AN9025 / Adlai Nortye, Aosaikang Pharma - LARVOL DELTA

Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations (clinicaltrials.gov) - P1 | N=200 | Not yet recruiting | Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor • HRAS • KRAS • NRAS

Research & Development (R&D) Highlights: AN9025 (GlobeNewswire) - "AN9025, an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, continues to be evaluated in a global Phase I clinical trial of patients with advanced or metastatic solid tumors harboring RAS mutations....Additional clinical trial sites in the U.S. will be activated in second half of 2026, in preparation for expansion cohorts. The Company remains on track to share initial Phase Ia dose escalation data in the first half of 2027 from the QD arm, with a potential early look at the QW arm."

P1 data • Trial status • Solid Tumor

Adlai Nortye Announces First Patient Dosed in Intermittent Weekly Dosing Arm of Global Phase 1 Trial of Pan-RAS(ON) Inhibitor AN9025 (GlobeNewswire) - "The Phase 1 study is a first-in-human, multicenter, open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AN9025 in patients with advanced or metastatic solid tumors harboring RAS mutations....With this announcement, both the QD and QW dose escalation arms are currently enrolling."

First-in-human • Trial status • Solid Tumor

AN9025, an orally bioavailable pan-RAS(ON) inhibitor with potent, broad-spectrum anti-tumor activity (AACR 2025) - "Additionally, AN9025 demonstrated cytotoxic activity in cell models resistant to KRAS(OFF) G12C inhibitors sotorasib and adagrasib, while showing no cytotoxicity in BRAF-mutant, RAS-independent cell lines. In summary, AN9025 is a highly potent pan-RAS(ON) inhibitor that forms a tri-complex with CypA and RAS, effectively blocking downstream signaling and demonstrating robust antitumor efficacy, including in models that are resistant to mutant-selective RAS(OFF) inhibitors. Preclinical studies support its advancement into clinical development as a promising targeted therapy for RAS-driven cancers."

Oncology • BRAF • DUSP6 • KRAS

Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations (clinicaltrials.gov) - P1 | N=91 | Recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Biliary Tract Cancer • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • ALK • BRAF • HRAS • KRAS • NRAS • RET • ROS1

Adlai Nortye Announces First Patient Enrolled in Global Phase 1 Trial of Pan-RAS (ON) Inhibitor AN9025 for Solid Tumors Harboring RAS Mutations (GlobeNewswire) - "The Phase 1 study is a first-in-human, multicenter, open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AN9025 in patients with advanced or metastatic solid tumors harboring RAS mutations."

First-in-human • Trial status • Solid Tumor

Adlai Nortye Enters Exclusive License Agreement with ASK Pharm for Pan-RAS (ON) Inhibitor AN9025 in Greater China (GlobeNewswire) - "Under the terms of the agreement, ASK Pharm will obtain exclusive rights to develop, manufacture, and commercialize AN9025 in mainland China, Hong Kong and Macao (the 'Licensed Territory'). Adlai Nortye will retain worldwide rights to the compound excluding the Licensed Territory. Adlai Nortye is eligible to receive total consideration of up to RMB 1.6 billion (approximately USD 230 million), including an upfront payment and near-term milestone payments exceeding USD 20 million, plus tiered royalties..."

Licensing / partnership • Solid Tumor

Evaluation of a Rat Sarcoma Oncogene (RAS) Inhibitor in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations (clinicaltrials.gov) - P1 | N=91 | Not yet recruiting | Sponsor: Adlai Nortye Biopharma Co., Ltd.

New P1 trial • Oncology • Sarcoma • Solid Tumor

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