Wednesday, May 26, 2021
TransThera Biosciences Co. Ltd. ( "TransThera" ), a clinical stage biotechnology company dedicated to developing innovative therapeutics across oncology, cardiovascular, and inflammatory diseases with major unmet medical needs globally and in China, today announced that it has entered into a collaboration agreement with Roche to explore the combination of TT-00420 and atezolizumab for the treatment of patients in China with gastrointestinal ("GI") tract cancers. The Investigational New Drug application of the combination therapy has been recently approved by China National Medical Products Administration (NMPA).
GI tract cancers represent one of the most challenging unmet medical needs in China. A lack of effective therapy calls for an emergent need for novel drug development. TT-00420, a unique small molecule kinase inhibitor, has demonstrated preliminary clinical benefits in Cholangiocarcinoma patients and other GI cancer patients in Phase I study. In addition to its targeted therapy attribute, TT-00420 also showed synergistic effect to modulate tumor microenvironment, rendering it a potential partner to checkpoint inhibitors for hard-to-treat solid tumors. Taken together, compelling pre-clinical and clinical data warrant the clinical development of TT-00420 in combination with atezolizumab.
"We are grateful to partner with Roche to tackle the challenge of GI tract cancers affecting people in China. GI cancers represent a huge unmet medical need and we are very excited about the potential of TT-00420 in this field. We are hoping to provide better options for GI cancer patients through the collaboration with Roche in the future", commented by Dr. Peng Peng, Vice President of TransThera in charge of the oncology pipeline development.
TT-00420 is a highly innovative clinical stage spectrum-selective kinase inhibitor that exerts anti-tumor effects by targeting tumor cells and improving the tumor microenvironment. A large number of preclinical studies have found that TT-00420 has an excellent inhibitory effect on triple-negative breast cancer, cholangiocarcinoma and other malignant tumors. In September 2018, TT-00420 was approved by the US FDA for the first human clinical trial; in February 2019, it was approved by China's NMPA for human clinical trials; and on November 7 of the same year, TT-00420 was granted the "Orphan Drug Designation" status (ODD) by FDA for the treatment of cholangiocarcinoma. On November 28, 2020, it was again approved by the US FDA targeting the clinical trial of new indication for cholangiocarcinoma. In March 2021, TransThera announced the completion of a phase I dose escalation clinical trial in China and the United States.
TransThera Biosciences is a clinical-stage biotechnology company dedicated to developing innovative therapeutics to target diseases with major unmet medical needs via internal research platform and open innovation. TransThera's current portfolio covers therapeutic areas such as oncology, cardiovascular, and inflammatory diseases. For more information, please visit www.transtherabio.com.