Adlai Nortye Group Ltd. (NASDAQ: ANL) announced it has dosed the first patient in a global Phase I clinical trial for its investigational drug candidate AN4035, initiating studies in Australia with plans to expand into the United States.
AN4035 is an antibody-drug conjugate that targets CEACAM5 and carries a pan-RAS(ON) inhibitor payload, developed using the company's RAS Inhibitor Conjugated Antibody platform. The trial will enroll patients with CEACAM5-enriched, RAS-addicted solid tumors — cancers including colorectal, pancreatic, and lung types that frequently harbor RAS mutations.
The global Phase I study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 both as a monotherapy and in combination with cetuximab.
Regulatory momentum has accelerated on multiple fronts. The U.S. Food and Drug Administration issued a "Study-May-Proceed" letter on the company's investigational new drug application, clearing the way for the trial to extend into the United States. Separately, Adlai Nortye received regulatory clearance to begin the study in Australia last month and plans to file an IND application with China's National Medical Products Administration.
Preclinical data showed AN4035 demonstrated cytotoxicity in CEACAM5-positive, RAS-addicted cancer cell lines and produced anti-tumor activity with tumor regression in CEACAM5-positive CDX and PDX models.
Dr. Archie Tse, the company's president and head of research and development, said Adlai Nortye remains on track to report full Phase Ia data in the second half of 2027.
Adlai Nortye also highlighted other pipeline assets, including AN9025, an oral pan-RAS(ON) inhibitor, and AN8025, a fusion protein that modulates T cells and antigen-presenting cells.
