First patient dosed in Europe within the Expansion Cohort of Phase I/II Clinical Study of SEL24/MEN1703 in Acute Myeloid Leukemia

KRAKOW, Poland, Sept. 16, 2020 /PRNewswire/ -- 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

About Ryvu Therapeutics

Ryvu Therapeutics is a clinical stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology. Pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, immuno-oncology and cancer metabolism targets. SEL120 is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase 1b clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. The second clinical program of Ryvu is SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

Other Ryvu programs developed through internal discovery platform are focused on new oncology targets in kinases, synthetic lethality, immunooncology and immunometabolism.

The company was founded in 2007 (until 2019 operating under the name Selvita S.A.) and currently employs more than 150 associates, including more than 80 PhDs. Ryvu is headquartered in Krakow, Poland. Ryvu Therapeutics is listed on the main market of the Warsaw Stock Exchange, and has been a component of sWIG80 index since March 2017. For more information, please see www.ryvu.
com

Contacts:
Natalia Baranowska (corporate)
+48 784 069 418
natalia.baranowska@ryvu.com

Julia Balanova (investors)
+1 646 378 2936
jbalanova@troutgroup.com

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SOURCE Ryvu Therapeutics

Company Codes: Warsaw:RVU