SEL24 (MEN1703) Clinical Data from DIAMOND-01 Trial to be Presented at ASCO and EHA Virtual Meetings 2021

SEL24 (MEN1703), a first in class, orally available, dual PIM/FLT3 inhibitor, discovered and initially developed by Ryvu Therapeutics, then licensed out to - and currently developed by - the Menarini Group, is being evaluated in the DIAMOND-01 trial for the treatment of Acute Myeloid Leukemia

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Ryvu Therapeutics

Jun 01, 2021, 05:11 ET

KRAKOW, Poland, June 1, 2021 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU) today announced that the latest results from the DIAMOND-01 clinical trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) will be disclosed through poster presentations at both the upcoming American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) Virtual Congresses, to be held on June 4-8, and June 9-17, respectively.

DIAMOND-01 is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24 (MEN1703), a first in class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini Group from Ryvu Therapeutics, which is currently investigated as single agent for the treatment of patients with Acute Myeloid Leukemia (AML).

In the dose escalation part of DIAMOND-01 trial, SEL24(MEN1703) demonstrated a manageable safety profile up to the recommended dose (RD) of 125 mg/day, along with initial evidence of anti-leukemic activity in a single agent setting.

Data reported in the ASCO and EHA posters refers to the patients enrolled in the Phase II, cohort expansion part of the study, which confirmed the manageable safety profile of the drug at the RD and showed preliminary single agent efficacy in relapsed/refractory AML, particularly in patients with IDH mutant disease either naïve or previously exposed to IDH inhibitors. These results warrant further investigation of SEL24 (MEN1703) in AML, with a potential to focus on the IDH mutated subset.

"We are thrilled to share encouraging results for SEL24 (MEN1703) in treating patients with Acute Myeloid Leukemia," said Dirk Laurent, M.D., Global Therapeutic Area Head – Oncology at Menarini Ricerche, the R&D division of the Menarini Group. "The data, which will be presented in our posters at both ASCO and EHA annual meetings, provides a strong rationale for further clinical development, including the potential to focus on a molecularly defined subset of patients. This accomplishment reflects our sustained commitment to improving the lives of patients with difficult-to-treat cancer and underscores the value of our precision oncology approach."

"We are very happy to see that SEL24 (MEN1703), developed in collaboration with Menarini, continues to build momentum in the clinic demonstrating promising single agent efficacy in a genetically well-defined patient population after earlier encouraging safety and efficacy data in all-comer AML setting" - said Setareh Shamsili, MD, PhD, Chief Medical Officer of Ryvu Therapeutics.

ASCO Poster details

Updated results from DIAMOND-01 (CLI24-001) trial: a Phase I/II study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in acute myeloid leukemia.

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract Code. 7023, Poster presentation

EHA Poster details

Results from DIAMOND-01 (CLI24-001) trial: First in Human Study of SEL24/MEN1703, a dual PIM/FLT3 Kinase Inhibitor, in patients with Acute Myeloid Leukemia

Session: Acute myeloid leukemia - Clinical

Abstract Code: EP455, Poster presentation

About SEL24 (MEN1703)

SEL24 (MEN1703) is a first-in-class, orally available, dual PIM/FLT3 inhibitor in-licensed by Menarini from Ryvu Therapeutics. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187) for the treatment of Acute Myeloid Leukemia.

About Ryvu Therapeutics

Ryvu Therapeutics is a clinical stage drug discovery and development company focused on novel small molecule therapies that address emerging targets in oncology. Internally discovered 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. RVU120 (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. SEL24 (MEN1703) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

The Company was founded in 2007 (until 2019 operating under the name Selvita S.A.) and currently employs over 160 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 is a component of sWIG80 index. For more information, please see www.ryvu.com.

SOURCE Ryvu Therapeutics