AN4035 is a first-in-class RAS-inhibitor ADC targeting CEACAM5, with a highly potent pan-RAS(ON) inhibitor payload. In July 2026, the Company received HREC approval in Australia for the Phase I clinical trial of AN4035 as monotherapy and in combination with cetuximab, in patients with CEACAM5-enriched, RAS-addicted solid tumors. IND submissions to the U.S. FDA and China NMPA are expected to follow. The Company is on track to dose the first patient with AN4035 in the second half of 2026, with initial clinical data expected to be available in the second half of 2027.

AN4035 targets CEACAM5, an antigen highly overexpressed in lung, pancreatic, and colorectal cancers—tumor types that frequently harbor RAS mutations. AN4035 has a homogeneous DAR 8 and shows excellent DAR stability over human plasma.

AN4035 demonstrates potent, nanomolar to picomolar cytotoxicity across a broad panel of RAS-addicted, CEACAM5-positive cancer cell lines. In addition, AN4035 also exhibits a robust bystander effect in multiple RAS-addicted, CEACAM5-positive cancer cell lines.

Notably, AN4035 has demonstrated robust anti-tumor activity in multiple CDX and PDX models in vivo.   

Reference

1.Discovery of AN4035: a novel CEACAM5-targeting antibody drug conjugate (ADC) armed with a proprietary pan-RAS(ON) inhibitor payload, designed to broaden the therapeutic window, AACR-NCI-EORTC Presentation 2025