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Treatment of metastatic brain tumor by administration of antibody-drug conjugate

A technology for brain tumors and metastases, applied in drug combinations, anti-tumor drugs, anti-animal/human immunoglobulins, etc., can solve problems such as unestablished standard therapies

Pending Publication Date: 2021-05-14
DAIICHI SANKYO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, these medical therapies have not yet been established as standard of care, and radiation therapy and surgery are considered the first options

Method used

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  • Treatment of metastatic brain tumor by administration of antibody-drug conjugate
  • Treatment of metastatic brain tumor by administration of antibody-drug conjugate
  • Treatment of metastatic brain tumor by administration of antibody-drug conjugate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0511] Example 1: Production of Antibody-Drug Conjugates

[0512] A humanized anti-HER2 antibody (an antibody comprising a heavy chain consisting of amino acid residues 1-449 of SEQ ID NO: 1 and a light chain) was used according to the production method described in International Publication No. WO 2015 / 115091 The light chain consists of the amino acid sequence consisting of amino acid residues 1-214 of SEQ ID NO: 2) to produce an antibody-drug conjugate in which the drug-linker represented by the formula is passed through Conjugation of thioether bond to anti-HER2 antibody (hereinafter, referred to as "antibody-drug conjugate (1)"):

[0513] [Formula 22]

[0514]

[0515] Where A represents the linking position with the antibody. The DAR of antibody-drug conjugate (1) was 7.8.

Embodiment 2

[0516] Example 2: Life extension test

[0517] Mice: Experiments were performed on 5-6-week-old female BALB / c nude mice (Charles River Laboratories Japan, Inc.).

[0518] Antibody-drug conjugate (1) was diluted with ABS buffer (10 mM acetate buffer (pH 5.5), 5% sorbitol) and administered intravenously at a solution volume of 10 mL / kg into the tail vein .

[0519] KPL-4-Luc, in which the luciferase gene was transfected into KPL-4 cells, was used by Dr. Junichi Kurebayashi from Kawasaki Medical School (British Journal of Cancer, (1999) 79 (5 / 6).707-717) A human breast cancer line was obtained. Suspend KPL-4-Luc in saline, add 1 x 10 4 Cells were transplanted intracranially into female nude mice, and the mice were randomized 7 days after transplantation (day 0). Antibody-drug conjugate (1 ) was administered intravenously at a dose of 10 mg / kg into the tail vein on days 0 and 21. The solvent was administered to the control group. The number of mice in each group was 5 and th...

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Abstract

A therapeutic agent for metastatic brain tumor, which contains, as an active ingredient, an antibody-drug conjugate comprising a drug linker represented by formula (1) (wherein A represents an antibody-binding site) and an antibody which are bonded to each other through a thioether bond; and / or a method for treating metastatic brain tumor, which is characterized by administering the antibody-drug conjugate to an individual who needs a treatment of metastatic brain tumor.

Description

technical field [0001] The present invention relates to a therapeutic agent for metastatic brain tumors comprising a specific antibody-drug conjugate, and / or a method for treating metastatic brain tumors, the method comprising administering the specific antibody-drug to a subject conjugate. Background technique [0002] Metastatic brain tumors are diseases that occur when a primary cancer metastasizes to the brain and are known to occur in 20-40% of cancer patients. Metastasis of cancer to the brain not only has a significant impact on prognosis but also leads to a significant decrease in quality of life (QOL), so there is a need to develop effective treatments for metastatic brain tumors (Non-Patent References 1, 2). [0003] Primary cancers of metastatic brain tumors include lung cancer, breast cancer, melanoma, renal cell carcinoma, kidney cancer, colorectal cancer, gastric cancer, head and neck cancer, hepatocellular carcinoma, liver cancer, ovarian cancer, prostate can...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/68A61K31/4745A61K39/395A61P35/00A61P35/02A61P35/04
CPCA61P35/00A61P35/02A61P35/04A61K47/6803A61K47/6851A61K47/6889C07K16/32A61K2039/80C07K2317/24A61K2039/505A61K31/4745A61K39/395A61K47/68A61K47/6849C07K16/30A61K47/6843A61K47/545A61K47/6855C07K16/18C07K16/28C07K16/2827
Inventor 杉原洁石井千晶
Owner DAIICHI SANKYO CO LTD