China’s Betta Pharmaceuticals (SHE: 300558) has announced receiving clinical trial approval from the US FDA for its Category 1 drug candidate BPI-460372. The trial will evaluate the drug as a potential treatment for advanced solid tumors, marking a significant milestone in the company’s oncology pipeline.
BPI-460372: Targeting the Hippo Signaling Pathway
BPI-460372 is a novel molecular entity (NME) discovered in-house by Betta Pharmaceuticals. It targets the Hippo signaling pathway, specifically inhibiting the transcriptional enhanced associate domain (TEAD) protein. Preclinical data have shown that BPI-460372 can effectively target the nuclear transcription factor TEAD, inhibiting the transcription and translation of downstream genes. This mechanism of action results in the suppression of tumor cell proliferation, survival, differentiation, and migration.
Preclinical Performance
Preclinical studies have demonstrated that BPI-460372 exhibits strong in vitro and in vivo activities, with excellent pharmacokinetic properties and good safety profiles. These results position the drug candidate as a promising therapeutic option for advanced solid tumors, with the upcoming clinical trial set to further assess its safety and efficacy in patients.-Fineline Info & Tech
