Adlai Nortye (NASDAQ: ANL) secures ethics nod for AN4035 Phase I cancer trial
Rhea-AI Filing Summary
Adlai Nortye Ltd. announced submission of a Clinical Trial Notification to Australia’s Therapeutic Goods Administration and receipt of Human Research Ethics Committee approval to commence a Phase I clinical trial of AN4035, a CEACAM5-targeting, pan-RAS(ON) inhibitor-based antibody drug conjugate for CEACAM5-enriched, RAS-addicted solid tumors.
The global Phase I study will assess safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AN4035 as monotherapy and combined with cetuximab. The company describes AN4035 as its first RASiCA™ platform drug and a first-in-class pan-RAS(ON) ADC, supported by preclinical data showing nanomolar to picomolar cytotoxicity, deep tumor regression and a favorable therapeutic index. Adlai Nortye is also preparing IND filings with the U.S. FDA and China NMPA, with patient dosing expected to begin in the second half of 2026.
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Key Figures
Clinical trial phase: Phase I
Expected start of patient dosing: second half of 2026
2 metrics
Clinical trial phase
Phase I
Phase of the global clinical trial evaluating AN4035
Expected start of patient dosing
second half of 2026
Planned timing for first patient dosing with AN4035
Key Terms
Clinical Trial Notification (CTN), Human Research Ethics Committee (HREC), antibody drug conjugate (ADC), RAS-addicted solid tumors, +2 more
6 terms
Clinical Trial Notification (CTN) regulatory
"submitted a Clinical Trial Notification (CTN) to Australia’s Therapeutic Goods Administration"
A clinical trial notification (CTN) is a formal notice filed with regulators or ethics bodies before enrolling people in a human drug or device study; it summarizes the study plan, safety measures, informed consent process and who is legally responsible for the trial. For investors, a CTN is a key regulatory milestone that affects whether a trial can start, how quickly a product can move toward approval, and the project’s risk and timeline — like securing a permit before construction.
Human Research Ethics Committee (HREC) regulatory
"received approval from the Human Research Ethics Committee (HREC) to commence its phase I"
A human research ethics committee (HREC) is an independent panel that reviews and approves studies involving people to make sure risks are minimized, consent is informed, and welfare is protected—like a safety inspector for medical research. For investors, HREC approval matters because it is often required before clinical work can start or continue; it affects development timelines, regulatory acceptance, and the credibility and legal risk of a company’s human-subject research.
antibody drug conjugate (ADC) medical
"pan-RAS(ON) inhibitor-based antibody drug conjugate (ADC) for the treatment"
A antibody drug conjugate (ADC) is a targeted medicine that combines an antibody, which seeks out specific cells, with a potent drug payload so the treatment delivers its toxic effect directly to diseased cells while sparing most healthy tissue—think of a guided missile carrying a small explosive. Investors care because ADCs can offer breakthrough therapies with high market value, but their worth depends heavily on clinical trial results, manufacturing complexity and regulatory approval, which create both upside and risk.
RAS-addicted solid tumors medical
"for the treatment of CEACAM5-enriched RAS-addicted solid tumors"
investigational new drug (IND) regulatory
"filing investigational new drug (IND) applications for AN4035 with the U.S. Food"
An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.
therapeutic index medical
"improved tumor selectivity over normal tissue -- resulting in an overall favorable therapeutic index"
The therapeutic index is a measure of a drug’s safety margin—the gap between the dose that produces a desired effect and the dose that causes harmful effects. For investors, a larger therapeutic index means a wider safety cushion, lower risk of dangerous side effects, smoother regulatory review and broader market acceptance, all of which can reduce clinical and commercial risk and affect a drug developer’s valuation.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did Adlai Nortye (ANL) announce about its AN4035 program in Australia?
Adlai Nortye (ANL) submitted a Clinical Trial Notification to Australia’s TGA and received HREC approval to start a global Phase I trial of AN4035 in CEACAM5-enriched, RAS-addicted solid tumors, enabling first-in-human clinical development in that country.
What is AN4035 in Adlai Nortye (ANL)’s pipeline and how is it described?
AN4035 is a first-in-class CEACAM5-targeting ADC carrying a pan-RAS(ON) inhibitor payload and is the first drug candidate from Adlai Nortye (ANL)’s RASiCA™ platform. It is designed to localize RAS pathway inhibition to tumors while limiting systemic exposure.
What will the Phase I trial of AN4035 from Adlai Nortye (ANL) evaluate?
The global Phase I trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AN4035, both as monotherapy and in combination with cetuximab, in patients with CEACAM5-enriched, RAS-addicted solid tumors, including cancers where CEACAM5 is overexpressed.
When is patient dosing with AN4035 from Adlai Nortye (ANL) expected to begin?
Patient dosing with AN4035 is expected to start in the second half of 2026. This timing follows the Australian HREC approval, CTN submission, and planned investigational new drug applications to regulators in the United States and China.
Is Adlai Nortye (ANL) planning to develop AN4035 outside Australia?
Yes. Adlai Nortye (ANL) is preparing IND applications for AN4035 with the U.S. Food and Drug Administration and China’s National Medical Products Administration, supporting a global Phase I development strategy for CEACAM5-enriched, RAS-addicted solid tumors.
What preclinical results has Adlai Nortye (ANL) reported for AN4035?
Preclinical studies showed AN4035 had nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cell lines, robust bystander killing, deep tumor regression in CDX/PDX models, favorable pharmacokinetics and enhanced tumor selectivity over normal tissue, contributing to a favorable therapeutic index.