Ryvu Therapeutics Presents Clinical and Translational Data Updates at the 63rd American Society of Hematology Annual Meeting
Current TAP Partner
Krakow, Poland – 13 December 2021 – Ryvu Therapeutics [WSE: RVU], a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today announced updated clinical and preclinical data demonstrating the single-agent activity of its lead oncology drug candidate RVU120 at the 63rd American Society of Hematology Annual Meeting, held December 11 – December 14, 2021, in Atlanta.
Presented data included updated clinical results for RVU120, a selective CDK8/19 inhibitor being developed for the treatment of hematological malignancies and solid tumors. The first-in-human (FIH) Phase 1b dose-escalation trial (CLI120-001), which is currently enrolling patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS), has thus far demonstrated an acceptable safety profile and preliminary signs of efficacy for RVU120.
With a data cutoff of November 16, 2021, data highlights include:
- A Complete Remission (CR) in an AML patient harboring mutations in DNMT3A and NPM1. Supportive translational data were also presented demonstrating the anti-leukemic activity of RVU120 in PDX AML models bearing DNMT3A and NPM1 mutations.
- An erythroid response (ER) in a HR-MDS patient who had relapsed after several lines of previous treatment; as of the data cutoff, this patient remains on study treatment with stable disease for more than 15 months. Supportive translational data were also presented demonstrating that RVU120 induces erythroid differentiation in (Lin-) CD34+ cells.
- Acceptable safety profile in 6 patients completing safety evaluations for cycle 1. None of these patients experienced dose-limiting toxicity (DLT). A total of 12 serious adverse events (SAEs) have been reported – none were deemed to be related to the study drug.
Posters presented at the 63rd ASH Annual Meeting & Exposition included:
- CLI120-001 Phase Ib Study of RVU120 (SEL120) in Patients with AML and High-Risk MDS: Updated Safety/Efficacy Results from Initial Dose Escalation (Publication Number: 3418)
- RVU120 (SEL120) CDK8/19 Inhibitor – a Drug Candidate for the Treatment of MDS Can Induce Erythroid Differentiation (Publication Number: 1518)
- Inhibition of Cyclin Dependent Kinase 8 (CDK8): A Novel Approach to Target the Leukemia Initiating Cells (LICs) in T-Cell Acute Lymphoblastic Leukemia (T-ALL) (Publication Number: 2250)
- Preclinical and Clinical Signs of Efficacy of RVU120 (SEL120), a Specific CDK8/19 Inhibitor in DNMT3A-Mutated AML (Publication Number: 2371)