Krakow, Poland – January 18, 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 its Project titled “Clinical development of an innovative drug candidate in solid tumors” has been approved for financing by the National Center for Research and Development (NCBiR) within the Smart Growth Operational Programme 2014-2020, measure 1.1.1. ” Fast Track”.

The goal of the project is to implement into Ryvu business portfolio a new drug candidate – inhibitor of CDK8/19 kinases, evaluated in phase I/II of clinical study (until stage of dose expansion) in patients with solid tumors. The compound should overcome limitations of current treatment options, benefitting patients with most aggressive solid tumors who have exhausted currently available therapeutic options.

• Project net value: PLN 42 696 464;
• Recommended grant financing: PLN 18 939 762.79 which is the total amount of grant financing requested by the Company;
• Project timelines: September 2020 – December 2023.

Earlier this month Ryvu also submitted a Clinical Trial Application for this study to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and to the study Central Ethics Committee.

 

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.