NANJING, China and GAITHURSBURG, Md., Dec. 21, 2023 /PRNewswire/ — TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announces the first patient has been dosed in the US for the Phase 3 trial FIRST-308 of tinengotinib (TT-00420), an investigational next generation FGFR inhibitor to treat advanced FGFR-altered cholangiocarcinoma（CCA）patients who had progressed on prior systemic therapy and FGFR inhibitors.
This study is a Phase 3, randomized, controlled, global multicenter study to evaluate the efficacy and safety of oral tinengotinib versus physician’s choice in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma. The study is planned to be conducted in the US, the EU, the UK, Asia, and other countries and regions, and the final results will support a global marketing application for tinengotinib.
“We are thrilled to have dosed the first US patient in our Phase 3 trial and appreciate the effort and participation by clinicians and patient. It is also an important indicator of TransThera’s international clinical execution capabilities.” said Jean Fan, M.D., Chief Medical Officer of TransThera Sciences. “We will be committed to advancing the development of tinengotinib that has potential to demonstrate clinical benefit for CCA patients with high unmet medical needs and are looking forward to the progress in FIRST-308 study to bring the novel therapy to CCA patients.”
Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan-Drug Designation and Fast Track Designation by the FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation (BTD) by NMPA in China.
TransThera, including TransThera Sciences (Nanjing), Inc. and TransThera Sciences (US) Inc., is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs via the internal research platform and open innovation. TransThera’s current portfolio covers therapeutic areas such as oncology, inflammatory, and cardiovascular diseases.
For more information, please visit www.transthera.com
This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned.
Source: TransThera Sciences (Nanjing) Inc.