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1. Corrigendum

Author

Zhan, Yao, Guo, Jun, Yang, William, Goncalves, Christophe, Rzymski, Tomasz, Dreas, Agnieszka, Zylkiewicz, Eliza, Mikulski, Maciej, Brzozka, Krzysztof, Golas, Aniela, Kong, Yan, Ma, Meng, Huang, Fan, Huor, Bonnie, Guo, Qianyu, da Silva, Sabrina Daniela, Torres, Jose, Cai, Yutian, Topisirovic, Ivan, Su, Jie, Bijian, Krikor, Alaoui-Jamali, Moulay A., Huang, Sidong, Journe, Fabrice, Ghanem, Ghanem E., Miller, Wilson H., Jr., and del Rincon, Sonia V.

Subjects
Health care industry
Abstract

Original citation: J Clin Invest. 2017;127(11):4179-4192. https://doi.org/10.1172/JCI91258. Citation for this corrigendum: J Clin Invest. 2024;134(8):e181338. https://doi.org/10.1172/JCI181338. The authors recently became aware that in the original Figure 2, A and C, [...]

Published
2024
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2. MNK1/2 inhibition limits oncogenicity and metastasis of KIT-mutant melanoma

Author

Zhan, Yao, primary, Guo, Jun, additional, Yang, William, additional, Goncalves, Christophe, additional, Rzymski, Tomasz, additional, Dreas, Agnieszka, additional, Żyłkiewicz, Eliza, additional, Mikulski, Maciej, additional, Brzózka, Krzysztof, additional, Golas, Aniela, additional, Kong, Yan, additional, Ma, Meng, additional, Huang, Fan, additional, Huor, Bonnie, additional, Guo, Qianyu, additional, da Silva, Sabrina Daniela, additional, Torres, Jose, additional, Cai, Yutian, additional, Topisirovic, Ivan, additional, Su, Jie, additional, Bijian, Krikor, additional, Alaoui-Jamali, Moulay A., additional, Huang, Sidong, additional, Journe, Fabrice, additional, Ghanem, Ghanem E., additional, Miller, Wilson H., additional, and del Rincón, Sonia V., additional

Published
2024
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3. Transcriptional Regulation of Protein Synthesis by Mediator Kinase in MYC-driven Medulloblastoma

Author

Wang, Dong, primary, Ritz, Caitlin, additional, Pierce, Angela, additional, Brunt, Breauna, additional, Luo, Yuhuan, additional, Dahl, Nathan, additional, Venkataraman, Sujatha, additional, Danis, Etienne, additional, Kuś, Kamil, additional, Mazan, Milena, additional, Rzymski, Tomasz, additional, Veo, Bethany, additional, and Vibhakar, Rajeev, additional

Published
2024
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4. P986: COMBINATION JAK1/2 AND CDK8/19 INHIBITION DEMONSTRATES ENHANCED EFFICACY IN MYELOPROLIFERATIVE NEOPLASMS

Author

Zaroogian, Zachary, primary, Adamczyk, Elżbieta, additional, Moszyńska, Adrianna, additional, Obacz, Marta, additional, Pakulska, Urszula, additional, Durham, Benjamin, additional, Mazan, Milena, additional, Mowla, Shoron, additional, Wnęk, Katarzyna, additional, Somasundara, Amritha Varshini Hanasoge, additional, Barczuk, Beata, additional, Gołas, Aniela, additional, Levine, Ross, additional, Rzymski, Tomasz, additional, and Rampal, Raajit K, additional

Published
2023
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5. P526: SAFETY AND EFFICACY UPDATE FROM CLI120-001: A PHASE1B DOSE ESCALATION STUDY IN RELAPSE-REFRACTORY ACUTE MYELOID LEUKEMIA AND HIGH-RISK MYELODYSPLASIA

Author

Lech-Marańda, Ewa, primary, Szymańska, Agata, additional, Zaucha, Jan, additional, Borthakur, Gautam, additional, Solomon, Scott, additional, Bradley, Terrence, additional, Mouhayar, Elie, additional, Angelosanto, Noemi, additional, Nogai, Hendrik, additional, Brzozka, Krzysztof, additional, Rzymski, Tomasz, additional, Littlewood, Peter, additional, Kus, Kamil, additional, Dudziak, Renata, additional, Glasmacher, Axel, additional, Burris, Howard, additional, and Abboud, Camille, additional

Published
2023
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7. 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

