IP Library Granted Patent US 12,291,502
Granted Patent B2
US 12,291,502 · App. 17/599,193 · Granted May 6, 2025

Topoisomerase II-alpha inhibitors and methods of treating cancer using the same

Inventors: Daniel V. LaBarbera (Aurora, CO); Qiong Zhou (Aurora, CO); Adedoyin D. Abraham (Aurora, CO)
Assignee: The Regents of the University of Colorado, A Body Corporate
C07D215/14C07D401/12C07D405/04
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,291,502
App. No.
17/599,193
Granted
May 6, 2025
Kind
B2
Abstract

A compound, or a pharmaceutically acceptable salt, solvate or prodrug thereof, having the chemical structure of formula I as defined in the text and methods of using these compounds to inhibit topoisomerase IIα and treat or prevent metastasis of cancer in a subject.

Claims (35)

1. A compound of formula:

or a pharmaceutically acceptable salt, or solvate, thereof,

wherein:

R 1 is —NR 7 CO—R 8 or —CO—NR 7 —R 8 , wherein R 7 is H or C1-C3 alkyl optionally substituted with one or more halogen, hydroxyl, or C1-C3 alkoxy and R 8 is H, or alkyl, or cycloalkyl both optionally substituted with one or more halogen, hydroxyl, C1-C3 alkyl, C1-C3 alkoxy, or heterocyclic optionally substituted with one or more oxo (═O), halogen, hydroxyl, C1-C6 alkyl, C3-C6 cycloalkyl, C1-C6 acyl, C1-C3 haloalkyl, C1-C3 alkoxy, C1-C3 hydroxyalkyl, or heterocyclic;

R 2 , R 3 and R 5 are independently H, halogen, C1-C3 alkyl or OR 9 , wherein R 9 is H or C1-C3 alkyl, where the C1-C3 alkyls are optionally substituted with one or more halogen, hydroxyl, C1-C3 alkoxy or C1-C3 hydroxyalkyl;

R 4 is aryl or heteroaryl, which are optionally substituted with one or more halogen, hydroxyl, C1-C6 alkyl, C3-C6 cycloalkyl, C1-C6 acyl, C1-C3 haloalkyl, C1-C3 alkoxy, C1-C3 hydroxyalkyl, or heterocyclic; and

R 6 is H, —COOR 11 , or —CONR 12 R 13 , wherein R 11 , R 12 , and R 13 are independently alkyl or cycloalkyl each optionally substituted with one or more halogen, hydroxyl, C1-C3 alkyl, C1-C3 alkoxy, or heterocyclic which in turn is optionally substituted with one or more halogen, hydroxyl, C1-C6 alkyl, C3-C6 cycloalkyl, C1-C6 acyl, C1-C3 haloalkyl, C1-C3 alkoxy, C1-C3 hydroxyalkyl, or heterocyclic, or aryl or heterocyclic optionally substituted with one or more halogen, hydroxyl, C1-C6 alkyl, C3-C6 cycloalkyl, C1-C6 acyl, C1-C3 haloalkyl, C1-C3 alkoxy, C1-C3 hydroxyalkyl, or heterocyclic.

2. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 1 is —NR 7 CO—R 8 .

3. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 1 is or —CO—NR 7 —R 8 .

4. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 1 is —NR 7 CO—R 8 , and wherein R 8 is alkyl, or cycloalkyl each of which is optionally substituted with a heterocyclic group which in turn is optionally substituted with one or more halogen, hydroxyl, C1-C6 alkyl, C3-C6 cycloalkyl, C1-C6 acyl, C1-C3 haloalkyl, C1-C3 alkoxy, C1-C3 hydroxyalkyl, or heterocyclic.

5. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 1 is —NHCO—CH 3 .

6. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 8 is alkyl, or cycloalkyl each of which is optionally substituted with a heterocyclic group which is in turn optionally substituted with one or more halogen, hydroxyl, C1-C6 alkyl, C3-C6 cycloalkyl, C1-C6 acyl, C1-C3 haloalkyl, C1-C3 alkoxy, C1-C3 hydroxyalkyl, or heterocyclic.

7. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 2 , R 3 and R 5 are independently, H, halogen, or C1-C3 alkyl.

8. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 6 is H.

9. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein R 4 is a phenyl group substituted with at least one fluorine or is an optionally-substituted heteroaryl group.

10. A compound of chemical structure:

or a pharmaceutically acceptable salt, or solvate, thereof,

wherein:

R 2 is H or OCH 3 ;

R 3 is H or OCH 3 ;

R 4 is phenyl optionally substituted with one or more of halogen, hydroxyl, C1-C6 acyl, or optionally-substituted heterocyclylalkyl; or

R 4 is benzofuranyl, furyl or thienyl each of which is optionally substituted with one or more of halogen, hydroxyl, C1-C3 alkyl or halomethyl;

R 6 is H, or COOH; and

R 8 is H, optionally-substituted C1-C6 alkyl, or optionally-substituted heterocyclylalky.

11. The compound of claim 1 or a pharmaceutically acceptable salt, or solvate thereof, of chemical structure selected from the group consisting of:

12. A pharmaceutical composition comprising at least one topoisomerase IIα (TOP2A) inhibitor compound, pharmaceutically acceptable salt, or solvate thereof, of claim 1 at least one pharmaceutically acceptable additive.

13. A pharmaceutical kit containing a pharmaceutical composition of claim 12 , prescribing information for the composition, and a container.

14. A method for inhibiting TOP2A activity in a subject, including administering to the subject a therapeutically effective amount of a TOP2A inhibitor compound, pharmaceutically acceptable salt or solvate thereof of claim 1 .

15. A method of treating, or ameliorating cancer, or preventing metastasis of a cancer in a subject, comprising administering a therapeutically-effective amount of a compound, pharmaceutically acceptable salt or solvate thereof of claim 1 inhibits TOP2A to a subject in need thereof.

16. The method of claim 15 , wherein the cancer is colorectal cancer, breast cancer, sarcomas, testicular cancer, lung cancer, lymphoma, leukemia, neuroblastoma, or ovarian cancer.

17. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein each of R 2 , R 3 , R 5 and R 6 is H.

18. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 10 , wherein R 2 and R 3 are H.

19. The compound, or pharmaceutically acceptable salt, or solvate thereof, of claim 1 , wherein:

R 4 is a phenyl group which is optionally substituted with one or more fluorine, hydroxyl, C1-C6 alkyl, C3-C6 cycloalkyl, C1-C6 acyl, C1-C3 haloalkyl, C1-C3 alkoxy, or C1-C3 hydroxyalkyl, and which is substituted with at least one fluorine; or

R 4 is benzofuranyl, furyl or thienyl each of which is optionally substituted with one or more of halogen, hydroxyl, C1-C3 alkyl or halomethyl.

