Adlai Nortye Group Ltd. (ANL)
Adlai Nortye Ltd. (ANL) is a clinical-stage biotechnology firm dedicated to the research and development of innovative pharmaceutical products. Their flagship compound, AN2025, a pan-phosphoinositide 3-kinase inhibitor, is currently undergoing Phase III clinical trials. It is being investigated as a potential treatment for recurrent or metastatic head and neck squamous cell carcinomas. The company's pipeline also features AN0025, a small molecule prostaglandin E receptor 4 antagonist designed to modulate the tumor microenvironment. This candidate is in Phase Ib clinical trials, exploring its efficacy in treating various conditions, including: recurrent non-small cell lung cancer; urothelial cancer (post-anti-PD-1/PD-L1 treatments); recurrent triple-negative breast cancer; microsatellite stable colorectal cancer; and cervical cancer (following standard-of-care treatments). Additionally, ANL is developing AN4005, an oral small-molecule PD-L1 inhibitor. This drug, which is in Phase I clinical trials, aims to induce and stabilize PD-L1 dimerization to disrupt the interaction between PD-1 and PD-L1. Beyond their clinical programs, Adlai Nortye has early-stage research candidates such as AN8025, a multifunctional antibody that acts as a modulator of T cells and antigen-presenting cells, and AN9025, an oral small molecule pan-KRAS inhibitor. Established in 2004, the company's headquarters are situated in Grand Cayman, Cayman Islands.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Adlai Nortye Ltd.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
Buparlisib & Paclitaxel
Head and Neck Cancer
NCT04338399Enrollment487StartDec 2020Primary CompletionNov 2025CompletionNov 2025 - Phase 1Completed
Preoperative Radiotherapy and E7046 in Rectum Cancer
E7046, capecitabine
Neoadjuvant Therapy in Rectal Cancer
NCT03152370Enrollment29StartMay 2017Primary CompletionAug 2021CompletionSep 2021 - Phase 1Unknown status
AN0025 and Pembrolizumab Combination in Advanced Solid Tumors
AN0025, Pembrolizumab
Triple-negative Breast Cancer, NSCLC, Squamous or Non-Squamous +3
NCT04432857Enrollment63StartAug 2020Primary CompletionMay 2024CompletionJan 2025est. - Phase 1Completed
Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors
AN2025, AN0025
Locally Advanced Solid Tumor
NCT04975958Enrollment47StartSep 2021Primary CompletionJan 2025CompletionJan 2025 - Phase 1Recruiting
First in Human, Dose Escalation Study of AN4005
AN4005-dose level 0, AN4005-dose level 1
Advanced Solid Tumor, Advanced Lymphoma
NCT04999384Enrollment31StartSep 2021Primary CompletionNov 2026est.CompletionDec 2026est. - Phase 1Suspended
AN0025 and Chemoradiotherapy Combination in Esophageal Cancer
AN0025
Esophageal Cancer
NCT05191667Enrollment32StartJan 2022Primary CompletionDec 2025est.CompletionDec 2025est. - Phase 1Completed
Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer
Pelareorep
Advanced or Metastatic Breast Cancer
NCT05519059Enrollment15StartOct 2021Primary CompletionSep 2022CompletionMay 2023 - Phase 1Recruiting
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
AN9025 oral capsule
Solid Tumors (Phase 1), RAS Mutation
NCT07252479Enrollment118StartJan 2026Primary CompletionJan 2028est.CompletionJun 2028est. - Phase 1Recruiting
An Initial Evaluation of AN8025 in Solid Tumors
AN8025 is a multifunctional antibody fusion protein
Advanced Solid Tumor (Phase 1)
NCT07639047Enrollment91StartNov 2025Primary CompletionJul 2027est.CompletionJan 2028est. - Phase 1Recruiting
A Study of AN4035 in Advanced Cancers With RAS Mutations and High CEACAM5 Expression
Intravenous AN4035, Intravenous AN4035 followed by intravenous EGFR Inhibitor.
Solid Tumor (Phase I), RAS Mutation +1
NCT07686445Enrollment228StartSep 2026Primary CompletionDec 2028est.CompletionDec 2028est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Buparlisib & Paclitaxel | NCT04338399 |
| Phase 1 | Completed | E7046, capecitabine | NCT03152370 |
| Phase 1 | Unknown status | AN0025, Pembrolizumab | NCT04432857 |
| Phase 1 | Completed | AN2025, AN0025 | NCT04975958 |
| Phase 1 | Recruiting | AN4005-dose level 0, AN4005-dose level 1 | NCT04999384 |
| Phase 1 | Suspended | AN0025 | NCT05191667 |
| Phase 1 | Completed | Pelareorep | NCT05519059 |
| Phase 1 | Recruiting | AN9025 oral capsule | NCT07252479 |
| Phase 1 | Recruiting | AN8025 is a multifunctional antibody fusion protein | NCT07639047 |
| Phase 1 | Recruiting | Intravenous AN4035, Intravenous AN4035 followed by intravenous EGFR Inhibitor. | NCT07686445 |