Menarini Ricerche Announces SEL24/MEN1703 Pharmacodynamic Data from the Dose Escalation Part of DIAMOND-01 Trial - Seite 2

The results of this assay confirmed that meaningful target engagement was achieved, both in PB and BM blast cells, in patients treated with SEL24/MEN1703 at 100 mg/day (one dose level below the recommended dose) and at 125 mg/day. Moreover, preliminary data suggest that the PIM/FLT3 pathway inhibition might be associated with blast count reduction, particularly in those patients showing high phosphorylation of S6 at baseline.

We will continue to measure target engagement with this assay in the cohort expansion part of the DIAMOND-01 trial, which is currently recruiting patients with relapsed or refractory AML in both the EU and the US.

About 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

Menarini Ricerche is the Menarini Group's division dedicated to R&D, with a strong commitment to oncology research and development, as well as an active engagement in the infectious disease area, being involved in the fight against the antimicrobial resistance threat, a rising global concern.

As part of its commitment to oncology, Menarini's pipeline includes five investigational compounds for the treatment of a variety of hematological and/or solid tumors: two biologics (the monoclonal antibody anti-CD157 MEN1112/OBT357, and toxin-conjugated anti-CD205 antibody MEN1309/OBT076), and three small molecules (the dual PIM and FLT3 kinase inhibitor SEL24/MEN1703, the PI3K inhibitor MEN1611, and the inhibitor of class I, II, and IV histone deacetylase, Pracinostat). The acquisition of Stemline Therapeutics, a New York-based biopharmaceutical company, strengthened Menarini's oncology portfolio with the addition of both commercial and clinical-stage assets. These assests include ELZONRIS^Ò (tagraxofusp), a targeted therapy directed to CD123, FDA-approved and commercially available in the U.S. for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). Menarini has also entered into a license agreement with Radius Health for the development and commercialization of Elacestrant, an oral SERD in late stage Phase 3 development as a potential hormonal treatment for breast cancer. Through the work of Menarini Silicon Biosystems, Menarini is also developing advanced technologies and products to study rare cells with single-cell precision.