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An open-label, Phase I/II clinical trial of romaciclib (RVU120) as monotherapy and in combination with ruxolitinib in patients with intermediate or high-risk, primary or secondary myelofibrosis (POTAMI-61)

Tomasz Sacha, Marcin Rymko, Katarzyna Dulik, Sebastian Grosicki, Rostislav Kuklík, Adam Falkowski, Nemanja Nikic, Gary Wilkinson, Ewelina Kowalewska, Agnieszka Szymula, Milena Mazan, Agnieszka Sroka-Porada, Tomasz Rzymski, Hendrik Nogai, Marta Sobas, Tomasz Wrobel, Aneta Szudy-Szczyrek

Blood (2025) 146 (Supplement 1): 2045.

https://doi.org/10.1182/blood-2025-2045

Published: 2025

Journal Articles

Preliminary results from RIVER-81, a phase 2 study of romaciclib (RVU120) + venetoclax in patients with acute myeloid leukemia failing first-line venetoclax + hypomethylating agent (HMA)

Blood (2025) 146 (Supplement 1): 3424.

https://doi.org/10.1182/blood-2025-3424

Published: 2025

Journal Articles

Trial in Progress: An Open-Label Clinical Trial of RVU120 As Monotherapy and in Combination with Ruxolitinib in Patients with Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)

Rostislav Kuklík, Adam Falkowski, Zachary Zaroogian, Milena Mazan, Agnieszka Szymula, Gary Wilkinson, Elżbieta Adamczyk, Jerzy Woźnicki, Marta Micek, Diego Coelho, Katarzyna Wiklik, Daniel Grzywczak, Hendrik Nogai, Tomasz Rzymski, Raajit Rampal

Blood (2024) 144 (Supplement 1): 6632.

https://doi.org/10.1182/blood-2024-204897

Published: 2024

Journal Articles

River-52: A Multicenter, Open-Label Clinical Trial of RVU120 in Patients with Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

Cristina Papayannidis, Krzysztof Mądry, Piotr Centkowski, Witold Prejzner, Aleksandra Butrym, Dominik Chraniuk, Chadi Saba, Noemi Angelosanto, Ruth Curley, Hendrik Nogai, Renata Dudziak, Oleksandr Moybenko, Tomasz Rzymski, Milena Mazan, Agnieszka Sroka-Porada, Gary Wilkinson, Eytan M. Stein

Blood (2024) 144 (Supplement 1): 6005.

https://doi.org/10.1182/blood-2024-206906

Published: 2024

Journal Articles

River-81: A Multicenter, Open-Label, Dose-Finding Clinical Trial to Assess Safety, PK, PD, Clinical Efficacy of RVU120 in Combination with Venetoclax in Patients with AML Failing Prior Venetoclax Plus Hypomethylating Agent Therapy

Blood (2024) 144 (Supplement 1): 5999.

https://doi.org/10.1182/blood-2024-200055

Published: 2024

Journal Articles

Preclinical and Clinical Evidence for Erythroid-Stimulating Activity of RVU120 CDK8/19 Inhibitor in AML and MDS

Noemi Angelosanto, Ewa Lech Marańda, Jan Maciej Zaucha, Camille N. Abboud, Agnieszka Sroka-Porada, Wiktoria Ogrodzińska, Magdalena Kozakowska, Urszula Głowniak-Kwitek, Karolina Bukowska-Strakova, Tomasz Rzymski, Milena Mazan, Urszula Pakulska, Kristina Göller, Ewa Zarzycka, Hendrik Nogai

Blood (2023) 142 (Supplement 1): 2800.

https://doi.org/10.1182/blood-2023-189064

Published: 2023

Journal Articles

Targeting CDK8/CDK19 to Disrupt Leukemic Stem Cell-like Population in Acute Myeloid Leukemia: Exploring RVU120 As a Promising Frontline Therapy

Milena Mazan, Urszula Pakulska, Adrianna Moszyńska, Agnieszka Sroka-Porada, Krzysztof Tomasz Szade, Michał Mikula, Magdalena Kozakowska, Przemysław Juszczyński, Katarzyna Wiklik, Kristina Göller, Marta Obacz, Camille N. Abboud, Jan Maciej Zaucha, Ewa Lech Marańda, Noemi Angelosanto, Hendrik Nogai, Tomasz Rzymski

Blood (2023) 142 (Supplement 1): 4175.

https://doi.org/10.1182/blood-2023-188866

Published: 2023

Journal Articles

Safety and Efficacy Results from CLI120-001 a Phase 1 Study in RR-AML and HR-MDS: Update from Higher Dose Levels

Blood (2023) 142 (Supplement 1): 2913.

https://doi.org/10.1182/blood-2023-186620

Published: 2023

Journal Articles

Novel Clinically Useful Inhibitor of Mediator Complex, RVU120, Relives Differentiation Block in MDS/AML

