Administration of sting agonist and checkpoint inhibitors

A checkpoint and inhibitor technology, applied in the direction of anti-animal/human immunoglobulins, chemical instruments and methods, medical preparations containing active ingredients, etc., which can solve the problem of reducing the effect of radiotherapy

Pending Publication Date: 2022-02-22
TAKEDA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Additionally, cancer cell growth in tumor allografted mice was reported to be inhibited by radiotherapy, but in STING and IFNAR1 (interfe

Method used

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  • Administration of sting agonist and checkpoint inhibitors
  • Administration of sting agonist and checkpoint inhibitors
  • Administration of sting agonist and checkpoint inhibitors

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0295] Example 1: In vivo tumor efficacy

[0296] General analysis method

[0297] Unless otherwise noted, obtained using Varian 300MHz 1 H NMR spectrum. HPLC was obtained on an Agilent 1100 Series and UPLC was obtained from Water Acuity Systems unless otherwise indicated.

[0298] Compound No. 14, as used in the following examples, can be synthesized according to the procedure described in Example 14 of PCT Publication No. WO 2018 / 100558.

[0299] General Experimental Conditions for Antitumor Efficacy in Mouse Tumor Models

[0300] Mouse Syngeneic Tumor Model

[0301] As specified below, the following homology models were utilized in each of Studies 1-5.

[0302] A20 Study 1: A20 is a mouse B-cell lymphoma cell line. By subcutaneously inoculating 0.4x10 6 A20 cells (cell suspension) were used to generate the A20 mouse syngeneic tumor model. When the average tumor volume reaches approximately 55 mm 3 , animals were randomly divided into a vehicle control group a...

Embodiment 2

[0337] Example 2: Evaluation of the clinical study of compound No. 14 combined with anti-PD-1 antibody in the treatment of patients with metastatic solid tumors

[0338] A Phase 1, open-label, parallel-assignment, dose-escalation study will be conducted to evaluate the safety, tolerability and tolerability of Compound 14 as a single agent (SA) and in combination with pembrolizumab in adult patients with metastatic solid tumors , pharmacokinetics (PK) and pharmacodynamics. This information will be used to independently assess the pharmacologically active dose (PAD) maximum tolerated dose (MTD) to determine the SA and the recommended second phase dose (RP2D) in combination with pembrolizumab. Based on discussion of the safety data by the investigator and the sponsor, dose escalation may be stopped after the determination of the PAD but before the determination of the MTD.

[0339] Approximately 100 patients will be enrolled in this study. Once enrolled, patients will be admini...

Embodiment 3

[0353] Example 3: Evaluation of the clinical study of compound No. 14 combined with anti-PD-1 antibody in the treatment of patients with metastatic solid tumors

[0354]A Phase 1, open-label, parallel-assignment, dose-escalation study will be conducted to evaluate the safety, tolerability and tolerability of Compound 14 as a single agent (SA) and in combination with pembrolizumab in adult patients with metastatic solid tumors , pharmacokinetics (PK) and pharmacodynamics. This information will be used to independently assess the pharmacologically active dose (PAD) maximum tolerated dose (MTD) to determine the SA and the recommended second phase dose (RP2D) in combination with pembrolizumab. Based on discussion of the safety data by the investigator and the sponsor, dose escalation may be stopped after the determination of the PAD but before the determination of the MTD.

[0355] Approximately 100 patients will be enrolled in this study. Once enrolled, patients will be adminis...

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Abstract

The present disclosure provides methods, pharmaceutical compositions, and kits for treating cancer in patients in need thereof. The methods comprise administering to a patient in need a STING (stimulator of interferon genes) agonist, such as Compound No. 14 as defined in the description, or a pharmaceutically acceptable salt thereof, in combination with one or more checkpoint inhibitors. Also provided are medicaments for use in treating cancer.

Description

technical field [0001] The present disclosure relates to methods of treating cancer. In particular, the present disclosure provides methods for treating various cancers by administering a STING (stimulator of interferon genes) agonist in combination with one or more checkpoint inhibitors. Background technique [0002] In 2012, there were an estimated 14 million diagnosed cases of cancer and approximately 8.2 million deaths worldwide. The global cancer burden is growing at an alarming rate; in 2030 alone, approximately 21.3 million new cancer cases and 13.1 million cancer deaths are expected to occur due to population growth and aging alone. Cancer is the second most common cause of death in the United States after heart disease, accounting for nearly a quarter of all deaths. The National Cancer Institute estimates that approximately 14.5 million Americans alive in 2014 had a history of cancer. Some of these individuals do not have cancer, while others still have evidence ...

Claims

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Application Information

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IPC IPC(8): A61K31/7084A61K39/395A61P35/00A61P35/02A61P35/04C07K16/28
CPCA61K31/7084A61K39/3955A61P35/00A61P35/02A61P35/04C07K16/2818A61K2039/545A61K2039/507A61K2300/00A61K39/39A61K39/395A61K45/06A61K2039/505A61K35/00
Inventor E·S·莱特卡普佐藤阳亮
Owner TAKEDA PHARMA CO LTD
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