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.
2021 - 6 - 1
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
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
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
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.