Press Releases

FDA Grants Clearance of IND Application to TransThera Biosciences of TT-00420 for the Treatment of Cholangiocarcinoma

December 02, 2020 – SAN DIEGO, California

Nanjing TransThera Biosciences Co., Ltd. announced on November 30, 2020 that the U.S. Food and Drug Administration (FDA) has granted clearance of the IND application to proceed with the clinical development of its lead product candidate, TT-00420, for the treatment of cholangiocarcinoma (CCA).

TT-00420 initially received IND clearance for a first-in-human phase I clinical study in patients with triple negative breast cancers and advanced solid tumors in September 2018. The global first-in-human clinical trial is currently still ongoing in the U.S. and China, and the trial has expanded to also investigate TT-00420 in patients with cholangiocarcinoma.

In November 2019, TransThera Biosciences also received Orphan Drug Designation for TT-00420 from the Office of Orphan Products Development for the treatment of cholangiocarcinoma.

Dr. Peng Peng, VP of Project Management and head of TransThera’s oncology pipeline stated, “the clearance of this IND for CCA represents another important milestone in the clinical development of TT-00420. TT-00420 has shown encouraging results in preclinical studies and the ongoing first-in-human trial. We look forward to working closely with the clinical sites and regulatory agency to try to tackle this unmet medical need as quickly as possible.”

Dr. Qinhua Cindy Ru, managing director of CRC Oncology stated, “we are very pleased to further our ongoing collaboration with TransThera and look forward to expanding the clinical development of TT-00420.”

About TT-00420

TT-00420 is a novel, spectrum-selective, multiple kinase inhibitor, developed by TransThera Biosciences. A global, phase I, first-in-human trial is currently ongoing to evaluate the safety and tolerability of TT-00420 in patients with advanced solid tumors. More information about this study can be found on, using identifier NCT03654547.

About Cholangiocarcinoma

Cholangiocarcinoma is a rare cancer that forms in the bile ducts with poor prognosis. Common treatment options for cholangiocarcinoma include surgery and chemotherapy, but recurrence is common and disease-free survival time is low. Thus, clinical trials are necessary to develop and evaluate effective therapies for treatment of this disease.

About TransThera Biosciences

TransThera Biosciences, specialized in developing novel NCE drugs, was founded in 2016 in Nanjing, China. It aims to become an innovation platform company with global vision by adopting a novel business model to adapt internal research and open innovation. TransThera’s current portfolio covers therapeutic areas such as oncology and inflammatory diseases.

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About CRC Oncology

CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs.

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