IP Library Patent Application 12921890
Patent Application
App. No. 12/921,890

HIGH THROUGHPUT PROTEIN INTERACTION ASSAY

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Patent No.
US None
App. No.
12/921,890
Abstract

A method to identify small molecules useful as therapeutics and/or vaccines to prevent, alleviate or ameliorate a pathogenic infection or an autoimmune disorder. The method can be used to screen small molecule test compounds for the ability to disrupt particular antigen-antibody interactions of interest. In one embodiment, the antigen is a pathogen-derived antigen and the antibody decreases or inhibits virulence of the pathogen when bound to the antigen (e.g., a neutralizing antibody, antibody with serum bactericidal activity, etc.). In another embodiment, the antigen is a self-antigen (autoantigen) and the antibody is an autoantibody that is known to be associated with a pathological condition (e.g., autoimmune disorder). Compounds that bind to the antigen or antibody disrupt binding can be used as therapeutics to decrease or inhibit the autoimmune disorder.

Claims (172)

1 . A method of identifying a small molecule mimotope of a pathogen-derived antigen comprising:

a) combining the following components

i) an antibody that binds to the antigen;

ii) the pathogen-derived antigen or a fragment or conformational mimetic thereof wherein said fragment or conformational mimetic has a conformation that is substantially similar to that of the antigen such that the antibody binds to the fragment or conformational mimetic; and

iii) a small molecule test compound;

b) incubating the components under conditions which allow components i and ii to bind;

c) measuring the amount of binding between components i and ii, wherein a decrease in binding between components i and ii in the presence of the test compound as compared to in the absence of the test compound indicates the test compound binds to component i or ii and is a candidate compound;

d) determining to which component the candidate compound binds,

wherein binding to the antibody indicates that the candidate compound is a mimotope of the pathogen-derived antigen.

2 . The method of claim 1 , wherein binding of the antibody to the pathogen decreases or inhibits virulence of the pathogen.

3 . The method of claim 1 , wherein the antigen is a fragment or conformational mimetic of the pathogen-derived antigen.

4 . The method of claim 1 , wherein the pathogen-derived antigen is from a pathogen selected from the group consisting of HIV, HCV, and Neisseria meningitidis.

5 . The method of claim 1 , wherein the pathogen-derived antigen is a polypeptide.

6 . The method of claim 5 , wherein the pathogen-derived antigen is a gp41 polypeptide from HIV or a 5-helix polypeptide.

7 . The method of claim 1 , wherein the pathogen-derived antigen is a carbohydrate.

8 . (canceled)

9 . The method of claim 2 , wherein the antibody is a neutralizing antibody.

10 . The method of claim 6 , wherein the antibody is D5.

11 . The method of claim 1 , wherein the antibody binds to polysialic acid on Neisseria meningitides capsules but not to NCAM-associated polysialic acid.

12 . A method of vaccinating an individual against a pathogen comprising administering the mimotope of the pathogen-derived antigen of claim 1 or a derivative thereof to the individual.

13 . A method of vaccinating an individual against HIV comprising administering a mimotope of gp41 or a derivative thereof to the individual, wherein the mimotope is selected from the group consisting of the compounds of any of Tables 2-4.

14 . The method of claim 12 wherein the mimotope is conjugated to an immunogenic carrier protein.

15 . The method of claim 14 , wherein the carrier protein is OMPC.

16 . A method of identifying a small molecule mimotope of a self-antigen or a small molecule antagonist of an autoantibody comprising:

e) combining the following components

i) an autoantibody that binds to the self-antigen, wherein the auto antibody is associated with a pathological condition;

ii) the self-antigen or a fragment or conformational mimetic thereof that has a conformation that is substantially similar to that of the self-antigen such that the autoantibody binds to the fragment or conformational mimetic; and

iv) a small molecule test compound;

f) incubating the components under conditions which allow components i and ii to bind;

g) measuring the amount of binding between components i and ii, wherein a decrease in binding between components i and ii in the presence of the test compound as compared to in the absence of the test compound indicates the test compound binds to component i or ii and is a candidate compound;

h) determining to which component the candidate compound binds,

wherein binding to the autoantibody indicates that the candidate compound is a mimotope of the self-antigen and wherein binding to the self-antigen, fragment or conformational mimetic thereof indicates that the candidate compound is an antagonist of the autoantibody.

