AN4035 / Adlai Nortye - LARVOL DELTA

Adlai Nortye Announces First Patient Dosed in Australia and U.S. FDA IND Clearance for AN4035, a First-in-Class Pan-RAS(ON) Inhibitor-Based ADC (GlobeNewswire) - "We look forward to advancing this asset globally and remain on track to report full Phase Ia data in the second half of 2027."

First-in-human • IND • P1 data • Trial status • Solid Tumor

Research & Development (R&D) Highlights: AN4035 (GlobeNewswire) - "Investigational New Drug (IND) submissions to the U.S. FDA and China NMPA are expected to follow. The Company is on track to dose the first patient with AN4035 in the second half of 2026, and initial clinical data is expected to be available in the second half of 2027."

IND • P1 data • Trial status • Solid Tumor

Adlai Nortye (ANL) announced that it has submitted a clinical trial notification, or CTN, to Australia’s Therapeutic Goods Administration, or TGA, and received approval from the Human Research Ethics Committee, or HREC, to commence its phase I clinical trial evaluating AN4035...for the treatment of CEACAM5-enriched RAS-addicted solid tumors. (TipRanks)

Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

A Study of AN4035 in Advanced Cancers With RAS Mutations and High CEACAM5 Expression (clinicaltrials.gov) - P1 | N=288 | Not yet recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd.

Monotherapy • New P1 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CEACAM5 • HRAS • KRAS • NRAS

Discovery of AN4035: A novel CEACAM5-targeting antibody drug conjugate (ADC) armed with a proprietary pan-RAS(ON) inhibitor payload, designed to broaden the therapeutic window (AACR-NCI-EORTC 2025) - "Although the tricomplex pan-RAS(ON) inhibitor RMC-6236 has demonstrated promising antitumor activity in clinical studies, its therapeutic potential is challenged by presumably on-target, off-tumor toxicities, particularly in skin and gastrointestinal (GI) tissues. These findings support the further development of AN4035 as a promising first-in-class ADC for RAS-driven, CEACAM5-expressing cancers. IND-enabling studies are currently underway."

Oncology • Pancreatic Cancer • CEACAM5 • KRAS • TOP1

Discovery of AN4035: A Novel CEACAM5-Targeting Antibody Drug Conjugate (ADC) Armed with a Proprietary Pan-RAS(ON) Inhibitor Payload, Designed to Broaden the Therapeutic Window (AACR-NCI-EORTC 2025) - "Although the tricomplex pan-RAS(ON) inhibitor RMC-6236 has demonstrated promising antitumor activity in clinical studies, its therapeutic potential is challenged by presumably on-target, off-tumor toxicities, particularly in skin and gastrointestinal (GI) tissues. These findings support the further development of AN4035 as a promising first-in-class ADC for RAS-driven, CEACAM5-expressing cancers. IND-enabling studies are currently underway."

Late-breaking abstract • Oncology • Pancreatic Cancer • CEACAM5 • KRAS • TOP1