TransThera Sciences (TRANSTHERA-B, 02617) announced the completion of patient enrollment for its global, multicenter, registrational Phase III study evaluating Tinengotinib (TT-00420) monotherapy in advanced cholangiocarcinoma (CCA).

The randomized, controlled trial compares oral Tinengotinib with physician’s choice in CCA patients exhibiting FGFR gene aberrations who have progressed after chemotherapy and a prior FGFR inhibitor. First‐patient‐in was recorded in December 2023, and enrollment has now concluded across sites in the United States, Europe and Asia.

Tinengotinib has received Orphan Drug and Fast Track designations from the U.S. FDA and Orphan Drug designation from the EMA for biliary tract cancer. In China, the therapy is listed for Priority Review and classified as a Breakthrough Therapeutic Drug by the NMPA.

Market data cited in the announcement place the global CCA therapeutics market at USD 2.00 billion in 2024, projected to rise to USD 3.20 billion by 2027. Approximately 25.20% of CCA patients present FGFR alterations, and resistance to existing FGFR inhibitors is common, underscoring the unmet medical need addressed by Tinengotinib.

Discovered in-house, Tinengotinib is a multi-kinase inhibitor targeting FGFR/VEGFR, Aurora A/B and JAK pathways, with ongoing trials in multiple solid tumors. As the first investigational agent to reach the application stage for CCA patients refractory to both chemotherapy and FGFR inhibitors, it offers a potential new late-line treatment option, subject to successful trial outcomes and regulatory approval.

In accordance with Listing Rule 18A.08(3), the company cautions there is no assurance that Tinengotinib will ultimately be successfully developed or commercialized.