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TransThera Biosciences Granted IND Approval from FDA to Soon Start Clinical Trials Targeting TNBC

TransThera Biosciences Granted IND Approval from FDA to Soon Start Clinical Trials Targeting TNBC

PR Newswire

NANJING, China, Sept. 28, 2018

NANJING, China, Sept. 28, 2018 /PRNewswire/ -- TransThera Biosciences Co. Ltd, announced today that the company received FDA IND application approval for TT-00420, a novel small molecule investigational drug targeting Triple-Negative Breast Cancer (TNBC).

TT-00420 is a selectively clustered multiple kinase inhibitor with novel dual mechanisms that simultaneously affect the cell cycle and tumor microenvironment.  Its unique profile grants it superior efficacy against certain tumor types such as TNBC in extensive pre-clinical studies. TNBC represents about 15% of all breast cancers. There exists a huge unmet medical need as there is currently no effective target therapy available for treating TNBC.

Dr. Frank Wu, Founder and CEO of TransThera, commented: "We are very pleased to advance TT-00420 into clinical trials and we hope to unleash the value of our breakthrough discovery to bring transformative therapy to our patients." He continued, "TransThera scientists have demonstrated that TT-00420 works not only effectively as a single agent but also synergistically with immuno-checkpoint inhibitors such as PD-1. This opens many exciting avenues to explore its huge potential."  

The company also recently completed the IND application submission to the National Medical Products Administration, the Chinese regulatory agency. The phase I clinical trials are planned to be conducted at clinical sites in both US and China hospitals.

TransThera Biosciences, specializing 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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Last Updated: 28-Sep-2018