# US 2025/0018012 A1 · Bioactive peptides and methods of use thereof

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- Number: US 2025/0018012 A1
- Document ID: US20250018012A1
- Status: Published application
- Kind: A1
- Application number: 18/746,393
- Filed: 2024-06-18
- Published: 2025-01-16
- Earliest claimed: 2020-04-17
- Assignees: Op-T LLC
- Applicants: Op-T LLC
- Inventors: David H. Wagner, JR.; Gisela M. Vaitaitis; Charles W. Henry; Martin Glenn Yussman
- Web page: https://patentgrep.com/patent/US20250018012A1

## CPC

- A61K 38/07: Tetrapeptides
- A61K 38/191: {Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta}
- A61K 38/08: Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 38/10: Peptides having 12 to 20 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 38/177: {Receptors; Cell surface antigens; Cell surface determinants}
- A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
- A61K 47/6811: {the drug being a protein or peptide, e.g. transferrin or bleomycin}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/14: for RNA viruses
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C07K 14/70575: {NGF/TNF-superfamily, e.g. CD70, CD95L, CD153, CD154 (NGF C07K14/48, TNF C07K14/525)}
- C07K 14/70578: {NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95 (NGF-receptor C07K14/71, TNF-receptor C07K14/7151)}
- C07K 19/00: Hybrid peptides {, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes}
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- 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
- 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)

## Abstract

Methods and compositions are disclosed for treating and preventing cytokine release syndrome (CRS). acute respiratory distress syndrome (CRS), and alveolar capillary injury (ACI) in a subject.

## Claims

### Claim at position 1

-50. (canceled)

### Claim 51

A method of treating cytokine release syndrome (CRS), the method comprising administering to a subject having CRS an effective amount of a peptide that alters or modulates the binding or interaction between CD40 complex and CD 154 proteins, wherein the peptide comprises SEQ ID NO: 4.

### Claim 52 (depends on 51)

The method of claim 51, wherein the peptide binds to CD40 complex.

### Claim 53 (depends on 51)

The method of claim 51, wherein the peptide disrupts or alters the interaction of CD40 complex with CD154 and reduces the number of Th40 cells in the subject.

### Claim 54 (depends on 51)

The method of claim 51, wherein the peptide comprises SEQ ID NO: 7.

### Claim 55 (depends on 51)

The method of claim 51, wherein administration of the peptide decreases an amount of inflammatory cytokine selected from the group of IL-2, IFNγ, IL-6, TNFγ, TGF, and IL-17A, and/or increases an amount of IL-10.

### Claim 56 (depends on 51)

The method of claim 51, wherein the peptide comprises a modification selected from phosphorylation, glycosylation, acetylation on the N-terminus and/or amidation on the C-terminus.

### Claim 57 (depends on 51)

The method of claim 51, wherein the peptide is linked to a polyethylene glycol (PEG) molecule.

### Claim 58 (depends on 51)

The method of claim 51, wherein the peptide is linked to one or more domains of an Fc region of human IgG immunoglobin.

### Claim 59 (depends on 58)

The method of claim 58, wherein the Fc region is human IgG hinge, CH2, CH3 region that is fused to at least one of the amino-terminus or carboxyl-terminus of the peptide.

### Claim 60 (depends on 51)

The method of claim 51, wherein the peptide is administered to the lungs of the subject.

### Claim 61 (depends on 51)

The method of claim 51, wherein the peptide is linked to an epitope tag polypeptide comprising between 6 and 50 amino acid residues.

### Claim 62 (depends on 51)

The method of claim 51, wherein the peptide is constructed by chemical means.

### Claim 63

A method of treating acute respiratory distress syndrome (ARDS), the method comprising administering to a subject having ARDS an effective amount of a peptide that alters or modulates the binding or interaction between CD40 complex and CD 154 proteins, wherein the peptide comprises SEQ ID NO: 4.

### Claim 64

A method of treating acute lung injury (ALI), the method comprising administering to a subject having ALI an effective amount of a peptide that alters or modulates the binding or interaction between CD40 complex and CD 154 proteins, wherein the peptide comprises SEQ ID NO: 4.
