# US 12,178,911 B2 · Dry powder formulations of thymic stromal lymphopoietin (TSLP)-binding antibodies and methods of use thereof

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- Number: US 12,178,911 B2
- Document ID: US12178911B2
- Status: Granted
- Kind: B2
- Application number: 18/053,941
- Filed: 2022-11-09
- Published: 2023-06-29
- Granted: 2024-12-31
- Earliest claimed: 2019-10-28
- Assignees: MedImmune, LLC
- Applicants: Medimmune Limited
- Inventors: Catherine Eugenie Chaillan Huntington; Susan Hoe; Prakash Manikwar; Roland Wilhelm Kolbeck; Emma Suzanne Cohen; David Lechuga-Ballesteros; Kellisa Beth Hansen; Dexter Joseph D'sa; Saba Ghazvini
- Web page: https://patentgrep.com/patent/US12178911B2

## CPC

- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61K 9/145: {with organic compounds}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 39/39591: {Stabilisation, fragmentation}
- A61P 11/06: Antiasthmatics
- C07K 16/244: {Interleukins [IL]}
- A61K 2039/505: {comprising antibodies}
- A61K 2039/543: {intranasal}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/22: from camelids, e.g. camel, llama or dromedary
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/55: Fab or Fab'
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- 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

The present technology relates generally to dry powder formulations of antibodies specific for thymic stromal lymphopoietin (TSLP), as well as methods of treating asthma, using the dry powder formulations, suitably via pulmonary delivery.

## Claims

### Claim 1

An antigen binding fragment of an anti-TSLP antibody comprising a heavy chain having the sequence set forth in SEQ ID NO:28 and a light chain having the sequence set forth in SEQ ID NO:29, wherein the antigen binding fragment is a Fab derived from IgG1.

### Claim 2 (depends on 1)

The antigen binding fragment of claim 1, wherein the heavy chain is encoded by the nucleotide sequence set forth in SEQ ID NO: 30 and the light chain is encoded by the nucleotide sequence set forth in SEQ ID NO: 31.

### Claim 3 (depends on 1)

The antigen binding fragment of claim 1, wherein the antigen binding fragment is stable at 5° C. over a three-month period.

### Claim 4 (depends on 1)

The antigen binding fragment of claim 1, wherein the antigen binding fragment is stable at 40° C. over a one-month period.

### Claim 5 (depends on 1)

The antigen binding fragment of claim 1, wherein the antigen binding fragment binds human TSLP with a picomolar affinity KD.