Therapeutically active compounds and their methods of use
Inventors
Assignees
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Publication Number
US-12303512-B2
Publication Date
2025-05-20
Expiration Date
Abstract
Provided are compounds useful for treating cancer and methods of treating cancer comprising administering to a subject in need thereof a purified compound described herein.
Core Innovation
The invention describes treating cancer or glioma by administering to a patient in need thereof a therapeutically effective amount of a purified compound or a pharmaceutically acceptable salt thereof, where the cancer or glioma is characterized by the presence of at least one mutation chosen from an IDH1 mutation or an IDH2 mutation. The purified compound is selected from compounds described in the patent, and the patient population is defined by the presence of an IDH1 or IDH2 mutation.
The description further relates to formulations for oral dosage forms of the purified compound or pharmaceutically acceptable salt, including solid dispersions made by spray-drying, including fluidized spray drying (FSD). A polymer is used to form the solid dispersion, and the formulation may include post-drying and/or polishing to meet residual solvent specifications.
The patent content also describes measuring R-(−)-2-hydroxyglutarate (2HG) levels, sequencing or genotyping, noninvasive imaging modalities such as MRI/MRS, and analytical sampling and processing using LC/MS and LC-MS/MS for demonstration of target engagement and efficacy monitoring. The treated cancers are described as including glioma and other cancers characterized by IDH1/IDH2 mutations.
Claims Coverage
The independent claims cover methods of treating cancer or glioma with purified compounds or pharmaceutically acceptable salts for tumors characterized by IDH1 or IDH2 mutations. The core inventive features are the purified-compound/salt administration and the mutation-defined selection of the patient’s cancer type, with some claims framed as compositions comprising the purified compound or salt.
Mutation-characterized cancer treatment using purified compound or pharmaceutically acceptable salt
Administering to a patient in need thereof a therapeutically effective amount of a purified compound or a pharmaceutically acceptable salt thereof, wherein the cancer is characterized by the presence of at least one mutation chosen from an IDH1 mutation or an IDH2 mutation and wherein the purified compound is selected from the compounds described in the patent.
Glioma treatment using purified compound or pharmaceutically acceptable salt
Administering to a subject a therapeutically effective amount of a purified compound or a pharmaceutically acceptable salt thereof, wherein the glioma is characterized by the presence of at least one mutation chosen from an IDH1 mutation or an IDH2 mutation and wherein the purified compound is selected from the compounds described in the patent.
Glioma treatment using composition comprising purified compound or pharmaceutically acceptable salt
Administering to a patient in need thereof a therapeutically effective amount of a composition comprising a purified compound or a pharmaceutically acceptable salt thereof, wherein the glioma is characterized by the presence of at least one mutation chosen from an IDH1 mutation or an IDH2 mutation and wherein the purified compound is selected from the compounds described in the patent.
Across the independent claims, the patent’s claim coverage is anchored in administering a therapeutically effective amount of a purified compound or pharmaceutically acceptable salt, or a composition comprising such, to treat cancers including glioma, where the disease is characterized by at least one IDH1 or IDH2 mutation.
Stated Advantages
Inhibit mutant IDH1 and/or mutant IDH2 neomorphic activity producing R(−)-2-hydroxyglutarate (2HG).
Documented Applications
Treating cancers characterized by IDH1/IDH2 mutations, including glioma.
A need to identify biologically active vorasidenib metabolites persisting after dosing.
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