Krakow, Poland – 16 September 2020 – Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, announced today that the first patient has been treated in Europe for the cohort expansion part of Phase II DIAMOND-01 clinical trial (CLI24-001; NCT03008187) investigating SEL24/MEN1703, a first-in-class, oral dual PIM/FLT3 inhibitor, as single agent in Acute Myeloid Leukemia (AML).

Based on the information received from Menarini Ricerche, the sole sponsor of SEL24/MEN1703 clinical trial, the patient has been dosed into the expansion cohort after the completion of the dose escalation part of the trial, which results have been recently presented by Menarini Ricerche, at the 25th Annual Meeting of the European Hematology Association (EHA). The above cohort expansion has already started in the U.S.

DIAMOND-01 is a First-In-Human, Phase I/II dose escalation and cohort expansion trial of SEL24/MEN1703 in AML – relapsed or refractory as well previously untreated – patients unsuitable for chemotherapy. The expansion cohort, will be run in major oncology centers both in the US and in Europe including clinical sites in Italy, Spain and Poland, and will enroll patients with relapsed or refractory AML. The aim of this phase is to further evaluate the single agent activity and the safety profile of SEL24/MEN1703 at the recommended dose, as determined in the dose escalation part of the study.

About SEL24/MEN1703

SEL24/MEN1703 is a clinical stage program discovered and developed by Ryvu Therapeutics and licensed to the Menarini Group. SEL24/MEN1703 is a first-in-class, dual PIM/FLT3 kinase inhibitor with a unique activity profile. By design, this profile may provide responses to treatment that are more durable than current options and address disease that has progressed following FLT3 inhibition. SEL24/MEN1703 is initially being developed for the treatment of patients with relapsed/refractory acute myeloid leukemia. Preclinical data suggests therapeutic potential in other hematological malignancies and in solid tumors. Ryvu has granted the Menarini Group an exclusive worldwide license to further research, develop, manufacture and commercialize SEL24/MEN1703.

More information on the study at: https://clinicaltrials.gov/ct2/show/NCT03008187