Author

Rzymski, Tomasz, primary, Sroka-Porada, Agnieszka, additional, Kozakowska, Magdalena, additional, Głowniak-Kwitek, Urszula, additional, Bukowska-Strakova, Karolina, additional, Obacz, Marta, additional, Littlewood, Peter, additional, Kuś, Kamil, additional, Goller, Kristina, additional, Kęska, Kinga, additional, Pakulska, Urszula, additional, Kozłowska-Tomczyk, Kamila, additional, Madej, Monika, additional, Mazan, Milena, additional, Juszczynski, Przemyslaw, additional, Zaucha, Jan M., additional, Zarzycka, Agnieszka, additional, Angelosanto, Noemi, additional, Nogai, Hendrik, additional, and Brzózka, Krzysztof, additional

Published
2022
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8. 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

Author

Garbicz, Filip, primary, Debek, Sonia, additional, Szumera-Ciećkiewicz, Anna, additional, Barankiewicz, Joanna, additional, Komar, Dorota, additional, Pawlak, Michał, additional, Matrejek, Aleksandra, additional, Stuehmer, Thorsten, additional, Salomon-Perzynski, Aleksander, additional, Malenda, Agata, additional, Ostrowska, Julia, additional, Dudkiewicz, Julia, additional, Brzózka, Krzysztof, additional, Rzymski, Tomasz, additional, Bellarosa, Daniela, additional, Lech-Marańda, Ewa, additional, Prochorec-Sobieszek, Monika, additional, Pilch, Zofia, additional, Nowis, Dominika, additional, Golab, Jakub, additional, Tanton, Helen, additional, Hideshima, Teru, additional, Dorfman, David M., additional, Misiewicz-Krzeminska, Irena, additional, Sewastianik, Tomasz, additional, Carrasco, Ruben D., additional, Szydlowski, Maciej, additional, and Juszczynski, Przemyslaw, additional

Published
2022
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9. CDK 8/19 Kinase Inhibitor RVU120 in Patients with AML or Higher-Risk MDS: Safety and Efficacy Results from New Dose Escalation Cohorts

Author

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

Published
2022
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10. Abstract CT131: RVU120 SOL-021: An open-label, single agent, phase I/II trial of RVU120 (SEL120) in patients with relapsed/refractory metastatic or advanced solid tumors

Author

Dziadziuszko, Rafal, primary, Garralda, Elena, additional, Angelosanto, Noemi, additional, Rzymski, Tomasz, additional, Dudziak, Renata, additional, Brzózka, Krzysztof, additional, Littlewood, Peter, additional, Nogai, Hendrik, additional, Glasmacher, Axel, additional, and Lugowska, Iwona, additional

Published
2022
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11. Abstract 2647: RVU120, a selective CDK8/CDK19 inhibitor, demonstrates efficacy against hormone-independent breast cancer cells in vitro and in vivo

Author

Pakulska, Urszula, primary, Obacz, Marta, additional, Gołas, Aniela, additional, Mazan, Milena, additional, Masiejczyk, Magdalena, additional, Stachowicz, Agata, additional, Martyka, Justyna, additional, Combik, Michał, additional, Kęska, Kinga, additional, Wiklik, Katarzyna, additional, Goller, Kristina, additional, Adamczyk, Elżbieta, additional, Brzózka, Krzysztof, additional, and Rzymski, Tomasz, additional

Published
2022
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13. Abstract P5-17-13: Selective CDK8/CDK19 inhibitor RVU120 demonstrates efficacy against hormone-independent breast cancer cells in vitro and in vivo

Author

Rzymski, Tomasz, primary, Gołas, Aniela, additional, Mazan, Milena, additional, Pakulska, Urszula, additional, Masiejczyk, Magdalena, additional, Stachowicz, Agata, additional, Martyka, Justyna, additional, Combik, Michał, additional, Wiklik, Katarzyna, additional, Goller, Kristina, additional, Obacz, Marta, additional, Adamczyk, Elżbieta, additional, and Brzózka, Krzysztof, additional

Published
2022
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14. 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

