIOLOGICS, INC.
Reel/Frame 066934/0506 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 28, 2024
From: ADMA BIOLOGICS, INC.
To: ADMA BIOMANUFACTURING, LLC
Reel/Frame 066934/0566 →
Continuity (4)
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