Ryvu Therapeutics announced updated data from the ongoing Phase 1b dose-escalation study of RVU120 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (HR-MDS) at the Annual European Hematology Association (EHA) 2022 Hybrid Congress, June 9-17 in Vienna, Austria. In addition, Ryvu's partner, Menarini Group, presented a clinical update on the Phase 1/2 study of SEL24 (MEN1703) in patients with IDH1/2-mutated AML. These clinical data support responder hypothesis in a molecularly defined subset of patients with DNMT3A and NPM1 mutations.

Based on the encouraging data, plan to continue dose escalation and further advance the clinical development of RVU120 in both biomarker-selected AML patients and the unselected broader AML population. As of the data cutoff date of May 26, 2022, 16 patients with AML or HR-MDS have been dosed (5 ongoing) with a median of three prior lines of therapy. Clinically meaningful benefit of RVU120 monotherapy has been observed at doses that resulted in less than complete target engagement, with one complete remission (CR) and stable diseases with blast reductions in several ongoing patients who failed multiple prior lines of therapy and presented with a very poor prognosis: Complete remission in an AML patient with FLT3/DNMT3A/NPM1 mutations.

Stable disease with a duration of therapy of more than 18 months in a high-risk MDS patient with DNMT3A mutations; significant reductions in red blood cells (RBC) transfusions at various timepoints. Three additional patients ongoing with stable disease and blast count reductions.