Ryvu Therapeutics will present clinical and preclinical data for the RVU120 program, a selective inhibitor of CDK8/19 kinases, during the 65th edition of the American Society of Hematology (ASH) conference, which will be held on December 9-12 this year. in San Diego, United States, the company announced. He estimates that the data “strongly supports” the RVU120 Phase II development plans presented in October this year.
“Updated data from the Phase I study of RVU120 in relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) clinically demonstrate significant benefits in 50% of patients evaluated. Preclinical data support the development of RVU120 as a monotherapy for the treatment of patients with low-risk myelodysplastic syndromes (LR-MDS) and demonstrate cytotoxic and differentiating effects on leukemic stem cells. The published data strongly supports the RVU120 Phase II development plans presented in October this year.” – we read in the announcement.
Based on the presented data and in accordance with previous announcements, the development plan for RVU120 assumes the initiation of phase II studies in patients with AML/HR-MDS (as monotherapy and in combination therapy), with myelofibrosis (MF) and with LR -MDS, as part of the so-called investigator-initiated trial (IIT). Phase II in AML is planned to start in the fourth quarter of 2023, and studies in LR-MDS and myelofibrosis in the first half of 2023. 2024
“At this year’s ASH conference, we are pleased to present updated clinical and preclinical data that highlight the potential of RVU120 in the treatment of hematologic malignancies. RVU120 consistently demonstrates clinical activity as monotherapy in patients with AML and HR-MDS, as well as a well-tolerated safety profile. Notably, several patients achieved bone marrow blast cell reduction, including one complete response. At the same time, in our clinical trial, we observed hematological improvement in several patients. Available clinical and preclinical data strongly support further development of RVU120 for the treatment of patients with LR-MDS and myelofibrosis. Additionally, we obtained evidence that RVU120 has cytotoxic and differentiating effects on leukemic stem cells, which highlights the compound’s potential as a first-line therapy in the treatment of AML,” said board member and medical director Hendrik Nogai, quoted in the material.
Ryvu Therapeutics was founded in 2007 (as Selvita). It is a Polish biotechnology company developing innovative small-molecule compounds with therapeutic potential in oncology. Ryvu Therapeutics is listed on the main market of the WSE; is included in the sWIG80 index.