By Fineline Cube 
China-headquartered TransThera Sciences (Nanjing) Inc., (HKG: 2617), which listed in Hong Kong this week, announced that it has received fast track designation from the US Food and Drug Administration (FDA) for its self-developed multi-target kinase inhibitor, tinengotinib (TT-00420). The drug is intended for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
Drug Profile
Tinengotinib is an oral small-molecule kinase inhibitor undergoing global Phase III regulatory studies. It works by targeting FGFR/VEGFR, JAK, and Aurora kinases. The drug has demonstrated potential efficacy in various solid tumors, including biliary tract cancer (BTC) and mCRPC.
Clinical Performance
In a Phase I/II monotherapy trial for mCRPC, tinengotinib showed an objective response rate (ORR) of 46% and a disease control rate (DCR) of 85% among 13 patients with measurable lesions. Over 90% of patients experienced tumor shrinkage, with more than 60% achieving greater than 30% tumor reduction. These results were presented at the 2024 ASCO GU (American Society of Clinical Oncology Genitourinary Cancers Symposium).
Regulatory Recognition
The drug has previously received Orphan Drug Designation, Breakthrough Therapy Designation from the FDA, and Orphan Drug Designation from the European Medicines Agency (EMA), underscoring its potential in addressing unmet medical needs.-Fineline Info & Tech