Adlai Nortye announced the first patient dosing in Australia and U.S. FDA IND clearance for AN4035

CAR-T Digest - August 2020

08 September 2026: Adlai Nortye announced the first patient dosing in Australia and U.S. FDA IND clearance for AN4035

Adlai Nortye announced that the first patient has been dosed in Australia in the global phase 1 trial of AN4035, a first-in-class CEACAM5-targeting ADC armed with a pan-RAS(ON) inhibitor, while the U.S. FDA has cleared the IND with a “Study-May-Proceed” letter
The global phase 1 study will evaluate AN4035 as monotherapy and in combination with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors, assessing safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy; full phase 1a data are expected in the second half of 2027
The program addresses a major unmet need in RAS-driven cancers, where systemic pan-RAS(ON) inhibitors have been limited by on-target, off-tumor toxicities, while the ADC field remains heavily reliant on topoisomerase I and microtubule inhibitor payloads, creating a need for differentiated payload mechanisms
AN4035 is a CEACAM5-directed ADC comprising an antibody linked to a highly potent pan-RAS(ON) inhibitor payload, designed to selectively deliver RAS pathway inhibition to CEACAM5-expressing tumor cells while limiting systemic exposure to normal tissues
Strategically, AN4035 marks the first proof-of-concept candidate from Adlai Nortye’s proprietary RASiCA platform and expands the company’s development into a novel ADC payload class, with U.S. and Australian clinical development now underway and an NMPA IND filing planned for China