Menarini Ricerche Announces C-PRECISE-01, a New Phase Ib/II Trial of MEN1611 in Colorectal Cancer

Study design presented at the ESMO World Congress on Gastrointestinal Cancer2020

POMEZIA, Italy, July 2, 2020 /PRNewswire/ -- Menarini Ricerche, the R&D division of the Menarini Group, announced today that it plans to launch in the second-half of 2020 a new phase Ib/II trial of MEN1611, a potent and selective orally available phosphatidylinositol 3-kinase inhibitor currently in development for the treatment of breast cancer. The new study, called C-PRECISE-01, will evaluate MEN1611 and cetuximab in patients with PIK3CA mutated, RAS and RAF wild-type metastatic colorectal cancer (mCRC), failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.

The study design will be presented at the virtual 2020 ESMO World Congress on Gastrointestinal Cancer on July [1-4], with the e-poster entitled "C-PRECISE-01 Study: a phase Ib/II trial of MEN1611, a PI3K inhibitor, and cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens".

MEN1611 is an oral PI3K inhibitor active on the p110α, β and γ isoforms, while sparing the δ. Preclinical and clinical evidence supports the development of MEN1611 in combination with other agents in the context of solid tumors. The presence of PIK3CA mutations in mCRC has been reported to correlate with a negative prediction of response to anti-EGFR treatment, making PI3K an attractive therapeutic target. The primary objective of the C-PRECISE-01 study is to determine the combination RP2D and to assess the antitumor activity of MEN1611. Secondary objectives will include the assessment of safety, tolerability and pharmacokinetics profile of MEN1611 in combination with cetuximab.

Andrea Pellacani, General Manager of Menarini Ricerche, commented: "Colorectal cancer is among the most prevalent malignancies in the world, and there is an urgent need to discover new therapeutic options to help CRC patients, especially those with metastatic lesions. The initiation of the C-PRECISE-01 trial will give us the possibility to investigate the potential of MEN1611 in a disease with high medical need, where PIK3CA represents a suitable therapeutic target. This confirms our commitment to advance precision oncology and develop effective healthcare solutions that can make the difference for cancer patients."

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 Inc., 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). 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 €3.8 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 11 Research and Development centers, Menarini's products are available in 136 countries worldwide. For further information please visit www.menarini.com

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