November 06, 2019 – SAN DIEGO, California
Nanjing TransThera Bioscience Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted orphan drug designation to its lead product candidate, TT-00420, for the treatment of cholangiocarcinoma.
Dr. Qinhua Cindy Ru, managing director of CRC Oncology stated, “we are pleased that the FDA has recognized TT-00420’s potential as a treatment option for cholangiocarcinoma. This designation marks another significant regulatory milestone for TT-00420 and for our collaboration with TransThera.”
Dr. Frank Wu, founder and CEO of TransThera commented, “receiving orphan drug status is a great achievement for our lead product, TT-00420. Recognizing its potential to treat cholangiocarcinoma with large unmet medical need, we are excited to accelerate the development of TT-00420 and bring its potential therapeutic benefits to the patients.”
A global phase I study is currently ongoing for TT-00420 in the U.S. and China. A phase Ib/II study in patients with cholangiocarcinoma is anticipated to initiate in 2020.
TT-00420 is a novel, small molecule, 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 ClinicalTrials.gov, using identifier NCT03654547.
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. For more information, please visit www.transtherabio.com.
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. For more information, visit www.crconc.com.