IP Library Granted Patent US 12,560,609
Granted Patent B2
US 12,560,609 · App. 17/294,475 · Granted Feb 24, 2026

Biomarkers predictive of cancer cell response to ML329 or a derivative thereof

Inventors: Rizwan Haq (Boston, MA); David Fisher (Newton, MA); Frank Schoenen (Lawrence, KS)
Assignees: Dana-Farber Cancer Institute, Inc.; The General Hospital Corporation; University of Kansas
G01N33/574A61K31/18G01N33/6875G01N2333/90209
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Quick Facts
Patent No.
US 12,560,609
App. No.
17/294,475
Granted
Feb 24, 2026
Kind
B2
Abstract

The present invention is based in part on the identification of biomarkers, including NQO1, NRF2 and KEAP1, predictive of cancer cell responsiveness to treatment with ML 329 or a derivative thereof.

Claims (21)

1 . A method of treating a cancer in a subject likely to be responsive to 4-[(1,4-dioxo-1,4-dihydronapthalen-2-yl)amino]benzenesulfonamide (ML329) or an ML329 derivative selected from:

the method comprising:

i) selecting the subject likely to be responsive to ML329 or the ML329 derivative, the subject having been identified by

determining the presence of a KEAP1 loss-of-function mutation in cancer cells from the subject

wherein the presence of the kelch-like ECH-associated protein 1 (KEAP1) loss-of-function mutation identifies the subject as likely to be responsive to ML329 or the ML329 derivative; and

ii) administering ML329 or the ML329 derivative to the selected subject.

2 . The method of claim 1 , wherein the subject's cancer cells have KEAP1 loss-of-function.

3 . The method of claim 1 , wherein the KEAP1 loss-of-function mutation is a coding region mutation.

4 . The method of claim 1 , wherein the cancer is selected from the group consisting of melanoma, lung cancer, head and neck squamous cell carcinomas, kidney cancer, pancreas cancer, prostate cancer, bladder cancer, uterine cancer, head and neck cancer, and esophagus cancer.

5 . The method of claim 1 , wherein the subject is likely to be responsive to ML329 and the method comprises administering ML329 to the selected subject.

6 . The method of claim 1 , wherein the subject is likely to be responsive to the ML329 derivative, SCAP105461, and the method comprises administering SCAP105461 to the selected subject.

7 . The method of claim 1 , wherein the subject is likely to be responsive to the ML329 derivative, SCAP105463, and the method comprises administering SCAP105463 to the selected subject.

8 . The method of claim 1 , wherein the subject is

a) an animal model of cancer;

b) a mammal;

c) a mouse; or

d) a human.

9 . The method of claim 1 , wherein the cancer is a lung cancer.

10 . The method of claim 5 , wherein the cancer is a lung cancer.

11 . The method of claim 6 , wherein the cancer is a lung cancer.

12 . The method of claim 7 , wherein the cancer is a lung cancer.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2024
From: HAQ, RIZWAN
To: DANA-FARBER CANCER INSTITUTE, INC.
Reel/Frame 067522/0647 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2024
From: FISHER, DAVID
To: THE GENERAL HOSPITAL CORPORATION
Reel/Frame 067522/0825 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 24, 2024
From: SCHOENEN, FRANK
To: UNIVERSITY OF KANSAS
Reel/Frame 067522/0902 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 9, 2024
From: HAQ, RIZWAN
To: DANA-FARBER CANCER INSTITUTE, INC.
Reel/Frame 067049/0531 →
CONFIRMATORY LICENSE Recorded Dec 5, 2023
From: DANA-FARBER CANCER INST
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 065774/0744 →
Continuity (4)
Provisional Application 62935386 · Nov 14, 2019
Provisional Application 62775181 · Dec 4, 2018
Provisional Application 62771429 · Nov 26, 2018
Related Publication 20220128562A1 · Apr 28, 2022
References Cited (11)
US 6406699B1 · Wood · 2002 [cited by applicant]
US 20170334842A1 · Faloon et al. · 2017 [cited by applicant]
US 20220128562A1 · Haq et al. · 2022 [cited by applicant]
WO WO2014201016A2 · 2014 [cited by examiner]
WO WO2020112672A1 · 2020 [cited by applicant]
Faloon et al., “A Small Molecule Inhibitor of the MITF Molecular Pathway.” Probe Reports from the NIH Molecular Libraries Program. Bethesda (MD): National Center for Biotechnology Information (US) (Sep. 18, 2014). [cited by applicant]
Taguchi et al., “The KEAP1-NRF2 system in cancer.” Frontiers in Oncology 7 (2017): 85. [cited by applicant]
Glorieux et al., “Overexpression of NAD(P)H:quinone oxidoreductase 1 (NQO1) and genomic gain of the NQO1 locus modulates breast cancer cell sensitivity to quinones,” Life Sciences, 145:57-65 (2016). [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US19/63072 dated Apr. 9, 2020. [cited by applicant]
Invitation to Pay Additional Fees for International Application No. PCT/US19/63072 dated Feb. 12, 2020. [cited by applicant]
Phillips et al., “Pharmacological and biological evaluation of a series of substituted 1,4-naphthoquinone bioreductive drugs,” Biochemical Pharmacology, 68(11):2107-2116 (2004). [cited by applicant]