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Adlai Nortye Announces First Patient Dosed in Australia and U.S. FDA IND Clearance for ...
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Fusion42 · 8 September 2026 · Fusion42 review
Adlai Nortye has dosed the first patient with AN4035 in Australia and received FDA clearance to expand its first-in-class pan-RAS(ON) inhibitor-based ADC cancer trial into the US. The global Phase I trial targets CEACAM5-enriched RAS-addicted solid tumors, focusing on tumour-selective delivery to avoid typical pan-RAS toxicities.
This Wire brief sits within Fusion42's coverage of Biotech.
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Your oncology drug can now enter US trials following FDA clearance for a novel RAS inhibitor ADC. This opens a direct path to the large US market and regulatory validation for your cancer drug asset.
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1 source · 8 Sep 2026
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