Adlai Nortye Announces First Patient Enrolled in Global Phase 1 Trial of Pan-RAS (ON) Inhibitor AN9025 for Solid Tumors Harboring RAS Mutations

Core Viewpoint - Adlai Nortye Ltd. has initiated dosing of the first patient in the U.S. for its Phase 1 clinical trial of AN9025, a pan-RAS (ON) inhibitor, marking a significant milestone in its clinical development strategy [1][3]. Group 1: Clinical Trial Details - The Phase 1 study is a first-in-human, multicenter, open-label trial aimed at assessing the safety, tolerability, pharmacokinetics, and anti-tumor activity of AN9025 in patients with advanced or metastatic solid tumors that have RAS mutations [2]. - This trial is being conducted in collaboration with Jiangsu Aosaikang Pharmaceutical Co. Ltd. as a multi-regional clinical trial, with Adlai Nortye retaining ex-China rights to AN9025 [2]. Group 2: Product Information - AN9025 is an oral small molecule pan-RAS(ON) inhibitor designed to target a wide range of RAS mutations across various tumor types, showing potent and durable efficacy in preclinical studies against pancreatic, lung, and colorectal adenocarcinomas [4]. - The drug demonstrates comparable or superior results relative to benchmark agents in the same class, indicating its potential as a best-in-class therapy [4]. Group 3: Company Overview - Adlai Nortye is a global clinical-stage biotechnology company focused on discovering and developing innovative cancer therapies, with a dual R&D presence in the U.S. and China [5]. - The company is building a robust pipeline that includes next-generation cancer immunotherapies and RAS-targeting therapies, with candidates such as AN8025 and AN4035 alongside AN9025 [5].