U-01 is under clinical development by Shanghai Unicar-Therapy Bio-Medicine Technology and currently in Phase II for Relapsed Acute Myeloid Leukemia. According to GlobalData, Phase II drugs for Relapsed Acute Myeloid Leukemia have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how U-01’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

U-01 overview

U-01 is under development for the treatment of B cell acute lymphocytic leukemia, relapsed or refractory acute lymphoblastic leukemia, and relapsed/refractory acute myeloid leukemia. The drug candidate consists of chimeric antigen receptor (CAR) modified T-cells which act by targeting CD19 expressing cancer cells. It is developed based on SMART(siRNA mediated acquired reprogramming technology) platform. It was under development for Hodgkin Lymphoma, non Hodgkin lymphoma and chronic lymphocytic leukemia.

Shanghai Unicar-Therapy Bio-Medicine Technology overview

Shanghai Unicar-Therapy Bio-Medicine Technology., is a pharmaceutical company and a tumor immunotherapy technology developer. The company is headquartered China.

For a complete picture of U-01’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.