Adlai starts AN4035 cancer trial
- Adlai Nortye dosed the first Australian patient in a global Phase I trial of AN4035, an antibody-drug conjugate targeting CEACAM5-positive solid tumors.
- The trial has received regulatory clearance in Australia and a U.S. FDA IND Study-May-Proceed letter allowing expansion into the United States.
- Adlai Nortye expects full Phase Ia data from the study in the second half of 2027.
Adlai Nortye (NASDAQ:ANL) dosed the first patient in Australia in a global Phase I trial evaluating AN4035, an antibody-drug conjugate designed to treat CEACAM5-enriched RAS-addicted solid tumors.
The trial began after regulatory clearance in Australia and a U.S. FDA investigational new drug Study-May-Proceed letter, allowing the company to expand the study into the United States.
The Phase I study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 as a standalone treatment and in combination with cetuximab.
AN4035 uses the company’s RAS Inhibitor Conjugated Antibody (RASiCA™) platform to deliver a pan-RAS(ON) inhibitor payload to CEACAM5-expressing tumors, with the goal of limiting effects on non-target tissues.
Adlai Nortye develops oncology therapies focused on targeted drug delivery approaches, including antibody-drug conjugates and treatments designed for genetically defined cancer populations.
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