A. MENARINI INDUSTRIE
FARMACEUTICHE RIUNITE SRL
Via Sette Santi, 1
50131 - Firenze (Firenze)
Phone +39 055 56801
Fax +39 055 582771
Everyday we put our values into action. 4 values, which have given life to Menarini and shaped its history.
Menarini is investing in advanced science and technology to develop a pipeline of new products that make a difference to the lives of patients affected by serious conditions.
MENARINI is a fully integrated privately owned pharma company with a long and successful heritage in strategic partnering across the globe. We have a profound know-how stemming from our strong R&D capabilities in key therapeutic areas, coupled with our excellence in commercial execution and our powerful direct presence on a global basis.
Our corporate dedicated Business Development team is committed to assess and explore innovative new opportunities.
Donations of backpacks and cases for school, distribution of meals and medicines, promotion of sport, support for pregnant women and much more: being responsible for Menarini means transforming good intentions into concrete efforts. By helping others, we want to contribute to improve the world around us, starting with us.
Discover our stories from all over the world
What does it really make Menarini unique? The diversity and authenticity of our key resource - the People.
Our cultural diversity helps us to drive innovation, adapt to business changes, face challenges, inspire ideas and develop our growth.
Menarini employees make all the difference, every day.
Ogni giorno mettiamo in pratica i nostri valori. 4 valori, che hanno dato vita a Menarini e ne hanno forgiato la storia.
Menarini investe continuamente nella scienza e nelle tecnologie all'avanguardia per lo sviluppo di una pipeline di nuovi prodotti che facciano la differenza nella vita dei pazienti affetti da gravi patologie.
Menarini è un’azienda privata completamente integrata con una lunga storia di collaborazioni di successo in tutto il Mondo.
In Menarini abbiamo una conoscenza ed esperienza consolidata frutto della nostra capacità di Ricerca & Sviluppo nelle aree terapeutiche chiave, accompagnate da un’eccellente presenza capillare in tutto il Mondo.
Il nostro Team dedicato di Business Development è impegnato a valutare ed esplorare nuove opportunità innovative.
Dalla distribuzione di pasti e medicinali, dai kit per andare a scuola alla promozione dello sport all'aiuto per le donne in gravidanza: essere responsabili, per noi di Menarini, significa tradurre le buone intenzioni in sforzi concreti. Aiutando gli altri diamo il nostro contributo a migliorare il mondo che ci circonda, a partire da noi.
Scopri le nostre storie da tutto il mondo
Che cosa rende davvero Menarini unica? La diversità ed autenticità del nostro valore più importante - le Persone.
La nostra diversità culturale ci aiuta a guidare l'innovazione, ad adattarci ai cambiamenti di mercato, ad affrontare le sfide, ad ispirare idee e a promuovere la nostra crescita.
Chi lavora in Menarini fa la differenza, ogni giorno.
2020 - 12 - 1
SEL24/MEN1703 is being Evaluated for the Treatment of Acute Myeloid Leukemia (AML)
Poster Accepted for Presentation at the 62nd American Society of Hematology (ASH) Annual Meeting
Pomezia, Italy, December 1st, 2020 – Menarini Ricerche, the R&D division of the Menarini Group, reported today the positive results of the pharmacodynamic assay demonstrating target engagement in the dose escalation part of the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187), a study investigating SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor as single agent in Acute Myeloid Leukemia (AML).
The poster entitled “SEL24/MEN1703 provides PIM/FLT3 Downstream Pathway Inhibition in Acute Myeloid Leukemia (AML) Blast Cells: Results of the Pharmacodynamic (PD) Assay in the Dose Escalation Part of First-in-Human DIAMOND Trial” will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place virtually on December 5-8.
“We are pleased with the preliminary, positive results observed with SEL24/MEN1703, a PIM/FLT3 inhibitor under investigation for the treatment of AML. As outlined in our ASH poster presentation, the dose escalation phase of the DIAMOND-01 trial showed that SEL24/MEN1703 has a manageable safety profile and results in a meaningful target engagement in peripheral blood and bone marrow blast cells from patients treated with SEL24/MEN1703,” said Andrea Pellacani, General Manager of Menarini Ricerche. “We look forward to continuing our investigation of SEL24/MEN1703 as a potential new treatment for this aggressive and hard-to-treat cancer, as part of our commitment to develop effective innovative therapies that can make a difference in the lives of cancer patients.”
DIAMOND-01 is the First-in-Human, Phase I/II dose escalation and cohort expansion trial of SEL24/MEN1703, in-licensed by Menarini from Ryvu Therapeutics, in AML. The study has completed the dose escalation part showing a manageable safety profile up to the recommended dose of 125 mg/day, with initial evidence of anti-leukemic activity in a single agent setting.
The objective of the pharmacodynamic assessment was to investigate the degree of target engagement achieved at different doses of SEL24/MEN1703, by measuring the phosphorylation of S6 (pS6), a downstream effector of the PIM/FLT3 signaling pathway. In addition, the correlation between pS6 levels and the anti-leukemic effect of SEL24/MEN1703 was assessed in samples collected from patients enrolled in the dose escalation part of the DIAMOND-01 trial. The quantitative assessment of pS6 at a single-cell level was performed both on peripheral blood (PB) and bone marrow (BM) blast cells samples.
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.
Everyday we put our values into action. 4 values, which have given life to Menarini and have shaped its history.
Discover our stories from all over the world
Menarini � un�azienda privata completamente integrata con una lunga storia di collaborazioni di successo in tutto il Mondo.
In Menarini abbiamo una conoscenza ed esperienza consolidata frutto della nostra capacità di Ricerca & Sviluppo nelle aree terapeutiche chiave, accompagnate da un�eccellente presenza capillare in tutto il Mondo.
Il nostro Team dedicato di Business Development � impegnato a valutare ed esplorare nuove opportunità innovative.