# US 10,441,584 B2 · Methods of enhancing immune response

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- Number: US 10,441,584 B2
- Document ID: US10441584B2
- Status: Granted
- Kind: B2
- Application number: 15/821,229
- Filed: 2017-11-22
- Published: 2018-06-14
- Granted: 2019-10-15
- Earliest claimed: 2016-11-23
- Assignees: Novartis AG
- Applicants: Novartis AG
- Inventors: Joan Mannick; Melody Morris
- Web page: https://patentgrep.com/patent/US10441584B2

## CPC

- A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48)
- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/02: of urine or of the urinary tract, e.g. urine acidifiers
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/12: Antivirals
- A61P 31/16: for influenza or rhinoviruses
- 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

## Abstract

The present invention relates to a method of enhancing immune response in a subject.

## Claims

### Claim 1

A method comprising the step of administering daily as a monotherapy about 8-12 mg of BEZ235 or a pharmaceutically acceptable salt thereof to a patient, wherein the patient experiences fewer illnesses due to respiratory tract infection than a patient not administered BEZ235 or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the patient's innate immunity is enhanced.

### Claim 3 (depends on 2)

The method according to claim 2, wherein antigen-specific immunity is not enhanced.

### Claim 4 (depends on 2)

The method according to claim 2, wherein at least one interferon-inducing gene (ISG) is upregulated.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the respiratory tract infection is a viral respiratory tract infection.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the patient is elderly.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the patient is at least 65 years old.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the patient is at least 75 years old.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the patient is at least 85 years old.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the BEZ235 or a pharmaceutically acceptable salt thereof, is administered to the patient for up to about 6 consecutive weeks.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the patient continues to experience fewer illnesses due to respiratory tract infection from about 1 day until about 1 year after the administration of the BEZ235 or a pharmaceutically acceptable salt thereof.

### Claim 12 (depends on 10)

The method according to claim 10, wherein the patient continues to experience fewer illnesses due to respiratory tract infection for at least 1 month and until about 1 year after the administration of the BEZ235 or a pharmaceutically acceptable salt thereof.

### Claim 13 (depends on 10)

The method according to claim 10, wherein the patient continues to experience fewer illnesses due to respiratory tract infection for at least 3 months and until about 1 year after the administration of the BEZ235 or a pharmaceutically acceptable salt thereof.

### Claim 14 (depends on 10)

The method according to claim 10, wherein the patient continues to experience fewer illnesses due to respiratory tract infection for at least 6 months after the administration of the BEZ235 or a pharmaceutically acceptable salt thereof.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the pharmacokinetic AUC variability of patients receiving the BEZ235 or a pharmaceutically acceptable salt thereof is lower than a patient receiving a higher dose of BEZ235 or a pharmaceutically acceptable salt thereof.

### Claim 16 (depends on 1)

The method according to claim 1, wherein BEZ235 or a pharmaceutically acceptable salt thereof is the monotosylate salt.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the subject is immunocompromised.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the subject has an impaired immune response.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the subject is immunosenescent.

### Claim 20 (depends on 1)

The method according to claim 1, wherein the BEZ235 or a pharmaceutically acceptable salt thereof is administered daily to the patient for up to about 16 consecutive weeks.

### Claim 21 (depends on 1)

The method according to claim 1, wherein the BEZ235 or a pharmaceutically acceptable salt thereof is administered daily to the patient for up to about 24 consecutive weeks.

### Claim 22 (depends on 1)

The method according to claim 1, wherein about 9-11 mg of BEZ235 or a pharmaceutically acceptable salt thereof is administered daily.

### Claim 23 (depends on 22)

The method according to claim 22, wherein about 10 mg of BEZ235 or a pharmaceutically acceptable salt thereof is administered daily.
