# US 10,501,526 B2 · Human antibodies to Ebola virus glycoprotein

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- Number: US 10,501,526 B2
- Document ID: US10501526B2
- Status: Granted
- Kind: B2
- Application number: 16/108,096
- Filed: 2018-08-22
- Published: 2019-02-14
- Granted: 2019-12-10
- Earliest claimed: 2015-01-26
- Assignees: Regeneron Pharmaceuticals, Inc.
- Applicants: Regeneron Pharmaceuticals, Inc.
- Inventors: Christos Kyratsous; William Olson; Peter Mason; Neil Stahl
- Web page: https://patentgrep.com/patent/US10501526B2

## CPC

- C07K 16/10: RNA viruses
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61P 31/14: for RNA viruses
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- C07K 2317/21: from primates, e.g. man
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- 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 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- 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)
- 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 provides monoclonal antibodies, or antigen-binding fragments thereof, that bind to Ebola virus glycoproteins, pharmaceutical compositions comprising the antibodies and methods of use. The antibodies of the invention are useful for inhibiting or neutralizing Ebola virus activity, thus providing a means of treating or preventing Ebola virus infection in humans. In some embodiments, the invention provides for use of one or more antibodies that bind to the Ebola virus for preventing viral attachment and/or entry into host cells. The antibodies of the invention may be used prophylactically or therapeutically and may be used alone or in combination with one or more other anti-viral agents or vaccines.

## Claims

### Claim 1

A method of treating or ameliorating at least one symptom of EBOV infection, or of decreasing the frequency or severity of at least one symptom of EBOV infection, the method comprising administering to a subject in need thereof at least one antibody or antigen-binding fragment thereof comprising three heavy chain complementarity determining regions (CDRs) (HCDR1, HCDR2 and HCDR3) and three light chain CDRs (LCDR1, LCDR2 and LCDR3) contained within any one of the heavy chain variable region (HCVR) and light chain variable region (LCVR) amino acid sequence pairs selected from the group consisting of SEQ ID NOs: 18/26, 66/74, and 146/154, or a pharmaceutically acceptable composition comprising the at least one antibody or antigen-binding fragment thereof.

### Claim 2 (depends on 1)

The method of claim 1, comprising administering an antibody cocktail comprising a mixture of at least two anti-EBOV antibodies.

### Claim 3 (depends on 1)

The method of claim 1, comprising administering an antibody cocktail comprising a mixture of three anti-EBOV antibodies, wherein the three anti-EBOV antibodies comprise HCVR/LCVR amino acid sequence pairs as set forth in SEQ ID NOs: 18/26, 66/74 and 146/154.

### Claim 4 (depends on 3)

The method of claim 3, wherein the at least one symptom is selected from the group consisting of fever, headache, fatigue, loss of appetite, myalgia, diarrhea, vomiting, abdominal pain, dehydration and unexplained bleeding.

### Claim 5 (depends on 3)

The method of claim 3, wherein the pharmaceutical composition is administered prophylactically or therapeutically to the subject in need thereof.

### Claim 6 (depends on 3)

The method of claim 3, wherein the antibody or antigen-binding fragment thereof, or the pharmaceutical composition comprising the antibody or antigen-binding fragment thereof is administered in combination with a second therapeutic agent.

### Claim 7 (depends on 6)

The method of claim 6, wherein the second therapeutic agent is selected from the group consisting of an anti-viral drug, an anti-inflammatory drug, a different antibody to EBOV, a vaccine for EBOV, small interfering RNAs that target viral RNA polymerase, brincidofovir, favipiravir, BCX-4430, antisense phosphorodiamidate morpholino oligomers that target Ebola virus VP24 gene, and interferons.

### Claim 8 (depends on 1)

The method of claim 1, wherein the antibody or antigen-binding fragment thereof, or the pharmaceutical composition comprising the antibody or antigen-binding fragment thereof is administered subcutaneously, intravenously, intradermally, intramuscularly, intranasally, or orally.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition comprises an antibody having the HCDR1/HCDR2/HCDR3/LCDR1/LCDR2/LCDR3 sequence combination of SEQ ID Nos: 20/22/24/28/30/32, respectively.

### Claim 10 (depends on 1)

The method of claim 1, where the composition comprises an antibody having the HCDR1/HCDR2/HCDR3/LCDR1/LCDR2/LCDR3 sequence combination of SEQ ID NOs: 68/70/72/76/78/80, respectively.

### Claim 11 (depends on 1)

The method of claim 1, wherein the composition comprises an antibody having the HCDR1/HCDR2/HCDR3/LCDR1/LCDR2/LCDR3 sequence combination of SEQ ID NOs: 148/150/152/156/158/160, respectively.

### Claim 12 (depends on 1)

The method of claim 1, wherein the composition comprises at least three antibodies, and wherein the antibodies comprise the HCDR1/HCDR2/HCDR3/LCDR1/LCDR2/LCDR3 sequence combination of SEQ ID NOs: 20/22/24/28/30/32, 68/70/72/76/78/80, and 148/150/152/156/158/160, respectively.

### Claim 13 (depends on 7)

The method of claim 7, wherein the second therapeutic agent is an anti-inflammatory selected from corticosteroids and non-steroidal anti-inflammatory drugs.