First-in-class pan-RAS(ON) ADC is cleared for clinical development
Designed to selectively deliver pan-RAS(ON) inhibition to tumors while minimizing systemic toxicity.
IND submissions to U.S. FDA and China NMPA are in process
SINGAPORE and NORTH BRUNSWICK, N.J., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (“Adlai Nortye” or the “Company”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced that it has submitted a Clinical Trial Notification (CTN) to Australia's Therapeutic Goods Administration (TGA) and received approval from the Human Research Ethics Committee (HREC) to commence its phase I clinical trial evaluating AN4035, a CEACAM5-targeting, pan-RAS(ON) inhibitor-based antibody drug conjugate (ADC) for the treatment of CEACAM5-enriched RAS-addicted solid tumors.
“AN4035 is a first-in-class CEACAM5-targeting ADC armed with a pan-RAS(ON) inhibitor payload, and is our first drug candidate to demonstrate proof-of-concept of our RASiCA™ (RAS Inhibitor Conjugated Antibody) platform.” said Dr. Archie Tse, President, Head of Research & Development. “To our knowledge, AN4035 is the first pan-RAS(ON) ADC to enter the clinic globally. We believe that utilizing targeted delivery via an ADC could localize pan-RAS(ON) inhibitor activity to the tumor while minimizing systemic RAS pathway inhibition, which could potentially both widen the therapeutic window and enable rational combinations. We are excited to see this asset advance into clinical development and the potential benefit it may bring to our patients globally.”
This global phase I trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AN4035 as monotherapy and in combination with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors. CEACAM5 is an antigen that is overexpressed in colorectal, pancreatic, and lung cancers, which frequently harbor RAS mutations. Adlai Nortye is also filing investigational new drug (IND) applications for AN4035 with the U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA). Patient dosing with AN4035 is expected to begin in the second half of 2026.
About AN4035
AN4035 is a first-in-class ADC targeting CEACAM5 and armed with a highly potent pan-RAS(ON) inhibitor payload. In preclinical studies, AN4035 demonstrated nanomolar to picomolar cytotoxicity in CEACAM5-positive / RAS-addicted cancer cell lines, along with a robust bystander killing effect. It also exhibited potent anti-tumor activity with deep regression in CDX/PDX models, favorable developability with desirable pharmacokinetic properties, and enhanced target-mediated tumor retention with improved tumor selectivity over normal tissue -- resulting in an overall favorable therapeutic index. Adlai Nortye is evaluating AN4035 in a global phase I trial in patients with CEACAM5-enriched RAS-addicted solid tumors.
About Adlai Nortye
Adlai Nortye (NASDAQ: ANL) is a global clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The company is building a rich and robust pipeline of drug candidates covering two key therapeutic areas:
1) Precision RAS pathway targeted therapies: including the oral pan-RAS(ON) inhibitor AN9025, and the CEACAM5-targeting ADC AN4035 engineered from the Company's proprietary RASiCA™ (RAS Inhibitor Conjugated Antibody) platform, which efficiently delivers a potent pan-RAS(ON) inhibitor to the tumor site.
2) Next-generation PD-1/L1 pathway modulating immunotherapies: including AN8025, a multi-functional fusion protein that simultaneously modulates T cells and antigen-presenting cells, and AN4005, a first-in-class oral PD-L1 inhibitor.
Forward-Looking and Cautionary Statements
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