Sakigake desig for valemetostat in Japan

June 11, 2019 0 By FM

Daiichi Sankyo announced that valemetostat, an investigational and potential first-in-class EZH1/2 dual inhibitor, has received Sakigake Designation for the treatment of adult patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) by the Japan Ministry of Health, Labour and Welfare (MHLW).

Valemetostat targets epigenetic regulation by inhibiting both the EZH1 (enhancer of zeste homolog 1) and EZH2 enzymes that act through histone methylation to regulate gene expression. Reactivation of the silenced genes results in decreased proliferation of EZH2-expressing cancer cells.

Preclinical research has shown that valemetostat suppressed trimethylation of H3K27 in cells more strongly than EZH2 selective inhibitors. Valemetostat also displayed antitumour activity in various haematological malignancies in preclinical models.

Sakigake Designation was granted based on the preliminary results of an ongoing phase 1 study assessing the safety and efficacy of valemetostat in patients with non-Hodgkin lymphomas (NHL) including PTCLs, which were presented at the 2017 annual meeting of the American Society of Hematology (ASH).

The Sakigake Designation System promotes R&D in Japan, driving early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines.