Composition, lipid particle manufacturing kit, substance delivery method, and detection method

Patent metadata

Field	Value
Publication number	US-12576038-B2
Application number	US-202117472173-A
Country	US
Kind code	B2
Filing date	Sep 10, 2021
Priority date	Mar 19, 2020
Publication date	Mar 17, 2026
Grant date	Mar 17, 2026

Abstract

According to one embodiment, a composition is for delivering an objective substance to the T-cell malignant tumor cell. The composition contains a substance delivery carrier. The substance delivery carrier has a lipid particle, and the objective substance encapsulated in the lipid particle. The lipid particle contains, as constituents thereof, at least a first lipid represented by formula (I) and a second lipid represented by formula (II).

First claim

What is claimed is:

1 . A composition suitable for delivering an objective substance to a T-cell malignant tumor cell, the composition comprising:
a substance delivery carrier comprising a lipid particle and the objective substance encapsulated in the lipid particle, wherein the lipid particle comprises, as constituents thereof, at least a first lipid represented by formula (I), and a second lipid represented by formula (II):

2 . The composition of claim 1 , wherein, in the constituents of the lipid particle, a compounding ratio of the second lipid accounts for a 40% mole ratio or more of a first fraction, wherein the first fraction consists of the first lipid and the second lipid.

3 . The composition of claim 1 , wherein the lipid particle further comprises, as the constituents, at least one of a cationic lipid, neutral lipid, anti-aggregation lipid and cholesterol.

4 . The composition of claim 1 , in a form suitable for reducing or extinguishing the T-cell malignant tumor cell.

5 . The composition of claim 1 in a form suitable for treating the T-cell malignant tumor cell in a subject.

6 . The composition of claim 1 , wherein the objective substance comprises an mRNA of a cytocidal gene.

7 . The composition of claim 6 , wherein the cytocidal gene is at least one selected from the group consisting of iCaspase 9 gene, Caspase 9 gene, Caspase 3 gene, Caspase 6 gene, Caspase 7 gene, Caspase 8 gene, Caspase 10 gene, p53 gene, ARF gene, Rb gene, Fas gene, TNF gene, DR4 gene, DR5 gene, Bax gene, Bak gene, Bim gene, Bid gene, Bad gene, Noxa gene, Puma gene, Smac gene, DIABLO gene and HSV-TK gene.

8 . The composition of claim 1 in a form suitable for detecting the T-cell malignant tumor cell.

9 . The composition of claim 1 in a form suitable for diagnosing T-cell malignancy in a subject.

10 . The composition of claim 8 , wherein the objective substance is a diagnostic agent that generates a first signal.

11 . The composition of claim 1 , wherein the lipid particle further encapsulates a pH adjustor, osmoregulator, and/or gene activator.

12 . A lipid particle manufacturing kit for delivering an objective substance to T-cell malignant tumor cell, the kit comprising:
a lipid mixture that comprises at least a first lipid represented by formula (I) and a second lipid represented by formula (II):

13 . The kit of claim 12 , wherein, in the lipid mixture, a compounding ratio of the second lipid accounts for a 40% mole ratio or more of a first fraction, wherein the first fraction consists of the first lipid and the second lipid.

14 . The kit of claim 12 , further comprising the objective substance.

15 . A method for delivering an objective substance to a T-cell malignant tumor cell, the method comprising:
contacting the composition of claim 1 with a T-cell malignant tumor cell, wherein the substance delivery carrier comprises a lipid particle, and the objective substance encapsulated in the lipid particle, and the lipid particle containing, as constituents thereof, at least a first lipid represented by formula (I), and a second lipid represented by formula (II)

16 . The method of claim 15 , wherein the objective substance comprises an mRNA of a cytocidal gene.

17 . The method of claim 15 , wherein, in the constituents of the lipid particle, a compounding ratio of the second lipid accounts for 40% (mole ratio) or more of a first fraction, and the first fraction is composed of the first lipid and the second lipid.

18 . The method of claim 15 , wherein said contacting reduces or extinguishes the T-cell malignant tumor cell.

19 . The method of claim 15 , wherein
the T-cell malignant tumor cell exists in vivo in a subject, the contacting is carried out by administering the composition to the subject, and a T-cell malignancy of the subject is treated by the contacting.

20 . A method of detecting a T-cell malignant tumor cell, the method comprising:
contacting the composition of claim 1 that comprises the lipid particle and a diagnostic agent capable of generating a first signal and being encapsulated in the lipid particle, with a sample cell; detecting a first signal; and determining presence or absence of T-cell malignant tumor cell in the sample cell on the basis of result of the detection, the lipid particle comprising, as constituents thereof, at least a first lipid represented by formula (I), and a second lipid represented by formula (II)

21 . The method of claim 20 , wherein, in the constituents of the lipid particle, a compounding ratio of the second lipid accounts for 40% (mole ratio) or more of a first fraction, wherein the first fraction consists of the first lipid and the second lipid.

22 . The method of claim 20 , wherein
the sample cell is a cell that exists in vivo in the subject, and the method further comprises diagnosing whether the subject has a T-cell malignancy or not, on the basis of result of the detecting and/or result of the determining the presence of.

Assignees

• Univ Shinshu
• Toshiba Kk

Inventors

• Ishihara Mitsuko
• Akahoshi Eiichi
• NAKAZAWA Yozo
• Saito Shoji

Classifications

• G01N33/575

  for cancer · CPC title

• A61K31/7105

  Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links · CPC title

• A61K48/0041

  the non-active part being polymeric · CPC title

• C12N15/88

  using microencapsulation, e.g. using {amphiphile} liposome vesicle · CPC title

• A61K9/5123

  Organic compounds, e.g. fats, sugars · CPC title