First patient dosed in intermittent QW dosing arm with AN9025
Intermittent dosing offers a differentiated approach in the pan-RAS(ON) inhibitor space and may widen the therapeutic window based on preclinical data
Both QD and QW arms are now enrolling
July 16, 2026 -- Adlai Nortye Ltd. (NASDAQ: ANL) (“Adlai Nortye” or the “Company”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that the first patient has been dosed in the United States in the intermittent weekly
“Dosing the first U.S. patient with AN9025 on an intermittent weekly schedule is a significant milestone and advances our clinical strategy to evaluate AN9025 with a differentiated approach. We believe based on our preclinical data that weekly dosing could widen the therapeutic window, enabling higher dosing and/or improving tolerability and combinability by giving normal tissue a break while maintaining tumor RAS-signaling inhibition,” said Dr. Archie Tse, President, Head of Research and Development at Adlai Nortye. “We look forward to efficiently progressing the global clinical development of AN9025 and generating meaningful data to support its future advancement. We continue to plan to share initial Phase 1 dose escalation data in 1H27 from the QD arm, with a potential early look at the QW arm.”
The Phase 1 study is a first-in-human, multicenter, open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AN9025 in patients with advanced or metastatic solid tumors harboring RAS mutations. This trial is being conducted by Adlai Nortye in collaboration with Jiangsu Aosaikang Pharmaceutical Co. Ltd. (“ASK Pharm”) as a multi-regional clinical trial (“MRCT”) pursuant to a license agreement, under which Adlai Nortye retains ex-China rights to AN9025, while ASK Pharm holds rights in mainland China, Hong Kong and Macao. With this announcement, both the QD and QW dose escalation arms are currently enrolling.
AN9025 is an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, designed to target a broad spectrum of RAS mutations across various tumor types. Preclinical studies have demonstrated that AN9025 effectively inhibits RAS-mutant cancers with potent and durable efficacy, including pancreatic, lung, and colorectal adenocarcinomas, and shows comparable or superior results relative to a benchmark agent of the same class.
Adlai Nortye (NASDAQ: ANL) is a global clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The company is building a rich and robust pipeline of drug candidates covering two key therapeutic areas:
1) Precision RAS pathway targeted therapies: including the oral pan-RAS(ON) inhibitor AN9025, and the CEACAM5-targeting ADC AN4035 engineered from the Company's proprietary RASiCA™ (RAS Inhibitor Conjugated Antibody) platform, which efficiently delivers a potent pan-RAS(ON) inhibitor to the tumor site.
2) Next-generation PD-1/L1 pathway modulating immunotherapies: including AN8025, a multi-functional fusion protein that simultaneously modulates T cells and antigen-presenting cells, and AN4005, a first-in-class oral PD-L1 inhibitor.
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