Author

Paoli, Alessandro, primary, Bellarosa, Daniela, additional, Bressan, Alessandro, additional, Bertolini, Francesco, additional, Solomon, Scott R., additional, Montesinos, Pau, additional, Mukherjee, Sudipto, additional, Strickland, Stephen A, additional, Marconi, Giovanni, additional, Santoro, Armando, additional, Walter, Roland B., additional, Cook, Rachel J., additional, Calbacho, Maria, additional, Vives, Susana, additional, Fazal, Salman, additional, Ravandi, Farhad, additional, Brzozka, Krzysztof, additional, Rzymski, Tomasz, additional, Mazan, Milena, additional, Baldini, Simone, additional, Ravenni, Niccolò, additional, Binaschi, Monica, additional, Laurent, Dirk, additional, and Pellacani, Andrea, additional

Published
2021
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15. CLI120-001 Phase Ib Study of RVU120(SEL120) in Patients with AML and High Risk MDS: Updated Safety/Efficacy Results from Initial Dose Escalation

Author

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

Published
2021
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16. RVU120 (SEL120) CDK8/19 Inhibitor - a Drug Candidate for the Treatment of MDS Can Induce Erythroid Differentiation

Author

Pakulska, Urszula, primary, Obacz, Marta, additional, Goller, Kristina, additional, Combik, Michal, additional, Keska, Kinga, additional, Zaucha, Jan, additional, Zarzycka, Ewa, additional, Mazan, Milena, additional, Mikula, Michal, additional, Cybulska, Magdalena, additional, Polak, Anna, additional, Juszczynski, Przemyslaw, additional, Flygare, Johan, additional, Chen, Jun, additional, Brzozka, Krzysztof, additional, Järås, Marcus, additional, Dziedzic, Katarzyna, additional, Angelosanto, Noemi, additional, Shamsili, Setareh, additional, and Rzymski, Tomasz, additional

Published
2021
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17. Preclinical and Clinical Signs of Efficacy of RVU120 (SEL120), a Specific CDK8/19 Inhibitor in DNMT3A-Mutated AML

Author

Rzymski, Tomasz, primary, Pakulska, Urszula, additional, Abboud, Camille, additional, Burris, Howard A., additional, Solomon, Scott R., additional, Obacz, Marta, additional, Goller, Kristina, additional, Combik, Michal, additional, Zaucha, Jan, additional, Mazan, Milena, additional, Mikula, Michal, additional, Cybulska, Magdalena, additional, Polak, Anna, additional, Juszczynski, Przemyslaw, additional, Järås, Marcus, additional, Chapellier, Marion, additional, Flygare, Johan, additional, Zawadzka, Magdalena, additional, Strakova, Karolina Bukowska, additional, Brzozka, Krzysztof, additional, Shamsili, Setareh, additional, and Angelosanto, Noemi, additional

Published
2021
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19. Novel Clinically Useful Inhibitor of Mediator Complex, RVU120, Relives Differentiation Block in MDS/AML

Author

Ajibade, Opeyemi, Pakulska, Urszula, Rabinovich, Emma, Fromowitz, Ariel, Sahu, Srabani, Aminov, Sarah, Ramachandra, Nandini, Aluri, Srinivas, Gordon Mitchell, Shanisha, Carbajal, Milagros, Keska-Izworska, Kinga, Combik, Michał, Obacz, Marta, Adamczyk, Elżbieta, Zaucha, Jan M., Zarzycka, Ewa, Juszczynski, Przemyslaw, Boultwood, Jacqueline, Pellagatti, Andrea, Pradhan, Kith, Steidl, Ulrich, Shastri, Aditi, Zhao, Rongbao, Mazan, Milena, Rzymski, Tomasz, and Verma, Amit

Published
2023
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20. Safety and Efficacy Results from CLI120-001 a Phase 1 Study in RR-AML and HR-MDS: Update from Higher Dose Levels

Author

Marańda, Ewa Lech, Patkowska, Elżbieta, Jakacka, Natalia, Abboud, Camille N., Burris, Howard A., Solomon, Scott R., Angelosanto, Noemi, Rzymski, Tomasz, Littlewood, Peter, Kuś, Kamil, Sroka-Porada, Agnieszka, Dudziak, Renata, Nogai, Hendrik, Glasmacher, Axel, Bradley, Terrence, Borthakur, Gautam, Mouhayar, Elie, Steckiewicz, Paweł, Kościółek- Zgódka, Sylwia, Szymańska, Agata, and Zaucha, Jan Maciej

Abstract

Background:RVU120, a first-in-class CDK8/19 kinase inhibitor, showed antileukemic activity mediated by inhibition of STAT5 phosphorylation in AML cell lines and patient-derived cells.Clinical activity in a population of patients with relapsed/refractory AML and HR-MDS with poor prognostic factors was shown in a currently ongoing phase 1 dose escalation study (NCT04021368) consistent with the preclinical evidence of both cytotoxic and erythroid and myeloid differentiation effects in cell and mouse models.

