T-1101 Receives TFDA Approval for Phase II Clinical Trial, Advancing Development Milestone

Taivex announced that its investigational drug T-1101 has received approval from Taiwan’s Food and Drug Administration (TFDA) to initiate Phase II clinical trials. The study will further evaluate the safety and efficacy of T-1101 in patients with neuroendocrine tumors (NET), supporting the path toward future regulatory filings. T-1101 is a first-in-class oral small-molecule inhibitor targeting Hec1/Nek2, designed to treat advanced, refractory solid tumors. It demonstrated favorable safety and preliminary efficacy in Phase I trials, supporting its potential as a novel therapeutic option. With approvals from both the U.S. FDA and Taiwan TFDA, Taivex will continue working closely with clinical research teams and regulatory authorities to ensure smooth execution and continued advancement of this novel oncology therapy.

The release as fetched from its publisher. taivex.com ↗