IP Library Granted Patent US 10,624,880
Granted Patent B2
US 10,624,880 · App. 16/425,826 · Granted Apr 21, 2020

Predicting response to alvocidib by mitochondrial profiling

Inventors: Steven L. Warner (Sandy, UT); David J. Bearss (Alpine, UT)
Assignee: Tolero Pharmaceuticals, Inc.
A61K31/453A61K31/136A61K31/7068C12Q1/6886G01N33/5011G01N33/5079G01N33/5748G01N33/57426C12Q2600/106C12Q2600/158G01N2333/82G01N2800/52
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Quick Facts
Patent No.
US 10,624,880
App. No.
16/425,826
Granted
Apr 21, 2020
Kind
B2
Abstract

The present disclosure provides diagnostic methods useful for predicting a patient's response to alvocidib and guiding a physician decision to administer alvocidib to the patient.

Claims (19)

1. A method of treating a mammal with acute myeloid leukemia (AML) whose disease is dependent on MCL-1 comprising administering alvocidib, cytarabine, and mitoxantrone to the mammal with bone marrow cells having MCL-1 priming of at least 15% determined by subjecting cells from the mammal's bone marrow to a BH3 mimetic that is selective for MCL-1 and determining the percentage change in the mitochondrial polarization which corresponds to the MCL-1 priming.

2. The method of claim 1 , wherein the determination of MCL-1 priming includes permeabilizing the bone marrow cells.

3. The method of claim 1 wherein the AML is refractory.

4. The method of claim 1 wherein the AML is relapsed or refractory.

5. The method of claim 1 wherein the MCL-1 priming is at least 20%.

6. The method of claim 1 wherein the MCL-1 priming is at least 25%.

7. The method of claim 1 wherein the MCL-1 priming is at least 30%.

8. The method of claim 1 wherein the MCL-1 priming is at least 35%.

9. A method of treating a mammal with acute myeloid leukemia (AML) whose disease is dependent on MCL-1 comprising:

acquiring a plurality of bone marrow cells from the mammal;

determining an MCL-1 priming of the bone marrow cells determined by subjecting cells from the mammal's bone marrow to a BH3 mimetic that is selective for MCL-1 and determining the percentage change in the mitochondrial depolarization which corresponds to the MCL-1 priming; and

administering alvocidib, cytarabine, and mitoxantrone to the mammal if the bone marrow cells have the MCL-1 priming of at least 15%.

10. The method of claim 9 wherein the determination of MCL-1 priming includes permeabilizing the bone marrow cells.

11. The method of claim 9 wherein the AML is refractory.

12. The method of claim 9 wherein the AML is relapsed or refractory.

13. The method of claim 9 wherein the MCL-1 priming is at least 20%.

14. The method of claim 9 wherein the MCL-1 priming is at least 25%.

15. The method of claim 9 wherein the MCL-1 priming is at least 30%.

16. The method of claim 9 wherein the MCL-1 priming is at least 35%.

Assignments (4)
CHANGE OF NAME Recorded Apr 27, 2022
From: SUMITOMO DAINIPPON PHARMA ONCOLOGY, INC.
To: SUMITOMO PHARMA ONCOLOGY, INC.
Reel/Frame 059809/0557 →
MERGER Recorded Jul 10, 2020
From: TOLERO PHARMACEUTICALS, INC.
To: BOSTON BIOMEDICAL, INC.
Reel/Frame 053181/0114 →
CHANGE OF NAME Recorded Jul 10, 2020
From: BOSTON BIOMEDICAL, INC.
To: SUMITOMO DAINIPPON PHARMA ONCOLOGY, INC.
Reel/Frame 053181/0133 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 19, 2020
From: WARNER, STEVEN L.; BEARSS, DAVID J.
To: TOLERO PHARMACEUTICALS, INC.
Reel/Frame 051855/0587 →