Published
2023
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21. Preclinical and Clinical Evidence for Erythroid-Stimulating Activity of RVU120 CDK8/19 Inhibitor in AML and MDS

Author

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

Abstract

Introduction:

Published
2023
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22. Targeting CDK8/CDK19 to Disrupt Leukemic Stem Cell-like Population in Acute Myeloid Leukemia: Exploring RVU120 As a Promising Frontline Therapy

Author

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

Abstract

Leukemic stem cells (LSCs) are implicated in the initiation, maintenance, and relapse of leukemia. The failure of current standard induction chemotherapy, which primarily targets dividing cells, has been linked to the quiescence of LSCs, leading to resistance to treatment. Consequently, there is an urgent need for novel therapies specifically aimed at eradicating LSCs to achieve more effective and durable treatment responses.

Published
2023
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23. CLI120-001 phase1B dose escalation study of RVU120 in patients with AML or high risk MDS -- safety and efficacy data update.

Author

Zaucha, Jan, Abboud, Camille, Borthakur, Gautam, Solomon, Scott, Burris, Howard, Bradley, Terrence, Mouhayar, Elie, Angelosanto, Noemi, Nogai, Hendrik, Glasmacher, Axel, Dudziak, Renata, Brzozka, Krzysztof, Rzymski, Tomasz, Littlewood, Peter, and Lech-Marańda, Ewa

Subjects
AZACITIDINE, ACUTE myeloid leukemia, BLAST injuries, CYCLIN-dependent kinases, FLOW cytometry, STAT proteins, KINASE inhibitors
Abstract

Introduction: CDK8 and its paralog CDK19 have central roles in the maintenance of cancer cell viability and undifferentiated state for a variety of tumor type.1,2RVU120 (SEL120), a first-in-class selective CDK8/CDK19 kinase inhibitor with significant anti-leukemic activity in preclinical AML models, has shown clinical efficacy in a currently ongoing phase 1b trial in patients with relapsed/refractory (R/R) AML or HR-MDS (NCT04021368). Objectives: Primary objective of the study is to determine the preliminary safety profile, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and the recommended phase 2 dose of RVU120 as a single agent. Secondary objectives include pharmacokinetic and pharmacodynamic profile, including in STAT5 phosphorylation changes and pattern of gene expression. Material and methods: CLI120-001 is an open-label dose-escalation study with 3 + 3 design, currently enrolling R/R AML or HR-MDS patients at 5 sites in the US and 2 sites in Poland. RVU120 is administered orally every other day, total of 7 doses, in a 3-week treatment cycle, until disease progression or unacceptable toxicity. Pharmacokinetic (PK) parameters are calculated by non-compartmental analysis. Pharmacodynamic (PD) activity is assessed by flow cytometry measure of pSTAT5 Ser725 levels, (highly dependent on the activity of CDK8 and CDK19 in AML/MDS cells). Results: As per May 26th 2022, 16 pts have been dosed (5 pts ongoing), median age 72 years, median 3 prior lines of therapy, 10/16 received Ven combo prior study entry. RVU120 treatment resulted in notable clinical benefits in some patients: 103-001: U2AF1/DNMT3A/RUNX1//BCOR/STAG2-positive HR-MDS, failing both azacytidine and venetoclax-decitabine remained on trial for more than 18 months with SD and significant reduction of transfusion requirement at different timepoints. 103-002: FLT3//NPM1/DNMT3A-positive AML, relapsing after chemotherapy + midostaurin, gilteritinib, and progressing under venetoclax-decitabine, with skin leukemia and ≥50% of BM blasts at study entry, showed complete clearance of BM blasts by the end of C1, hematologic recovery on C2 and CR (due to resolution of skin leukemia) on C7. 106-002: JAK2 V617F positive AML secondary to PV, progressing on prior venetoclax-azacytidine, showed a 36% decrease of BM blasts from C1 to C6 and is ongoing. 107-002: AML MRC, relapsing after 2 prior intensive chemotherapies, is ongoing with SD for more than 3 months 107-005: TP53 positive AML, relapsing after 2 prior intensive chemotherapy regimens, experienced a 37% reduction of BM blasts at the end of C2 and is currently ongoing at C3. As dose escalation continues, RVU120 showed a favorable safety profile with no DLTs and no drug-related SAEs. In addition, RVU120 was not associated with QT prolongation or myelosuppression. Conclusions: Clinically meaningful benefit of RVU120 monotherapy has been observed, with one CR and disease stabilizations with blast reductions in several ongoing patients who failed multiple prior therapy lines. Initial PD assessments of pSTAT5 inhibition indicate less than complete target inhibition at doses of up to 85 mg. Dose escalation is continuing, and assessment of the 100 mg cohort is currently ongoing. [ABSTRACT FROM AUTHOR]

