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Combination Therapies for the Treatment of Malignancies

A utility, acute technique in the field of combination therapy for the treatment of malignant tumors

Active Publication Date: 2021-12-03
LES LAB SERVIER +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, even with a good overall response, there is a genetic burden in patients

Method used

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  • Combination Therapies for the Treatment of Malignancies
  • Combination Therapies for the Treatment of Malignancies
  • Combination Therapies for the Treatment of Malignancies

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0303] Example 1. Effect of the combination of compound 2 and azacitidine on EPO-differentiation in AML cells

[0304] TF1-IDH1 R132H EPO differentiation assay in cells. in TF1-IDH1 R132H Measures of cell differentiation, growth and death were assessed in cells using the in vitro EPO differentiation assay and the dose-schedule paradigm shown in Figure 1 . Cells were treated with vehicle, AZA alone, Compound 2 alone or the combination of AZA+Compound 2. In the sequential protocol, cells were pretreated with AZA for three days, followed by the addition of Compound 2. In the simultaneous protocol, cells were co-treated with AZA and Compound 2 throughout the test. Endpoint assessment assays were: assessment of cell pellet color (hemoglobinization test); HBG and KLF1 RNA by RT-qPCR; CD235a-positive cell population by flow cytometry (marker of differentiation); and growth and apoptosis by IncuCyteZoom real-time imaging.

[0305] Compounds: Compound 2 was used as a 10 mM stock ...

Embodiment 2

[0323] Example 2. Phase 1b / 2 open-label randomized study of 2 combinations of isocitrate dehydrogenase (IDH) mutant-targeted therapy and azacitidine: oral compound 2 plus subcutaneous azacitidine and oral Compound 1 plus subcutaneous azacitidine in newly diagnosed acute myeloid leukemia subjects carrying IDH1 or IDH2 mutations, respectively, who are not candidates for intensive induction chemotherapy

[0324] Indications: For the treatment of subjects 18 years of age or older with newly diagnosed acute myeloid leukemia (AML) carrying IDH1 or IDH2 mutations, respectively, who are not candidates for intensive induction chemotherapy

[0325] Treatment of newly diagnosed acute myeloid leukemia (AML) patients over 18 years of age with IDH1 or IDH2 mutations who are not candidates for intensive induction chemotherapy (IC).

[0326] Key Target - Phase 1b (Dose Escalation Phase)

[0327] main target

[0328] To evaluate oral compound 2 plus subcutaneous (SC) azacitidine and oral 2-m...

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Abstract

The present invention provides methods and compositions for treating cancer in patients carrying IDH1 mutations using combinations of inhibitors of mutant IDH1 enzymes and DNA demethylating agents.

Description

[0001] priority claim [0002] This application claims priority to U.S.S.N. 62 / 242,282 filed October 15, 2015, each of which is hereby incorporated by reference in its entirety. technical field [0003] Combination therapies for the treatment of hematologic malignancies and solid tumors are provided herein. In one embodiment, the therapy involves treatment with an IDH1 inhibitor and a DNA demethylating agent. Background technique [0004] Isocitrate dehydrogenase (IDH) catalyzes the oxidative decarboxylation of isocitrate to 2-oxoglutarate (ie, alpha-ketoglutarate). These enzymes belong to two different subclasses, one of which utilizes NAD(+) as an electron acceptor and the other utilizes NADP(+) as an electron acceptor. Five isocitrate dehydrogenases have been reported: three NAD(+)-dependent isocitrate dehydrogenases localized to the mitochondrial matrix, and two NADP(+)-dependent isocitrate dehydrogenases, one of which One is mitochondrial and the other is predominant...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4439C07H19/12A61P35/00
CPCA61K45/06A61K31/444A61K31/706A61P35/02A61K2300/00A61K31/4439
Inventor S.V.阿格雷斯塔K.维斯瓦纳丹J.迪马蒂诺V.S.K.乔普拉K.J.麦克贝思R.D.奈特L.肯文Q.徐
Owner LES LAB SERVIER
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