Menarini Progresses Into the Clinic With MEN1611, a PI3K Inhibitor for the Treatment of HER2 Positive Metastatic Breast Cancer

POMEZIA,Italy,October 19,2018 -- Menarini Ricerche announced today the initiation of the B-PRECISE-01 clinical trial,a multicenter phase Ib study that will evaluate the safety and efficacy of MEN1611 plus trastuzumab with or without fulvestrant. The study will enroll patients with PIK3CA-mutated,HER2-positive,advanced or metastatic (a/m) breast cancer who have failed anti-HER2 based therapy. MEN1611 is a potent,selective,orally available class I PI3k inhibitor showing high activity against p110α mutant isoforms,and minimal inhibition of the δ isoform. The compound has been in-licensed by Menarini from Chugai Pharmaceuticals in Nov 2016 after the successful completion of the FIH study (PA-799EU),which showed a promising safety profile.

Menarini,in collaboration with a broad network of oncology centers of excellence,including the Memorial Sloan-Kettering Cancer Center (New York,USA) and the Vall d'Hebron Institute of Oncology (Barcelona,Spain),has conducted additional,extensive preclinical investigations using multiple animal models. In these experiments,MEN1611 as single agent and in combination showed anti-tumor activity against a panel of solid cancers where the PI3k mutation has an important,negative impact on prognosis and response to treatment.

The B-PRECISE-01 study of MEN1611 will be conducted in major European oncology sites in Italy,Spain,Belgium,France,UK and The Netherlands. The study is designed to identify the optimal dose of MEN1611 to be administered in combination with trastuzumab with or without fulvestrant,and to collect preliminary evidence of clinical activity in patients with a/m Her2-positive breast cancer. While the B-PRECISE-01 study is on-going,Menarini is committed to expand the clinical investigation of MEN1611 in breast cancer as well as in other solid tumors with high medical need,where PIK3CA represents a suitable therapeutic target.

"Focusing on targeted therapies that can be developed based on precision medicine approaches is a key component of the Menarini strategy in oncology," said Andrea Pellacani,MD,PhD,General Manager of Menarini Ricerche. "The design of the B-PRECISE-01 study focused on a sub-group of patients with high unmet need and selected on the basis of the specific mechanism of action of MEN1611 is completely aligned with our strategy,and strongly confirms our commitment to oncology and precision medicine."

About Menarini

Menarini Group is an Italian pharmaceutical company,13th in Europe out of 5,345 companies,and 35th company in the world out of 21,587 companies,with a turnover of more than 3.6 billion Euro and 17,000 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,namely the anti CD157 antibody MEN1112,and the toxin-conjugated,anti CD205 antibody MEN1309. In addition,Menarini has recently added two small molecules to its oncology pipeline,the dual PIM and FLT3 kinase inhibitor MEN1703,and the PI3K inhibitor MEN1611,in clinical development for the treatment of a variety of hematological and/or solid tumors. 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 Group products are available in 136 countries worldwide.

For further information please visit http://www.menarini.com