Menarini Ricerche Announces Initiation of Cohort Expansion for the Clinical Study of SEL24/MEN1703 in Acute Myeloid Leukemia

First patient treated in Europe into the expansion cohort of Phase I/II DIAMOND-01 trial

POMEZIA, Italy, Sept. 16, 2020 /PRNewswire/ -- Menarini Ricerche, the R&D division of the Menarini Group, announced today that it has treated the first patient in Europe for the cohort expansion part of DIAMOND-01 clinical trial (CLI24-001; NCT03008187) investigating SEL24/MEN1703, a first-in-class, oral dual PIM/FLT3 inhibitor, as the single agent in Acute Myeloid Leukemia (AML). The patient has been dosed into the expansion cohort after the completion of the dose escalation part of the trial, the results of which have been presented at the most recent 25^th Annual Meeting of the European Hematology Association (EHA). The above cohort expansion had already started in the US, with the first patient being treated as of 21 July 2020.

DIAMOND-01 is a first-in-Human, Phase I/II dose escalation and cohort expansion trial of SEL24/MEN1703 in AML – relapsed or refractory as well as previously untreated patients unsuitable for chemotherapy. The expansion cohort, which will be run in major oncology centers both in the US and in Europe (Italy, Spain and Poland) and will enroll patients with relapsed or refractory AML, will further evaluate the single agent activity and the safety profile of SEL24/MEN1703 at the recommended dose as determined in the dose escalation part of the study.

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 new drugs 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, including ELZONRIS® a novel targeted therapy for the treatment of 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 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.

The Menarini Group is a leading international pharmaceutical and diagnostics company, with 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, diabetology, inflammation, and analgesia. With 16 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

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