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Publication Number
US-12102639-B2
Publication Date
2024-10-01
Expiration Date
Abstract
Imipridones selectively modulate Class A G protein-coupled receptors (GPCRs), such as the D2-like subfamily of dopamine receptors, and are useful for treating conditions and disorders in need of such modulation, such as cancers. Specifically, the cancer is a midline glioma, a cancer having a histone H3 mutation, or both. In addition, methods of identifying whether a subject having these conditions, is likely to be responsive to a treatment regimen, such as imipridone administration, are provided. Furthermore, methods of assessing the effectiveness of a treatment regimen, such as imipridone administration, monitoring, or providing a prognosis for a subject with these condition are also provided.
Core Innovation
The patent describes treating a brain cancer by administering a pharmaceutical composition comprising compound (1) or a pharmaceutically acceptable salt, where the cancer has a histone H3 K27M mutation. The treatment includes selecting a dosing frequency from predetermined regimens such as once daily, once weekly, once every four weeks, twice a week, once every two weeks, once every three weeks, and repeated cycles combining those intervals.
The patent further characterizes the histone H3 K27M mutation context by specifying H3.3 K27M or H3.1 K27M and by relating the mutation to one or more selected histone genes including H3F3A, H3F3B, HIST1H3A, HIST1H3B, HIST1H3C, HIST1H3D, HIST1H3E, HIST1H3F, HIST1H3G, HIST1H3H, HIST1H3I, or HIST1H3J. In additional claim-supported refinements, the cancerous tissue may have DRD2 overexpression, DRD5 underexpression, or both.
The patent also defines dosing as predetermined doses based on patient weight or patient body surface area, using compound (1) or a pharmaceutically acceptable salt. One dosing formulation specifies a predetermined dose of about 5 mg/kg to about 10 mg/kg based on patient weight, and another specifies a predetermined dose of about 280 mg/m2 to about 330 mg/m2 based on patient body surface area.
Claims Coverage
Independent claim coverage is provided for three distinct method formulations that share the core use of compound (1) for brain cancer treatment where the cancer has a histone H3 K27M mutation. The inventive features are 3: predetermined dose with selected dosing frequency regimens, weight-based predetermined dosing range, and body-surface-area-based predetermined dosing range.
Histone H3 K27M brain cancer treatment with selected dosing frequency regimens
Administering to the patient a pharmaceutical composition comprising a therapeutically effective amount of compound (1) or a pharmaceutically acceptable salt thereof, at a predetermined dose with a frequency selected from once daily; according to an infrequent dosing regimen; according to a frequent dosing regimen; once weekly; once every four weeks; twice a week; once every two weeks; once every three weeks; and in a repeated cycle of once weekly, once every two weeks, once every three weeks, once every four weeks, wherein the cancer has a histone H3 K27M mutation.
Histone H3 K27M brain cancer treatment with weight-based predetermined dose range
Administering to the patient a pharmaceutical composition comprising a therapeutically effective amount of compound (1) or a pharmaceutically acceptable salt thereof, in a predetermined dose of about 5 mg/kg to about 10 mg/kg, based on patient weight; wherein the cancer has a histone H3 K27M mutation.
Histone H3 K27M brain cancer treatment with body surface area-based predetermined dose range
Administering to the patient a pharmaceutical composition comprising a therapeutically effective amount of compound (1) or a pharmaceutically acceptable salt thereof, in a predetermined dose of about 280 mg/m2 to about 330 mg/m2, based on patient body surface area; wherein the cancer has a histone H3 K27M mutation.
Across the independent claims, the claimed coverage is a method of treating brain cancer with histone H3 K27M mutation using compound (1) or a pharmaceutically acceptable salt with predetermined dosing and selected frequency regimens, or predetermined dosing based on patient weight or patient body surface area.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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