Adlai Nortye to Showcase Novel Cancer Immunotherapy and RAS Inhibitor at AACR 2025
Key Insights
Adlai Nortye will present findings on two innovative cancer therapies at the AACR Annual Meeting in Chicago this April, highlighting their expanding oncology pipeline.
The company's tri-specific antibody fusion protein AN8025 demonstrates enhanced APC function and T cell activation, with IND submission planned for mid-2025.
Their oral pan-RAS (search)(ON) inhibitor AN9025 shows potent efficacy against multiple RAS-mutant cancers including pancreatic, lung, and colorectal adenocarcinomas, with IND filing expected in late 2025.
Adlai Nortye Ltd. (NASDAQ: ANL), a clinical-stage biotechnology company developing innovative cancer therapies, has announced it will present research findings on two promising drug candidates at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, April 25-30, 2025.
The company will showcase advances in its multi-specific immune-oncology platform and small molecule pan-RAS (search) inhibitor program through two poster presentations, highlighting significant progress in their oncology pipeline.
"We are especially proud of our R&D capabilities in designing and developing our multi-specific immune-oncology platform, highlighted by AN8025 (αPDL1xLag3variant xCD86variant), and highly innovative small molecule pan-RAS (search)(ON) inhibitors, exemplified by AN9025," said Archie Tse, MD, PhD, Head of Research and Development at Adlai Nortye. "This breakthrough work underlines our commitment to delivering transformative therapies for cancer patients."
Novel Tri-Specific Antibody Shows Promise in Cancer Immunotherapy
The first poster presentation, scheduled for Monday, April 28, will feature AN8025, a proprietary tri-specific antibody fusion protein derived from an approved αPD-L1 antibody and fused with functionally optimized CD86 and LAG3 variants.
Titled "Coordinated stimulation of APC and T cell functions by first-in-class, tri-specific AN8025 for next-generation cancer immunotherapy" (Abstract #3420), the presentation will detail how this novel therapeutic approach modulates both T cell and antigen-presenting cell (APC) functions.
Preclinical studies have demonstrated that AN8025 enhances both the quantity and quality of APCs while also inducing robust PD-L1 (search)-dependent T cell activation and anti-tumor efficacy in vivo. This dual mechanism of action represents a potentially significant advancement in cancer immunotherapy.
The company plans to submit an Investigational New Drug (IND) application for AN8025 in mid-2025, moving this promising candidate toward clinical development.
Oral Pan-RAS Inhibitor Shows Broad Anti-Tumor Activity
The second poster, "AN9025, an orally bioavailable pan-RAS (search)(ON) inhibitor with potent, broad-spectrum anti-tumor activity" (Abstract #4377), will be presented on Tuesday, April 29.
AN9025 is an in-house developed oral small molecule pan-RAS (search)(ON) inhibitor designed to target a broad spectrum of RAS mutations across various tumor types. RAS mutations are among the most common oncogenic drivers in human cancers, present in approximately 30% of all cancers, yet have historically been considered "undruggable."
Preclinical studies have demonstrated that AN9025 effectively inhibits RAS (search)-mutant cancers with potent and durable efficacy, including pancreatic, lung, and colorectal adenocarcinomas—three cancer types with significant unmet medical needs. The compound has shown comparable or superior results relative to benchmark agents of the same class.
Adlai Nortye plans to submit an IND application for AN9025 in the second half of 2025, potentially adding another promising candidate to the growing field of RAS (search)-targeted therapies.
Expanding Oncology Pipeline
These two candidates complement Adlai Nortye's existing oncology pipeline, which includes Buparlisib (AN2025), a pan-PI3K (search) inhibitor currently in a registrational Phase 3 trial for recurrent or metastatic head and neck squamous cell cancer (search) (HNSCC (search)) that has progressed after prior anti-PD(L)1 treatment.
The company is also advancing AN4005, an oral small molecule PD-L1 (search) inhibitor, further diversifying its approach to cancer treatment.
With global R&D centers in the U.S. and China, Adlai Nortye is positioning itself as an emerging player in the development of next-generation cancer therapies, particularly in the fields of immune modulation and targeted therapy.
Full details of the presentations will be available to AACR registrants via the online itinerary planner, with copies of the presentations to be made available on Adlai Nortye's website following the conference.