Adlai Nortye Brings Lilly and Merck KGaA Into First-in-Class AN4035 Cancer Trial

Adlai Nortye Group Ltd. (NASDAQ: ANL), a clinical-stage biotechnology company developing RAS pathway and immunotherapy treatments for cancer, announced on October 15, 2026 clinical trial collaboration and supply agreements with Eli Lilly and Company and Merck KGaA, Darmstadt, Germany. The agreements cover cetuximab, which the companies will supply for a combination arm of Adlai Nortye’s ongoing Phase I trial of AN4035.

Two Suppliers, One Combination Arm

Cetuximab is an anti-EGFR antibody marketed as ERBITUX. Under the agreements, Lilly will supply cetuximab at no cost for the U.S. clinical trial sites, while Merck KGaA, Darmstadt, Germany will supply it at no cost for the Australia and China sites. Adlai Nortye is the sponsor of the trial. The companies did not disclose any other financial terms.

The global Phase I trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AN4035 both on its own and in combination with cetuximab, in patients with CEACAM5-enriched, RAS-addicted solid tumors. The monotherapy and cetuximab combination arms will start on a staggered timeline.

How AN4035 Is Designed to Work

AN4035 is an antibody-drug conjugate that targets CEACAM5, a protein expressed on certain tumors, and carries a pan-RAS(ON) inhibitor as its payload. In August, Adlai Nortye said that AN4035 is, to its knowledge, the first pan-RAS(ON) ADC to enter the clinic globally. The company dosed its first patient in Australia in September and received a “Study-May-Proceed” letter from the FDA, clearing the trial to expand into the U.S. It expects to report full Phase Ia data in the second half of 2027.

“Dual inhibition of EGFR and RAS signaling is a compelling strategy for treating RAS-addicted cancers, but overlapping toxicities may limit systemic combinations,” said Dr. Archie Tse, President and Head of Research and Development. “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.”

In preclinical studies, the company reported that AN4035 showed robust anti-tumor activity with deep tumor regression in CEACAM5-positive models.

Funding the RAS Pipeline

AN4035 is one of two pan-RAS(ON) assets in the pipeline. The other, the oral inhibitor AN9025, is on track to share initial Phase Ia dose escalation data in the first half of 2027. Adlai Nortye has licensed AN9025 to Jiangsu Aosaikang Pharmaceutical Co., Ltd., and that agreement accounted for all $13.1 million of its revenue in the first half of 2026.

The company raised capital twice this year to support that work: a $140.0 million private placement at $6.50 per ADS in February and a $150.0 million private placement at $13.25 per ADS in April. As a result, cash, cash equivalents and short-term investments reached $231.9 million as of June 30, 2026, up from $8.1 million at the end of 2025. Research and development expenses were $14.6 million in the first half, and net loss narrowed to $5.3 million from $18.3 million a year earlier.

Strategic Investment Summary

• Pharma Collaborations: Adlai Nortye (NASDAQ: ANL) signed clinical trial collaboration and supply agreements with Lilly and Merck KGaA, Darmstadt, Germany for cetuximab.
• No-Cost Supply: Lilly will supply cetuximab for U.S. sites and Merck KGaA for Australia and China sites, with Adlai Nortye as trial sponsor.
• First-in-Class ADC: AN4035 targets CEACAM5 and carries a pan-RAS(ON) inhibitor payload, which the company believes is the first of its kind in the clinic.
• Clinical Timeline: The first patient was dosed in September, and full Phase Ia data is expected in the second half of 2027.
• Second RAS Asset: Initial Phase Ia data for the oral pan-RAS(ON) inhibitor AN9025 is expected in the first half of 2027.
• Capital Position: Cash, cash equivalents and short-term investments totaled $231.9 million as of June 30, 2026, following two private placements.

Find out more about the latest corporate developments and financial reports at the Adlai Nortye investor portal.