On October 15, 2026 Adlai Nortye Group Ltd. (NASDAQ: ANL) ("Adlai Nortye" or the "Company"), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, reported 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).
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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.
(Press release, Adlai Nortye Biopharma, OCT 15, 2026, View Source [SID1234673512])