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- Adlai Nortye received HREC approval and submitted a CTN in Australia to begin a Phase I trial of AN4035, the first pan-RAS(ON) inhibitor-based ADC to enter clinical development globally. - AN4035 targets CEACAM5-expressing tumors and delivers a pan-RAS(ON) inhibitor payload designed to localize activity to tumors while minimizing systemic toxicity. - The global Phase I study will evaluate AN4035 as monotherapy and in combination with cetuximab in approximately 288 patients with colorectal, pancreatic, and lung cancers harboring RAS mutations. - Preclinical data presented at AACR 2026 showed a 73% objective response rate in PDX models, with patient dosing expected to begin in the second half of 2026.
- Adlai Nortye has entered an exclusive licensing agreement with ASK Pharm for its pan-RAS inhibitor AN9025, granting development and commercialization rights in Greater China. - The deal is valued at up to $230 million, including upfront payments exceeding $20 million and tiered royalties from high single-digit to mid-teens percentage of net sales. - AN9025 is an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, targeting multiple RAS mutations across various tumor types including pancreatic, lung, and colorectal cancers. - Phase I clinical trials are expected to begin in the first quarter of 2026, addressing significant unmet medical needs for patients with RAS-mutated cancers.
- 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(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's short interest increased by 28.0% in December, reflecting market activity around the stock. - AN2025, a pan-PI3K inhibitor, is currently in Phase III trials for recurrent or metastatic head and neck squamous cell carcinoma. - HC Wainwright reaffirmed a "buy" rating for Adlai Nortye with a price objective of $9.00 per share.
• Adlai Nortye's Buparlisib, a pan-PI3K inhibitor, is in Phase III trials for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) after anti-PD-(L)1 treatment. • The BURAN trial assesses Buparlisib combined with paclitaxel versus paclitaxel alone, with overall survival data expected in Q1 2025. • The global market for recurrent/metastatic HNSCC post-anti-PD-(L)1 therapy is projected to exceed $2.0 billion, positioning Buparlisib for significant market impact. • Adlai Nortye also has AN4005, a PD-L1 inhibitor, in Phase Ia trials and AN0025, a chemoradiotherapy enhancer, in investigator-initiated trials.