Blood (2023) 142 (Supplement 1): 3225.

https://doi.org/10.1182/blood-2023-186227

Published: 2023

Journal Articles

Multiomics Analysis Confirms Effective Target Engagement for RVU120 - a First-in-Class CDK8/19 Kinase Inhibitor in AML and MR-MDS Patients and Reveals the Mechanism of Action

Blood (2022) 140 (Supplement 1): 5939–5940.

https://doi.org/10.1182/blood-2022-168906

Published: 2022

Journal Articles

CDK 8/19 Kinase Inhibitor RVU120 in Patients with AML or Higher-Risk MDS: Safety and Efficacy Results from New Dose Escalation Cohorts

Camille Abboud, Sr., Jan Maciej Zaucha, Scott R. Solomon, Terrence Bradley, Elie Mouhayar, Noemi Angelosanto, Hendrik Nogai, Renata Dudziak, Tomasz Rzymski, Peter Littlewood, Krzysztof Brzózka, Axel Glasmacher, Gautam Borthakur, Howard A. Burris, Sr., Ewa Lech Marańda

Blood (2022) 140 (Supplement 1): 6228–6229.

https://doi.org/10.1182/blood-2022-163150

Published: 2022

Journal Articles

Super-Enhancer-Driven PIM Kinase Upregulation in Multiple Myeloma Maintains the Plasma Cell-Specific Oncogenic and Microenvironmental Circuits, and Can be Efficiently Targeted By the Pan-PIM Inhibitor MEN1703

Blood (2022) 140 (Supplement 1): 4189–4190.

https://doi.org/10.1182/blood-2022-168770

Published: 2022

Journal Articles

Inhibition of Cyclin Dependent Kinase 8(CDK8): A Novel Approach to Target the Leukemia Initiating Cells (LICs) in T-Cell Acute Lymphoblastic Leukaemia (T-ALL)

Sujan Piya, Huaxian Ma, Sujan Piya, Vivian Ruvolo, Mahesh Basyal, Aniela Golas, Renata Windak, Tomasz Rzymski, Michael Andreeff, Gautam Borthakur

Blood (2021) 138 (Supplement 1): 2250.

https://doi.org/10.1182/blood-2021-148853

Published: 2021

Journal Articles

Preclinical and Clinical Signs of Efficacy of RVU120 (SEL120), a Specific CDK8/19 Inhibitor in DNMT3A-Mutated AML

Blood (2021) 138 (Supplement 1): 2371.

https://doi.org/10.1182/blood-2021-152273

Published: 2021

Journal Articles

RVU120 (SEL120) CDK8/19 Inhibitor - a Drug Candidate for the Treatment of MDS Can Induce Erythroid Differentiation

Blood (2021) 138 (Supplement 1): 1518.

https://doi.org/10.1182/blood-2021-150662

Published: 2021

Journal Articles

CLI120-001 Phase Ib Study of RVU120(SEL120) in Patients with AML and High Risk MDS: Updated Safety/Efficacy Results from Initial Dose Escalation

Camille Abboud, Sr., Gautam Borthakur, Scott R. Solomon, Howard A. Burris, Sr., Terrence Bradley, JAN Maciej Zaucha, Sr., Ewa Lech-Marańda, Krzysztof Brzozka, Tomasz Rzymski, Peter Littlewood, Elie Mouhayar, Setareh Shamsili, Noemi Angelosanto

Blood (2021) 138 (Supplement 1): 3418.

https://doi.org/10.1182/blood-2021-151030

Published: 2021

Journal Articles

SEL24/MEN1703 Inhibits PIM/FLT3 Downstream Target in Acute Myeloid Leukemia (AML) Patients: Results of the Pharmacodynamics (PD) Assay and Genomic Profiling in the First-in-Human Diamond-01 Trial

Blood (2021) 138 (Supplement 1): 3436.

https://doi.org/10.1182/blood-2021-150277

Published: 2021

Journal Articles

PIM Kinase Inhibition Decreases the Proangiogenic Properties of Multiple Myeloma Cells and Affects the Metabolic State of the Vascular Endothelium

Filip Garbicz, MD, Anna Szumera-Ciećkiewicz, MD PhD, Joanna Barankiewicz, MD, Dorota Komar, PhD, Michał Pawlak, PhD, Sonia Dębek, MSc, Aleksandra Matrejek, MSc, Thorsten Stuehmer, PhD, Aleksander Salomon-Perzynski, MD, Agata Malenda, MD PhD, Krzysztof Brzózka, PhD, Tomasz Rzymski, PhD, Andrea Massimiliano Tomirotti, PhD, Ewa Lech-Marańda, MD PhD, Monika Prochorec-Sobieszek, MD PhD, Maciej Szydlowski, PhD, Przemyslaw Juszczynski, MD PhD

Blood (2020) 136 (Supplement 1): 16–17.

