TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
The IMTB technology platform, enables us to generate antibodies to both non-conserved and conserved proteins, which are difficult to generate in rodents, and to discover hidden epitopes that are challenging to discover using conventional platforms. This allows us to obtain lead candidate antibodies with expanded epitope diversity, differentiated and robust CMC profiles, resulting in selecting candidate molecules with enhanced druggability attributes and intellectual property position. Leveraging this IMTB technology platform, we have generated TST001, TST005, TST003 and TST010. These antibodies are humanized and further optimized using our antibody engineering technologies. In the future, we will be able to bring more effective and affordable biologic therapies to patients.
Our translational research platform enables us to model tumor responses to our investigational agents and to better understand PK/PD profiles, which guides design and conduct of clinical study and evaluates the options of combination therapy with agents targeting different signaling disease pathways. We also have a platform that allows us to screen antibodies for target-detection using immunohistochemistry and to develop immunohistochemistry detection assays for patient selection in clinical trials, which enables us to maximize potential trial success by enrolling patients with a high probability of responding to the drug treatment in selected indications.
Process development plays a critical role throughout biopharmaceutical candidate lifecycle from early discovery all the way to post-marketing surveillance, including target validation, genetic engineering, cell line development, cell culture/purification process development, analytical method development, formulation development and GMP manufacture. In the race to IND filing and clinical trials, companies with deep CMC knowledge and capability often find themselves have an edge over their competitors.
In Transcenta, our CMC team comprises competent SMEs from various functions spanning all aspects of biologics development. Supported by Integrated Continuous Bioprocessing Platform, the flexible modular manufacturing facilities and other cutting-edge technologies, we strike a balance among speed, quality and cost to drive our highly druggable candidates through the pipeline into IND filing and clinical trials.
Leveraging our global expertise and footprint, we adopt a global approach to maximize operational efficiency. Concurrently, we leverage the efficient regulatory approval pathway to accelerate IND applications and early-phase clinical trials in the United States and to advance the execution of clinical trials in the indications with highly unmet medical needs from the large patient population in China. We design the trials that allow clinical data from each trial to be used for pooled analysis and for the use of supporting global registration. In addition, clinical data from multi-regional clinical trials will enable future indication expansion for the drug(s) investigated. Based in Beijing, Shanghai, Guangzhou and Princeton, US, our global clinical development and regulatory teams have extensive knowledge and experience in designing and executing clinical trials at all stages in indications with significantly unmet medical needs globally.