Krakow, Poland – January 04, 2021 – Ryvu Therapeutics (WSE: RVU), a clinical-stage biotechnology company, focusing on discovery, research and development of novel small molecule drugs that address emerging targets for cancer treatment, announced today that it has submitted a new Clinical Trial Application (CTA), seeking approval to commence a Phase I/II trial, investigating the safety and efficacy of RVU120 (SEL120) in patients with relapsed / refractory metastatic or advanced solid tumors. The CTA has been submitted to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and to the study Central Ethics Committee.
The study is designed in 2 phases. Phase I part has the key objectives of assessing safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RVU120 (SEL120) during dose escalating cohorts, and determination of the recommended phase II dose (RP2D), and the phase II part, subsequently will include specific tumor indications, enrolled at distinct study groups, such as Triple Negative Breast Cancer (TNBC). The study will start in selected investigational sites in Europe, and later on at start of phase II, will expand also to other regions.
RVU120 (SEL120) is a selective CDK8/19 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 RVU120 (SEL120), 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).
“We are excited to be proceeding with an additional track of development of RVU120 (SEL120). With this clinical trial application, we are aiming at a simultaneous clinical development of RYVU120 (SEL120), in both haematological and solid malignancies”, comments Setareh Shamsili, MD, PhD, Chief Medical Officer and EVP at Ryvu Therapeutics.
Following the approval of the CTA, expected in H1 2021, Ryvu Therapeutics will be able to activate the selected clinical sites in Poland and start enrolling patients.
About RVU120 (SEL120)
RVU120 (SEL120) 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 RVU120(SEL120), 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 RVU120 (SEL120) is particularly effective in undifferentiated AML STAT5-positive cancers. Administration of RVU120 (SEL120) 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 RVU120 (SEL120) 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 RVU120 (SEL120), for the treatment of patients with acute myeloid leukemia (AML).
SEL120 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.