Cyclin-dependent kinase 8

FDA lifts Partial Clinical Hold on Phase Ib Clinical Trial of RVU120 (SEL120) in Acute Myeloid Leukemia and Myelodysplastic Syndrome

Retrieved on: 
Wednesday, July 14, 2021
Enzymes, Chemical compounds, Branches of biology, Tyrosine kinase receptors, Leukemia, Protein kinase inhibitors, CD135, Cyclin-dependent kinase 8, Tumors of the hematopoietic and lymphoid tissues, Acute myeloid leukemia, Myeloid leukemia, Clonal hypereosinophilia

Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.

Key Points: 
  • Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.
  • The partial clinical hold was issued following Ryvu's recent report to the FDA of a Serious Adverse Event (SAE) involving a patient death that may possibly be related to RVU120.
  • RVU120 is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase 1b clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome.
  • SEL24 (MEN1703) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

Ryvu Therapeutics Receives Orphan Drug Designation From FDA for SEL120 to Treat Acute Myeloid Leukemia

Retrieved on: 
Saturday, March 28, 2020
Chemical compounds, Enzymes, Cancer, Tyrosine kinase inhibitors, Acute myeloid leukemia, Leukemia, CD135, Cyclin-dependent kinase 8, Oncology, Tumors of the hematopoietic and lymphoid tissues, Myeloid leukemia, Entospletinib

KRAKOW, Poland, March 28, 2020 /PRNewswire/ --Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu's SEL120, for the treatment of patients with acute myeloid leukemia (AML).

Key Points: 
  • KRAKOW, Poland, March 28, 2020 /PRNewswire/ --Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Ryvu's SEL120, for the treatment of patients with acute myeloid leukemia (AML).
  • SEL120 is an oral, selective inhibitor of CDK8 kinase which is implicated in the development of hematological malignancies and solid tumors.
  • Orphan drug status (ODD) is intended to advance drug development for rare diseases.
  • SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia.

Ryvu Therapeutics Announces Presentations on CDK8 Inhibitor SEL120 at the 61st ASH Annual Meeting

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Wednesday, November 6, 2019
Enzymes, Cancer, Branches of biology, Leukemia, Acute myeloid leukemia, Tyrosine kinase inhibitors, Cell Cycle, Cyclin-dependent kinase 8, Proteins, CD135, Tumors of the hematopoietic and lymphoid tissues, Oncology

6, 2019 Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that two abstracts have been accepted for presentation at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, FL, taking place from December 7-10, 2019.

Key Points: 
  • 6, 2019 Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that two abstracts have been accepted for presentation at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, FL, taking place from December 7-10, 2019.
  • Details of the poster presentations are as follows:
    Session: 602.
  • SEL120 is a selective CDK8 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome.
  • SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia.

Ryvu Therapeutics to Present at BIO-Europe 2019

Retrieved on: 
Tuesday, November 5, 2019
Enzymes, Chemical compounds, Cancer, Tyrosine kinase inhibitors, Leukemia, CD135, Cyclin-dependent kinase 8, Oncology, Tumors of the hematopoietic and lymphoid tissues, Acute myeloid leukemia, Myeloid leukemia, Entospletinib

KRAKOW, Poland, Nov. 5, 2019 /PRNewswire/ --Ryvu Therapeutics (WSE: RVU) today announced that Pawel Przewiezlikowski, Chief Executive Officer, will present a corporate overview at the following conference in Hamburg, Germany:

Key Points: 
  • KRAKOW, Poland, Nov. 5, 2019 /PRNewswire/ --Ryvu Therapeutics (WSE: RVU) today announced that Pawel Przewiezlikowski, Chief Executive Officer, will present a corporate overview at the following conference in Hamburg, Germany:
    Ryvu Therapeutics is a clinical stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology.
  • Pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, immuno-oncology and cancer metabolism targets.
  • SEL120 is a selective CDK8 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome.
  • SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia.

Selvita Announces U.S. FDA Acceptance of Investigational New Drug Application to Commence Clinical Development of SEL120 in the Treatment of Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Retrieved on: 
Tuesday, March 26, 2019
Enzymes, Cancer, Chemical compounds, Acute myeloid leukemia, Oncogenes, Tyrosine kinase inhibitors, CD135, Cyclin-dependent kinase 8, Tumors of the hematopoietic and lymphoid tissues, Entospletinib, ETV6

The open-label, dose-escalation study is designed to evaluate safety and tolerability of SEL120 as well as to establish the recommended dose of SEL120 for subsequent clinical development.

Key Points: 
  • The open-label, dose-escalation study is designed to evaluate safety and tolerability of SEL120 as well as to establish the recommended dose of SEL120 for subsequent clinical development.
  • SEL120 has received support from the Leukemia & Lymphoma Society Therapy Acceleration Program and is in clinical development for the treatment of acute myeloid leukemia or HR-MDS as initial indications.
  • SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia.
  • SEL120 is a selective CDK8 kinase inhibitor in clinical development for the treatment of acute myeloid leukemia or HR-MDS with potential therapeutic applications in additional hematological cancers and solid tumors.

Selvita to Present Data From Multiple Oncology Programs at AACR 2019 Annual Meeting

Retrieved on: 
Monday, March 4, 2019
Enzymes, Branches of biology, Cell biology, CD135, Cyclin-dependent kinase 8, Tyrosine kinase inhibitors, Piperazines

KRAKOW, Poland, March 4,2019 /PRNewswire/ -- Selvita (WSE: SLV), a clinical stage drug discovery and development

Key Points: 
  • KRAKOW, Poland, March 4,2019 /PRNewswire/ -- Selvita (WSE: SLV), a clinical stage drug discovery and development
    company engaged in the research and development of novel cancer therapies, today announced that data from multiple Selvita oncology programs will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place March 29 to April 3, 2019, in Atlanta.
  • Data presented will include results from the SEL120, CDK8 kinase inhibitor program as well as data from small-molecule STING agonist and dual A2A/A2B adenosine receptors antagonist programs.
  • Selvita is developing novel small molecule therapies that address emerging targets in oncology with industry-leading research expertise supported by a research services division.
  • SEL24 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia.