# US 10,501,534 B2 · Anti-malarial compositions

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- Number: US 10,501,534 B2
- Document ID: US10501534B2
- Status: Granted
- Kind: B2
- Application number: 16/133,143
- Filed: 2018-09-17
- Published: 2019-01-03
- Granted: 2019-12-10
- Earliest claimed: 2013-12-05
- Assignees: Leidos, Inc.; The U.S. of America, as represented by the Secretary, Dept. of Health & Human Services
- Applicants: Leidos, Inc.; The United States of America, as represented by the Secretary, Dept. of Health and Human Services
- Inventors: Gabriel M. Gutierrez; James Pannucci; Amy Noe; Steve Chienwen Huang; Scott Winram; Annie Xiaoyan Mo
- Web page: https://patentgrep.com/patent/US10501534B2

## CPC

- C07K 16/205: {Plasmodium}
- A61K 39/015: Hemosporidia antigens, e.g. Plasmodium antigens
- A61K 39/39575: {against materials from other living beings excluding bacteria and viruses, e.g. protozoa, fungi, plants}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 33/06: Antimalarials
- A61K 2039/505: {comprising antibodies}
- 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 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

This disclosure provides antibodies that are useful for preventing and/or treating malaria. The epitope to which the antibodies bind is in close proximity to the conserved proteolytic cleavage site of P. falciparum circumsporozoite protein (CSP), and the antibodies provided in this disclosure can prevent cleavage and inhibit P. falciparum sporozoites from invading the liver.

## Claims

### Claim 1

A method of producing a heavy chain of an antibody, comprising growing a host cell comprising a gene expression construct encoding the heavy chain under conditions which permit expression of the gene expression construct, wherein the gene expression construct comprises a coding sequence for the heavy chain, wherein the variable region of the heavy chain comprises:
(i) a first heavy chain complementarity determining region (CDRH) comprising the amino acid sequence SEQ ID NO:1; a second CDRH comprising the amino acid sequence SEQ ID NO:2; and a third CDRH comprising the amino acid sequence SEQ ID NO:3; or
(ii) the complementarity determining regions of the heavy chain variable region of the antibody deposited under Accession No. MRA-1242.

### Claim 2 (depends on 1)

The method of claim 1, wherein the variable region of the heavy chain comprises the first CDRH comprising the amino acid sequence SEQ ID NO:1; the second CDRH comprising the amino acid sequence SEQ ID NO:2; and the third CDRH comprising the amino acid sequence SEQ ID NO:3.

### Claim 3 (depends on 1)

The method of claim 1, wherein the variable region of the heavy chain comprises the CDRs of the heavy chain of the antibody deposited under Accession No. MRA-1242.

### Claim 4

A method of producing a light chain of an antibody, comprising growing a host cell comprising a gene expression construct encoding the light chain under conditions which permit expression of the gene expression construct, wherein the gene expression construct comprises a coding sequence for the light chain, wherein the variable region of the light chain comprises:
(i) a first CDRL comprising the amino acid sequence SEQ ID NO:4; a second CDRL comprising the amino acid sequence SEQ ID NO:5; and a third CDRL comprising the amino acid sequence SEQ ID NO:6; or
(ii) the CDRs of the light chain variable region of the antibody deposited under Accession No. MRA-1242.

### Claim 5 (depends on 4)

The method of claim 4, wherein the light chain variable region comprises the first CDRL comprising the amino acid sequence SEQ ID NO:4; the second CDRL comprising the amino acid sequence SEQ ID NO:5; and the third CDRL comprising the amino acid sequence SEQ ID NO:6.

### Claim 6 (depends on 4)

The method of claim 4, wherein the light chain variable region comprises the CDRs of the light chain of the antibody deposited under Accession No. MRA-1242.

### Claim 7 (depends on 1)

The method of claim 1, wherein the host cell further comprises a second gene expression construct comprising a coding sequence for a light chain of the antibody, wherein the light chain variable region comprises:
(i) a first CDRL comprising the amino acid sequence SEQ ID NO:4; a second CDRL comprising the amino acid sequence SEQ ID NO:5; and a third CDRL comprising the amino acid sequence SEQ ID NO:6; or
(ii) the CDRs of the light chain variable region of the antibody deposited under Accession No. MRA-1242,
wherein the conditions under which the host cell is grown permit expression of the second gene expression construct.

### Claim 8 (depends on 7)

The method of claim 7, wherein the variable region of the heavy chain comprises the CDRs of the heavy chain of the antibody deposited under Accession No. MRA-1242 and wherein the variable region of the light chain comprises the CDRs of the light chain of the antibody deposited under Accession No. MRA-1242.

### Claim 9 (depends on 1)

The method of claim 1, wherein the method further comprises producing a light chain of the antibody, wherein the gene expression construct further comprises a coding sequence for the light chain of the antibody, wherein the light chain variable region comprises:
(i) a first CDRL comprising the amino acid sequence SEQ ID NO:4; a second CDRL comprising the amino acid sequence SEQ ID NO:5; and a third CDRL comprising the amino acid sequence SEQ ID NO:6; or
(ii) the CDRs of the light chain variable region of the antibody deposited under Accession No. MRA-1242.

### Claim 10 (depends on 9)

The method of claim 9, wherein the variable region of the heavy chain comprises the CDRs of the heavy chain of the antibody deposited under Accession No. MRA-1242 and wherein the variable region of the light chain comprises the CDRs of the light chain of the antibody deposited under Accession No. MRA-1242.

### Claim 11 (depends on 1)

The method of claim 1, wherein framework regions of the heavy chain are humanized.

### Claim 12 (depends on 1)

The method of claim 1, wherein framework regions of the heavy chain are human framework regions.

### Claim 13 (depends on 4)

The method of claim 4, wherein framework regions of the light chain are humanized.

### Claim 14 (depends on 4)

The method of claim 4, wherein framework regions of the light chain are human framework regions.