https://doi.org/10.1182/blood-2020-134979

Published: 2020

Journal Articles

CDK8 Inhibitors Induce Transcriptional Reprogramming of AML Cells Associated with Differentiation

Milena Mazan, PhD, Marion Chapellier, PhD, Marcus Järås, PhD, Michal Mikula, MD PhD, Eliza Majewska, PhD, Katarzyna Wiklik, PhD, Michal Combik, PhD, Aniela Golas, PhD, Magdalena Masiejczyk, MSc, Elzbieta Fiedor, MSc, Federico Malusa, MSc, Przemyslaw Juszczynski, Prof., MD PhD, Magdalena Cybulska, DVM, Maciej Mikulski, PhD, Jerzy Ostrowski, Prof., MD PhD, Pawel Chrom, MD PhD, Krzysztof Brzózka, PhD, Tomasz Rzymski, PhD

Blood (2019) 134 (Supplement_1): 3774.

https://doi.org/10.1182/blood-2019-128073

Published: 2019

Journal Articles

SEL120 - a First-in-Class CDK8/19 Inhibitor As a Novel Option for the Treatment of Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome - Data from Preclinical Studies and Introduction to a Phase Ib Clinical Trial

Blood (2019) 134 (Supplement_1): 2651.

https://doi.org/10.1182/blood-2019-127835

Published: 2019

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An open-label, Phase I/II clinical trial of romaciclib (RVU120) as monotherapy and in combination with ruxolitinib in patients with intermediate or high-risk, primary or secondary myelofibrosis (POTAMI-61)

Preliminary results from RIVER-81, a phase 2 study of romaciclib (RVU120) + venetoclax in patients with acute myeloid leukemia failing first-line venetoclax + hypomethylating agent (HMA)

Trial in Progress: An Open-Label Clinical Trial of RVU120 As Monotherapy and in Combination with Ruxolitinib in Patients with Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)

River-52: A Multicenter, Open-Label Clinical Trial of RVU120 in Patients with Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

River-81: A Multicenter, Open-Label, Dose-Finding Clinical Trial to Assess Safety, PK, PD, Clinical Efficacy of RVU120 in Combination with Venetoclax in Patients with AML Failing Prior Venetoclax Plus Hypomethylating Agent Therapy

Preclinical and Clinical Evidence for Erythroid-Stimulating Activity of RVU120 CDK8/19 Inhibitor in AML and MDS

Targeting CDK8/CDK19 to Disrupt Leukemic Stem Cell-like Population in Acute Myeloid Leukemia: Exploring RVU120 As a Promising Frontline Therapy

Safety and Efficacy Results from CLI120-001 a Phase 1 Study in RR-AML and HR-MDS: Update from Higher Dose Levels

Novel Clinically Useful Inhibitor of Mediator Complex, RVU120, Relives Differentiation Block in MDS/AML

Multiomics Analysis Confirms Effective Target Engagement for RVU120 - a First-in-Class CDK8/19 Kinase Inhibitor in AML and MR-MDS Patients and Reveals the Mechanism of Action

CDK 8/19 Kinase Inhibitor RVU120 in Patients with AML or Higher-Risk MDS: Safety and Efficacy Results from New Dose Escalation Cohorts

Super-Enhancer-Driven PIM Kinase Upregulation in Multiple Myeloma Maintains the Plasma Cell-Specific Oncogenic and Microenvironmental Circuits, and Can be Efficiently Targeted By the Pan-PIM Inhibitor MEN1703

Inhibition of Cyclin Dependent Kinase 8(CDK8): A Novel Approach to Target the Leukemia Initiating Cells (LICs) in T-Cell Acute Lymphoblastic Leukaemia (T-ALL)

Preclinical and Clinical Signs of Efficacy of RVU120 (SEL120), a Specific CDK8/19 Inhibitor in DNMT3A-Mutated AML

RVU120 (SEL120) CDK8/19 Inhibitor - a Drug Candidate for the Treatment of MDS Can Induce Erythroid Differentiation

CLI120-001 Phase Ib Study of RVU120(SEL120) in Patients with AML and High Risk MDS: Updated Safety/Efficacy Results from Initial Dose Escalation

SEL24/MEN1703 Inhibits PIM/FLT3 Downstream Target in Acute Myeloid Leukemia (AML) Patients: Results of the Pharmacodynamics (PD) Assay and Genomic Profiling in the First-in-Human Diamond-01 Trial

PIM Kinase Inhibition Decreases the Proangiogenic Properties of Multiple Myeloma Cells and Affects the Metabolic State of the Vascular Endothelium

CDK8 Inhibitors Induce Transcriptional Reprogramming of AML Cells Associated with Differentiation

SEL120 - a First-in-Class CDK8/19 Inhibitor As a Novel Option for the Treatment of Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome - Data from Preclinical Studies and Introduction to a Phase Ib Clinical Trial

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