Core Viewpoint - JingTai Technology (02228) announced a significant clinical development milestone for the next-generation PRMT5 inhibitor PEP08, which has received clinical trial approvals from regulatory bodies in Australia and Taiwan, marking the initiation of Phase I clinical trials [1][3]. Group 1: Clinical Development - PEP08 has achieved important clinical research milestones, receiving approvals from the Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA) in Australia, as well as the Taiwan Food and Drug Administration (TFDA) [1]. - The project has led to milestone payments for JingTai Technology, confirming the progress made in collaboration with PharmaEngine, Inc. [1][3]. Group 2: Drug Characteristics - PRMT5 is a key enzyme overexpressed in various cancers, and inhibiting its activity can lead to a "synthetic lethality" effect in tumors with homozygous deletion of MTAP, which accounts for approximately 10-15% of human cancers [1]. - PEP08, as a second-generation PRMT5 inhibitor, exhibits high activity and selectivity, forming a stable ternary complex with PRMT5 through an MTA cooperative binding mode, specifically targeting MTAP-deficient tumor cells while minimizing effects on normal cells [2]. Group 3: Preclinical Research and Efficacy - Preclinical data indicate that PEP08 shows significant advantages in toxicity and safety compared to first-generation non-selective PRMT5 inhibitors, with good blood-brain barrier penetration and ideal overall drug-like properties [3]. - PEP08 demonstrates strong in vivo efficacy at lower doses in multiple animal efficacy models, showcasing potential best-in-class effects and broad potential for combination with other therapies [3].
晶泰科技助力智擎生技新一代“合成致死”新药获临床实验审批 AI制药再迎里程碑