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

Adlai Nortye Group Ltd. (NASDAQ: ANL) (“Adlai Nortye” or the “Company”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, 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.