Anti-HERV-K envelope protein antibodies and methods for detecting HERV-K envelope protein in patients with sporadic amyotrophic lateral sclerosis

Patent metadata

Field	Value
Publication number	US-10981977-B2
Application number	US-202016903947-A
Country	US
Kind code	B2
Filing date	Jun 17, 2020
Priority date	Jan 20, 2017
Publication date	Apr 20, 2021
Grant date	Apr 20, 2021

Abstract

The present invention relates to a novel antibody against HERV-K envelope that targets a conserved region not affected by glycosylation or by native conformation, and its use in diagnostics and/or is therapy.

First claim

The invention claimed is:

1. An antibody that recognizes human endogenous retrovirus K (HERV-K) envelope protein having an epitope comprising the amino acid sequence of SEQ ID NO: 9, wherein said antibody comprises
a light chain comprising a light chain variable region (VL) which comprises three complementary determining regions (CDR-L1, CDR-L2 and CDR-L3), and
a heavy chain comprising a heavy chain variable region (VH) which comprises three complementary determining regions (CDR-H1, CDR-H2 and CDR-H3),
wherein the CDR-L1 comprises the amino acid sequence of SEQ ID NO: 1, the CDR-L2 comprises the amino acid sequence of SEQ ID NO:2, the CDR-L3 comprises the amino acid sequence of SEQ ID NO:3, the CDR-H1 comprises the amino acid sequence of SEQ ID NO:4, the CDR-H2 comprises the amino acid sequence of SEQ ID NO:5, and the CDR-H3 comprises the amino acid sequence of SEQ ID NO:6.

2. The antibody according to claim 1 , wherein:
the light chain variable region (VL) comprises the amino acid sequence of SEQ ID No: 7; and
the heavy chain variable region (VH) comprises the amino acid sequence of SEQ ID No: 8.

3. The antibody according to claim 1 , wherein said antibody is a murine monoclonal antibody, a chimeric monoclonal antibody or a humanized monoclonal antibody.

4. A pharmaceutical composition comprising the antibody according to claim 1 and a pharmaceutically acceptable excipient.

5. A method for detecting HERV-K envelope protein in a biological sample obtained from a subject comprising the steps of
contacting said biological sample with an anti-HERV-K envelope protein antibody as defined in claim 1 ; and
detecting binding of the anti-HERV-K envelope protein antibody to the HERV-K envelope protein; wherein the HERV-K envelope protein has an epitope comprising the amino acid sequence of SEQ ID NO: 9.

6. A method for detecting an increased level of HERV-K envelope protein in a sporadic amyotrophic lateral sclerosis (ALS) patient comprising the steps of
contacting a biological sample obtained from said patient with an anti-HERV-K envelope protein antibody as defined in claim 1 ;
detecting binding of the anti-HERV-K envelope protein antibody to the HERV-K envelope protein; and
comparing a level of binding in the biological sample to a healthy control sample, wherein the level of binding in the biological sample is increased as compared to the healthy control sample, wherein the biological sample is serum or cerebrospinal fluid, and wherein the HERV-K envelope protein has an epitope comprising the amino acid sequence of SEQ ID NO: 9.

Assignees

• Geneuro Sa
• Us Health
• The United States Of America Dept Of Health And Human Services

Inventors

• Perron Hervé
• Medina Julie
• Nath Avindra
• Steiner Joseph Perry
• Li Wenxue
• Lee Myoung-Hwa

Classifications

• C07K16/1145

  Env proteins, e.g. gp41, gp110/120, gp160, V3, principal neutralising domain [PND] or CD4-binding site · CPC title

• C07K16/112 Primary

  Retroviridae (F), e.g. leukemia viruses · CPC title

• G01N33/536

  with immune complex formed in liquid phase · CPC title

• G01N2800/285

  Demyelinating diseases; Multipel sclerosis · CPC title

• G01N2469/00

  Immunoassays for the detection of microorganisms · CPC title