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
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:
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
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.
+48 784 069 418
Julia Balanova (investors)
+1 646 378 2936
SOURCE Ryvu Therapeutics