T-1101

T-1101 is a novel small molecule and a first-in-class oral agent for treatment of cancer. It specifically disrupts the interaction between Hec1 and Nek2 which are involved in mitotic regulation of cancer cells. Such disruption leads to downregulation of Nek2, chromosomal misalignment, and cancer cells death which provides a potential cancer therapy.

In in vitro studies, T-1101 shows potent anti-tumor effects in a variety of cancer cell types such as breast, liver, leukemia and colorectal and multidrug resistance protein 1 (MDR1)-driven chemorefractory cancer cell lines. T-1101 also exhibits effective growth inhibitions in xenograft animal models harboring liver and triple negative breast cancer cells. Comparing with marked liver and breast cancer drugs, T-1101 has the advantages of oral administration, cancer targeting and synergy activity when combined with other anticancer drugs such as Doxorubicin, Topotecan and Paclitaxel etc.

T-1101 is developed in capsule form, offering convenient storage and ease of use, which improves patient compliance. The drug has received approval for human clinical trials in both the United States and Taiwan and has completed Phase I clinical trial enrollment in Taiwan. The trial results demonstrated that T-1101 exhibits rapid absorption, favorable safety, and good tolerability with no dose-limiting toxicities (DLTs) observed. The recommended Phase 2 dose (RP2D) has been determined to be 200 mg/day, which can be administered either as 200 mg once daily (QD) or 100 mg twice daily (BID). T-1101 has successfully obtained FDA approval to initiate Phase II clinical trials, focusing on patients with advanced neuroendocrine tumors (NETs) who have failed prior standard treatments.