Adlai Nortye Wins HREC Approval for AN4035 Pan-RAS ADC Phase I Trial

Adlai Nortye received Human Research Ethics Committee (HREC) approval in Australia for its AN4035 pan-RAS antibody-drug conjugate (ADC) to enter a phase I trial, with patient dosing slated for late 2026. The firm is pursuing parallel IND filings with the FDA and China's NMPA, aiming for a global launch, and the trial will explore AN4035 both as monotherapy and combined with cetuximab to potentially overcome RAS mutation resistance.

This Wire brief sits within Fusion42's coverage of Biotech.