# US 9,872,831 B2 · Pharmaceutical composition of oxidised avidin suitable for inhalation

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- Number: US 9,872,831 B2
- Document ID: US9872831B2
- Status: Granted
- Kind: B2
- Application number: 14/236,445
- Filed: 2012-07-25
- Published: 2014-05-15
- Granted: 2018-01-23
- Earliest claimed: 2011-08-02
- Assignees: Alfasigma S.P.A.
- Applicants: Rita De Santis
- Inventors: Rita De Santis
- Web page: https://patentgrep.com/patent/US9872831B2

## CPC

- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- A61K 38/1703: {from vertebrates}
- A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34)
- A61K 47/665: {the pre-targeting system, clearing therapy or rescue therapy involving biotin-(strept) avidin systems}
- A61K 51/0453: {having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole}
- 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 35/00: Antineoplastic agents
- B82Y 5/00: Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
- 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
- B82Y: SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES

## Abstract

The present invention describes oxidized avidin, suitable for inhalation, for conditioning the lung affected by inoperable/diffuse diseases, enabling the targeted delivery of biotinylated therapeutic agents to it.

## Claims

### Claim 1

A method for treating a lung cancer disease comprising:
administering to a patient in need thereof an effective amount of oxidized avidin via nebulization and inhalation of a pharmaceutical inhalable formulation comprising oxidized avidin, a sterile buffer solution comprising sodium acetate at pH of from 5.0 to 6.9, and a non-ionic agent selected from the group consisting of mannitol, glycerol, glucose, lactose, trehalose, sucrose, propylene-glycol, sorbitol, xylitol, polyethylene-glycol, ethanol and isopropanol, wherein the oxidized avidin is at a concentration of from 0.005% to about 0.5% (w/v), and thereafter
administering to the patient a biotinylated therapeutic agent selected from the group consisting of radioactive agents, monoclonal antibodies, cytokines, chemokines, enzymes, chemotherapeutics, viral or plasmid vectors and cells.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the biotinylated therapeutic agent is a biotinylated derivative of a monoclonal antibody selected from the group consisting of anti-EGFR, anti-CEA, anti-MUC1, anti-EpCAM, anti-cMET, anti-CTL4, anti-TNF, anti-Tweak, anti-IL-17, anti-IL-23, anti-IL-6, and anti-IL-1.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the biotinylated therapeutic agent is a biotinylated adduct of a cytokine selected from the group consisting of TNF, Tweak, TRAIL, gamma interferon, G-CSF, GM-CSF, IL-2, and IL-12.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the biotinylated therapeutic agent is a biotinylated adduct of a chemokine selected from the group consisting of CXC and CC chemokine families.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the biotinylated therapeutic agent is biotin-DOTA labelled with a radioisotope selected from the group consisting of 52Fe, 52mMn, 55Co, 64Cu, 67Cu, 67Ga, 68Ga, 99mTc, 111In, 123I, 125I, 131I, 32P, 47Sc, 90Y, 109Pd, 111Ag, 149Pm, 186Re, 188Re, 211At, 212Pb, 212Bi and 177Lu.

### Claim 6

A kit comprising a pharmaceutical inhalable formulation contained in a nebulizer and comprising oxidized avidin, a sterile buffer solution comprising sodium acetate at pH of from 5.0 to 6.9, and a non-ionic agent selected from the group consisting of mannitol, glycerol, glucose, lactose, trehalose, sucrose, propylene-glycol, sorbitol, xylitol, polyethylene-glycol, ethanol, and isopropanol, wherein the oxidized avidin is at a concentration of from 0.005% to about 0.5% (w/v).