Adlai Nortye Enters into Clinical Collaboration with Lilly and Merck KGaA, Darmstadt, Germany to Evaluate Combination of AN4035 and Cetuximab
Lilly and Merck KGaA will provide cetuximab at no cost for trial sites in the United States, Australia and China.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Adlai Nortye (NASDAQ: ANL) entered clinical collaboration and supply agreements with Lilly and Merck KGaA, Darmstadt, Germany, to evaluate AN4035 with cetuximab.
The agreements support the company's ongoing global Phase I trial of investigational AN4035 alone and in combination with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors. AN4035 is an antibody-drug conjugate, an antibody carrying a drug payload, designed to target CEACAM5 and deliver a pan-RAS(ON) inhibitor. Adlai Nortye sponsors the trial. Lilly will supply cetuximab at no cost to U.S. sites; Merck KGaA will do so for Australia and China sites.
The trial evaluates safety, tolerability, drug behavior in the body and preliminary efficacy. The monotherapy and combination arms will begin on a staggered timeline.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointClinical collaboration agreements with Lilly and Merck KGaA support AN4035's Phase I combination evaluation.
- Minor point. Forward-looking: it has not happened yet and may not happen.No-cost cetuximab supply covers U.S. sites through Lilly and Australia and China sites through Merck KGaA.
Negative
- Minor point. Forward-looking: it has not happened yet and may not happen.Overlapping toxicities may limit systemic EGFR and RAS combinations, the company cautions.
Details
Market Reaction – ANL
On Oct 15, the day this news came out, the latest delayed price for ANL is 3.40% above the previous close. Argus tracked a trough of -22.5% from its starting point during tracking. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $11.25.
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Key Figures
- Trial phase
- Phase I
- Ongoing global AN4035 trial
Historical Context
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First AN4035 patient dosed in Australia after U.S. IND clearance enabled trial expansion.
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Australia CTN submission and HREC approval supported the planned Phase I AN4035 trial.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
adc medical
pharmacokinetics medical
pharmacodynamics medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
AN4035, a first-in-class investigational pan-RAS(ON) inhibitor-based ADC, will be evaluated as monotherapy and in combination with cetuximab in the ongoing global Phase I trial
Cetuximab will be supplied by Lilly for the U.S. trial sites
Cetuximab will be supplied by Merck KGaA, Darmstadt, Germany for the Australia and China trial sites
SINGAPORE and NORTH BRUNSWICK, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Adlai Nortye Group Ltd. (NASDAQ: ANL) (“Adlai Nortye” or the “Company”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced clinical trial collaboration and supply agreements (CTCSAs) with Eli Lilly and Company (“Lilly”) and Merck KGaA, Darmstadt, Germany for the anti-EGFR antibody cetuximab (marketed as ERBITUX®).
These agreements will support Adlai Nortye’s ongoing Phase I trial evaluating AN4035, a pan-RAS(ON) inhibitor-based ADC, both as monotherapy and in combination with cetuximab, in CEACAM5-enriched RAS-addicted solid tumors. Adlai Nortye is the sponsor of the trial. Lilly will supply cetuximab at no cost for the U.S. clinical trial sites. Merck KGaA, Darmstadt, Germany will supply cetuximab at no cost for the Australia and China clinical trial sites.
“We are pleased to enter clinical trial collaborations with both Lilly and Merck KGaA, Darmstadt, Germany to explore cetuximab in combination with AN4035, our first-in-class investigational ADC targeting CEACAM5 and armed with a highly potent pan-RAS(ON) inhibitor payload,” said Dr. Archie Tse, President, Head of Research & Development. “Dual inhibition of EGFR and RAS signaling is a compelling strategy for treating RAS-addicted cancers, but overlapping toxicities may limit systemic combinations. By selectively delivering a potent pan-RAS(ON) inhibitor to CEACAM5-expressing tumors through an ADC, AN4035 may broaden the therapeutic window for this rational combination with cetuximab. We are excited to evaluate this approach with participation by Lilly and Merck KGaA, Darmstadt, Germany in these patients with high unmet need.”
The ongoing global phase I trial is evaluating 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 highly overexpressed in colorectal, pancreatic, and lung cancers – tumor types that frequently harbor RAS mutations. The monotherapy and cetuximab combination arms will be initiated on a staggered start timeline.
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, the ADC demonstrates favorable thermal and plasma stability with desirable pharmacokinetic properties. Strong intracellular payload retention drives nanomolar to picomolar cytotoxicity in CEACAM5-positive, RAS-addicted cancer cell lines, coupled with a potent bystander-killing effect. In vivo, AN4035 has shown robust anti-tumor activity with deep tumor regression in CEACAM5-positive CDX and PDX models. Compared with the payload alone, the ADC exhibits enhanced target-mediated tumor retention and significantly improved tumor selectivity over normal tissues, 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 is a global clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The global infrastructure supports the efficient execution of our 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.
Forward-Looking and Cautionary Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “potential,” “continue,” “ongoing,” “targets” and similar statements. Among other things, statements that are not historical facts, including statements about the Company’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as the Company’s strategic and operational plans, are or contain forward-looking statements.
The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. Factors that could cause the Company's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of the Company's preclinical studies, clinical trials and other therapeutic candidate development efforts; the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; whether the clinical trial results will be predictive of real-world results; the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of the Company's therapeutic candidates; the Company's ability to establish, manage, and maintain corporate collaborations, as well as the ability of its collaborators to execute on their development and commercialization plans; the implementation of the Company’s business model and strategic plans for its business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of the Company's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the PRC and United States or elsewhere. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this press release and in the attachments is as of the date of this press release, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
Contacts:
Investor Relations:
ir@adlainortye.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is Adlai Nortye's AN4035 and cetuximab trial evaluating?
The ongoing global Phase I trial evaluates AN4035 alone and with cetuximab in patients with CEACAM5-enriched, RAS-addicted solid tumors. It assesses safety, tolerability, pharmacokinetics (drug behavior in the body), pharmacodynamics (drug effects on the body) and preliminary efficacy.
Why is Adlai Nortye combining AN4035 with cetuximab?
Adlai Nortye believes selectively delivering a RAS inhibitor to CEACAM5-expressing tumors may broaden the therapeutic window, the range between effective and harmful doses, for combination treatment with cetuximab. This approach aims to address overlapping toxicities that may limit systemic combinations targeting EGFR and RAS signaling.