KF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemia

Abstract Blast phase chronic myeloid leukemia (BP-CML) poses significant clinical challenges due to its drug resistance, resulting from BCR::ABL1-dependent mutations and BCR::ABL1-independent pathways. Previously, we reported that FLT3 pathway is activated in ~ 50% of BP-CML cases, indicating a pote...

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Main Authors: Hyun-Jin Kwon, Ji Eun Shin, Amir Khan, So Yeon Park, Jiyoung Kim, Jee-Young Lee, Doohyun Lee, Seungyeon Lee, Chun Young Im, Heegyum Moon, Ye Ri Han, Minori Tamai, Koshi Akahane, Takeshi Inukai, Wonhwa Lee, Hyelim Kim, Hong Nam Kim, Sung-Min Ahn, Hyun Woo Park, Dong-Wook Kim
Format: Article
Language:English
Published: BMC 2025-04-01
Series:Molecular Cancer
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Online Access:https://doi.org/10.1186/s12943-025-02292-z
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author Hyun-Jin Kwon
Ji Eun Shin
Amir Khan
So Yeon Park
Jiyoung Kim
Jee-Young Lee
Doohyun Lee
Seungyeon Lee
Chun Young Im
Heegyum Moon
Ye Ri Han
Minori Tamai
Koshi Akahane
Takeshi Inukai
Wonhwa Lee
Hyelim Kim
Hong Nam Kim
Sung-Min Ahn
Hyun Woo Park
Dong-Wook Kim
author_facet Hyun-Jin Kwon
Ji Eun Shin
Amir Khan
So Yeon Park
Jiyoung Kim
Jee-Young Lee
Doohyun Lee
Seungyeon Lee
Chun Young Im
Heegyum Moon
Ye Ri Han
Minori Tamai
Koshi Akahane
Takeshi Inukai
Wonhwa Lee
Hyelim Kim
Hong Nam Kim
Sung-Min Ahn
Hyun Woo Park
Dong-Wook Kim
author_sort Hyun-Jin Kwon
collection DOAJ
description Abstract Blast phase chronic myeloid leukemia (BP-CML) poses significant clinical challenges due to its drug resistance, resulting from BCR::ABL1-dependent mutations and BCR::ABL1-independent pathways. Previously, we reported that FLT3 pathway is activated in ~ 50% of BP-CML cases, indicating a potential avenue for therapeutic intervention via dual inhibition of BCR::ABL1 and FLT3. Here, we aimed to evaluate the efficacy of KF1601, a dual inhibitor of BCR::ABL1 and FLT3, in overcoming drug resistance in BP-CML while also comparing its thrombo-inflammatory responses with those of ponatinib, known to have severe cardiovascular adverse events in human. Our findings revealed that KF1601 effectively inhibited of BCR::ABL1 signaling pathway, even in the presence of the T315I mutation. KF1601 achieved complete tumor regression in K562 xenograft mouse models, and prolonged survival significantly in orthotopic mouse models. Furthermore, KF1601 effectively inhibited the FLT3 signaling pathway in imatinib-resistant K562 cells expressing FLT3 and TAZ, suppressing cell proliferation through dual inhibition of BCR::ABL1 and FLT3. These findings were corroborated using drug-resistant BP-CML cells from patients. In assessing thrombo-inflammatory responses using a murine thrombosis model, ponatinib induced severe responses, leading to carotid artery occlusion and extensive vessel wall damage. In contrast, in mice treated with KF1601, carotid arteries remained unoccluded, with vessel walls preserved intact. In summary, KF1601 demonstrated promising preclinical efficacy in overcoming resistance mechanisms, including the BCR::ABL1T315I mutation, while also addressing FLT3 signaling implicated in BP-CML progression. Unlike existing therapies such as ponatinib, KF1601 offers a favorable safety profile, potentially minimizing the risk of life-threatening adverse effects.