17 . The method of claim 16 , wherein the pathological condition is selected from the group consisting of myasthenia gravis, rheumatoid arthritis, lupus erythematosis, diabetes mellitus type 1, and multiple sclerosis.

18 . A method of treating an autoimmune disorder comprising administering to an individual in need thereof the mimetic or the antagonist of claim 16 or a derivative thereof.

19 . The method of claim 18 , wherein the individual is further administered one or more drugs selected from the group consisting of corticosteroid drugs, nonsteroidal anti-inflammatory drugs, and immunosuppressant drugs.

20 . A compound of Formula I

or a pharmaceutically acceptable salt thereof, wherein

R 1 is an optionally substituted aryl or heteroaryl; R 2 is an optionally substituted aryl or heteroaryl;

R 3 is either H or a C 1 -C 6 alkyl;

R 4 is either H or a C 1 -C 6 alkyl;

X is either N or C;

R 5 is selected from the group consisting of:

H,

(C═O)OC 1 -C 6 alkyl,

(C═O)OC 1 -C 6 cyloalkyl,

(C═O)OC 1 -C 6 aryl,

(C═O)OC 1 -C 6 heterocyclyl,

(C═O)OC 1 -C 6 alkyl,

aryl,

C 2 -C 6 alkenyl,

C 2 -C 6 alkynyl,

heterocyclyl,

C 3 -C 6 cycloalkyl,

SO 2 R a , and

(C═O)NR b 2 ,

said alkyl, cycloalkyl, aryl, heterocylyl, alkenyl, and alkynyl is optionally substituted with one or more substituents selected from R 7 ,

R 6 is selected from the group consisting of

H,

C (0-6) alkyl optionally substituted with a heterocyclic ring or aryl,

said alkyl, heterocyclic ring and aryl is optionally substituted with R a ; or

R 5 and R 6 together with X form a monocyclic or bicyclic ring with 5-7 members in each ring and,

when X is C, it optionally contains a 1-4 heteroatoms selected from N, O and S, and

when X is N, it optionally contains 1 to 4 additional heteroatoms selected from N, O and S, said monocylcic or bicyclic ring optionally substituted with one or more substituents selected from R 7 ;

R 7 is selected from the group consisting of:

(C 1 -C 6 )alkyl,

(C═O) r O s (C 1 -C 6 )alkyl,

O r (C 1 -C 3 )perfluoroalkyl,

S(O) m R a ,

SR a ,

(C 1 -C 6 )alkylene-S(O) m R a ,

oxo,

OH,

halo,

CN,

(C 2 -C 6 )alkenyl,

(C 2 -C 6 ) alkynyl,

(C 3 -C 6 )cycloalkyl,

aryl

(C 1 -C 6 )alkylene-aryl,

heterocyclyl,

(C 1 -C 6 )alkylene-heterocyclyl

N(R b ) 2 ,

(C 1 -C 6 )alkylene-N(R b ) 2 ,

C(O) R a ,

CO 2 R a ,

(C 1 -C 6 )alkylene-CO 2 R a ,

C(O)H, and

CO 2 H

(C 1 -C 6 )alkylene-CO 2 H

said alkyl, alkenyl, alkynyl, alkylene, cycloalkyl, aryl, and heterocyclyl is optionally substituted with up to three substituents selected from R b , OH, (C 1 -C 6 )alkoxy, halogen, CO 2 H, CN, O(C═O) (C 1 -C 6 )alkyl, oxo, and N(R b ) 2 ; and wherein each R is independently 0 or 1, each s is independently 0 or 1, and each m is independently 0, 1, or 2

R a is selected from the group consisting of:

(C 1 -C 6 ) alkyl,

(C 3 -C 6 ) cycloalkyl,

aryl,

or heterocyclyl; and

R b is selected from the group consisting of:

H,

(C 1 -C 6 ) alkyl,

aryl,

heterocyclyl,

(C 3 -C 6 ) cycloalkyl,

(C═O)O(C 1 -C 6 )alkyl,

(C═O)(C 1 -C 6 )alkyl or

S(O) 2 R a .

