MEN 1611 is a phosphatidylinositol 3-kinase (PI3K) inhibitor discovered by Chugai and acquired by the Menarini Group at the end of 2016.
PI3K is considered a critical component in the signaling pathway that regulates proliferation, differentiation and survival of tumor cells.
MEN 1611 has been successfully tested in a phase I study for solid tumors in Europe, displaying high selectivity for class I enzyme that may lead to a differentiated profile compared to other PI3K inhibitors.
Technology Transfer of the manufacturing process from Chugai to Menarini is ongoing. Meanwhile, preclinical studies to strengthen the rationale for the selected indications and to support the design of clinical trials are in progress.
The development plan is focused on clearly defined target populations with high unmet medical need, i.e. patients with advanced/metastatic breast cancer and patients with advanced/metastatic colon-rectal cancer harboring PIK3CA mutation.