TransThera Sciences (HKG:2617) said the US Food and Drug Administration has granted fast-track designation for tinengotinib to treat metastatic castration-resistant prostate cancer (mCRPC), according to a Tuesday Hong Kong bourse filing.
In a phase 1/2 study, the drug showed a 46% objective response rate and 85% disease control rate among 13 mCRPC patients with measurable disease, the filing said.
TransThera said the latest designation reflects consistent clinical execution and supports further development of the drug for advanced prostate cancer.
Shares of the clinical-stage biopharmaceutical firm rose about 3% in recent trade.