21 . The compound of Formula I or a pharmaceutically acceptable salt thereof, wherein

R 1 is an optionally substituted aryl;

R 2 is an optionally substituted phenyl;

R 3 is either H or a C 1 -C 6 alkyl;

R 4 is either H or a C 1 -C 6 alkyl;

X is either N or C;

R 5 is selected from the group consisting of:

H,

(C═O)OC 1 -C 6 alkyl,

(C═O)OC 1 -C 6 cyloalkyl,

(C═O)OC 1 -C 6 aryl,

(C═O)OC 1 -C 6 heterocyclyl,

(C═O)OC 1 -C 6 alkyl,

aryl,

C 2 -C 6 alkenyl,

C 2 -C 6 alkynyl,

heterocyclyl,

C 3 -C 6 cycloalkyl,

SO 2 R a , and

(C═O)NR b 2 ,

said alkyl, cycloalkyl, aryl, heterocylyl, alkenyl, and alkynyl is optionally substituted with one or more substituents selected from R 7 ,

R 6 is selected from the group consisting of

alkyl substituted with a heterocyclic ring or aryl, and

C (1-6) alkyl substituted with a heterocyclic ring or aryl,

each of which is optionally substituted with R a ; or

R 5 and R 6 together with X form a monocyclic or bicyclic heterocycle with 5-7 members in each ring and,

when X is C, it contains at least one heteroatom selected from N, O and S and optionally containing 1 to 4 additional heteroatoms selected from N, O and S, and

when X is N, it optionally contains 1 to 4 additional heteroatoms selected from N, O and S, said monocylcic or bicyclic heterocycle optionally substituted with one or more substituents selected from R 7 ;

R 7 is selected from the group consisting of:

(C═O) r O s (C 1 -C 6 )alkyl,

O r (C 1 -C 3 )perfluoroalkyl,

S(O) m R a ,

(C 1 -C 6 )alkylene-S(O) m R a ,

oxo,

OH,

halo,

CN,

(C 2 -C 6 )alkenyl,

(C 2 -C 6 ) alkynyl,

(C 3 -C 6 )cycloalkyl,

aryl

(C 1 -C 6 )alkylene-aryl,

heterocyclyl,

(C 1 -C 6 )alkylene-heterocyclyl

N(R b ) 2 ,

(C 1 -C 6 )alkylene-N(R b ) 2 ,

C(O) R a ,

CO 2 R a ,

(C 1 -C 6 )alkylene-CO 2 R a ,

C(O)H, and

CO 2 H

(C 1 -C 6 )alkylene-CO 2 H

said alkyl, alkenyl, alkynyl, alkylene, cycloalkyl, aryl, and heterocyclyl is optionally substituted with up to three substituents selected from R b , OH, (C 1 -C 6 )alkoxy, halogen, CO 2 H, CN, O(C═O) (C 1 -C 6 )alkyl, oxo, and N(R b ) 2 ; and wherein each R is independently 0 or 1, each s is independently 0 or 1, and each m is independently 0, 1, or 2

R a is selected from the group consisting of:

(C 1 -C 6 ) alkyl,

(C 3 -C 6 ) cycloalkyl,

aryl,

or heterocyclyl; and

R b is selected from the group consisting of:

H,

(C 1 -C 6 ) alkyl,

aryl,

heterocyclyl,

(C 3 -C 6 ) cycloalkyl,

(C═O)O(C 1 -C 6 )alkyl,

(C═O)(C 1 -C 6 )alkyl or

S(O) 2 R a .

22 . (canceled)

Assignments (4)
CHANGE OF NAME Recorded Aug 29, 2012
From: SCHERING CORPORATION
To: MERCK SHARP & DOHME CORP.
Reel/Frame 028866/0511 →
MERGER Recorded Aug 27, 2012
From: MERCK SHARP & DOHME CORP.
To: SCHERING CORPORATION
Reel/Frame 028850/0515 →
CHANGE OF NAME Recorded May 31, 2011
From: MERCK & CO., INC.
To: MERCK SHARP & DOHME CORP.
Reel/Frame 026359/0953 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 26, 2011
From: CAULFIELD, MICHAEL J.; MILLER, MICHAEL D.; JOYCE, JOSEPH; ZUCK, PAUL D.; GETTY, KRISTA L.; DUDKIN, VADIM; OTTINGER, ELIZABETH A.
To: MERCK & CO., INC.
Reel/Frame 026346/0570 →