AN8025 / Adlai Nortye - LARVOL DELTA

Study of AN8025 in Patients With Unresectable Advanced or Metastatic Solid Tumors (ANZCTR) - P1 | N=91 | Not yet recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd.

New P1 trial • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Coordinated stimulation of APC and T cell functions by first-in-class, tri-specific AN8025 for next-generation cancer immunotherapy (AACR 2025) - "AN8025 demonstrates superior in-vitro and in-vivo activities compared to ICIs, supporting its further preclinical and clinical development."

IO biomarker • Trispecific • Oncology • CD80 • CD83 • CD86 • CTLA4 • IL2 • LAG3

Adlai Nortye to Present Research Findings at AACR Annual Meeting 2025 (GlobeNewswire) - "Adlai Nortye Ltd....today announced the presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago. Adlai Nortye has two abstracts scheduled for presentations at AACR....We are pleased to present the progress of our innovative pipeline at the upcoming 2025 AACR Annual Meeting. 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(ON) inhibitors, exemplified by AN9025."

Preclinical • Solid Tumor

Adlai Nortye Reports Unaudited First Half 2024 Financial Results and Highlights Recent Operational Progress (GlobeNewswire) - "Pipeline updates...The Company is conducting BURAN (NCT04338399), a randomized, open-label phase 3 trial to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with recurrent or metastatic HNSCC that has progressed after prior anti-PD(L)1 treatment...The Company remains on track to present overall survival (OS) data in the first quarter of 2025; In an ongoing Phase 1 study (NCT04999384), the Company is investigating the safety of AN4005, its oral small-molecule PD-L1 inhibitor...The Company plans to provide a clinical update in the second half of 2024; AN8025 is an in-house developed multifunctional fusion protein, which serves as a T cell and APC modulator. The Company anticipates submitting the investigational drug application (IND) in mid-2025; AN9025 is an in-house developed oral small molecule...The Company anticipates submitting the IND in the second half of 2025."

IND • New molecule • P1 data • P3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck