Shanghai, China, July 7, 2019 – Transcenta Holding, a global biotherapeutics company with fully integrated capabilities in the research, development, regulatory affairs and manufacturing of biologics, today announced that its Death Receptor 5 (DR5) Agonist, an innovative antibody internally named as JCT205, has been cleared by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) to conduct phase I clinical trial in China.

As a third-generation tetravalent agonist, JCT205 can bind to four DR5 receptors simultaneously to form polymerized molecules that trigger tumor cell death. Compared to antibodies of previous generation, JCT205 is uniquely engineered to provide improved safety and efficacy profiles as demonstrated by preclinical data. Specifically, JCT205’s optimized structure is without naturally occuring binding sites sequence for anti-drug antibodies (ADA), enabling it to avoid recognition by antibodies that can pre-exist in human serum as confirmed by screening of human sera from healthy volunteers and cancer patients.

This approval is a milestone for JCT205. Further research will be focused on gastrointestinal tumors including stomach cancer and colorectal cancer and other solid tumors. JCT205’s efficacy and safety profiles will also be monitored to explore its clinical values and advantages. Additionally, Transcenta’s partner InhibRx already initiated phase I clinical trials in the US for JCT205 in December last year.

Transcenta’s Co-founder and Chief Executive Officer Dr. Xueming Qian said, “JCT205 is a third-generation novel nanobody drug against DR5 with innovative structure and excellent preclinical profile. Its clinical trial in the US has already been initiated by our partner last year and we are excited that NMPA has approved the IND in less than 3 months. We will further study its safety, tolerability and efficacy in cancer patients in China as well as its potential for combination use with other products in our pipeline.”

Transcenta’s Co-founder and Executive Chairman Dr. Jonathan Zhao added, “JCT205 is the first product to get IND approval in China since the merger earlier this year. We will accelerate its clinical trials in China and explore its safety, tolerability and efficacy in multiple cancer types to provide an effective treatment for Chinese patients.”