Assignments (2)
CONFIRMATORY LICENSE Recorded Jan 26, 2023
From: UNIVERSITY OF COLORADO
To: UNITED STATES GOVERNMENT
Reel/Frame 062512/0803 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 17, 2022
From: LABARBERA, DANIEL V.; ZHOU, QIONG; ABRAHAM, ADEDOYIN D.
To: THE REGENTS OF THE UNIVERSITY OF COLORADO, A BODY CORPORATE
Reel/Frame 060240/0626 →
Continuity (2)
Provisional Application 62827818 · Apr 1, 2019
Related Publication 20230105776A1 · Apr 6, 2023
References Cited (25)
US 9616047B2 · Bode et al. · 2017 [cited by applicant]
US 20010051620A1 · Berger et al. · 2001 [cited by applicant]
US 20080175814A1 · Phiasivongsa et al. · 2008 [cited by applicant]
US 20140309257A1 · LaBarbera · 2014 [cited by applicant]
WO WO2013071306A1 · 2013 [cited by examiner]
Abraham (Dec. 2011) “Design and Synthesis of Novel Topoisomerase Iiα Inhibitors,” Master's degree thesis, University of Colorado Denver, 79 pp. [cited by applicant]
Abraham et al. (Nov. 2019) “Drug Design Targeting T-Cell Factor-Driven Epithelial—Mesenchymal Transition as a Therapeutic Strategy for Colorectal Cancer,” J. Med. Chem. 62, 22, 10182-10203. [cited by applicant]
Bailly (2012) “Contemporary Challenges in the Design of Topoisomerase II Inhibitors for Cancer Chemotherapy,” Chem. Rev. 112:3611-3640. [cited by applicant]
Bates et al. (2011) “The ancestral role of ATP hydrolysis in type II topoisomerases: prevention of DNA double-strand breaks,” Nucleic Acids Res. 39:6327-6339. [cited by applicant]
Chène et al. (2009) “Catalytic inhibition of topoisomerase II by a novel rationally designed ATP-competitive purine analogue,” BMC Chem. Biol. 9:1, doi: 10.1186/1472-6769-9-1. [cited by applicant]
Daumar et al. (2014) “Synthesis and evaluation of [cited by applicant]
International Search Report and Written Opinion dated Jul. 28, 2020 in PCT/US2020/026206, from which the present application claims priority, 15 pp. [cited by applicant]
Jain, et al. (2015) “Selective killing of G2 decatenation checkpoint defective colon cancer cells by catalytic topoisomerase II inhibitor,” Biochimica et Biophysica Ata 1853:1195-1204. [cited by applicant]
Kagaya et al. (2006) “NK314, a novel antitumor agent, induces rapid double strand DNA breaks by specific inhibition of topoisomerase Iiα,” [Abstract 5525] Proc Am Assoc Cancer Res 2006; 47:1299-a. [cited by applicant]
LaBabera et al. (2007) “The Total Synthesis of Neoamphimedine,” J. Org. Chem. 72:8501-8505. [cited by applicant]
Li et al. (2014) “An Improved High Yield Total Synthesis and Cytotoxicity Study of the Marine Alkaloid Neoamphimedine: An ATP-Competitive Inhibitor of Topoisomerase Ilα and Potent Anticancer Agent,” Mar. 12 Drugs, 4833-… [cited by applicant]
Nakahara, et al. “Synthesis of pantherinine, a cytotoxic fused tetracyclic aromatic alkaloid,” Tetrahedron Letters 39(31) :5521-5522 (Abstract Only), (1998). [cited by applicant]
Nitiss (2009) “DNA topoisomerase II and its growing repertoire of biological functions,” Nature Rev. Cancer, 9:327-337. [cited by applicant]
Nitiss (2009) “Targeting DNA topoisomerase II in cancer chemotherapy,” Nature Rev. Cancer, 9:338-350. [cited by applicant]
Ponder et al. (2011) “Neoamphimedine Circumvents Metnase-Enhanced DNA Topoisomerase Iiα Activity Through ATP-Competitive Inhibition,” Mar. 9 Drugs, 2397-2408. [cited by applicant]
Rogojina et al. (Jan. 2012) Chapter 11 Topoisomerase II Inhibitors: Chemical Biology, p. 211-243. [cited by applicant]
Suresh et al. (2003) “A facile approach to dibenzo [b,f][1,6]naphthyridines using Vilsmeier conditions,” Heterocyclic Communications 9(1), 83-88. [cited by applicant]
Toyoda (2008) “NK314, a Topoisomerase II Inhibitor That Specifically Targets the α Isoform,” Journal of Biological Chemistry, 283, 35, 23711-23720. [cited by applicant]
Wei et al. (2005) “Nucleotide-dependent Domain Movement in the ATPase Domain of a Human Type IIA DNA Topoisomerase,” J. Biol. Chem. 280, 37041-37047. [cited by applicant]
Zhou et al. (2016) “Topoisomerase IIα mediates TCF-dependent epithelial—mesenchymal transition in colon cancer,” Oncogene 35:4990-4999. [cited by applicant]