Taivex received US FDA Investigational New Drug Application (IND) Approval for T-1101 capsule on Nov. 2021, to initiate phase I clinical trial.
T-1101: T-1101 acts through disrupting the interaction between Hec1 and Nek2 to leads to tumor cells apoptosis. T-1101 demonstrated potent anti-cancer activity in different mouse xenograft models of human cancers, including liver and triple negative breast cancer.
In the previous clinical study (TAI-001 under USFDA IND 127330), T-1101 was prepared as OPC (oral powder for constitution) formulation and evaluated in the subjects with advance solid tumor for drug tolerability and pharmacokinetics. The study results indicated that T-1101 was rapidly absorbed and tolerated at current dose levels. For better patient compliance and a more marketable product, T-1101 formulation has been optimized as conventional dry powder gelatin capsules for further clinical investigation in cancer patients (Study TAI-003).