Adlai Nortye clears Australian regulatory steps for AN4035 phase I trial

Adlai Nortye Ltd. said on August 3, 2026 that it submitted a Clinical Trial Notification to Australia's Therapeutic Goods Administration and received Human Research Ethics Committee approval to begin a phase I trial of AN4035, a CEACAM5-targeting, pan-RAS(ON) inhibitor-based antibody drug conjugate for CEACAM5-enriched, RAS-addicted solid tumors.¹

The global phase I study will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 both as monotherapy and combined with cetuximab¹. The company noted that CEACAM5 is overexpressed in colorectal, pancreatic, and lung cancers, tumor types that frequently carry RAS mutations¹.

Beyond Australia, Adlai Nortye is also filing IND applications for AN4035 with the U.S. FDA and China's NMPA¹. The company said patient dosing with AN4035 is expected to begin in the second half of 2026¹.

On the science, the company described preclinical findings showing nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cancer cell lines along with a bystander killing effect¹, as well as tumor regression in CDX/PDX models, favorable pharmacokinetic properties, and improved tumor selectivity over normal tissue¹.

AN4035 is part of a broader pipeline that includes the oral pan-RAS(ON) inhibitor AN9025, the PD-1/L1 modulating fusion protein AN8025, and the oral PD-L1 inhibitor AN4005¹. The filing constitutes a Form 6-K report of a foreign private issuer, dated August 2026, signed by CEO and Chairman Yang Lu.