ROME, Italy I September 23, 2019 I Promising results from the preclinical study conducted by Menarini Ricerche on MEN1611, a potent and selective orally available phosphatidylinositol 3-kinase (PI3K) inhibitor currently in development for the treatment of breast cancer. The poster entitled “Characterization of the mechanism of action and efficacy of MEN1611, a novel PI3K inhibitor, in breast cancer preclinical models” will be presented at the ESMO Annual Meeting 2019, which will take place in Barcelona on September 27th, during the poster display session scheduled on September 30th (time 12-13).

The PI3K/AKT signaling pathway is often dysregulated in patients with cancer: about 25% of HER2-positive breast cancers carry PIK3CA gene mutations, known to confer resistance to anti-HER2 therapy (i.e. trastuzumab). This study, conducted in several HER2-positive PIK3CA-mutated breast cancer cell lines and patient-derived xenograft models, shows that MEN1611 is able to down-modulate the PI3K/AKT pathway both in vitro and in vivo, and acts synergistically when combined with trastuzumab; moreover, the in vivo efficacy in trastuzumab-resistant models is demonstrated by a long lasting antitumor activity.

These promising preclinical data, provide a strong rationale for MEN 1611 progression in clinical development in breast cancer patients.  In this regard, the B-Precise-01 clinical trial (NCT03767335), a multicentre phase Ib study, is currently ongoing in Europe with the aim to evaluate the preliminary clinical activity of MEN1611 in combination with trastuzumab +/- fulvestrant, in patients affected by advanced or metastatic HER2-positive breast cancer, and to select the recommended phase 2 dose

This year Menarini Ricerche will be present at ESMO congress also with a dedicated area at the Menarini Silicon Biosystems booth, where it will be possible to get more detailed information about the entire Menarini oncology pipeline and the ongoing clinical trials. Indeed, MEN1611 is part of an innovative pipeline of investigational new drugs focused on precision medicine approaches, that represents the strong and growing commitment of Menarini to oncology and to patients affected by difficult to treat cancers.

About Menarini

Menarini Group is an Italian pharmaceutical company with a turnover of 3.667 billion Euro and more than 17,600 employees. The Menarini Group has always pursued two strategic objectives: research and internationalization, and has a strong commitment to oncology research and development. As part of such commitment to oncology, Menarini, is developing four investigational new oncological drugs. Two of them are biologics, one is the monoclonal antibody anti-CD157 MEN1112/OBT357, and the other is a toxin-conjugated, anti-CD205 antibody MEN1309/OBT076. Other two are small molecules, the dual PIM and FLT3 kinase inhibitor SEL24/MEN1703, and the PI3K inhibitor MEN1611, in clinical development for the treatment of a variety of hematological and/or solid tumors. In addition, Menarini has recently signed a licensing agreement for a small molecule, an inhibitor of class I, II, and IV histone deacetylase, Pracinostat, for the treatment of patients with hematological diseases. The Menarini Group’s commitment to precision oncology is also supported by Menarini Silicon Biosystems’ technologies and products to study rare cells with single-cell precision. The integration of its CELLSEARCH® and DEPArray NxT technologies provides a streamlined solution for the enumeration, isolation, and molecular characterization of circulating tumor cells (CTCs) from a simple blood test in the clinical research setting. This will help drive the clinical utility and correlation of CTCs with the effectiveness of specific therapies.

Menarini is active commercially in the most important therapeutic areas with products for cardiology, gastroenterology, pneumology, infectious diseases, diabetology, inflammation, and analgesia.

With 16 production sites and 7 Research and Development centers, the Menarini Group has a strong presence throughout Europe and Asia, Africa, Central and South America. Menarini’s products are available in 136 countries worldwide.

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SOURCE: Menarini Ricerche