Adlai Nortye 的 AN4035 获澳洲伦理批准进入 I 期临床

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SINGAPORE and NORTH BRUNSWICK, N.J. - Adlai Nortye Ltd. (NASDAQ:ANL) received approval from Australia’s Human Research Ethics Committee to begin a phase I clinical trial of AN4035, an antibody drug conjugate for treating certain solid tumors, according to a press release statement.
The company submitted a Clinical Trial Notification to Australia’s Therapeutic Goods Administration and obtained the necessary ethics committee clearance. AN4035 targets CEACAM5 and delivers a pan-RAS(ON) inhibitor payload designed to treat CEACAM5-enriched RAS-addicted solid tumors.
The global phase I trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AN4035 as a single treatment and in combination with cetuximab. The trial will enroll patients with CEACAM5-enriched, RAS-addicted solid tumors. CEACAM5 is overexpressed in colorectal, pancreatic and lung cancers that frequently harbor RAS mutations.
Adlai Nortye is also filing investigational new drug applications with the U.S. Food and Drug Administration and China National Medical Products Administration. Patient dosing is expected to begin in the second half of 2026.
"AN4035 is a first-in-class CEACAM5-targeting ADC armed with a pan-RAS(ON) inhibitor payload," said Dr. Archie Tse, President and Head of Research & Development.
In preclinical studies, AN4035 demonstrated nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cancer cell lines and showed anti-tumor activity in CDX/PDX models.
Adlai Nortye is a clinical-stage biotechnology company developing cancer therapies, including RAS pathway targeted therapies and PD-1/L1 pathway immunotherapies.
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