Published
2022

24. Immunomodulująca rola inhibitorów kinazy CDK8 w chłoniakach DLBCL.

Author

Komar, Dorota, Cysewski, Dominik, Dadlez, Michał, Szumera-Ciećkiewicz, Anna, Krupski, Aleksander, Ostrowska, Julia, Matrejek, Aleksandra, Domagała, Joanna, Serin, Nazli, Winiarska, Magdalena, Szydłowski, Maciej, Chapuy, Bjoern, Rzymski, Tomasz, Brzózka, Krzysztof, and Juszczyński, Przemysław

Abstract

Copyright of Acta Haematologica Polonica is the property of VM Medica-VM Group (Via Medica) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2022

25. Inhibicja kinaz PIM indukuje śmierć komórek szpiczaka plazmocytowego oraz zaburza ich interakcje z komórkami śródbłonka naczyniowego.

Author

Garbicz, Filip, Dębek, Sonia, Szumera-Ciećkiewicz, Anna, Barankiewicz, Joanna, Komar, Dorota, Pawlak, Michał, Matrejek, Aleksandra, Stuehmer, Thorsten, Salomon-Perzyński, Aleksander, Malenda, Agata, Brzózka, Krzysztof, Rzymski, Tomasz, Lech-Marańda, Ewa, Prochorec-Sobieszek, Monika, Tanton, Helen, Dorfman, David M., Misiewicz-Krzemińska, Irena, Sewastianik, Tomasz, Carrasco, Ruben D., and Szydłowski, Maciej

Abstract

Copyright of Acta Haematologica Polonica is the property of VM Medica-VM Group (Via Medica) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2022

26. Inhibiting the MNK1/2-eIF4E axis impairs melanoma phenotype switching and potentiates antitumor immune responses.

Author

Huang F, Gonçalves C, Bartish M, Rémy-Sarrazin J, Issa ME, Cordeiro B, Guo Q, Emond A, Attias M, Yang W, Plourde D, Su J, Gimeno MG, Zhan Y, Galán A, Rzymski T, Mazan M, Masiejczyk M, Faber J, Khoury E, Benoit A, Gagnon N, Dankort D, Journe F, Ghanem GE, Krawczyk CM, Saragovi HU, Piccirillo CA, Sonenberg N, Topisirovic I, Rudd CE, Miller WH Jr, and Del Rincón SV

Published
2024
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27. Transcriptional Regulation of Protein Synthesis by Mediator Kinase in MYC-driven Medulloblastoma.

Author

Wang D, Ritz C, Pierce A, Brunt B, Luo Y, Dahl N, Venkataraman S, Danis E, Kuś K, Mazan M, Rzymski T, Veo B, and Vibhakar R

Abstract

MYC-driven medulloblastoma (MB) is a highly aggressive cancer type with poor prognosis and limited treatment options. Through CRISPR-Cas9 screening across MB cell lines, we identified the Mediator-associated kinase CDK8 as the top dependence for MYC-driven MB. Loss of CDK8 markedly reduces MYC expression and impedes MB growth. Mechanistically, we demonstrate that CDK8 depletion suppresses ribosome biogenesis and mRNA translation. CDK8 regulates occupancy of phospho-Polymerase II at specific chromatin loci facilitating an epigenetic alteration that promotes transcriptional regulation of ribosome biogenesis. Additionally, CDK8-mediated phosphorylation of 4EBP1 plays a crucial role in initiating eIF4E-dependent translation. Targeting CDK8 effectively suppresses cancer stem and progenitor cells, characterized by increased ribosome biogenesis activity. We also report the synergistic inhibition of CDK8 and mTOR in vivo and in vitro . Overall, our findings establish a connection between transcription and translation regulation, suggesting a promising therapeutic approach targets multiple points in the protein synthesis network for MYC-driven MB.

Published
2024
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