# US 11,897,943 B2 · Anti-pneumococcal hyperimmune globulin for the treatment and prevention of pneumococcal infection

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- Number: US 11,897,943 B2
- Document ID: US11897943B2
- Status: Granted
- Kind: B2
- Application number: 17/397,915
- Filed: 2021-08-09
- Published: 2022-01-27
- Granted: 2024-02-13
- Earliest claimed: 2017-03-15
- Assignees: Adma Biomanufacturing, LLC
- Applicants: ADMA Biologics, Inc.
- Inventors: James Mond; Adam S. Grossman
- Web page: https://patentgrep.com/patent/US11897943B2

## CPC

- C07K 16/1275: Streptococcus (G)
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 35/16: Blood plasma; Blood serum (umbilical cord blood A61K35/51)
- A61P 31/04: Antibacterial agents
- C07K 16/06: from serum
- C07K 16/065: {Purification, fragmentation}
- C07K 2317/10: characterized by their source of isolation or production
- C07K 2317/21: from primates, e.g. man
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 4)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 13)

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.

### Claim 15 (depends on 13)

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.