Krakow, Poland – January 07, 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, announced today that its Clinical Trial Application (CTA) to commence the First In Human (FIH), Phase I trial investigating SEL120 (RVU120), a selective CDK8/CDK19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (HRMDS), who have failed the prior standard treatment, has been fully approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee.
Following these approvals, Ryvu Therapeutics can expand the clinical trial already ongoing in the United States also in Poland, aiming to assess the safety and tolerability of SEL120 (RVU120), as well as to determine the Recommended Phase II Dose (RP2D) of the study drug, in participants with AML or HRMDS.
“We are very pleased about the prospect of starting Ryvu’s first European clinical trial by obtaining this CTA approval in Poland. We already had the privilege of working with highly experienced Polish researchers at the discovery stage of SEL120 (RVU120) small molecule, and we are very glad to be able to bring now the fruits of our joint investigations to focus on the further development of this compound, also in Poland. We are very much hoping to proceed with the start of the study in Poland smoothly, despite of the current operational challenges induced by COVID-19 pandemics, across the oncology early phase clinical trials” – comments Setareh Shamsili, MD, PhD, Chief Medical Officer and EVP at Ryvu Therapeutics.
About SEL120 (RVU120)
SEL120 (RVU120) is a highly selective first-in-class CDK8/CDK19 inhibitor, which has demonstrated efficacy in a number of solid tumor types in in vitro and in vivo models as well as in onco-hematological malignancies. The first-in-human (FIH) phase I study with SEL120 (RVU120), in relapsed or refractory AML or high-risk myelodysplastic syndromes (HRMDS), is currently enrolling patients in 6 investigational sites in USA (https://clinicaltrials.gov/ct2/show/NCT04021368).
Current translational data suggest that SEL120 (RVU120) is particularly effective in undifferentiated AML STAT5-positive cancers. Administration of SEL120 (RVU120) in orthotopic AML patient derived xenograft models reduced tumor burden to the level undetectable in the peripheral blood, decreased splenomegaly and resulted in partial bone marrow recovery at well tolerated doses, providing therefore a strong rationale for the clinical development of SEL120 (RVU120) as an effective treatment for AML and potentially other hematological malignancies.
On March 25, 2020 the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to SEL120 (RVU120), for the treatment of patients with acute myeloid leukemia (AML).
SEL120 (RVU120) was discovered with the Ryvu Therapeutics discovery engine platform and has received support from The Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers. More information about TAP program is available at: https://www.lls.org/therapy-acceleration-program.