# US 2014/0154239 A1 · Anti-interferon alpha monoclonal antibodies and methods for use

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- Number: US 2014/0154239 A1
- Document ID: US20140154239A1
- Status: Published application
- Kind: A1
- Application number: 13/705,289
- Filed: 2012-12-05
- Published: 2014-06-05
- Earliest claimed: 2012-12-05
- Inventors: Jacques Banchereau; Kiley Prilliman; Virginia Pascual; Anna Karolina Palucka
- Web page: https://patentgrep.com/patent/US20140154239A1

## CPC

- C07K 16/249: {Interferons}
- 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 2317/565: 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: 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 invention includes compositions and methods that include antibodies that selectively neutralize a bioactivity of at least two interferon alpha (“IFNα”) protein subtypes for the protein subtypes A, 2, B2, C, F, G, H2, I, J1, K, 4a, 4b and WA, but does not neutralize at least one bioactivity of IFNα protein subtype D. Examples of bioactivity for measurement include activation of the MxA promoter or antiviral activity and variants, derivatives and fragments thereof. The invention also includes host cells, hybridomas and plasmacytomas that produce antibodies. Because of their unique selectivity and affinity, the antibodies of the present invention are useful to detect IFNα subtypes in sample or tissue and/or for therapeutic applications that include, but are not limited to the treatment and/or amelioration of an IFNα related disorder such as SLE, lupus, type I diabetes, psoriasis, AIDS and Graft versus Host Disease.

## Claims

### Claim 1

A method for treating a disease or condition associated with increased expression of at least one IFNα protein subtype selected from the group consisting of protein subtypes A, 2, B2, C, F, G, H2, I, J1, K, 4a, 4b and WA in a subject comprising administering to a subject having said disease or condition an effective amount of an antibody selected from the group consisting of:
a) an anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557;
b) a humanized antibody that is a humanized form of the anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557;
c) a humanized antibody that is a humanized form of the antibody ACO-1;
d) a humanized antibody that is an antibody fragment of a humanized form of the anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557, wherein the antibody fragment specifically neutralizes a bioactivity of at least ten interferon alpha protein subtypes selected from the group consisting of IFNα protein subtypes A, 2, B2, C, F, G, H2, I, J1, K, 4a, 4b and WA, but does not significantly neutralize said bioactivity of IFNα protein subtype D, wherein said bioactivity is activation of the MxA promoter or antiviral activity;
e) the humanized antibody of (d) that is an Fab, Fab′, F(ab′)2, Fv or sFv fragment;
f) an antibody comprising at least one light chain that comprises the CDRs:
VL1 having the amino acid sequence of SEQ ID NO:12;
VL2 having the amino acid sequence of SEQ ID NO:14; and
VL3 having the amino acid sequence of SEQ ID NO:16; and
at least one heavy chain that comprises the CDRs:
VH1 having the amino acid sequence of SEQ ID NO:4;
VH2 having the amino acid sequence of SEQ ID NO:6;
VH3 having the amino acid sequence of SEQ ID NO:8; and
g) the antibody of any of (a) through (f) that is an IgG4 isotype antibody,
wherein said disease or condition is AIDS, and whereby at least one symptom of said disease or condition is treated or ameliorated.

### Claim 2 (depends on 1)

The method of claim 1, wherein the antibody is a humanized antibody that is a humanized form of the anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557.

### Claim 3 (depends on 1)

The method of claim 1, wherein the antibody is a humanized antibody that is a humanized form of the antibody ACO-1.

### Claim 4

A method of neutralizing at least one IFNα protein subtype in the blood of a subject, wherein the IFNα protein subtype is selected from the group consisting of protein subtypes A, 2, B2, C, F, G, H2, I, J1, K, 4a, 4b and WA, and wherein said method comprises administering to said subject an effective amount of an antibody selected from the group consisting of:
a) an anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557;
b) a humanized antibody that is a humanized form of the anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557;
c) a humanized antibody that is a humanized form of the antibody ACO-1;
d) a humanized antibody that is an antibody fragment of a humanized form of the anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557, wherein the antibody fragment specifically neutralizes a bioactivity of at least ten interferon alpha protein subtypes selected from the group consisting of IFNα protein subtypes A, 2, B2, C, F, G, H2, I, J1, K, 4a, 4b and WA, but does not significantly neutralize said bioactivity of IFNα protein subtype D, wherein said bioactivity is activation of the MxA promoter or antiviral activity;
e) the humanized antibody of (d) that is an Fab, Fab′, F(ab′)2, Fv or sFv fragment;
f) an antibody comprising at least one light chain that comprises the CDRs:
VL1 having the amino acid sequence of SEQ ID NO:12;
VL2 having the amino acid sequence of SEQ ID NO:14; and
VL3 having the amino acid sequence of SEQ ID NO:16; and
at least one heavy chain that comprises the CDRs:
VH1 having the amino acid sequence of SEQ ID NO:4;
VH2 having the amino acid sequence of SEQ ID NO:6;
VH3 having the amino acid sequence of SEQ ID NO:8; and
g) the antibody of any of (a) through (f) that is an IgG4 isotype antibody,
wherein said subject has a disease or condition that is AIDS, and wherein at least IFNα protein subtype in the blood of said subject is neutralized.

### Claim 5 (depends on 4)

The method of claim 4, wherein the antibody is a humanized antibody that is a humanized form of the anti-interferon alpha antibody produced by the hybridoma deposited with the ATCC as Accession No. PTA-6557.

### Claim 6 (depends on 4)

The method of claim 4, wherein the antibody is a humanized antibody that is a humanized form of the antibody ACO-1.