Menarini Announces Results from New Preclinical Studies on MEN1611 for the Treatment of Breast Cancer at the 2020 San Antonio Breast Cancer Symposium

POMEZIA, Italy, Dec. 7, 2020 /PRNewswire/ -- Menarini Group announced today that it will present the results of two different preclinical studies on MEN1611, a potent and selective phosphatidylinositol 3-kinase inhibitor (PI3Ki) currently in clinical development for the treatment of breast cancer, at the upcoming 2020 San Antonio Breast Cancer Symposium, which will be held virtually on December 8-11.

"We are pleased to present at the San Antonio Breast Cancer Symposium and look forward to discussing in more detail the encouraging preliminary results achieved by our preclinical studies on MEN1611," commented Andrea Pellacani, General Manager of Menarini Ricerche, R&D Division of the Menarini Group. "This data contributes to a greater understanding of the mechanism of action of MEN1611 and further support its clinical development for the treatment of breast cancer, reinforcing our strong commitment to advancing precision oncology to the benefit of patients living with difficult-to-treat cancer."

MEN1611 is a potent and selective PI3Ki targeting the p110 , and isoforms, while sparing the subunit. B-PRECISE-01 is a multicenter, Phase Ib, dose escalation and expansion study, investigating MEN1611 in patients with HER2-positive, PIK3CA mutated, advanced or metastatic breast cancer.

The poster entitled "MEN1611 is a PI3K / selective and sparing inhibitor with long-lasting antitumor activity in different genetic backgrounds of PIK3CA mutant breast cancer models" presents the results of a preclinical study on the antitumor activity of MEN1611 in p110 - and -dependent tumors, providing evidence that in these animal models MEN1611 is active against HER2-positive, PIK3CA mutated and PTEN-null breast tumor.

A second poster, entitled "MEN1611 promotes immune activating myeloid cell polarization" presents the results of a study aimed at characterizing the effects of MEN1611 on the PI3K isoform, highly expressed in tumor-associated macrophages, to investigate whether the anti-tumor activity of MEN1611 might also be mediated by MEN1611-mediated modulation of tumor inflammatory microenvironment. The results of this study show that MEN1611 inhibition of the PI3K isoform leads to macrophage reprogramming, from an immune-suppressive to an immune-activating phenotype. Moreover, the tumor regression induced by MEN1611 was associated to changes of the inflammatory microenvironment, characterized by an increased recruitment of T cells, which may contribute to the anti-tumor activity of MEN1611 in this model.

About MEN1611

MEN1611 is a potent and selective PI3K inhibitor targeting the p110 , and isoforms, while sparing the subunit. It is an investigational compound, not approved for use by regulatory authorities, currently being evaluated in the B-PRECISE-01 trial ( identifier: NCT03767335), and in the C-PRECISE-01 trial ( identifier: NCT04495621) for the treatment of breast cancer and colorectal cancer, respectively.

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 compounds 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. These assets include ELZONRIS® (tagraxofusp), a targeted therapy directed to CD123, FDA-approved and commercially available in the U.S. for the treatment of adult and pediatric patients, two years and older, with 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 a potential 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 a turnover of EUR3.793 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for oncology, cardiology, gastroenterology, pneumology, infectious diseases, diabetology, inflammation, and analgesia. With 17 production sites and 10 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit

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