CN115989321A

CN115989321A - Virus preparation, solution for preparing virus preparation and use thereof

Info

Publication number: CN115989321A
Application number: CN202280005157.6A
Authority: CN
Inventors: 吴可行
Original assignee: Shanghai Xingshen Biotechnology Co ltd
Current assignee: Shanghai Xingshen Biotechnology Co ltd
Priority date: 2021-08-17
Filing date: 2022-08-17
Publication date: 2023-04-18
Also published as: WO2023020556A1

Abstract

A viral formulation, a solution for formulating the viral formulation and uses thereof are provided. Wherein the virus preparation comprises: a virus; sucrose; magnesium chloride. Wherein the virus preparation contains Tris-HCl buffer solution, and the pH value is 7.2-7.6.

Description

PCT国内申请，说明书已公开。PCT domestic application, specification has been published.

Claims

A viral formulation comprising:

a virus;

sucrose;

magnesium chloride;

wherein the virus preparation contains Tris-HCl buffer solution, and the pH value is 7.2-7.6.
The viral formulation according to claim 1, wherein the virus is a recombinant oncolytic virus.
The viral formulation according to claim 2, wherein the recombinant oncolytic virus is a vesicular stomatitis virus.
The viral formulation according to claim 2 or 3, wherein the recombinant oncolytic virus expresses a viral protein with high affinity for a cellular receptor selected from the group consisting of:

(a)SEQ ID NO:1；

(b) 2, SEQ ID NO; or

(c) An amino acid sequence having at least 80% homology to (a) or (b).
The viral formulation according to claim 4, wherein the binding capacity of the viral protein to the cellular receptor has a ZDOCK score of not less than 1800.
The viral preparation according to claim 5, wherein the cellular receptor comprises at least one selected from CHRNA5, SSTR5, KISS1R, HTR1D, CCR8.
The viral formulation according to claim 2, wherein the recombinant oncolytic virus further expresses at least one selected from the group consisting of: nucleoprotein, phosphoprotein, matrix protein and RNA-dependent RNA polymerase.
The viral formulation according to claim 1, wherein the viral formulation comprises, based on the total amount of the viral formulation:

4.5 to 5.5 weight percent of sucrose; and

1.5-2.5 mmol/L magnesium chloride.
The virus preparation according to claim 1, wherein the concentration of Tris in the Tris-HCl buffer is 50mmol/L.
The viral formulation according to claim 1, wherein the viral formulation comprises, based on the total amount of the viral formulation:

5% by weight of sucrose; and

2mmol/L magnesium chloride.
A solution for formulating a viral formulation, comprising:

sucrose;

magnesium chloride;

Tris-HCl buffer, and

the pH of the solution is 7.2-7.6.
The solution of claim 11, comprising:

4.5 to 5.5 weight percent of sucrose; and

1.5-2.5 mmol/L magnesium chloride.
The solution of claim 12, comprising:

5% by weight of sucrose; and

2mmol/L magnesium chloride.
The solution of claim 11, wherein the Tris concentration in the Tris-HCl buffer is 50mmol/L.
Use of a viral formulation according to any one of claims 1 to 10 or a solution according to any one of claims 11 to 14 for the preparation of a medicament for the treatment or prevention of cancer or a tumour.
The use of claim 15, wherein the cancer or tumor comprises at least one selected from the group consisting of lung cancer, stomach cancer, liver cancer, intestinal cancer, esophageal cancer, breast cancer, cervical cancer, malignant lymphoma, nasopharyngeal cancer, and leukemia.
A method of preventing or treating cancer or a tumor, comprising: administering to a subject a viral formulation according to any one of claims 1 to 10 or a solution according to any one of claims 11 to 14.
The method of claim 17, wherein the cancer or tumor comprises at least one selected from the group consisting of lung cancer, stomach cancer, liver cancer, intestinal cancer, esophageal cancer, breast cancer, cervical cancer, malignant lymphoma, nasopharyngeal cancer, and leukemia.