IP Library Patent Application 17940117
Patent Application
App. No. 17/940,117

IMMUNOTHERAPEUTIC COMPOSITIONS

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Patent No.
US None
App. No.
17/940,117
Abstract

The present disclosure provides compositions and methods useful for treating Glioblastoma Multiforme (GBM) which comprise virus-like particles (VLPs) comprising murine leukemia virus (MLV) core proteins and the human cytomegalovirus epitopes, gB and pp65, formulated with an adjuvant comprising a saponin and a TLR4 agonist.

Claims (45)

1 . An immunogenic composition comprising:

(i) a virus like particle (VLP) comprising:

(a) a murine leukemia virus (MLV) gag protein;

(b) an HCMV pp65 protein; and

(c) an HCMV glycoprotein B (gB) protein;

and

(ii) an adjuvant comprising a saponin and a TLR4 agonist.

2 . A kit for the preparation of an immunogenic composition, said kit comprising:

(i) a first container comprising a virus like particle comprising:

(a) a murine leukemia virus (MLV) gag protein;

(b) an HCMV pp65 protein; and

(c) an HCMV glycoprotein B (gB) protein;

and

(ii) a second container comprising an adjuvant comprising a saponin and a TLR4 agonist.

3 . A method for eliciting an immune response in a subject, said method comprising the administration of a saponin, a TLR4 agonist and a virus like particle comprising:

(a) a murine leukemia virus (MLV) gag protein;

(b) an HCMV pp65 protein; and

(c) an HCMV glycoprotein B (gB) protein.

4 . The method according to claim 3 , wherein the saponin, the TLR4 agonist and the virus like particle are administered in the form of an immunogenic composition comprising:

(i) a virus like particle (VLP) comprising:

(a) a murine leukemia virus (MLV) gag protein;

(b) an HCMV pp65 protein; and

(c) an HCMV glycoprotein B (gB) protein;

and

(ii) an adjuvant comprising a saponin and a TLR4 agonist.

5 . A method for the treatment of an HCMV associated cancer in a subject, said method comprising the administration of a saponin, a TLR4 agonist and a virus like particle comprising:

(a) a murine leukemia virus (MLV) gag protein;

(b) an HCMV pp65 protein; and

(c) an HCMV glycoprotein B (gB) protein.

6 . The method according to claim 5 , wherein the VLP comprises a MLV Gag polypeptide comprising an amino acid sequence at least 80% identical to SEQ ID NO:1.

7 . The method according to any claim 5 , wherein the VLP comprises a gB protein comprising an amino acid sequence which is at least 80% identical to SEQ ID NO: 8.

8 . The method according to claim 5 , wherein the VLP comprises a pp65 protein comprising an amino acid sequence which is at least 80% identical to SEQ ID NO: 11.

9 . The method according to claim 5 , wherein the VLP comprises a fusion protein comprising an amino acid sequence at least 80% identical to SEQ ID NO:4.

10 . The method according to claim 5 , wherein the saponin is QS21.

11 . The method according to claim 5 , wherein the TLR4 agonist is 3-de-O-acylated monophosphoryl lipid A (3D-MPL).

12 . The method according to claim 5 , wherein the subject is human.

13 . The method according to claim 5 , for the treatment of an HCMV associated cancer selected from breast, colon, ovarian and prostate cancer, rhabdomyosarcoma, hepatocellular cancer, salivary gland tumours, neuroblastoma and brain tumours.

14 . The method according to claim 5 , for the treatment of GBM.

15 . The method according to claim 14 , for use in the treatment of GBM in a subject experiencing their first occurrence.

16 . The method according to claim 5 , for use in the treatment of GBM in a subject having a tumour with a maximum cross-sectional area of 400 mm 2 or less.

17 . The method according to claim 12 , wherein the subject has a CD4/CD8 ratio of at least 2 at initiation of treatment.

18 . The method according to claim 17 , wherein the subject has a CD4/CD8 ratio of at least 3 at initiation of treatment.

19 . The method according to claim 12 , wherein the subject has a CD4/CD8 ratio of less than 3 at initiation of treatment.

20 . The method according to claim 5 , wherein a human dose comprises a gB protein content of 1/200 th to 1/10 th of content of pp65, such as 1/120 th to 1/40 th of content of pp65, in particular 1/100 th to 1/60 th of content of pp65 on a weight basis.

21 . The method according to claim 5 , wherein administration is intramuscularly with a composition comprising VLPs containing 10 ug pp65 protein, and an adjuvant comprising 50 ug of QS21 and 50 ug of 3D-MPL in a liposomal formulation and administration is repeated every 4 weeks.

Assignments (3)
SECURITY INTEREST Recorded Jul 20, 2023
From: VARIATION BIOTECHNOLOGIES INC.
To: K2 HEALTHVENTURES LLC, AS CANADIAN COLLATERAL AGENT
Reel/Frame 064325/0840 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2022
From: SCHNEIDER-OHRUM, KIRSTEN
To: GLAXOSMITHKLINE BIOLOGICALS SA
Reel/Frame 061022/0515 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2022
From: ANDERSON, DAVID EVANDER
To: VARIATION BIOTECHNOLOGIES INC.
Reel/Frame 061022/0561 →