Results Confirmed Manageable Safety Profile of SEL24/MEN1703 and Showed Preliminary Efficacy in Relapsed/Refractory Acute Myeloid Leukemia

Data to be Presented at ASCO and EHA Virtual Meetings 2021

Pomezia (Italy) June 1st, 2021 – The Menarini Group announced today that additional data have been generated on SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, as part of the DIAMOND-01 trial. The results will be presented at both the upcoming American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) Virtual Congresses, held on June 4-8, and June 9-17, respectively.

DIAMOND-01 (CLI24-001; clinicaltrials.gov identifier NCT03008187) 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 licensed by Menarini from Ryvu Therapeutics and currently investigated as a single agent for the treatment of patients with Acute Myeloid Leukemia (AML).

In the dose escalation part of the 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 refer to 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 in 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.”

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.
Topic: 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
Topic: 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 Menarini in Oncology
At Menarini, we understand that patients’ hope for a better life is inextricably linked to the progress of scientific and medical research – that is what drives us forward.

Menarini Ricerche is the Menarini Group’s division dedicated to R&D, with a strong commitment to oncology research and development, focused both on therapeutics and diagnostics. We invest in the development of precision medicine through our pipeline of investigational drugs, which includes both small molecules and biologics investigated for the treatment of hematologic and solid tumors. We are also committed to developing innovative technologies for the detection and analysis of circulating tumor cells through the work of Menarini Silicon Biosystems.

The acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company, marked the entry of the Menarini Group into the U.S. biopharmaceutical oncology market and, together with the license agreement reached with Radius Health, strengthened Menarini’s oncology portfolio with the addition of both commercial and clinical-stage assets.

For further information about Menarini’s pipeline, please visit the dedicated page on our website at https://www.menarini.com/en-us/innovation-research/our-pipeline-and-products

About Menarini
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of €3.793 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, gastroenterology, pneumology, infectious diseases, oncology, diabetology, inflammation, and analgesia. With 18 production sites and 10 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit www.menarini.com