Krakow, Poland – 14 May 2020 – Ryvu Therapeutics [WSE:RVU] today announced that abstracts regarding Phase 1/2 study of its selective CDK8 inhibitor SEL120 and dual PIM/FLT3 inhibitor SEL24/MEN1703, accepted for poster presentations at the Virtual 25th Annual European Hematology Association (EHA) Congress, are now available online.
The poster concerning SEL24/MEN1703, is the first report on the successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia: “Results of the dose escalation part of DIAMOND trial (CLI24-001): First-in-human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia”.
The study was initiated in March 2017 and is the first clinical trial testing a dual PIM/FLT3- inhibitor. The dual PIM/FLT3 inhibition of SEL24/MEN1703 suggested its potential to be active in acute myeloid leukemia (AML) regardless of FLT3 status and to overcome FLT3 inhibitor resistance.
The primary objectives of the dose escalation part of the study were the identification of dose limiting toxicities, the determination of the maximum tolerated dose and recommended dose for the phase 2 part of the study, as well as characterization of the pharmacokinetics of SEL24/MEN1703 in AML – relapsed or refractory as well previously untreated – patients unsuitable for chemotherapy.
Throughout the dose escalation part, SEL24/MEN1703 showed an acceptable safety profile up to the recommended dose established at 125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial evidence of single agent efficacy was observed with 1 CR and 1 CRi in elderly patients who had exhausted standard therapeutic options. Cohort Expansion study planned in relapsed/refractory AML patients in the United States and Europe including Poland will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
“The promising results from the dose-escalation phase of the DIAMOND trial provide a strong rationale to progress to the cohort expansion phase of the study” said Dirk Laurent, Global Therapeutic Area Head – Oncology of Menarini Ricerche. “We look forward to further revealing the potential of the SEL24/MEN1703 program to the benefit of AML patients who need innovative and effective therapeutic options”.
“We are thrilled with the initial Phase 1 results for SEL24/MEN1703 reported by Menarini, which demonstrate early signs of single agent efficacy of SEL24/MEN1703 in treatment of patients with AML. We couldn’t be more happy to see that the first drug discovered internally by Ryvu, is showing therapeutic potential in treatment of AML, a disease where patients still face poor prognosis.” – comments Krzysztof Brzozka, PhD, Chief Scientific Officer and Executive VP at Ryvu Therapeutics.
Additional information on the Phase 1/2 study, which is being conducted by Ryvu’s partner Menarini Group, is available at https://clinicaltrials.gov/ct2/show/NCT03008187.
The second poster concerning SEL120, entitled “A First-in-human study of SEL120, a novel oral selective CDK8/19 inhibitor, in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome” (abstract EP636) reports on the current development of the project.
SEL120 is an oral, selective inhibitor of CDK8 kinase which is implicated in the development of hematological malignancies and solid tumors. A clinical phase 1b study of SEL120 is currently enrolling in 6 investigational sites in USA, investigating safety and preliminary efficacy of SEL120 in treatment of patients with relapsed or refractory AML or high-risk myelodysplastic syndrome (HR-MDS).
Current translational data suggest that SEL120 is particularly effective in undifferentiated AML STAT5-positive cancers. Administration of 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 SEL120 as an effective treatment for AML and potentially other hematological malignancies. The SEL120 FIH study is currently recruiting adult patients with relapsed/refractory AML or HR-MDS in the United States and aims to assess safety and tolerability of SEL120.
On March 25, 2020 the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to SEL120, for the treatment of patients with acute myeloid leukemia (AML).
Both poster abstracts can be obtained from conference site: https://ehaweb.org/. Both posters will be presented as an e-Poster presentation and made available on the virtual Congress platform.
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About the 25th EHA Congress
The Annual Congress of EHA is a flagship meeting held in a major European city every June—a significant meeting place for hematologists from every area of specialization. Annual congresses encompass the entire spectrum of hematological studies, where over 11,000 participants who share passion for this field, can learn about the latest findings and innovations. Due to the massive worldwide impact of the COVID-19 crisis, the 25th Congress of the European Hematology Association (EHA) will be replaced by a Virtual Edition: “Unfolding the future!”