IP Library Granted Patent US 9,134,311
Granted Patent B2
US 9,134,311 · App. 13/061,146 · Granted Sep 15, 2015

Methods and compositions for treating and preventing malaria using an invasion ligand directed to a protease-resistant receptor

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Quick Facts
Patent No.
US 9,134,311
App. No.
13/061,146
Granted
Sep 15, 2015
Kind
B2
Abstract

This invention relates to an immunogenic molecule comprising a contiguous amino acid sequence of an invasion ligand of a strain of Plasmodium falciparum , the invasion ligand capable of binding to an erythrocyte receptor, the receptor function being resistant to trypsin and neuraminidase and chymotrypsin, wherein when administered to a subject the molecule is capable of inducing an immune response to the strain. The invention further relates to compositions and methods for the treatment of diseases such as malaria.

Claims (18)

1. A composition comprising a combination of:

(a) an isolated immunogenic molecule consisting of a sequence selected from the group consisting of SEQ ID NOS: 2, 4, 5, 6, 7, 8, 9, 10, 11 and 12, or an isolated immunogenic molecule consisting of a sequence selected from the group consisting of the amino acid sequence set forth in SEQ ID NOS: 2, 4, 5, 6, 7, 8, 9, 10, 11 and 12 except for the amino acid substitution in a corresponding residue where applicable in any of SEQ ID NOS: 2, 4, 5, 6, 7, 8, 9, 10, 11 and 12 selected from:

E at amino acid 25 in SEQ ID NO: 2 is replaced with K, Y at amino acid 124 in SEQ ID NO: 2 is replaced with H, H at amino acid 125 in SEQ ID NO: 2 is replaced with N, S at amino acid 174 in SEQ ID NO: 2 is replaced with Y, C at amino acid 180 in SEQ ID NO: 2 is replaced with Y, I at amino acid 181 in SEQ ID NO: 2 is replaced with K or R, N at amino acid 324 is replaced with Y or D, Y at amino acid 335 in SEQ ID NO: 2 is replaced with F, E at amino acid 339 in SEQ ID NO: 2 is replaced with D, V at amino acid 348 in SEQ ID NO: 2 is replaced with I, I at amino acid 384 in SEQ ID NO: 2 is replaced with V, I at amino acid 387 in SEQ ID NO: 2 is replaced with M, and K at amino acid 406 in SEQ ID NO: 2 is replaced with N;

(b) an isolated immunogenic molecule consisting of amino acids 761-1271 of the erythrocyte binding antigen (EBA) protein EBA175 of SEQ ID NO: 17 or an isolated immunogenic molecule consisting of amino acids 761-1271 of the erythrocyte binding antigen (EBA) protein EBA175 of SEQ ID NO: 17 except for the amino acid substitution selected from: S at amino acid 768 in SEQ ID NO: 17 replaced with N, E at amino acid 923 of SEQ ID NO: 17 replaced with K, K at amino acid 932 in SEQ ID NO: 17 replaced with E, E at amino acid 1058 in SEQ ID NO: 17 replaced with V, and G at amino acid 1100 in SEQ ID NO: 17 replaced with D; and

(c) an effective amount of a vaccine adjuvant;

wherein the composition induces an immune response to a strain of Plasmodium falciparum when administered to a subject.

2. The composition according to claim 1 , wherein the immune response is an invasion-inhibitory immune response.

3. The composition according to claim 1 wherein the strain of Plasmodium falciparum is a wild type strain.

4. The composition according to claim 1 further comprising a pharmaceutically acceptable excipient.

5. A method of treating a condition caused by or associated with infection by Plasmodium falciparum comprising administering to a subject in need thereof an effective amount of the composition according to claim 1 .

6. A composition comprising a combination of:

(a) an isolated immunogenic molecule consisting of a sequence selected from the group consisting of SEQ ID NOS: 2, 4, 5, 6, 7, 8, 9, 10, 11 and 12, or an isolated immunogenic molecule consisting of a sequence selected from the group consisting of the amino acid sequence set forth in SEQ ID NOS: 2, 4, 5, 6, 7, 8, 9, 10, 11 and 12except for the amino acid substitution in a corresponding residue where applicable in any of SEQ ID NOS: 2, 4, 5, 6, 7, 8, 9, 10, 11 and 12 selected from:

E at amino acid 25 in SEQ ID NO: 2 is replaced with K, Y at amino acid 124 in SEQ ID NO: 2 is replaced with H, H at amino acid 125 in SEQ ID NO: 2 is replaced with N, S at amino acid 174in SEQ ID NO: 2 is replaced with Y, C at amino acid 180 in SEQ ID NO: 2 is replaced with Y, I at amino acid 181 in SEQ ID NO: 2 is replaced with K or R, N at amino acid 324 is replaced with Y or D, Y at amino acid 335 in SEQ ID NO: 2 is replaced with F, E at amino acid 339 in SEQ ID NO: 2 is replaced with D, V at amino acid 348 in SEQ ID NO: 2 is replaced with I, I at amino acid 384 in SEQ ID NO: 2 is replaced with V, I at amino acid 387 in SEQ ID NO: 2 is replaced with M, and K at amino acid 406 in SEQ ID NO: 2 is replaced with N;

(b) an isolated immunogenic molecule consisting of amino acids 761-1271 of the erythrocyte binding antigen (EBA) protein EBA175 of SEQ ID NO: 17 or an isolated immunogenic molecule consisting of amino acids 761-1271 of the erythrocyte binding antigen (EBA) protein EBA175 of SEQ ID NO: 17 except for the amino acid substitution selected from: S at amino acid 768 in SEQ ID NO: 17 replaced with N, E at amino acid 923 of SEQ ID NO: 17 replaced with K, K at amino acid 932 in SEQ ID NO: 17 replaced with E, E at amino acid 1058 in SEQ ID NO: 17 replaced with V, and G at amino acid 1100 in SEQ ID NO: 17 replaced with D; and

(c) an effective amount of a vaccine adjuvant;

wherein at least one immunogenic molecule is fused to Glutathione S-transferase (GST) or histidine (HIS) tag or is conjugated to a carrier protein and wherein the composition induces an immune response to Plasmodium falciparum when administered to a subject.

7. The composition of claim 6 wherein the immunogenic molecule of subpart (b) is fused to Glutathione S-transferase (GST) or histidine (HIS) tag or is conjugated to a carrier protein.

8. The composition of claim 6 wherein the immunogenic molecule of subpart (b) is a Fusion protein or is conjugated to a carrier protein.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE APPLICATION NUMBER 61831594 PREVIOUSLY RECORDED AT REEL: 032459 FRAME: 0246. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Nov 12, 2015
From: ASTUTE MEDICAL, INC.
To: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Reel/Frame 037207/0287 →
SECURITY INTEREST Recorded Mar 17, 2014
From: ASTUTE MEDICAL, INC.
To: CAPITAL ROYALTY PARTNERS II L.P.; CAPITAL ROYALTY PARTNERS II - PARALLEL FUND "A" L.P.; PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P.
Reel/Frame 032459/0246 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2011
From: COWMAN, ALAN; CHEN, LIN; BAUM, JACOB
To: WALTER AND ELIZA HALL INSTITUTE OF MEDICAL RESEARCH
Reel/Frame 025868/0495 →