TransThera Biosciences Filed the IND Application of TT-00434 to FDA

TransThera Biosciences announces the Investigational New Drug (IND) application of TT-00434 has been submitted to Food and Drug Administration (FDA) in the United States on December 16, 2020. This is the fourth investigational drug developed by the company entering clinical trials.

TT-00434 is a novel, potent and selective inhibitor of Fibroblast Growth Factor Receptor 1/2/3 (FGFR1/2/3). With unique differentiation profile, TT-00434 will be explored in tumors that have no approved therapies.

Alterations in FGFRs are closely related to the occurrence and development of multiple malignancies. For most advanced cancer patients, the treatment option is limited and the survival rate is low. There remains a huge unmet medical need. Alterations in FGFRs also cause the genetic diseases such as achondroplasia, craniosynostosis and others.

“The advancement of TT-00434 into clinical development is another important milestone for TransThera. The kick-off of clinical studies of TT-00434 will mark an important step forward to provide a new therapeutic option for patients in years to come. This is the 4th program discovered and developed by our internal platform since the company was founded 4 years ago, which enriches our existing tumor R&D pipeline and produces strategic synergy. I congratulate the team for the extraordinary team effort and project execution.” Said Dr. Peng Peng, VP of Project Management of TransThera Biosciences.