T-1101 is a First-in-Class Hec1/Nek2 inhibitor that disrupts cancer cell cycle division thereby inhibits tumor growth in the body and receives TFDA approval to initiate Phase I clinical study in Taiwan. Patients with advanced tumors have been enrolled into an ongoing open-label, Phase I dose escalation study in Taiwan. Enrollment for this study in Taiwan started in July 2017.
T-1101 acts through disrupting the interaction between Hec1 and Nek2, these proteins involved in mitotic regulation that are highly expressed in cancer cells.
T-1101 demonstrated potent anti-cancer activity across numerous human cancer cell lines and also showed tumor growth inhibition in different mouse xenograft models of human cancers, including liver and triple negative breast cancer. The Phase I clinical trial is to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) to assess the safety and tolerability of T-1101, and also evaluate the pharmacokinetics and the preliminary anti-tumor activities of T-1101.