Pomezia, Italy, May 23, 2019 – Menarini Ricerche will present three different projects related to the compounds in clinical development SEL24/MEN1703, MEN1611 and MEN1309/OBT076 at the ASCO Annual Meeting 2019 in Chicago.

During the poster session “Breast Cancer – Metastatic” on June 2nd 2019, 08:00AM- 11:00AM, the poster “B-PRECISE-01 Study: a phase Ib trial of MEN1611, a PI3K Inhibitor, combined with trastuzumab ± fulvestrant for the treatment of HER2-positive advanced or metastatic breast cancer” will be presented.

MEN1611 is a potent, selective class I inhibitor of PI3K, a key enzyme in the transduction of various extracellular growth factor signals essential for cell survival and apoptosis. This poster will report the study design of the Phase Ib B-PRECISE-01 (dose escalation and cohort expansion phases). This study is currently ongoing in Europe, with the objective to select the recommended phase 2 dose and preliminary clinical activity of MEN1611 in combination with trastuzumab +/- fulvestrant (NCT03767335). The correlation of clinical end-points with PIK3CA mutations and other relevant cancer genes mutational status will be also analyzed during the trial.

During the poster session “Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant” on June 3^rd 2019, 08:00AM- 11:00AM, the poster “CLI24-001: First-in-human study of SEL24/MEN1703, an oral dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia” will be presented.

This poster will report the study design of the FIH clinical trial DIAMOND-01 of SEL24/MEN1703 in patients with newly diagnosed Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia and Primary Refractory Acute Myeloid Leukemia and no available therapeutic options (NCT03008187). The main aim of the study, conducted in the US, is the identification of the recommended phase 2 dose. Menarini Ricerche is eager to present this study which is the first trial testing a dual PIM/FLT3 inhibitor in AML regardless of FLT3 mutational status, and with a potential to overcome FLT3 inhibitor resistance.

A third abstract reporting the results from a retrospective evaluation of CD205 expression on tissue samples collected from patients diagnosed with triple negative breast carcinomas, pancreatic adenocarcinomas and bladder urothelial carcinomas will be disclosed by ASCO as e-publication (abstract number for publication e14726). CD205 is the target antigen of MEN1309/OBT076, a humanized IgG1 antibody against CD205, conjugated through a cleavable linker to DM4. MEN1309/OBT076 is currently in phase I in Europe (CD205-SHUTTLE study), recruiting patients affected by solid tumors and Non-Hodgkin Lymphoma (NCT03403725). A second phase I trial conducted by OBT is imminent in the US.

The results of this investigation on the target distribution will be important in supporting the clinical investigation of MEN1309/OBT076 in these tumor types.

The contribution of Menarini Ricerche to ASCO with data related to three compounds in our current pipeline, demonstrates the commitment of Menarini to oncology, and to develop new drugs for patients with difficult to treat cancers and poor prognosis.