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spelling doaj-art-eb24135d11bf4d5c85ea355aa5e9075a2025-08-20T02:17:57ZengBMCMolecular Cancer1476-45982025-04-012411810.1186/s12943-025-02292-zKF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemiaHyun-Jin Kwon0Ji Eun Shin1Amir Khan2So Yeon Park3Jiyoung Kim4Jee-Young Lee5Doohyun Lee6Seungyeon Lee7Chun Young Im8Heegyum Moon9Ye Ri Han10Minori Tamai11Koshi Akahane12Takeshi Inukai13Wonhwa Lee14Hyelim Kim15Hong Nam Kim16Sung-Min Ahn17Hyun Woo Park18Dong-Wook Kim19ImmunoForge, Co. LtdDepartment of Biochemistry, College of Life Science and Biotechnology, Brain Korea 21 FOUR Program, Yonsei UniversityIcahn School of Medicine at Mount SinaiDepartment of Biochemistry, College of Life Science and Biotechnology, Brain Korea 21 FOUR Program, Yonsei UniversityImmunoForge, Co. LtdDaegu-Gyeongbuk Medical Innovation Foundation, New Drug Development CenterDaegu-Gyeongbuk Medical Innovation Foundation, New Drug Development CenterDaegu-Gyeongbuk Medical Innovation Foundation, New Drug Development CenterDaegu-Gyeongbuk Medical Innovation Foundation, New Drug Development CenterDaegu-Gyeongbuk Medical Innovation Foundation, New Drug Development CenterDepartment of Chemistry, College of Science and Technology, Duksung Women’S UniversityDepartment of Pediatrics, University of YamanashiDepartment of Pediatrics, University of YamanashiDepartment of Pediatrics, University of YamanashiDepartment of Chemistry, Sungkyunkwan UniversityBrain Science Institute, Korea, Institute of Science and Technology (KIST)Brain Science Institute, Korea, Institute of Science and Technology (KIST)ImmunoForge, Co. LtdDepartment of Biochemistry, College of Life Science and Biotechnology, Brain Korea 21 FOUR Program, Yonsei UniversityHematology Department, Eulji Medical Center, Eulji UniversityAbstract Blast phase chronic myeloid leukemia (BP-CML) poses significant clinical challenges due to its drug resistance, resulting from BCR::ABL1-dependent mutations and BCR::ABL1-independent pathways. Previously, we reported that FLT3 pathway is activated in ~ 50% of BP-CML cases, indicating a potential avenue for therapeutic intervention via dual inhibition of BCR::ABL1 and FLT3. Here, we aimed to evaluate the efficacy of KF1601, a dual inhibitor of BCR::ABL1 and FLT3, in overcoming drug resistance in BP-CML while also comparing its thrombo-inflammatory responses with those of ponatinib, known to have severe cardiovascular adverse events in human. Our findings revealed that KF1601 effectively inhibited of BCR::ABL1 signaling pathway, even in the presence of the T315I mutation. KF1601 achieved complete tumor regression in K562 xenograft mouse models, and prolonged survival significantly in orthotopic mouse models. Furthermore, KF1601 effectively inhibited the FLT3 signaling pathway in imatinib-resistant K562 cells expressing FLT3 and TAZ, suppressing cell proliferation through dual inhibition of BCR::ABL1 and FLT3. These findings were corroborated using drug-resistant BP-CML cells from patients. In assessing thrombo-inflammatory responses using a murine thrombosis model, ponatinib induced severe responses, leading to carotid artery occlusion and extensive vessel wall damage. In contrast, in mice treated with KF1601, carotid arteries remained unoccluded, with vessel walls preserved intact. In summary, KF1601 demonstrated promising preclinical efficacy in overcoming resistance mechanisms, including the BCR::ABL1T315I mutation, while also addressing FLT3 signaling implicated in BP-CML progression. Unlike existing therapies such as ponatinib, KF1601 offers a favorable safety profile, potentially minimizing the risk of life-threatening adverse effects.https://doi.org/10.1186/s12943-025-02292-zKF1601Chronic myeloid leukemia (CML)Chronic phase CML (CP-CML)Blast phase CML (BP-CML)Tyrosine kinase inhibitor (TKI)TKI resistance
spellingShingle Hyun-Jin Kwon
Ji Eun Shin
Amir Khan
So Yeon Park
Jiyoung Kim
Jee-Young Lee
Doohyun Lee
Seungyeon Lee
Chun Young Im
Heegyum Moon
Ye Ri Han
Minori Tamai
Koshi Akahane
Takeshi Inukai
Wonhwa Lee
Hyelim Kim
Hong Nam Kim
Sung-Min Ahn
Hyun Woo Park
Dong-Wook Kim
KF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemia
Molecular Cancer
KF1601
Chronic myeloid leukemia (CML)
Chronic phase CML (CP-CML)
Blast phase CML (BP-CML)
Tyrosine kinase inhibitor (TKI)
TKI resistance
title KF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemia
title_full KF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemia
title_fullStr KF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemia
title_full_unstemmed KF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemia
title_short KF1601, a dual inhibitor of BCR::ABL1 and FLT3, overcomes drug resistance in FLT3+ blast phase chronic myeloid leukemia
title_sort kf1601 a dual inhibitor of bcr abl1 and flt3 overcomes drug resistance in flt3 blast phase chronic myeloid leukemia
topic KF1601
Chronic myeloid leukemia (CML)
Chronic phase CML (CP-CML)
Blast phase CML (BP-CML)
Tyrosine kinase inhibitor (TKI)
TKI resistance
url https://doi.org/10.1186/s12943-025-02292-z
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